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SEPTEMBER 27, 2005


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††††††††††† The meeting convened in Whetstone Room of the Gaithersburg Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, Maryland, 20877, at 9:03 a.m., pursuant to notice, Carolyn B. Hendricks, M.D., Chair, presiding.





CHARLES FINDER, M.D., Executive Secretary





CAROL J. MOUNT, R.T. (R)(M), Member



LINDA S. PURA, R.N., M.P.A., Member



JANE B. SEGELKEN, B.S., M.A., Member






†††††††††††††††††††† I-N-D-E-X


Opening Statement

††††† Chair Hendricks††††††††††††††††††††††††††† 3


Conflict of Interest Statement†††††††††††††††††† 3

††††† Exec. Secretary Finder


Committee Business†††††††††††††††††††††††††††††† 7

††††† Chair Hendricks


Open Public Hearing

Interventional Mammography Regulation††††††††††† 9

††††† Ms. Judith Wagner


Interventional Mammography Regulation†††††††††† 16

††††† Dr. Richard Wagner


Full Field Digital Mammography Guidance†††††††† 25

††††† Dr. Murray Reicher


Radiological Health Update††††††††††††††††††††† 34

††††† LCDR Sean Boyd, USPHS


Update on Current Voluntary Interventional

Mammography Accreditation Program

††††† Ms. Priscilla Butler††††††††††††††††††††† 43

††††† Dr. Kambiz Dowlatshahi††††††††††††††††††† 67


Iowa Mandatory Interventional Mammography†††††† 88


††††† Mr. Donald Flater


Institute of Medicine Recommendation Regarding 103

Interventional Mammography

††††† Dr. Helen Barr


Discussion of Recently Issued Guidance†††††††† 196

Documents and Other Related Topics

††††† Dr. Charles Finder


Departing Members††††††††††††††††††††††††††††† 237

Review of Summary Minutes of April 2004††††††† 238


†††††††††††††† P-R-O-C-E-E-D-I-N-G-S

†††††††††††††††††††††††††††††††††††††† (9:03 a.m.)

††††††††††† CHAIR HENDRICKS:On the record.I'd like to call this National Mammography Quality Assurance Advisory Committee meeting to order.My name is Carolyn Hendricks and I'll be chairing this meeting with assistance from Dr. Charles Finder to my right who is the Executive Secretary of the National Mammography Quality Assurance Advisory Committee.

††††††††††† I note for the record that the voting members present constitute a quorum as required by 21 CFR Part 14.We also have Dr. Miles Harrison participating in this Advisory Committee via telephone and he had some difficulty yesterday hearing the speakers particularly the speakers from the audience.So I'm going to ask again if individuals participating at the podium to please state clearly your first and last name and your affiliation.

††††††††††† Now Dr. Finder is going to review again the Conflict of Interest Statement for the participants.

††††††††††† EXEC. SECRETARY FINDER:The following announcement addresses conflict of interest issues associated with this meeting and is made a part of the record to preclude even the appearance of any impropriety.To determine if any conflict existed, the Agency reviewed the submitted agenda and all financial interests reported by the Committee participants.

††††††††††† The conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employers' financial interest.However, the Agency has determined that participation of certain members the need for whose services outweighs the potential conflict of interest involved is in the best interest of the government.

††††††††††† Therefore, waivers permitting full participation in general matters that come before the Committee have been granted for certain participants because of their financial involvement with facilities that will be subject to FDA's regulation on mammography quality standards with accrediting, certifying or inspecting bodies, with manufacturers of mammography equipment or with their professional affiliation since these organizations could be affected by the Committee's deliberations.These individuals are Ms. Diane Rinella,Ms. Jacquelin Holland, Dr. Debra Monticciolo, Mr. William Passetti, Dr. Mark Williams and Ms. Jane Segelken.

††††††††††† Waivers are currently on file for Dr. Carolyn Hendricks, Dr. Scott Ferguson, Ms. Carol Mount, Ms. Alisa Gilbert, Dr. Miles Harrison, Ms. Linda Pura and Ms. Melissa Martin.Copies of the waivers may be obtained from the Agency's Freedom of Information Office, Room 12A-15 of the Parklawn Building.

††††††††††† We would like to note for the record that if any discussion of state certifying bodies was to take place in any meetings of the Committee it would be a general discussion only.No vote would be taken and no consensus sought.In the interest of getting as many viewpoints as possible, all SGEs including state employees would be allowed to participate in the general discussion so that all viewpoints could be heard.

††††††††††† In the event that the discussions involve any other matters not already on the agenda in which an FDA participant has financial interest, the participant should excuse himself or herself from such involvement and the exclusion will be noted for the record.With respect to all other participants, we ask in the interest of fairness that all persons making statements or presentations disclose any current or previous financial involvement with accreditation bodies, state doing mammography, inspections under contract to FDA, certifying bodies, mobile units, breast implant imaging, consumer complaints and mammography equipment.

††††††††††† CHAIR HENDRICKS:Thank you.Again at this time, I would like the members of the panel to reintroduce themselves for the record and for the audience.

††††††††††† MEMBER PURA:Linda Pura, Clinical Coordinator, Los Angeles County Regional Cancer Detection Program.

††††††††††† MEMBER HOLLAND::Jacquelin Holland, Program Director - Diversity Enhancement, James Cancer Hospital and Soloff Research Institute, Columbus, Ohio.

††††††††††† MEMBER GILBERT:Alisa Gilbert, Office of Native Cancer Survivorship, Anchorage, Alaska.

††††††††††† MEMBER WILLIAMS:Mark Williams, Associate Professor of Radiology, Biomedical Engineering and Physics, University of Virginia.

††††††††††† MEMBER SEGELKEN:Jane Segelken, Breast Cancer Survivor, Ithaca, New York.

††††††††††† MEMBER MONTICCIOLO:Debra Monticciolo, Professor of Radiology and Section Chief of Breast Imaging at Texas A&M.

††††††††††† MEMBER FERGUSON:Scott Ferguson, Diagnostic Radiologist from West Memphis, Arkansas.

††††††††††† MEMBER RINELLA:Diane Rinella.I'm a Mammography Technologist and Consultant from California.

††††††††††† EXEC. SECRETARY FINDER:Dr. Charles Finder.I'm the Executive Secretary of this Committee.

††††††††††† CHAIR HENDRICKS:Carolyn Hendricks.I'm a Medical Oncologist practicing in Bethesda, Maryland.

††††††††††† MEMBER PASSETTI:Bill Passetti.I'm the Director of Florida's Radiation Control Agency.

††††††††††† MEMBER MOUNT:Carol Mount, Manager of Breast Imaging and Intervention, Mayo Clinic, Rochester, Minnesota.

††††††††††† MEMBER MARTIN:Melissa Martin.I'm an Consulting Medical Physicist in Southern California.

††††††††††† CHAIR HENDRICKS:Dr. Harrison.

††††††††††† MEMBER HARRISON:Miles Harrison, Breast Cancer Surgeon, Sinai Hospital, Baltimore.

††††††††††† CHAIR HENDRICKS:Thank you very much.As the last item of Committee business before we begin the meeting, I would like to read a brief statement addressed at the individuals in the audience who make a public statement today.

††††††††††† Both the Food and Drug Administration and the public believe in a transparent process for information-gathering and decision-making.To ensure such transparency at this open public hearing session of the Advisory Committee, the FDA believes that it is important to understand the context of an individual's presentation.

††††††††††† For this reason, the FDA encourages you, the open public hearing speaker, at the beginning of your written or oral statement to advise this committee of any financial relationship that you may have with the sponsor, its product and if known, its direct competitors.For example, this financial information may include the sponsor's payment of your travel, lodging or other expenses in connection with your attendance at this meeting.

††††††††††† Likewise, the FDA encourages you at the beginning of your statement to advise this committee if you do not have any such financial relationship.If you choose not to address this issue of financial relationships at the beginning of your statement, it will not preclude you from speaking.

††††††††††† Now we'll move into the open public hearing portion of this meeting by inviting to the podium Judith Wagner who is going to speak on Interventional Mammography Regulation.Ms. Wagner.The speakers will be confined to ten minutes.

††††††††††† EXEC. SECRETARY FINDER:Before you start, I just want to make mention.We no longer have our timer.So I'm going to have to motion to you.If I start making signals.

††††††††††† MS. WAGNER:Welcome.Thank you.Thank you all for having me speak today.As a nurse, breast cancer advocate and breast cancer survivor.

††††††††††† My advocacy for quality breast care began two years ago when suspicious lesions were found on my yearly screening mammogram and a stereotactic biopsy was attempted by a surgeon who could not localize my lesion and perform the I went to an accredited breast center where a diagnostic radiologist localized my calcifications without difficulty, performed the biopsy and I was diagnosed with low-grade DCIS (Ductal Carcinoma In Situ).

††††††††††† This began my quest of knowledge regarding the standards necessary to perform image-guided breast biopsies.Why did the hospital that I had worked in for 20 years and trusted not have an expert in imaging doing my stereotactic breast biopsy?As a nurse, I was really unaware of the standards.I had worked 20 years in the ICU and went about life and didn't really realize what the standards were for performing these image-guided breast biopsies.And after I found out, I wanted other women to know what I didn't know before they had this experience.

††††††††††† So I went the process of my DCIS treatment and I gathered information.I had hundreds of articles from the internet.I contacted my senators, my congressmen, Senator Mikulski, the FDA, the ACR, Tommy Thompson who was at that time Health and Human Services Secretary and I built my knowledge base because this was going to be the biggest advocacy of my nursing career.

††††††††††† I actually last week presented my talk.I have a PowerPoint presentation called "Choosing Wisely: How to Make Informed Breast Biopsy Decisions" at the Milwaukee Athletic Club and I was sitting with one of the board members who said, "And how do you get paid?Are you paid for doing this?"I said, "No, this is my mission in life.This is my mission to let women know before they get into this position where someone says you have a lesion or a suspicious mammogram and they go ballistic because I was that woman.I wanted an answer yesterday."Even though I felt I was a very strong woman, you hear that, and I think many of you know, you just short circuit.

††††††††††† So I began writing articles in national magazines, nursing publications, one called "Nursingmatters" and I received calls from Parish Nurses who read "Nursingmatters" to speak at churches and I speak where anyone will listen.I've appeared on a local NBC affiliate in my area regarding my advocacy of quality breast centers and accredited breast centers and women contacted me regularly about questions and concerns that they have about their breast biopsy decisions.I correspond with nurses in hospitals throughout the country who have issues of concern related to the quality and performance of breast biopsy and the standards of practice for physicians who perform them.

††††††††††† I believe that early diagnosis of breast cancer when it is less that 15 mm is critical for improvement in breast cancer mortality and morbidity and that quality standards must be mandated for performance in all these areas of mammography from screening to diagnosis, biopsy and treatment.Women need to be able to trust the medical system.I trusted a system that I worked in 20 years and they need to be assured that this physician who performs these procedures maintains the high quality standards.

††††††††††† So I speak as I say wherever I'm invited and I have a handout called "Key Questions That Determine a Quality Breast Center" and I give it to women and I make them think.

††††††††††† I have spoken before the IOM Committee,Improving Mammography Quality Standards in September 2004 and I requested that all image-guided breast biopsies, stereotactic, ultrasound and MRI be required to have mandated accreditation.This request was discussed by the committee and it was stated that the name MQSA would need to be changed in order to include non-mammographic imaging modalities.My request was, "Then change the name."

††††††††††† When the study did come out, it was titled "Improving Breast Imaging Quality Standards" because breast care has evolved.The umbrella has gotten bigger.We need to include everything underneath itin the diagnostic process of breast care.

††††††††††† I found a very important statement in the IOM Study of 1999 and I use this at all my presentations.It's right up on my slide."These studies identify multiple steps during the diagnostic evaluation of breast cancer at which the quality of care may be affected by the quality of the procedure.Poor quality at any step could significantly impact the overall quality of the care provided."About two weeks ago, I had the privilege to spend time in London with Dr. Nicolas Perry who is the Consultant Radiologist and Head of Mammography at St. Bartholomew's in London.He echoed the same sentiment in this statement.He said, "I believe that quality is more than just a word and a chain is no stronger than its weakest link."In fact, in London, they are going to be doing the fourth edition of their European Guidelines for Mammography and he was requested by the European Parliament to incorporate more on the diagnostic portion of it and the physicians who perform it.So that will be coming out in October of this year.He will be presenting it before the European Parliament.

††††††††††† I believe that the Diagnostic Radiologist should be the sub specialist dedicating 100 percent of his time to breast imaging in order to perform quality care.I have found in all my studies that the majority of radiology groups do not have radiologists who perform breast care 100 percent because they still have to take call and weekends and because of the financial impact of not getting enough for mammography, they can't afford to raise this area of radiology to the level that it deserves.

††††††††††† And there's a recent article by Jerry Kolb the National Consortium of Breast Centers, it's called the "Bulletin," and it's entitled "Good Enough - The Enemy of Great."

††††††††††† I have been in communication with numerous breast care leaders in this country and keep echoing to me the same concerns: medical legal issues, inability to fill Breast Fellowship positions; and cost of proposed auditing if the IOM Study Recommendations would be accepted.So I speak out for quality being mandated and yet I realize none of this can happen unless reimbursement for mammography and the above concerns are put into place before the recommendations are mandated.There needs to be increases in reimbursement for mammography and biopsy procedures before these recommended mandates can be put into place.

††††††††††† How are we going to get new fellowship positions filled when radiologists are unhappy because they have to do mammography?I know that screening mammography saves lives for women, wives and mothers and if you ask Tommy Thompson, daughters because his 33-year-old daughter was diagnosed last year with breast cancer.Dr. Daniel Kopans in a recent cover story, "MQSA Historic Success Becomes Regulatory Threat," Diagnostic Imaging, September 2005 stated, "Mammography is difficult, stressful work but since screening began, the breast cancer death rate in the U.S. has dropped by 25%.Better therapies have also contributed, but the majority of that decrease is from screening."And I am one of those people who had good screening and they found my micro calcifications.

††††††††††† That is why I believe that mammography deserves to be a sub specialty of radiology and radiology groups should give it the same reverence that they do MRI, Interventional Radiology because after all, isn't mammography important?You all have mothers and daughters and wives.After all, we are also looking at these costs and by the 2010, and this is in an article by Dr. William Eckland, 50% of all women in this country will be mammography eligible.†† The baby boomers are coming.I'm the first.

††††††††††† If mammography is not made a sub specialty and radiologists are forced by their groups to read the 480 mammograms per year often without a committed desire how will medical students and residents ever learn this broad scope of breast care?That's what Dr. Perry says.It's a broad scope.

††††††††††† I would request, I hope and desire, that this committee will take the necessary steps to insure that the recommendations of the IOM Study are adopted by both the FDA and Congress so that women throughout this country will receive their breast care, including screening, diagnostic, image-guided biopsies performed by dedicated Accredited Imagining Physicians who practice breast care with the highest of standards mandated under the BIQSA (Breast Imaging Quality Standards Act).And we need to have centers of excellence so that this can be performed.

††††††††††† I would also request that the committee and Congress address the costs of implementing these proposed recommendations so that mammography will not lose physicians and centers due to the increased cost incurred due to the mandating of improved standards of care.The burden of increasing mandates on an already low-reimbursed procedure will put further stress on radiology groups and all facets of mammography.Thank you.

††††††††††† CHAIR HENDRICKS:Thank you very much.Any comments on the presentation from the audience or the panel?Then we move to Dr. Richard Wagner who is going to speak on interventional mammography regulation.

††††††††††† DR. WAGNER:Thank you for giving me the opportunity to present my statements in person to this advisory committee.I have no conflict of interest.

††††††††††† My name is Richard Wagner.I have been a general radiologist in private practice in the Milwaukee area for almost 27 years.I have performed almost all aspects of general radiology including CT, MRI, ultrasound, nuclear medicine, many interventional procedures and mammography including screening and diagnostic.

††††††††††† After 25 years, I was removed from my sites of practice after raising quality of practice issues having to do with nonradiologists performing poorly interventional breast procedures.This initially began after my wife developed suspicious calcifications on her screening mammogram.A non-radiologist attempted a stereotactic biopsy but could not find the calcifications.This prompted taking mywife to an accredited breast center where a dedicated breast radiologist easily found the calcifications which were biopsied and DCIS was diagnosed.

††††††††††† This made me question why there was a difference in her experience and treatment between the two facilities. I began to discover that there were too many poorly performed biopsies including image-guided as well as open surgical.Also, because of poor concordance, there were delays in diagnosis.There were more than 50% open biopsies being performed.  Patients were not informed of their biopsy options.I also questioned whether the hospital's credentialing and re-credentialing standards regarding breast biopsies were being met.

††††††††††† I brought these issues to the Quality Assurance Committee with no substantive action.Meanwhile, I regularly began speaking to patients regarding alternatives to open biopsies.This further angered my non-radiology colleagues.Initially I was verbally harassed.  Ultimately economic pressure was applied to my group.If they would not remove me from my sites of practice where I had spent my entire professional career, the clinic contract would not be renewed.I was moved to other sites that my group covered.

††††††††††† The contract was recently renewed but not before two other partners were also removed from the clinic for also raising quality issues and speaking to the patients.Recently in on of our ACR stereotactic and ultrasound accredited sites, a different group of non-radiologists is pressuring administration into performing stereotactic biopsies by threatening to move their breast patients to another facility.It appears at this time that they will succeed which would put this site at risk for losing its accreditation.Again, economic pressures succeed at the expense of quality.

††††††††††† I have spent the last year working in friendlier venues within my group.I have developed a passion for performing quality breast care.I have dedicated a large portion of my time, including vacation, educating myself in breast care.This includes reading, breast conferences and mini fellowships.I recently submitted my resignation to my group and plan to spend the remainder of my career as a dedicated breast radiologist.

††††††††††† There are significant differences in the practice environment of radiologists performing breast care in private practice versus those in academic settings and certain multi-specialty practices.A major negative difference is the turf issue which unfortunately is frequently economically driven.Many image-guided breast procedures are performed by highly skilled, qualified, and dedicated physicians but all too frequently many are performed by less-qualified physicians who have control of the patient and/or the equipment to perform these procedures.

††††††††††† This problem could be resolved by implementing mandated accreditation standards for all image-guided breast biopsy procedures thus resulting in the highest of standards being met by any physician performing these procedures.This would require uniform accreditation and changing MQSA to BIQSA (Breast Imaging Quality Standards Act) so that all image-guided breast biopsies would be included.

††††††††††† Currently there are a multitude of credentialing bodies with varying standards.It is natural that the least qualified providers will seek credentialing with the organization for which they can meet their standards.Mandating one high quality standard for all physicians to achieve will improve quality and outcomes and decrease costs.

††††††††††† The patient is unaware that there are different credentialing standards and is often not informed.This would also eliminate the turf issues which often lead to a very unpleasant practice environment for a significant number of physicians who would prefer to deliver quality breast care without having to deal with often hostile professional relationships due to these turf issues.These issues also contribute to recruitment problems and veteran providers abandoning breast care.

††††††††††† It has become increasingly evident since I have become an advocate for quality breast care that voluntary methods for accreditation are not working.These are providers that comply with the recommended standards, but unfortunately a large number do not. These are the providers who could not meet these standards if they were mandated.I strongly believe that if mandated standards of accreditation for all aspects of breast care were implemented there would be a greater interest in practicing this specialty by physicians who are truly dedicated and would provide high quality-high volume service.

††††††††††† Conversely, the radiologists who are disinterested in breast care but are forced by their group to do breast care would be weeded out, very often to the benefit for the women who are not aware of the current vast differences in breast care standards and the level of competence and degree of interest of their providers.More physicians would probably be inclined to enter the specialty of breast care if it was a sub specialty that received the respect it deserved for decreasing the mortality of breast cancer.

††††††††††† It is discouraging to practice in an environment where quality is superseded by economic incentives when non-specialized practitioners "skim the gravy" but refer the difficult cases to those who have greater proficiency and expertise in the performance of these more difficult image-guided procedures.There is a fear that if accreditation standards were raised and mandated, there would become a shortage of breast care providers.

††††††††††† I believe that this would be a short-term effect at worst.It would discourage and ultimately eliminate physicians with little "true" interest in breast care.The remaining providers would be truly qualified as well as interested in providing high quality breast care.This would become a "respected specialty," not the poor orphan that it is now.High quality providers would result in lower incidence of malpractice.

††††††††††† However this issue should also be addressed via tort reform.Reimbursement issues need to be addressed.This is a real concern for a large number of breast care specialists who are in favor of the proposed reforms but are very concerned about the costs of their implementation.To mandate recommendations without a plan to finance them is a setup for failure.

††††††††††† As addressed in the recent IOM Study, "Improving Breast Imaging Quality Standards," there is a need to recruit new physicians into breast care.However these new physicians need protection from the various negative factors which are currently preventing recruitment and causing practicing providers to quit in frustration.These factors are turf issues, low reimbursement and malpractice concerns.

††††††††††† The principal goal of screening mammography is to decrease the mortality and morbidity of breast cancer.This has been shown to have an effect when cancers are detected when they are small and have not had a chance to metastasize.At this early stage, they are curable and, from an economic standpoint, early stage cancers are much less costly to treat than more advanced cancers.Unless cancers are found in an early stage when they are small, there is little improvement in mortality over those that are found clinically.

††††††††††† Current treatments have had little effect on improving survival for later stage cancers.From a screening standpoint, missing the small cancers and only finding the larger cancers defeats the purpose of screening and is wasted money.

††††††††††† To achieve this goal of early detection, there is a need for highly trained, dedicated breast imaging specialists who have high quality screening skills who regularly find these early cancers and are capable of performing the image-guided, minimally invasive biopsies that are often required for diagnosis and treatment planning.These image-guided procedures require imaging equipment that is user-dependent.

††††††††††† Too many biopsies are performed without the knowledge of the proper indications of these image-guided procedures and are often economically driven.All too many biopsies are performed in private offices where the quality of the imaging equipment is suboptimal, high standards of practice and proper documentation of the procedures are not performed, and individual performance standards are not monitored nor are they currently required.

††††††††††† In summary, the patients and dedicated breast care providers need protection which would be provided by mandatory accreditation of all aspects of breast care.There needs to be improvement in reimbursement for breast care.Why is breast care less valued than other aspects of medicine, yet it is the most regulated?This regulation is expensive and is the responsibility of the provider.There needs to be malpractice reform particularly relating to breast care.

††††††††††† These issues are of major concern for people who are currently in breast care.They are deterrents for future breast care providers and must be addressed if quality breast care can continue and hopefully expand its scope.†† Thank you for allowing me to present my views during this important era in improving breast care.

††††††††††† CHAIR HENDRICKS:Thank you very much.Any questions from the panel or the audience regarding the presentation?Then at this time, Dr. Finder's going to read some written comments submitted by Dr. Murray Reicher on "Full Field Digital Mammography Guidance."

††††††††††† EXEC. SECRETARY FINDER:These comments will basically apply to our discussion later on today when we discuss our various guidance documents.But the following comment was received from Dr. Murray Reicher who is Chairman of DR Systems, an RIS and PACS vendor.So that's his conflict of interest acknowledgment.

††††††††††† His specific input is as follows:Page 15, question 5 of the Guidance document which everybody should have in the handouts and again we'll go over it in detail in the afternoon section.This section refers to the labeling of images at the time of presentation and I agree with the comments.You may be aware that FFDM Manufacturers deal with the issue of labeling of laterality and view in various ways.One vendor I know of burns left and right and view markers such as LCC in the FFDM image just as if the technologist used the lead marker with film.

††††††††††† Another vendor does not but only provides the information necessary for a third party viewer to derive that data in the DICOM header field.Another vendor doesn't provide the view dated in standard DICOM field but instead it seems to provide this information in a private tag.I suggest that FFDM Manufacturers should be encouraged to follow one manufacturer's lead and actually embed the laterality and view label in the image pixel since this eliminates the chance of mislabeling by other viewers down the line.

††††††††††† Next comment refers to page 26, question 2.The answer seems to open the door for users to try less than five megapixel monitors although not explicitly stated.My opinion is that readers should have the discretion to pick the monitor they desire as long as there is some instruction or method that encourages display of every pixel so that subsampled viewing of pixels in not-routinely performed inadvertently.That's what it says.

††††††††††† My concern is as I have expressed it before is that current mammography's soft copy viewing systems make it easy for viewers to inadvertently subsample pixels when displaying images such as when a four-to-one format is used without understanding what they are doing.I would suggest that you consider the following comments in preparing future guidance documents.

††††††††††† With regard to all imaging, but mammography, the PACS vendor's responsibility with regard to data compression is to provide labeling.But readers can select to perform the primary reading of exams CT, MRI with lossy data compression.This is becoming a very common practice and is supported by medical literature.There is clearly a difference between lossy data compression and perceptible visually destructive data compression.A computerized radiography image or CT image with a JPEG five-to-one is lossy compressed but not distinguishable from the original by human observers.

††††††††††† With regard to data compression, the Office of Device Evaluation holds device manufacturers to a different standard when it comes to mammography and I don't fully understand what the scientific or legal basis for this different approach is.With mammography, manufacturers are required to label any lossy compressed image not for primary reading or at least DR Systems does that based on our understanding of what we were required to do by the Office of Device Evaluation and MQSA.

††††††††††† If this different approach comes from MQSA and not ODE, your input would be important.If it's coming strictly from ODE, does that mean that if ODEapproves a display device that uses lossy compression data for primary mammography reading, then MQSA policy with regard to that practice immediately changes de factum?

††††††††††† Our pilot research seems to indicate that we can compress GE FFDM mammograms down to three to four hundred kilobytes per image and Lorad/Fischer mammograms down to under one megabyte per image without resulting in visually detectable change in the image and perhaps more before we could alter an ROC curve.That's a big benefit for any mammography provider with multiple sites seeking to improve their mammography by centralizing reading to a single site where an expert mammographer interprets the exams.As you know, data shows that experts may detect the breast cancer with twice the frequency far more as compared with general radiologists readers.

††††††††††† The same logic applies to need for guidance with regard to digitization of all film screen mammograms with discard of the original.This current guidance makes it clear that a facility may elect to digitize prior film mammograms for comparison purposes.We want to go to the next step and allow a facility with proper quality controls to digitize the prior film and discard the original or give it to the patient.Our belief is that this will not only lower cost but actually enhance safe storage in electronic clinical access for future comparison.

††††††††††† In summary, my questions with regard to both digitizing films and data compression may be condensed into one basic question.In upholding the requirement to view and store the "original mammogram," how can a facility or vendor properly demonstrate that a "nonidentical original" as the result of data compression, for example, is in fact so functionally identical to the origin that it can replace the original?Of course, with regard to both printing of film and display and monitors, one must recognize that all existing systems slightly alter the original today since no two printers or monitors are exactly alike.

††††††††††† So if a provider or vendor can follow a quality process that insures that other data altering steps such as data compression functionally and visually preserve the information in the original image, why provide any barrier to that process with regard to mammography in distinction to all other forms of medical imaging?Again, we will discuss thisin greater detail in the afternoon.

††††††††††† CHAIR HENDRICKS:Any questions or comments from the panel or from the audience related to the written comments?At this time, all of these presentations are open for discussion from the panel or from the audience.Barring any comments, we'll move then to the next speaker.I welcome Lt. Commander Sean M. Boyd who is Chief of the Electronic Products Branch to the podium to give us a radiologic health update.Lt. Commander Boyd, welcome.

††††††††††† LT. COMMANDER BOYD:Thank you.I do have handouts.I'm Sean Boyd.I'm going to give you a brief overview of some work that we've been doing over the past year to reconceive FDA's radiological health program.We've been working the past ten or twelve months to do this, acknowledging that many of the public health problems and issues that prompted the promulgation of the Radiation Control for Health and Safety Act in 1968 have changed although our public health mission today remains.So we have a fairly-detailed-but-in-process plan to address current public health problems for today.

††††††††††† What has changed since 1968?The three areas in your slides you'll see are first product environment.We believe that the markets have become global, not longer products just primarily made for the U.S. or in the U.S. market.Manufacturing processes have advanced, promoting safer building and testing and evaluation of products and more effective international voluntary standards are in place today; whereas,25, 30 plus years ago, the standards that were in place were primarily FDA standards.

††††††††††† Public health needs have also changed where product problems or manufacturing problems were our primary concern in the late 1960s and early 1970s where today we believe that those problems either can be or already have been addressed for many of the products that we began regulating years ago.And the issues today are more related to product use.

††††††††††† Finally, CDRH resources have changed where over the past few decades our focus has shifted more towards medical devices and our radiological staff and expertise has declined which primarily if you look at the FDA history on the next slide, the point of this slide is to say not that we don't have as many people as we used to, certainly we don't, but we need to be more cognizant of the resources, the few resources, that we have and best use those resources to deal with high priority problems, dose-intensive equipment and real public health risk.

††††††††††† Slide 5 shows the CDRH program mission; again, remains to protect the public from hazardous or unnecessary electronic emissions.The way we do that is by maintaining awareness of radiation-emitting products and their manufacturers, who is making what and what they're making, assessing radiation emission levels and conditions of use for these products, understanding the effects of the emissions and their potential risk to health for the public, providing guidance to mitigate these risks both to the users, to the public and to manufacturers and encouraging manufacturers to comply with requirements or available standards while pursuing enforcement action when necessary.

††††††††††† Slide 6 shows our five program elements that we have developed in our Radiological Health Plan for the future.I'm going to focus on the top three today, standards, monitoring and education.

††††††††††† Slide 7 shows the goals for standards which are primarily using performance standards that are enforceable and appropriate for today's technology and these would be FDA performance standards that are required that manufacturers comply by law while increasing use and reliance on either international or national voluntary consensus standards.What we hope to do is establish processes that we are able to insure conformance with whichever of these two standards, a mandatory or consensus standard, by manufacturers when they're appropriate.

††††††††††† Some of the activities on Slide 8 that we're hoping to cover and currently have in process with regard to standards are increasing our and other stakeholder participation and development of international and national consensus again focusing on high risk products and dose-intensive equipment by allowing conformance to consensus standards, by guidance which would be followed by adopting a standard by reference.We have done that with our Federal Laser Standard where we've adopted the IEC or we allow manufacturers to conform with the IEC Laser Standard by guidance and are moving to adopt that standard by reference.We are going to look into a similar paradigm for other standards to include the CT, ultrasound or other diagnostic x-ray standards.

††††††††††† Another thing that we hope to do or we're looking into right now is pursuing legislative change that would allow adoption and enforcement of voluntary consensus standards.This is not something that would be required or impact other portions of the plan but if this is something that we could do to facilitate our use of approach consensus standards as necessary that might help us insure product safety.Finally, we want to base enforcement actions within the standards to lower risk.

††††††††††† Slide 9 shows goals for monitoring and the monitoring portion of our plan.Essentially, we'll want to maintain awareness of radiation-emitting electronic products and their manufacturers.We want to be able to assess electronic product emissions and their conditions of use.And we want to be able to understand the effect of emissions and exposure on risk.

††††††††††† Some of the activities on Slide 10 that we are pursuing and monitoring right now are to require only essential manufacturer reporting.We're going to relieve or provide some relief to manufacturers of low-risk products and not require as many or all the types of reports that we have in the past for low-risk products but maintaining the reporting requirements for higher risk, dose-intensive equipment.

††††††††††† At the same time, we want to move away from routine field and lab test programs that we currently have and move toward more-cause testing, field and lab testing and primarily to manufacture inspections.One of the things you probably talked about is we're exploring elimination of the dose measurement during MQSA inspections.We're exploring phasing out routine laboratory and field testing again in favor of for-cause testing where we would be able to identify a specific problem or a manufacturer that would be of higher risk than another that might be covered in a routine program.

††††††††††† We're looking to phase out certain instrumentation calibration capabilities that we currently have in favor of maintaining instrumentation expertise and the capability to measure a variety of types of radiation from a variety of products.

††††††††††† And finally under monitoring, we want to work to emphasize assessment of use and exposures by harvesting data from organizations that are currently collecting exposure and dose information rather than collecting that data ourselves.We may or may not have the resources to go out and collect all the type of data that we want, whereas other organizations are already collecting it.So if we can work together with people to collect that, that's what we would like to do.

††††††††††† Slide 11 shows our goals for education.We have a goal of having a public able to make informed choices about their own exposure in a variety of settings that might include medical, occupational or the home environment, a goal of having users able to minimize their own exposures and optimize the exposure and dose they're providing to the people they are treating or exposing.Manufacturers today are able to understand their responsibilities in educating the public and users and are sensitive to the risk their product poses and appropriate information or actions they need to take to minimize that risk as well as FDA and state regulators that assess users in minimizing radiation exposure to the public.

††††††††††† Some of the activities that we're pursuing right now under education include creating a coordinated education program where we're working to partner to disseminate information and create training opportunities with groups of organizations and primarily invest in the website as an educational tool.We're working right now to revise our web page to provide more timely and current information on radiation risk, the products we regulate both to consumers, users and manufacturers of the products that we regulate.

††††††††††† The benefits that we hope to reap from our efforts include aligning our efforts with today's current and evolving public health needs as opposed to what we have done over the past decades.We hope to expand our focus on patient and consumer needs while maintaining the oversight we have over the manufacturing community, targeting our regulation to dose-intensive equipment and where the true public health risks are, increasing the information that we provide to our stakeholders, manufacturers, users, regulators and the public and improving coordination across the radiological health community.

††††††††††† That concludes my remarks.I've provided my contact information.There is information available on the CDRH web page on these new initiatives and you can get a copy of the plan there.There's also a public meeting that will happen on October 31th and November 1st.And there's a Federal Register notice that published recently on that as well.

††††††††††† CHAIR HENDRICKS:Thank you very much.Any questions or input from the panel or from the audience related to the presentation?I just do have a simple question for clarification regarding the devices that you were referring to as higher risk and I wanted to have a clarification for what those devices might be.

††††††††††† LT. COMMANDER BOYD:FDA regulates virtually any electronic product that emits any form of radiation.Television products and microwave oven products are two examples of products that we began regulating when the Radiation Control for Health and Safety Act was promulgated decades ago.Those would be examples of low risk devices.CT scanner, radiation therapy equipment, primarily ionizing medical types of equipment are things that we view as highest priority for this.

††††††††††† CHAIR HENDRICKS:So all the medical applications are really considered high risk.

††††††††††† LT. COMMANDER BOYD:Right.

††††††††††† CHAIR HENDRICKS:Thank you.Okay.As we move along, we have two speakers who are going to speak jointly or split the time.We have Priscilla Butler from the American College of Radiology speaking first on providing an update on the Current Voluntary Interventional Mammography Accreditation Programs.†† Welcome.

††††††††††† MS. BUTLER:Thank you.I thought we were ready for the break but here I am.I'll be giving you a brief update on what's going on with stereotactic breast biopsy accreditation.Next slide, Mike, please.The Stereo Accreditation Program was first offered in 1996.It was modeled after the Mammo Accreditation Program which was very successful even though voluntary at that time.

††††††††††† I do want to point out that the stereo program only evaluates breast biopsy procedures.There's no needle localization or ductography or other interventional procedures evaluated during this program and as with all of our accreditation programs, we look at personnel qualifications, clinical image quality, phantom image quality and dose, all of our x-ray programs look at dose, and the facility's quality control program.

††††††††††† Just like mammography, we evaluate personnel's initial qualifications.That includes their initial training as well as their initial experience, what they get during continuing education and continuing experience.

††††††††††† The physicians, we look at physicians, medical physicists and technologists.Back in 1996 with the realization that stereotactic breast biopsy was being performed not only by radiologists but also by other physicians.The ACR and the American College of Surgeons worked out and published a very detailed set of qualifications and they also defined several settings which these physicians would practice in.

††††††††††† The collaborative setting is the setting where a radiologist and other physicians would work together in the same setting both performing stereotactic breast biopsy procedures but perhaps focusing on different aspects.But they would basically support each other in those efforts.And most accredited facilities that we look at tend to practice in an independent setting where the radiologist or the other physician would work independently or as a group from the other specialty.

††††††††††† I'm not going to go into the details of those requirements.I have provided a handout with those requirements if you want the other information.

††††††††††† With regards to clinical images, at this time we look at both masses and calcifications facilities must submit what they consider to a good example of a mass biopsy and a calcification biopsy.We evaluate needle devices, vacuum suction devices and since there has been recently a number of FDA approved core biopsy devices such as M block, we've also started evaluating those.

††††††††††† The basic criteria for clinical image quality has to do with accurate needle positioning of the targeted lesion.So this is what our pass/fail criteria is based on.

††††††††††† For the phantom images and dose, first of all, dose must be less than 300 millirads and the phantom image quality criteria is going to vary depending on phantom is used.Just like mammography, we look at fibro specks and masses and there are two phantoms that we tell the facilities they can use.There is a mini phantom which has an abbreviated set of test objects which actually is good for defying gravity because it has a little lip that can hang off the devices and then they can also use the standard mammography accreditation phantom for the image quality evaluation.And we have separate procedures to use both of those tools.

††††††††††† We require that facilities perform quality control and the quality control that we ask for are those tests which are outlined in the 1999 Stereo Breast Biopsy Quality Control Manual.

††††††††††† Our reviewers must essentially meet the same qualifications as the mammography accreditation program reviewers.The reviewers must be ABR certified and must be ACR members.They have to participate in a formal training program.They have to have a minimum of five years of experience and they must in current or clinical physics practice across the United States.

††††††††††† We are very careful to address potential conflict of interest issues.We have an automated system to remove them from evaluating any facilities which may be from the same state or any other state which they've identified a conflict of interest and we also perform quality control on the reviewers.

††††††††††† With that background, I would just like to show you some of our current data.This is a chart showing the volume of accredited facilities over time.Currently we accredit 436 units at 428 facilities.There are a couple facilities out there that do have multiple units.We've seen a slight increase over the past year.We were getting worried from 2002 to 2004 because it looked like we were seeing a trend with facilities pulling out accreditation and there was less and less of an interest getting accredited.Recently we've seen an increase in accreditation.I'm not exactly sure what to attribute that to but we'll continue watching this.

††††††††††† The other thing I think is of interest is what our pass/fail rates are.And just like mammography accreditation, facilities have three attempts at accreditation.Basically, it's not a three strikes you're out but a three strikes we show up on your doorstep.And the first attempt at accreditation if they do not pass they get a deficiency.

††††††††††† Now what I'm showing you on this slide is first let's focus on the green bar.This is the overall pass rate after the first attempt at accreditation.In 2000, it looks we just had about 60 percent overall pass rate which means 40 percent of the facilities applying were not passing accreditation.

††††††††††† We thought we were seeing an increase in the number of passing back in 2004 because we had almost reached 70 percent.With the data that I just ran last week, it looks like it's just dropped slightly.But I'm not sure because of these numbers how statistically significant they are for the year.But again, one thing that's really important to realize is in a very similar program and in fact in some sense more strict because of the MQSA regulations, mammography passes 90 percent of the units on their first attempt at accreditation now.In mammography when the program was still voluntary, we were seeing about a 70 percent pass rate.This pass rate hasn't changed significantly over the past four or five years.

††††††††††† Now the other thing that's interesting to note is the red and the blue bars.The red bars are the number of units, are the initial accreditation, which means that the unit goes through accreditation for the first time.Then the blue bars are renewal accreditation.We were seeing again in 2003 and 2004 a significant improvement in the number of passes upon renewal which was really a good sign.

††††††††††† In 2005 again we need to look at this data carefully.I'm not exactly sure what has happened but one thing that we did see in the mammography program is as the program got out, many facilities were replacing their old units and all of a sudden, we started seeing the initial accreditation creep up in the pass rate because these initials were brand new units that these facilities were installing.They were higher quality.They were doing a better job.

††††††††††† Then some of the renewal, the pass rates started going down, because they were renewing with the same old units they've had for the past 15 years.So this is a trend that we have to watch to see if it's following what we've seen in mammography.But we will watch this.

††††††††††† Then the last piece of the pie that I want to present is that why are facilities failing accreditation.The vast majority are failing because of clinical failures and we have 63 percent failing due to clinical only and another 10 percent failing due to clinical plus phantom.What this means is that the facility submitting their accreditation applications and they think it's their best work, our reviewers have determined that they have not been able to adequately target the lesion and that's why they're failing.So similar to the mammography, most of the deficiencies that they're getting are due to clinical reasons rather than a phantom or a dose issue.

††††††††††† I'll be happy to take any questions or we can wait until after our next speaker.

††††††††††† CHAIR HENDRICKS:I have a question just for clarification.

††††††††††† MS. BUTLER:Yes.

††††††††††† CHAIR HENDRICKS:Regarding the clinical process, are the facilities submitting the pre biopsy films and then the procedure related films and also the images that are obtained of the cores and then maybe some post procedure films?I'm not sure what the process is for the clinical review.

††††††††††† MS. BUTLER:Okay.The details of the process are in the handout that I gave you and in a nutshell, they submit the mammograms where they've identified the lesions they want to target and then they will submit pre biopsy images, post biopsy images and for calcs, they'll submit the specimen radiography exams.

††††††††††† CHAIR HENDRICKS:And the post procedure films if they are available?

††††††††††† MS. BUTLER:In terms of mammograms or as far as the biopsy?

††††††††††† CHAIR HENDRICKS:Yes, mammography.

††††††††††† MS. BUTLER:No, not the post procedure mammograms.

††††††††††† CHAIR HENDRICKS:So it's a question of whether the calcifications were present in the core specimens?Is that the critical question?

††††††††††† MS. BUTLER:They need to be able to see the calcifications on the original mammograms and then they need to be able to target those calcifications if it's a calc and then show on the core and that would be during the post biopsy exam and then on the core be able to show that they got those calcifications on the specimen radiography exams.

††††††††††† CHAIR HENDRICKS:I understand.And during the accreditation procedure, for example, how many of these examples are submitted?This may be in the text but I just wanted to know how many samples are submitted to determine the pass or fail in the clinical.How many examples are submitted by the facility?

††††††††††† MS. BUTLER:We ask them to submit two cases, one showing an example of the accurate targeting for a mass and also one for calcifications.If they do FNAC, we also ask them to submit those cases too.

††††††††††† CHAIR HENDRICKS:So in order to receive a passing grade on the accreditation, then both of those sets need, in other words, confirmation procedure, if they fail on one, they receive a fail.

††††††††††† MS. BUTLER:That is correct.If they do not pass on one of those exams, if they receive a deficiency, then they don't get accredited.

††††††††††† CHAIR HENDRICKS:I see.Thank you.

††††††††††† MS. BUTLER:And one other thing I did forget to mention is we have a very similar program for breast biopsy accreditation and the criterion in a lot of ways is very similar.

††††††††††† CHAIR HENDRICKS:The facility is selecting the images that are submitted to ACR for accreditation.

††††††††††† MS. BUTLER:That is correct.We asked them to submit an example of their best work.

††††††††††† CHAIR HENDRICKS:So then are you surprised at these failure rates since the facilities have identified these two case as their best work?

††††††††††† MS. BUTLER:Yes.

††††††††††† CHAIR HENDRICKS:Then you point out that that's the same as mammography accreditation facilities, similar to the best work for people --

††††††††††† MS. BUTLER:Yes, in mammography accreditation, facilities are also asked to submit examples of their best work and I do need to point out that our reviewers know that they're evaluating best work and they judge this accordingly.

††††††††††† CHAIR HENDRICKS:Thank you.Other questions or comments from the panel first for this speaker?Dr. Williams.

††††††††††† MEMBER WILLIAMS:I just missed your comment there, Penny, about you also have a program for what other kind of breast biopsy that are similar.

††††††††††† MS. BUTLER:Breast ultrasound.

††††††††††† MEMBER WILLIAMS:For ultrasound.Okay.

††††††††††† MS. BUTLER:For breast ultrasound and that evaluates not only breast ultrasound image quality for routine breast ultrasound imaging, but also breast ultrasound biopsy procedures.

††††††††††† EXEC. SECRETARY FINDER:Can I just have people hold for a minute so we can get Dr. Harrison back on hopefully.

††††††††††† (Pause.)

††††††††††† CHAIR HENDRICKS:I have another questionfor clarification regarding the numbers of the facilities so far that have participated in the voluntary program, two questions really.What percentage of this volume is the total pie of the number of stereotactic equipment that we think we have in the United States right now, just a ballpark?What fraction?

††††††††††† MS. BUTLER:We estimate that there's about 3,000 units.

††††††††††† CHAIR HENDRICKS:Three thousand units.†† Okay.And the other questions in terms of the individuals in the facilities that have agreed to do this voluntary program, was it primarily academic centers or individuals radiology groups, surgeons?What is the mix of the individuals who agreed to participate in the voluntary program?

††††††††††† MS. BUTLER:In this program it's primarily radiologists and the practice setting really are all over the place, lots of academic centers.We also have a lot of community practices, smaller hospitals, that go through accreditation.

††††††††††† CHAIR HENDRICKS:So you felt like you got a reasonable mix.

††††††††††† MS. BUTLER:Yes.

††††††††††† CHAIR HENDRICKS:Although it's a fairly small sample of what's going on out there?

††††††††††† MS. BUTLER:Yes.

††††††††††† CHAIR HENDRICKS:Thank you.Questions or comments from the panel first and then from the audience?We do have a question from the audience.Can you come to the microphone and reintroduce yourself for our speaker or our panel member at a distance?

††††††††††† MS. WAGNER:I'm Judy Wagner.I have a question just to clarify.The first bar is the initial.The second bar is the redo.And the third bar is the total of the two?

††††††††††† MS. BUTLER:†† Yes.

††††††††††† MS. WAGNER:And one other question, whereyou have for comparison over 90 percent of mammography units currently pass on the first attempt.So what really stands out to me, and clarify this if I'm wrong, is that mandating these things raises the bar for quality rather than it being voluntary.Would that be correct?

††††††††††† MS. BUTLER:Yes.

††††††††††† MS. WAGNER:Thank you.

††††††††††† MS. BUTLER:What we saw during the mammography accreditation program is after MQSA went into effect was a steady increase in the pass rate. What we also saw in mammography accreditation is that immediately after MQSA went into, just prior to MQSAgoing into effect, facilities that did not pass accreditation many of them dropped out and they didn't continue pursuing accreditation.After MQSA went into effect, that didn't happen any more because they didn't have that option.It may be applicable to stereotactic breast biopsy.There's a lot of similarities that we're seeing right now.

††††††††††† CHAIR HENDRICKS:A question from the panel.

††††††††††† MEMBER MONTICCIOLO:I just have a question for Ms. Butler.Penny, you said that it's mainly radiologists who have applied so far even though the practice settings vary.We don't really have a good handle on what non radiologists are doing from the numbers.Is that correct?

††††††††††† MS. BUTLER:We have several surgeon practices that have applied for accreditation and the next speaker will be talking about the American College of Surgeons Program which we provide support for.

††††††††††† CHAIR HENDRICKS:Dr. Barr.

††††††††††† DR. BARR:†† Helen Barr, FDA.Penny, do you follow these submitted cases to look at what the diagnosis was?In other words, is there any correlation between failure?Does failure prove that the biopsy was not diagnostic?Is there any correlation between your failures and diagnosis of the lesion?Do we have any evidence on that?

††††††††††† MS. BUTLER:This is not something that we've been tracking and I guess I'm trying to figure out how we would do that.But no, I have no data on that.

††††††††††† CHAIR HENDRICKS:I just have another question for clarification regarding the process because we've been talking about how burdensome some of these processes are and that that might be a deterrent for voluntary participation in these programs.So in terms of the clinical component, what is the obligation to the facility?How much time does it take in terms of preparation for this accreditation in your estimation?What is the burden to the facility to participate in this program in terms of manpower, fees?

††††††††††† MS. BUTLER:As far as fees go, it's $1,200 for the first unit and I believe it's $1,050 for the second unit.We don't have that many for second units out there.

††††††††††† As far as time goes, the documentation of personnel requirements is critical but most of the physicians, for example, and even the technologists, certainly when the medical physicists are involved, they are already in the habit of documenting this information because they're required to under MQSA and in fact, many of the personnel requirements really parallel what MQSA requires.

††††††††††† The quality control, there certainly is time associated with that and I don't have immediate figures on that right now.But once again, a lot of the tests are very similar to what's required for MQSA.An annual medical physicist survey is also required.But all these things I think are good practices that have been established through MQSA and I wouldn't say that this is more burdensome than MQSA perhaps in some sense because it may be less burdensome, but just because MQSA has already taken a lot of the burden regarding the personnel stuff.

††††††††††† CHAIR HENDRICKS:Thank you very much.Dr. Monticciolo.

††††††††††† MEMBER MONTICCIOLO:This is Dr. Monticciolo.I would echo some of the things that Penny said like my site is accredited for a stereotactic.So I've been through this process and a lot of the things we would do anyway just for quality purposes, it's a good idea.We QA the machine every single morning so that we're ready and make sure everything is calibrated for every patient.So we would do that anyway.I think most of the requirements for the accreditation program are reasonable.

††††††††††† The only issue that we're having and is probably going to be addressed in committee and you could speak to this, Penny, is that it's currently required that we submit images on masses and calcifications and almost all masses we see well with ultrasound.So we probably see them with ultrasound.The last time we went up for accreditation we had a hard time getting the mass because I didn't want to put somebody on the table just to get the accreditation when I knew it was easier for the patient to have an ultrasound if you're a reasonable clinician and you care about your patient.

††††††††††† People said to me, "Why don't you just put somebody on the table with a mass" and I couldn't just bring myself to do that.So it took me a long time to find a mass that we couldn't see with ultrasound and we could the stereo biopsy.That's probably something that's easily addressed.

††††††††††† MS. BUTLER:I'd like to comment on that.That's why I carefully chose my words when I talked about masses at this time.Dr. Phil Evans who is chair of the committee is actually convening a meeting to look at the mass issue and where we are at this point in time.Medicine evolves and I think our programs have to evolve to appropriately reflect how we evaluate these medical procedures.

††††††††††† CHAIR HENDRICKS:Thank you.I just have one quick question just for clarification again.How were the participants identified to participate in this voluntary program?Were they new machine purchasers of new equipment or facilities who had already been involved in the MQSA inspections?How were the participants identified?

††††††††††† MS. BUTLER:Basically, they self-identified themselves.This is a study.This is an accreditation program and these facilities applied to us for accreditation in order to try to do demonstrate the quality of the work that they're doing there.As with all of our accreditation programs, they start this way.

††††††††††† CHAIR HENDRICKS:Thank you.I question from Dr. Williams and then from an audience participant.

††††††††††† MEMBER WILLIAMS:This is Mark Williams.Just in follow-up to the question about the burden just from the standpoint of the physicist, I don't know if Melissa and the other physicists in the audience share this experience, but we found that the annual physics survey for the stereotactic systems actually takes less time than for a normal mammo unit.So the burden level there, I would say, is less even than a normal unit.

††††††††††† CHAIR HENDRICKS:Melissa.

††††††††††† MEMBER MARTIN:Melissa Martin.I would reiterate what Dr. Williams just said.Certainly the time on the machine for the physicist is definitely less than on a standard mammography system and I think there is a direct correlation with that.We have several facilities in a range of settings.

††††††††††† As a consulting physicist, we have very few academic centers.So ours are primarily community based hospitals and private offices.Several have voluntarily gone through the accreditation program and they do not find the QC for the stereotactic, that is, the least burdensome process that they have of all the breast imaging equipment in the department.

††††††††††† I would just also offer.We actually have several sites too that have voluntarily gotten the ACR manual for quality control, adopted that program and use it in-house even though they haven't paid the $1,200 to get accredited.But they want that QC program and that's what they use to document for quality control just within their own centers which I would find if that is a truly burdensome process, it wouldn't be done voluntarily in-house.So I would just reiterate.The QC part is not burdensome on that program.

††††††††††† CHAIR HENDRICKS:Thank you very much.Any other questions or comments from panel members?

††††††††††† MEMBER PASSETTI:Bill Passetti.You said there was about 3,000 facilities in the country, somewhere around that neighborhood.

††††††††††† MS. BUTLER:Yes.

††††††††††† MEMBER PASSETTI:Do we know how many of those are MQSA accredited facilities or totally separate?

††††††††††† MS. BUTLER:We have no data on that.I would imagine just from our anecdotal experience that most stereo units are associated with an MQSA certified facility.So if it's a dedicated prone table, obviously it wouldn't require MQSA accreditation.There are some add-on units out thereand most of these add-on units actually mammography.So they would have to be covered under MQSA.

††††††††††† CHAIR HENDRICKS:Yes.Carol Mount.

††††††††††† MEMBER MOUNT:I just wanted to echo the quality control program from the technologist standpoint is also very easy to do.The technologist in the breast imaging department are very familiar as Penny said with going through and doing the weekly QC and it takes minutes in the morning to get the machine ready and then they do their checklist and their quality control.So it's not a burden at all to the technologist to add this to their daily work.

††††††††††† CHAIR HENDRICKS:One final comment from the audience before we move on.

††††††††††† MS. WAGNER:Judy Wagner, R.N.I just want to tell you that in my presentation I get questions from women all the time and the big question is where do I find in an accredited breast center.So I have now put it in my PowerPoint presentation.The ACR has a wonderful site.You go under under Facilities and you can find if your sister lives in Missouri, you look up all.You look under stereotactic.You plug in stereotactic and you plug in the city.If you can't find that city, just use Missouri and all of the accredited centers for stereotactic will come up in that area.Same with ultrasound.So it's a really good resource.I have it in my handouts to women so that they can network this knowledge to other women.

††††††††††† MS. BUTLER:Thank you.

††††††††††† CHAIR HENDRICKS:Thank you very much and thank you for your presentation.We'll move then to the next speaker who is Kambiz Dowlat, Dr. Dowlat, welcome, to talk about interventional procedures related to breast disease.

††††††††††† DR. DOWLATSHAHI:Ladies and Gentlemen, thank you for inviting me to present the views of the College of Surgeons as well as myself regarding the stereotactic programs.I was called in because I was involved with this device from the first day but I didn't have a lot of time to collect information and data.So my presentation is going to be very general and hopefully I will give you some message as to what we surgeons think about the stereotactic needle biopsy and it's safety and efficiently.

††††††††††† Some historical notes.This is a little bit of too much writing but I'll try to read it for you.Screening mammography as most of you may know started in the ?60s with the Shapiro reporting in New York the data and subsequently on a wider scale around the country in the late ?70s.Then it became very widely applied tests in the United States, I would say, in the late ?80s and early ?90s.

††††††††††† The suspicious lesions that were detected by mammography were wire localized by radiologists and removed by surgeons for diagnosis.This is where I was involved with the mammography and this is how I became more interested in breast cancer detection and diagnosis and treatment.

††††††††††† As I said, I introduced the stereotacticneedle biopsy in the United States from Sweden only because I did not think that wire localization and excision was a good way of doing things because 75 to 80 percent of the biopsies that we did at the time were all benign.I thought that was unfair to women.

††††††††††† So the technique was developed in Sweden and the first unit was brought into the University of Chicago and that's where I worked with it and tested it against the open biopsy and others have done equally well and subsequently this was accepted by radiologists at first because I couldn't sell it to surgeons and then the surgeons came into the field at a later stage.

††††††††††† Breast ultrasound was also a diagnostic step for intervention.It was popularized by my colleague, Dr. Staren, at Rush in Chicago.This was again a historical note which I want to introduce because both the stereotactic and ultrasound came together in the mid ?90s when the need for intervention became obvious.

††††††††††† In 1997, the surgeons felt somewhat threatened that their practice was taken over by intervention or radiologists and they went to the College of Surgeons and they asked me and Dr. Staren and we formed a group and started the stereotactic and ultrasound courses given at the College meetings twice a year.

††††††††††† In the earlier phases of these courses, we were giving certificates to the participating individuals so that they could go back to their hospitals and start practicing the intervention of steps being either stereotactic or ultrasound.

††††††††††† A set of guidelines as was pointed out by the previous speaker was developed in conjunction with the College of Radiology and I have a copy of that for the panel.Unfortunately, as I said, I didn't have enough time to make a lot of copies, but it describes what this voluntary program which is place by the College of Surgeons for their fellows and for their practicing fellows is all about.

††††††††††† My comment is that the practice of surgery is becoming more and more image dependent.And you can see that if you go into any set of operating rooms in the hospital that something like eight out of ten surgeons are operating on the screen.Laparoscopic cholecystectomy is a good example as most of you know in the arthroscopic procedures and so on and so on.

††††††††††† The 21st century practice of surgery has become very image dependent.Therefore, surgeons have to become cognizant of what the mammographic problems are and therefore become familiar and become skilled at reading and intervening whenever is necessary.

††††††††††† Of course, safety of the patient and accuracy of the procedure through correct diagnosis is paramount.If you miss a cancer overdue or over practice the needle biopsy at the slightest risk ofmalignancy, it's a very fine skill and find experience to obtain.It takes time to be able to do this procedure both with ultrasound and the stereotactic.

††††††††††† Now image-guided treatment of breast cancer is also on the horizon.I'm sure a lot of you know about the laser treatment of these tumors as well as the radio frequency, cryosurgery.These are all minimally invasive means of treating but image dependent methods of treating breast cancers.Surgeons are also involved with the placement of the radiation devices for partial treatment of breast tumors.So as I said, earlier on, more and more image dependent technology is coming into the field and we just have to learn about them.

††††††††††† In my opinion, the current stereotactic biopsy program as I have given copies to the panel members is adequate for practicing surgeons and should serve the primary goals of patient safety and the diagnosis of cancer.It's not popular with surgeons and radiologists for a variety of reasons.It adds a little bit more to their busy schedule.You just have to submit, I'm just saying that by having spoken to several surgeons in the past week, that if they are working with radiologists, life is made easier for them because the mechanism is already in existence for the submission of the application.

††††††††††† But if they are independent, they have to come up with the resources in order to fulfill the requirements and I think that's one of the questions that was brought up earlier on does everyone fulfill these requirements or participate in these voluntary programs or not.I'm trying to explain one of the reasons why it has not been followed through by a lot of surgical practitioners as independent practitioners.

††††††††††† I personally believe that the problem of dealing with breast disease and breast abnormalities should be addressed by the Residency Review Committee.This is a committee which reviews the material taught to the surgical residents.I think image guided breast biopsy and therapy should become part of the resident training program.

††††††††††† What we are dealing with now is insure that today's practicing surgeons are familiar and they practice correctly and they know how to handle biopsy or how to read the mammogram and so on.I think for the future this should be addressed at a much earlier stage of training of the surgeons.

††††††††††† You should be taught at the residency level at the major teaching hospitals.They all should have image guided training programs.This is a rapidly evolving field for which the trainees should be given instructions and then subsequently the American Board of Surgery should test them in order to assure that they are qualified for practice in this field.

††††††††††† That's my last one.I addressed the subject in a very general way but I would be happy to answer any specific questions to the best of my ability.

††††††††††† CHAIR HENDRICKS:Yes.From the panel first.Dr. Williams.

††††††††††† MEMBER WILLIAMS:This is Mark Williams.This is actually a question for either of the last two speakers.I was wondering.The ACR was obviously involved in putting together this accreditation program for the ACS.Could either of you just say in a couple of sentences what the major differences are between the two in terms of either the accreditation application process or in the quality control procedures recommended?

††††††††††† DR. DOWLATSHAHI:As far as I know, there isn't a whole lot of difference.The brochure that I gave you I was involved with this development about four or five years ago and then it was recently revised.But it was developed jointly with the College of Radiologists.Would you like to add to that?

††††††††††† MS. BUTLER:Penny Butler, American College of Radiology.The requirements of the program are exactly the same between the American College of Surgeons' program and the American College of Radiology's program.The really only difference is administrative.The initial contact is made through the American College of Surgeons' Office but the review is done by the American College of Radiology reviewers for the American College of Surgeons program and then the results letter obviously goes to the facility from the American College of Surgeons.

††††††††††† CHAIR HENDRICKS:I have a question for clarification, Penny, please regarding the applications.Have they all been under the collaborative track or have some facilities, some physicians, applied and been accredited on the independent setting track?

††††††††††† MS. BUTLER:In the American College of Radiology program, I would say most of the applications come under the independent setting track and because mostly radiologists are attracted to the ACR program, most of those would be radiologists.Although we do have some surgeons apply to our programand they'll also apply to the American College of Surgeons.

††††††††††† CHAIR HENDRICKS:I do note in reviewing the document that there do seem to be some differences related to the quality assurance activities.This is in response to Dr. Barr's comment about following up the number, some audits details, of biopsies, cancers, followed, biopsies needing repeat biopsies and then the false negative and PPV values in the practice.So is there some of that data that is being generated now as part of the current accreditation process for the physicians on the independent track?

††††††††††† MS. BUTLER:Unfortunately at this time, we are requesting this audit data but it's not a requirement that they do it and I think I have that in here.But we're trying to get that data.I don't have that data analyzed in order to present.

††††††††††† But another thing I did want to point out to Dr. Barr's question, of course you only think of these after you sit down, is regarding the diagnosis and correlation we don't have that for mammography either.

††††† ††††† CHAIR HENDRICKS:Thank you.I have oneother question for both of you related to how the surgeons who participate in the collaborative setting track to meet these accreditation criteria, how they document that they have read the 480 mammograms in conjunction with a radiologist or independently with separate, I don't know what the language is, for confirmation of their mammography requirement to be accredited?

††††††††††† DR. DOWLATSHAHI:I think if I just answer that question with the focus on surgeons who more than 50 percent of their practice is breast surgery.They see easily, myself I see, more than 20 patients a week and that comes up to 1,000.I think that's because 95 percent of my practice is breast surgery.But for those who are even 50 percent of their practice is breast they easily see 480 mammograms either independently or in conjunction with a radiologist.

††††††††††† CHAIR HENDRICKS:So is that an assumption that those physicians met that criteria based on this descriptor or is there someway to quantitate the matter?

††††††††††† DR. DOWLATSHAHI:Do they actually write it down on a daily or weekly basis?I think some do but not all.

††††††††††† CHAIR HENDRICKS:So it's not a requirement at this point in time to demonstrate that the physicians on the collaborative setting track the mammograms.

††††††††††† DR. DOWLATSHAHI:That's part of the requirements.It's part of the requirements that they should read or interpret that many mammograms every year in order to remain on the ball.

††††††††††† CHAIR HENDRICKS:Thank you.Yes, Penny.

††††††††††† MS. BUTLER:Penny Butler, ACR.From the American College of Radiology perspective just to differentiate, the American College of Surgeons evaluate the personnel qualifications and the ACR evaluates the personnel qualifications for facilities accrediting through us.We require them to sign anattestation that they have met these qualifications and then when we do site visits, we notify them that they must agree to a site visit at any time.When we do our site visits, one of the things that we look for is a log for whatever setting they're in that they actually have that documentation in place.

††††††††††† CHAIR HENDRICKS:Thank you very much.Other questions or comments from the panel or from the audience?Yes, Carol.

††††††††††† MEMBER MOUNT:I have a question for both of you or either one.What happens when you have a facility where the radiology department has an accredited biopsy table and the radiologist and their team is accredited.The surgeon also wishes to use that table and they are not accredited?What happens or does it work?

††††††††††† DR. DOWLATSHAHI:This is Dowlat from Chicago.I think the surgeon usually has taken the training course either by the College of Surgeons or by another accredited organization and is familiar with this procedure.Therefore he may not have that document from the College of Surgeons yet if that is what you are talking about.

††††††††††† MEMBER MOUNT:Right.I'm just wondering.Is it then legal for him to use this machine that is accredited?

††††††††††† DR. DOWLATSHAHI:Is it legal?

††††††††††† MEMBER MOUNT:If it were a mandated process, would it be?

††††††††††† DR. DOWLATSHAHI:I think that would be yes.But at this point because it's a voluntary program the onus is on the surgeon to have taken the course and to have passed the test because also taking the course, they are given a test to insure that they have understood and they know how the machinery works before they go to the site.When they go to the site, they usually are supervised in the first cases either by another surgeon or by a radiologist.

††††††††††† MS. BUTLER:Penny Butler, American College of Radiology.In the ACR program, I would hope that scenario would be covered under a collaborative setting and that the surgeon would be working with a radiologist in that setting and would have the appropriate documentation available to show that the individual is qualified.

††††††††††† Unfortunately, that's not always the case and the accreditation has been applied for by a radiologist.One thing that we have in our survey agreement with all of our voluntary accreditation participants is that all personnel that work in the procedure must be qualified and that the lead interpreting physician there is responsible to making sure that all personnel meet the qualifications.If the qualifications can't be documented that they've been met, the American College of Radiology would have to look at as to whether their accreditation could be maintained.

††††††††††† CHAIR HENDRICKS:Thank you very much.Any other questions or comments from the panel?Yes, Dr. Ferguson.

††††††††††† MEMBER FERGUSON:Does the American College of Surgeons believe that accreditation should be mandatory?

††††††††††† DR. DOWLATSHAHI:Not being directly in the College myself, I think the answer is that at this time they think if the voluntary system works they should keep it as such.This very question was actually debated several years ago when I was intimating involved with this program and it was tabled.I don't know what is the official view of the college at this time.

††††††††††† MEMBER FERGUSON:Your personal view.

††††††††††† DR. DOWLATSHAHI:My personal view is that this is a kind of a skill that a surgeon should have.If he or she is going to treat a patient for diagnosis or treatment, it makes no difference whether it is an imaging program related to breast or to the heart or liver or gall bladder or something.He and she should have that skill.It's the same as a biopsy, introduce that instead of full dissection.Thirty patients area minimum number of cases done before the surgeon knows that he or she is adequately skilled to operate on their own.

††††††††††† The same thing is here.I think they should know enough to be comfortable and secure that they do a good job and they fulfill the criteria for QA and QC.

††††††††††† MEMBER SEGELKEN:Jane Segelken.I just have a comment about that and in a rural community for example where I'm from, there are only 20 people a year even diagnosed with breast cancer.So when you're talking about such a small number of people to have that kind of experience may or may not happen.So at least you'll have an important comment to make.

††††††††††† CHAIR HENDRICKS:The access question.Do you want to respond to her before we move to the next comment from a panel member?

††††††††††† DR. DOWLATSHAHI:Sure.You want me to respond to that.I think a small community is when 20 breast cancers are diagnosed a year.It may unfair for a surgeon or radiologist to go into the trouble of learning this procedure and to become quite skilled at it.I think it may be better if the people from the small community went to a larger community near by.I don't know the geographic location of your center, but I think it would be to the advantage of the patient to travel maybe 50 miles to a larger center where the surgeons and radiologists are very accustomed to this technology.

††††††††††† CHAIR HENDRICKS:Thank you.Another comment from the panel?

††††††††††† MEMBER MARTIN:Melissa Martin.A question and maybe I missed it.You're both talking about programs.We've heard numbers about 3,000 units available.We saw numbers around 475 are currently voluntarily accredited.Do you have a breakdown of how many are accredited through the ACS program and how many of those 475 or so through the ACR program are the standalone surgical centers?

††††††††††† DR. DOWLATSHAHI:I think most of the numbers that given to you are by the ACR.Very few are through the ACS.

††††††††††† MS. BUTLER:Penny Butler, American College of Surgeons.(Laughter.)Let me take that back.

††††††††††† DR. DOWLATSHAHI:Now that you brainwash her.

††††††††††† MS. BUTLER:Currently with the American College of Radiology.Currently we have in our records I believe it's 12 facilities accredited through the American College of Surgeons.I don't have a precise number for the number of independent surgical practices that are accredited through the American College of Radiology.It's not a large number though.

††††† ††††† CHAIR HENDRICKS:Carolyn Hendricks, just a follow-up.What steps can ACR take and ACS take to increase the proportion of centers that participate in the program if we want to continue along the voluntary pathway?

††††††††††† MS. BUTLER:We have been trying.For all of our voluntary accreditation programs, we've embarked on a marketing effort to raise the visibility of these programs.There has been some success working through third party payers who are obviously very much interested in scorecards and paper performance and everything else and some of them have become more interested.But I think if you look at the tracking of the number of facilities that have achieved accreditation since 2000 it doesn't appear that this has made a significant difference.

††††††††††† CHAIR HENDRICKS:Thank you.Maybe we'll take one more comment before our break.Welcome.

††††††††††† MS. WILCOX:In terms of the third party payer --

††††††††††† CHAIR HENDRICKS:Please introduce yourself.

††††††††††† MS. WILCOX:I'm sorry.Pam Wilcox, American College of Radiology.

††††††††††† CHAIR HENDRICKS:Thank you.

††††††††††† MS. WILCOX:In terms of third party payers, the ACR has been heavily marketing our accreditation programs to payers as a way to improve quality.And unfortunately, although my soapbox isfrequently to talk about stereotactic breast biopsy and breast ultrasound and the deficiency rates that we see there, they're really not interested because they're not high ticket enough items.They're much more interested in MR, CT and PET.So it is highly unlikely from my experience that the payers are going to look at making these programs mandatory.Thank you.

††††††††††† CHAIR HENDRICKS:Thank you.Yes, one comment.Diane.

††††††††††† MEMBER RINELLA:Just one quick final question.Diane Rinella.Of these facilities that are accredited with the ACS, these stereotactic tables, then that facility that is ACS certified does not have to have onsite a radiologist.Is that correct?So then the surgeon is going to be looking at films that the patient has brought in, assessing those films and then targeting the area themselves.

††††††††††† DR. DOWLATSHAHI:That's correct.

††††††††††† MEMBER RINELLA:Okay.Thank you.

††††††††††† MS. SPRINKLE:I just have one comment.

††††††††††† CHAIR HENDRICKS:Please introduce yourself at the mike first.

††††††††††† MS. SPRINKLE:Yes.Susan Sprinkle, mammographer, mammography technologist and consultant with Advanced Health Education Center in Houston.I just have a comment.Since Diane brought that up, it's the perfect time.It is also if you are not accredited, if your stereotactic program is not accredited, through the American College of Radiology, you do not have to have a qualified mammographer doing the procedure with the radiologist or the surgeon.We have gotten request at my company to train RTs to do stereotactic procedures and we have issues with that.We believe that a technologist that is assisting a radiologist or a surgeon in a stereotactic procedureshould be a qualified mammographer.

††††††††††† CHAIR HENDRICKS:Thank you for that comment and with that we'll take a 15 minute break.Off the record.

††††††††††† (Whereupon, the foregoing matter went off the record at 10:48 a.m. and went back on the record at 11:03 a.m.)

††††††††††† CHAIR HENDRICKS:On the record.I'd like to reconvene the meeting and ask the panel members in the audience to take their seats.Again just as housekeeping item, we want to ask all the speakers at the podium to state their names clearly so that it can be incorporated in the transcript of the meeting and so that our panel member at a distance can hear all the comments.We would like to keep the noise in the audience at a minimum so the participants and the panel members can hear the speakers.

††††††††††† With that, we'd like to welcome our speaker to the podium, Donald Flater who is Chief of the Iowa Bureau of Radiologic Health.Welcome.

††††††††††† MR. FLATER:Good morning.I want to make something perfectly clear and that is in Iowa stereotactic accreditation and certification is mandatory.

††††††††††† I'd like to first start out by giving you a little bit of information about the State of Iowa and our program.We only have 2.8 million people in the whole State of Iowa.We have 138 hospitals.Of that, 96 of the hospitals are below 50 beds and probably half of that number are below 20 beds.So we don't have a lot of big ones.We have one large one or we think it's large and that's a 1,200 bed and that of course is the University of Iowa Hospital.We currently have 156 mammography units in the State of Iowa plus we have two digital units.That does not include the count on the stereotactics.

††††††††††† Now I'll refer to the handout that you have.Stereotactic units in Iowa, we have 24 which of that 24 there are two units that are mobile and there are three units that are upright.The rest of them are the supplying type units.Currently we have 85 radiologists in 22 facilities and physicians that are not radiologists, we have 24 that are in six facilities.Two of those facilities are solely surgeon facilities.They have no connection to radiologists.And four of those facilities have both radiologists and surgeons that use the stereotactic units.

††††††††††† Listed below, the information on the physicians, are the noncompliance issues that we've had so far in 2005 relative to our regulatory program.We inspect each and every mammography unit and stereotactic unit annually and the reason we do that is the Iowa Administrative Code mandates that we have no choice but to do that.

††††††††††† You can see listed there the different types of noncompliances that we have found and I would call your attention to Items 7, 8 and 9.Seven, 8 and 9 all refer to one facility.The reason for Item No. 7 being there is that this whole process on these units happens to be a fraud issue where an individual fraudulently manufactured the phantom pictures.She did this on 11 different times that we know of.The reason that No. 7 is there is our attorney believes that in doing this she definitely jeopardized the public health and safety relative to patients that are going through stereotactics.

††††††††††† This individual has in fact gone to court and we are waiting the final decision of the judge.What we have asked is that her certificate to practice mammography be revoked which basically means that it never could come back into effect.This happens to be an individual that has 26 years of experience at the facility where she did in fact the fraudulent activity and she does have about four years in another place.So she has 30 years of experience.We also found the same type of fraudulent activity in the regular mammography program.

††††††††††† You can see the rest of the information that's down there, the different ways that physicians can become qualified.Also attached there are the rules do specifically address the stereotactic processes and on the bottom of it you will notice the note the Iowa Administrative Code.

††††††††††† You have to be a little careful in Iowa.We talk about things like Iowa Code and Iowa Administrative Code.Iowa Code is law.Iowa Administrative Codes are rules.I give you this information and if you'll note that on page 42 of the document is where the actual stereotactic information can be found.

††††††††††† We change rules on a routine of about once a year.As things change, we change rules as they're necessary.So it's a process we don't worry about.We're not like some places that take a long time to get rules through.Our maximum amount of time for a rule is from the time it becomes a notice, about five months, and it's in place.So we don't have a long period of time.

††††††††††† I would say that the program has worked well.We started back in the mid ?90s.We have not had a lot of complaints at least that have come to my office.We did have some difficulties with the surgeons at first because they had never been through such a program or such a process.So they did have some trouble meeting some of the requirements.We've kept the same requirements ever since we started and in most cases, they have met them.

††††††††††† We did have a bit of a problem with some of the physicists inspections and that getting them done in a timely fashion and that kind of thing.But that will all straight out.It's just a matter of bringing it to their attention and asking them to get it.

††††††††††† So it's been a good process.We do enjoy it.Of course, this is one where we do not have oversight from the FDA, but we're more than willing to share our information with them and we do talk with Dr. Finder every once and a while about issues that come up.

††††††††††† One other point that we are in fact trying to deal with at this point in time is the radiologist assistants.In this area, we have received a request from a training program that they be allowed to provide training to the radiology assistants.

††††††††††† Where our concern comes in is I know in the information that has been put out it says that they won't do any interpretation.That may be true in your setting that is not rural.But we have a number of facilities in Iowa where the radiologist is located at another hospital.The radiology assistant come in.They do their work and then they take all that information back to the hospital and at times, they do make interpretations.

††††††††††† So I can see this program going the one step further and running into that issue.I'm not too sure it's not going to go that same way on our regular mammography program.I think those requests are going to come in as we have the continued problem with people and the number of people going into the practices and that kind of thing especially in the rural communities.We have one radiologist that covers seven different facilities.He likes to fly.So he flies from one to the next one to the next one.But we still run into some problems there.

††††††††††† So we're going to have to deal with that issue.We do approve schools and that kind of thing.So I'm sure we're going to get into the middle of that.

††††††††††† Again as I said, the rules are there.They're very specific.We do mandate and this is where we try to plagiarize quite bit on the ACR.We do use their quality control information and we do mandate those kind of things.That's all I have unless I can answer some questions for your folks.

††††††††††† CHAIR HENDRICKS:Dr. Williams.

††††††††††† MEMBER WILLIAMS:This is Mark Williams.I just have one little question.You plagiarize thequality control from the ACR, but I notice that you didn't, unless I'm just overlooking it, include assessment of the collimation which actually can be a fairly important thing in stereotactic biopsy.Was that on purpose?

††††††††††† MR. FLATER:It probably wasn't on purpose.I didn't realize it was an issue but we certainly can take it up and we'll take it back and find out what's the problem.We do use physicists in fact in Iowa.In order to be a physicist on list you have to be either board certified or board eligible, one of the two.And that has never come up as an issue.

††††††††††† One of the noncompliance problems that we have had, you'll notice that No. 1 is they're not following the recommendation of or the indication from the physicist which we go back and force them to do once we find out they haven't followed that.So the collimation issue may be addressed at that point intime.If the physicist says there's a collimation problem, they're going to have to fix it.

††††††††††† MEMBER WILLIAMS:Okay.I just didn't see it in your list.So I don't know if the physicist is looking at it or not.

††††††††††† MR. FLATER:I certainly will check on it.

††††††††††† CHAIR HENDRICKS:Carolyn Hendricks, Panel Chair.Just for clarification, does your program have the same clinical component as the ACR program and, if so, what are the details related to the image review?

††††††††††† MR. FLATER:The image review, we require that they do provide images.The images go in front of what we call our clinical image review group.We have seven radiologists under contract.We provided the funding for them to all be trained as individuals that do stereotactics.We had that done at the University of Iowa and then they are required to meet the same requirements as we have here.Even though they don't necessarily have stereotactic at their facility, they have to meet the same requirements inorder to be an interpreting physician.

††††††††††† CHAIR HENDRICKS:Did you employ similar criteria for pass and fail and, if so, what kind of data do you have on your facilities at this point in time regarding pass rates and failure rates?

††††††††††† MR. FLATER:I can't answer that question because I'm not the one that takes care of that part of it.I listened to what Penny had to say and I'm certainly going to go back and ask our folks exactly what criteria they do use for the actual image review process.

††††††††††† CHAIR HENDRICKS:Yes.Dr. Barr from the audience.

††††††††††† DR. BARR:Helen Barr, FDA.Mr. Flater, do you have any evidence that with your mandatory program that there has been either an increase in capture of lesions during stereotactic biopsy or a decrease in missed lesions?Do you have any measurable evidence that quality in this area has been improved with your mandatory program in effect?Thank you.

††††††††††† MR. FLATER:No, ma'am.We do not.We do not track that.

††††††††††† CHAIR HENDRICKS:Yes.Dr. Ferguson.

††††††††††† MEMBER FERGUSON:My question after listening to all the discussion earlier about mandating accreditation which I think would certainly improve in a lot of areas.The only area that I hesitate in is in access for rural areas.I think you started off saying about you had many small hospitals and Iowa is a rural state.Do you have problems with access?How far do people have to go to be able to get a stereotactic biopsy?

††††††††††† MR. FLATER:I can't tell you on the stereotactic side, but I can tell you on the normal side.We may be one of those aberrations in the whole process.We have grown in size ever since the program started in the 1990s.We started out with 141 mammography facilities.As I said, we are now at 156.

††††††††††† For whatever reason, our farming communities want their mammography facilities so that they are very accessible and they're more than willing to pay for that.We have two of the digital units in the State of Iowa.One of those is one in a very small town of Storm Lake, Iowa.It was given by a farmer who gave the hospital the farm and said, "You must make a women's center" which was paid for with cash including a stereotactic unit.

††††††††††† So we are having no problem with accessibility.We haven't lost any of the stereotactic units as far as them quitting or anything like that.We haven't had that kind of a problem.

††††††††††† MEMBER FERGUSON:And you do have them in relatively small communities.

††††††††††† MR. FLATER:They're spread out.Most of them are in the 200 bed and greater hospitals but they're spread out throughout the state.We have the major centers of course spread clear out through the state.They do have to go a little further but not that far.Most of them will take that when they get to that far part.The surgery when they get the confirmed cancer, they will do whatever they need to do in order to get that kind of service.

††††††††††† MEMBER FERGUSON:Do you, and I'll be short, have any type of program for women who don't have the means to travel for care, for gas, for transportation?Do you have any programs like that?

††††††††††† MR. FLATER:We have the breast cancer detection centers set up within the state health department and they will pay for individuals that need to have the different kinds of exams.I cannot tell you for sure what they will do for the stereotactic.I know for the diagnostic that they pay for them on a routine basis.

††††††††††† MEMBER FERGUSON:Thank you.

††††††††††† CHAIR HENDRICKS:Carolyn Hendricks, Panel Chair.Just a question about the pattern of violations that you've seen during your inspections of the stereotactic units.For example, from the data that we see from MQSA is there a high proportion of facilities with no violations or where these violations scattered across facilities?Other than the three that you indicated might be related to fraudulent behavior of one employee, how were the remainder of the violations scattered across the facilities?

††††††††††† MR. FLATER:We don't see them.There are a few here and there like we missed some of the surveys and that kind of thing, but they're sort ofsporadic and sometimes they are ones that it's just an "Oops" they didn't make it within the 14 months.It may be because it was 15 months.Many of our physicists are much like Melissa or they travel so getting them coordinated so they happen at the exact time.They may be at 15 months instead of 14 months and that kind of thing.

††††††††††† So we're not seeing them lumped together or anything like that and we're not seeing repeats.Repeats we watch very closely because in our system of regulation if it repeats, if you repeat one time, you are eligible for civil penalty and our civil penalty is $1,000 per violation, I'm sorry, $1,000 per violation per day for every day of violation.So if you find it and it runs for a routine period of time, it can get expensive real quick.So they are very much aware of that and they try very hard to not have it.We don't have anybody who are "bad actors" if you will.We've gotten rid of most of those through the regular MQSA program.

††††††††††† CHAIR HENDRICKS:Thank you very much.When you added stereotactic to your mammography inspection procedures, did you find or did the facilities or the physicians, the technicians, the physicists feel that the requirements increased their burden?

††††††††††† MR. FLATER:I don't believe it did for the same reasons that Penny gave.We had the MQSA in.They were used to that.My folks are in there so often that it's just a routine type thing.We call ahead of time.We make scheduled visits.We've even gone to a point that if they're very busy on the day we need to come in that we'll do it late afternoon or some time when the unit isn't in use.So we've accommodated the facilities that way.I don't think that there's been a problem with patient flow.There may have been a bit of a problem with people having to spend a little overtime if we come in at night and that kind of thing.

††††††††††† CHAIR HENDRICKS:Thank you very much.Other questions or comments from the panel or from the audience?

††††††††††† CHAIR HENDRICKS:I do have a follow-up question related to how you handle specifically the physician personnel.If you had, for example, surgeons who wanted to participate who did not meet your criteria as outlined in the guidelines, how do you manage that in your facilities?

††††††††††† MR. FLATER:They aren't allowed to do it. It's plain and simple.It's the rule and they have to meet the rule.The rule went through a complete hearing process.We've worked with the surgeons group.We've worked with the radiologists and if you can't do it, you can't do it because it relates back to the care of the patient and it needs to be a qualified individual who is properly trained and that's the general philosophy that we follow.

††††††††††† CHAIR HENDRICKS:Other questions or comments, Panel members?The audience?Thank you.Very interesting presentation.

††††††††††† MR. FLATER:Thank you.

††††††††††† CHAIR HENDRICKS:Next we welcome Dr. Barr back to the microphone to continue her discussion for the panel and for the audience reviewing the Institute of Medicine Recommendations Regarding Interventional Mammography.Dr. Barr.

††††††††††† DR. BARR:Thank you very much.Again since this is probably my last opportunity to speak with you, I wanted to thank you once again all for being here and for giving us your expertise and thank you to the members of the audience who have provided their expertise, thoughts and opinions.

††††††††††† First, I would like to go back to yesterday because I thought that there was a slide in here about this IOM recommendation and there wasn't.So I neglected to cover this yesterday and a couple of people have spoken about it today.One of the IOM recommendations was to change MQSA to Breast Imaging Quality Standards Act to include all breast imaging procedures apparently.I'd like to point out that when we were discussing things like ultrasound and MRI, etc. that since that's not defined as x-ray of the breast, this particular thing instead of a regulation would require statutory change to include other non x-ray imaging modalities under a statutory act like this.I just wanted to make sure that everybody was aware of that.

††††††††††† What I'm going to do is quickly run through the slides I have on the IOM recommendations related to stereotactic breast biopsy and then after lunch, we can have a discussion related to this.

††††††††††† One of the IOM's recommendations was to remove the exemption for stereotactic breast biopsy procedures and develop regulations.Section 900.2(aa) states that mammography means radiography of the breast but the purposes of this part does not include radiography of the breast performed during invasive interventions for localization or biopsy procedures, but they would like to delete those words, or biopsy procedures and radiography of the breast performed with an investigational mammographic device as part of the scientific study with FDA's investigational device exemption.This is also not part of this.

††††††††††† So the rational to remove the part that would exclude biopsies, stereotactic breast biopsy, this is IOM's rational.While it uses mammographic

x-ray imaging, FDA indicated its intent to regulate interventional and that was in the preamble to the proposed final regulations in 1996.The profession now has more experience with stereotactic procedures and I would assume in there is the fact that there is an accreditation program for stereotactic imaging.

††††††††††† These are some comments in the report by IOM on interventional mammography regulations.It talks about the ACR and American College of Surgeon joint qualification set for physicians performing stereotactic breast biopsy which includes requirementsfor CME and continuing experience.These standards became the basis for ACR's and American College of Surgeons' voluntary accreditation program.

††††††††††† It says, "However in testimony to the Senate Committee on Health, Education, Labor and Pensions on the reauthorization of MQSA, the American Cancer Society noted of the 4,000 to 5,000 interventional mammography machines," I note the up to 2,000 increase in stereotactic units predicted than we've heard from other sources.Fewer than 500 are accredited through the ACR program.Only 11 are accredited by the American College of Surgeons' program.In similar testimony, speakers on behalf of the Komen Breast Foundation and the Society of Breast Imaging advocated removing the exemption on interventional mammography procedures.

††††††††††† The committee urges FDA to remove the exemption of all interventional mammography from MQSA.I see here that they're including all stereotactic biopsy procedures and equipment used for interventional procedures such as needle localization.But I'm not sure that the wording to make that happen was part of the recommendation.But anyway, here it says that they apparently intend their recommendationto include needle localization should be regulated.There is no accreditation process for needle localization in place at the moment.

††††††††††† The committee believes mandatory accreditation of interventional equipment, not the interventional procedures themselves is sufficient.That stands on its own, I guess.In addition, FDA inspectors should be trained to perform onsite inspections of stereotactic breast biopsy procedures and interventional equipment as a paper review and review of films obtained by the site would be insufficient for insuring quality.

††††††††††† Just some thoughts as we prepare to discuss this issue this afternoon.Since I came into FDA six years ago, I have repeatedly asked the question and some of you have heard it because you've been on this committee before that we're a public health agency and where is the public health risk to patient if we're not regulating these biopsy procedures.So far, I have heard reasoning that we should regulate them because we said that we were going to.I've heard reasoning that we should because these procedures involve x-ray, imaging of the breast.I've heard, and not to diminish them in any way, anecdotal reports of patients who have had their lesion missed on core biopsy which of course if we go through we can hear about any medical procedure.

††††††††††† What I have not heard is the evidence that we had back when MQSA came into effect that there's a risk to the general public health, not to individualpatients, but to the public in general where we had a nation wide survey that showed us the poor image quality of mammography and the problems with dose and I have not to-date heard evidence that in places where there are mandatory programs that there is factual evidence that we can point to that regulation has improved quality in this area.I think in MQSA we have the 25 percent reduction in breast mortality and although we can't specifically say that's MQSA we know that in large part in addition to improved treatment that MQSA has to be a part of that mortality decline.

††††††††††† We searched our own database here from our Office of Surveillance and Biometrics who gets reports in on any medical device that's being used that has some sort of problem related to it.We had them look back in the last two and a half years.They found six reports related to interventional procedures.

††††††††††† It was often difficult to sort out what the person reporting was actually trying to report.But as best as we could determine of those six reportsa number of them were related to inadvertently pulling out a needle during procedure.I can only assume that probably was related to needle localization.I can't see where that would happen too often with core biopsy.At one point a couple years ago, there were reports of one stereotactic needle that the tip could shear off.So that's information that we have that we can add into this discussion here.

††††††††††† MEMBER MARTIN:Dr. Melissa Martin.I guess the only thing I would reiterate is the data that Penny Butler showed from the voluntary accreditation program that approximately one-third of these facilities who we would assume are the ones that think they are doing good work are not meeting the initial or the repeat rate for accreditation.I think that is hard data that we have to work with.

††††††††††† DR. BARR:And that same thing did happen in mammography when we first started too.What I was asking Ms. Butler is if we have any evidence that those failures relate to a lesion not being captured.Since the facility is submitting its best work, it's certainly hard for me to believe that they would submit films on procedures where they didn't obtain the diagnosis.

††††††††††† So do we have any correlation that these failures relate to a nondiagnostic core biopsy?Certainly there are accreditation failures and we can say whatever we want.It just like Ms. Butler said.We don't have it for mammography.Does failing mammography accreditation mean that they're nondiagnostic mammograms?

††††††††††† I've seen a number of the mammograms in our review process that fail accreditation and there are things that could be better about the mammogram.But in most circumstances, it doesn't mean the mammogram wasn't diagnostic.In these circumstances, do these accreditation failures mean that if we're saying one-third of these facilities are missing?They're not diagnosing, not capturing, the lesion on core biopsy then I think that's a serious problem.I'm not sure that accreditation failure means that.

††††††††††† CHAIR HENDRICKS:Yes.Dr. Williams.

††††††††††† MEMBER WILLIAMS:This is Mark Williams.My guess is that the data that you're looking for are probably a little bit difficult to obtain since what we need to get would be some tracking somehow of what ultimately turned out to be false negatives on missedbiopsies.One example that strikes me is that is that of excisional biopsies in which wire localization was used.We get reports that wire localization is done correctly and that it's accurate and I think in most cases it is.

††††††††††† However we talk to the surgeons and the surgeons say, "The wire sometimes misses the lesion by up to a centimeter or more" and the reexcision rate for positive margins is about 50 percent.Now not all of that can be attributed certainly to poor localization.However it just shows that if you dig into the process as to what all the things that could contribute to those that those miss, I think it's very feasible that's part of the localization or the imaging process that could be playing a role.It's just very hard to segment that out from the other things.

††††††††††† DR. BARR:Yes.And I certainly agree with you and I certainly agree with your statement about wire localization.I think it is a fairly inaccurate way to go about making the diagnosis of breast cancer.Yet interestingly enough, where we probably have more evidence that repeat excision rateindicates that wire localization is not always accurate we don't have an accreditation program that deals with people's ability to do wire localization.

††††††††††† MEMBER WILLIAMS:Right.

††††††††††† CHAIR HENDRICKS:Input from other panel members?Yes.

††††††††††† MEMBER MOUNT:Carol Mount.In my observation of some of the rural areas where we have both radiologist and surgeons using a stereotactic table that is not accredited, I get frequent calls from the radiologists at those facilities saying, "What can we do about this because the surgeon is in there without a technologist trying to position this patient?"Finally I said, "Why don't you count the number of exposures that they have taken, the number of times they've tried to position that patient and not been able to find the area that they're looking for?Maybe then you could work with the physicist to actually get the dose that patient received during that attempt."

††††††††††† They started doing that.The surgeon is still doing stereotactic biopsies and they are going to get accredited and thus my earlier question as to what do you do if the radiology department is accredited and the surgeon is not, so two facilities that I know of in our immediate area that that very thing is happening.I think if this does move forward there has to be very specific dose and positioning training offered to those physicians if they're not going to have a technologist in the room helping them.

††††††††††† CHAIR HENDRICKS:Thank you.That's a useful comment and it's exactly the kind of information as a public health official that I would like to see which I'm not seeing at least on a basis other than anecdotal exactly the kinds of things that you're talking about.

††††††††††† MEMBER MOUNT:They don't know what to do with it or who to go to.

††††††††††† CHAIR HENDRICKS:Thank you.Other comments from the panel?I do have a follow-up question for you, Dr. Barr, related to how we can today as part of this meeting use the preliminary data from the ACR voluntary accreditation process.Because as I heard that data for the first time, I do think that it speaks to some significant technical problems and issues related to the skill of the surgeons and radiologists performing the procedure at this point in time.

††††††††††† Because if you look at the information that was presented, the bar was set relatively low as I understand it.In the two tracks, the requirement is to perform perhaps the 12 procedures in a year and then submit one set of films really on the calcifications which is really the role of stereotactic biopsy procedure.So the facilities, the voluntary participants, have submitted just one case out of the minimum of 12 and we have acknowledge that the failure rate does speak to a significant issue related to skill.

††††††††††† Now it's true if we don't have the outcome, we will never be able to produce survival data, I think, in this area, but it does speak to a significant problem with the technical and the skill of the physicians doing the procedure in my mind.

††††††††††† DR. BARR:I think what it speaks to if it's my understanding and certainly Ms. Butler can correct me if I'm wrong is that we have reviewers saying that we don't think that your needle is placed properly to obtain a diagnosis or perhaps again it would seem to me kind of insane to submit specimen radiographs of a lesion with calcifications and not include them in the specimen.Certainly, that's a technical issue.

††††††††††† I don't think we need outcome data.It would be very easy to have the radiology report and the pathology report submitted along with that so we could see if these needle placement failures result in the lesion being missed or are we failing people on something that doesn't relate to the outcome?

††††††††††† I think the way we can use the information is in a number of different ways.We could do what the IOM says and we could remove the exemption for stereotactic.We could adopt the existing accreditation programs and we could develop an certification procedure and then an inspection procedure.We could say that everybody has to be accredited but have no certification or inspection procedure.There's a number of different ways we could go about this.

††††††††††† I don't know what we would do actually in the case of wire localizations since there is no accreditation program.And certainly, I'm not ignoring the failure rate just as we didn't ignore it in mammography.I'm just not sure what it means and I'm not sure what other evidence like we had with MQSA that we are putting the public at risk by continuing to have the exemption for this.

††††††††††† CHAIR HENDRICKS:Thank you.Dr. Dowlatshahi.Please reintroduce yourself for the record.

††††††††††† DR. DOWLATSHAHI:Dr. Dowlat, Chicago.I have a question about the actual number of the stereotactic devices in the country.The Institute of Medicine quotes to 4,000 to 5,000 machines.I think someone mentioned as far as I called up the manufacturers is it's about 2,000, maybe 2,500.Which one is correct?

††††††††††† DR. BARR:I don't know and I brought that point up.I don't know.It appears the Institute of Medicine is quoting the American Cancer Society with their estimate.Again, I'm not sure we have an accurate answer to that.It would seem to me that manufacturers are the people that could give us the most accurate information about how many units were sold.

††††††††††† EXEC. SECRETARY FINDER:It's Dr. Finder.I just want to clarify one thing and ACR and ACS can correct me if I'm wrong.The review of the calcifications and mass, it's one per facility, not per physician and a facility.Is that correct?

††††††††††† MS. BUTLER:Penny Butler, ACR.It's one per unit.

††††††††††† EXEC. SECRETARY FINDER:Per unit.Sorry.

††††††††††† DR. BARR:So I think Dr. Finder at least obliquely gets to a point which I brought up earlier. I think experience has told us it's not equipment necessarily that's the problem, but the use of that equipment.As you heard Lt. Commander Boyd say our whole focus around health, our strategic planning is to focus on high risk procedures and those where use is a problem we find that users of devices are more where the problem lies.

††††††††††† Here even in this accreditation program it doesn't appear that we address each user of that but again the equipment.Obliquely the user or someone had to place the needle for the films we're looking at.

††††††††††† MEMBER MARTIN:Melissa Martin.I am a consulting physicist and like I said, we cover all of these units because it's a state requirement.But there is really no teeth to any requirement as to what the image quality has to be.

††††††††††† I would go back to, I think, Dr. Williams made the point earlier or Penny Butler may have made the point earlier, when MQSA first became effective we did see a number of units that were removed from service because they are equipment related problems.It's a generation problem.They do wear out and a lot of exactly what I'm finding.It's the older equipment that is getting worn out.It doesn't meet state-of-the-art, what we would have in a modern day if you went out and bought a new unit.But until there's some requirement that says the unit you bought ten years ago is not adequate now, they're going to continue to use it.

††††††††††† DR. BARR:Now we do have, I would like to point out, equipment requirements in MQSA, at least, that equipment has to meet.

††††††††††† MEMBER MONTICCIOLO:This comment actually just relates to the needle localization issue and I don't know about the other radiologists or surgeons here but I wasn't really prepared to address that as a regulatory issue.While localization requires a tremendous amount of cooperation between the radiologist and surgeon, I don't personally having practiced in several different types of practices in different areas of the country, I've never seen wire localization be a significant issue.

††††††††††† The reason is if you're not wire localizing well, the surgeon is going to know it in a second and they're going to come down.Having been a division chief at several places, now I'm going to be the first one to hear about if any of my staff can't wire loc adequately.It's a very basic procedure.It's fairly straightforward.It can be very difficult if a lesion is in a difficult spot in a patient's breast.But we put the wire through the lesion and we have to document it because the films come out with the wire and the breast there on the same film.So it's very hard for us to wiggle out of that.Then a specimen comes back.

††††††††††† Now we do have a problem with some of the older surgeons not believing they need a specimen x-ray to confirm the lesion has been removed.I don't know if regulation would deal with that or not.But certainly the pathologist's report is there.There's either pathology in the specimen that corresponds or it doesn't.I'm not sure if that type of program is needed.It would be onerous I think to develop.

††††††††††† DR. BARR:I know in my practice once we go stereotactic unit even if the patient was for open biopsy, we use the stereotactic unit to localize the lesion rather than free-hand localization.Do you find that in your practice?

††††††††††† MEMBER MONTICCIOLO:No, we don't use the stereotactic table for that.It's useful for lesions that are only seen in one projection because on the stereotactic table as you know, you can do slight off-angle views and get an idea of where the lesion lies.

††††††††††† DR. BARR:Yes.

††††††††††† MEMBER MONTICCIOLO:But that doesn't happen to us very much nowadays with the current equipment.I have done several localizations with stereotactic and usually the issue is that the patient is in a lot of compression and so I find I have to compensate for that and then drop the wire deeper than I would normally for a regular loc.But we generally just use the mammographic equipment and our mammographic equipment is all accredited and passed by MQSA.So I don't see the issues that we have with stereo with localization.

††††††††††† DR. BARR:Since the IOM is apparently including wire localization in their recommendation, could I get some further sense of the committee in that particular area where there is an accreditation program that exists?Is that something we should look to include in federal regulation leaving stereo aside for the moment?

††††††††††† MEMBER MONTICCIOLO:I think that the equipment should be accredited because you ought to be able to form a diagnostic image and I'm not too fond of the idea of somebody saying that old machine we have over there we'll just use that wire locs.I think we're wire localizing smaller and smaller lesions and so the equipment has to be accredited in the equivalent of the others.

††††††††††† We use a mammogram unit that's used for regular mammogram to do our localizations and I think the equipment regulation would be important.Developing an entire program to see if people doing the wire locs are able to do them, it requires so much cooperation with the surgeon that even if I wire loc something perfectly they can miss a lesion just by yanking on the wire.That wire will come right out.

††††††††††† I have a very good relationship with my surgeon.She's fantastic but she occasionally will miss it and she'll say, "I let a resident and he grabbed on the wire and away it went."Those thingshappen.It's not something intended but then we have to go back and help each other do what's right for the patient.So that would be pretty hard to put into a regulatory statute.

††††††††††† DR. BARR:So you would be in favor of lifting the fact that there can now be equipment if it's only used for wire localization, it doesn't have to meet MQSA requirements.You would say that it does.

††††††††††† MEMBER MONTICCIOLO:I think it should.Yes, I would.

††††††††††† DR. DOWLATSHAHI:Dr. Dowlat from Chicago.I think the published report on the wire localization cancer being missed is under two percent and I got the impression from you that you're talking about a much higher figure.I agree with Dr. Monticciolo too that the wire localization is an issue between radiologists and the surgeons.There are times that you do get displacement of the wire and while I double localize, I put wire as well as dyes.So if the wire comes out, the dye is still there.But there are times that you have missed it and the specimen doesn't show it and you have problems, but you tell the patient and you go after it in a couple weeks or thereafter.You don't let the suspicious lesion go by.

††††††††††† DR. BARR:I agree with you.I was only commenting on Dr. Williams' comment that we have reexcision data related to wire localizations.I'm not sure that we have the data like you can tell me how many lesions are generally missed, being excised with wire localization.But can you tell me how many lesions are missed or what the repeat rate is for stereotactic or how many lesions are missed on stereotactic that then go to wire loc?

††††††††††† DR. DOWLATSHAHI:I think the wire localization with the stereotactic is a little bit more dicey the same as it was pointed out a minute ago because after decompression, the wire may move.In my experience, I put more than one for sure.I put usually two.Sometimes if the lesion is a little bit spread out, maybe I even put three wires just for security and add the methylene blue dye to it.

††††††††††† But I think the localization not being perfect, by that I mean with one centimeter, hooking within one centimeter of the lesion, it occurs more with the stereotactic localization than with the orthogonal technique.

††††††††††† DR. BARR:Right.But my point is you were able to come up to this podium and right away tell me that the miss rate on excisional biopsy with wire localization is under two percent.Do we have the same data for stereo?

††††††††††† DR. DOWLATSHAHI:For stereotactic, no, I think the number I gave you is probably the orthogonal technique and not stereotactic because I can't think of the papers.But it is at least close to eight to ten years old.

††††††††††† DR. BARR:Thank you.

††††††††††† DR. DOWLATSHAHI:It was pre stereo I think.

††††††††††† DR. BARR:Thank you very much.Did you want to go first?

††††††††††† MEMBER WILLIAMS:Yes, if I could.I have three comments that I think we ought to bear in mind.One is that places like, I agree with Debbie 100 percent that it's a cooperative venture, the wire loc, between the radiologist and the surgeon.I think that in places that work together well and have very well trained personnel, it can come off very well.But that may leave out a vast portion of our country where people are not necessarily working as tightly together and not necessarily as well trained.So that's one thing.

††††††††††† The second thing is that when I speak to our surgeons at the University of Virginia, we have our breast care center is among the top, what I find out is that really what's going on and this is not to take anything away from the radiologist, they're very good, but the surgeons are very good at being able to take the two views with the wire in there and triangulate and correct if they can see the lesion inthe image and figure out where the wire was really supposed to go.So part of this is we have to ask ourselves to want to really have to force the surgeons to have to do that.

††††††††††† The third comment I would make is that as we detect cancers earlier and earlier and we get a larger fraction of non-palpable lesions, I think even these compensations are going to become tougher and tougher, that is, for the surgeon to make on the fly because it may not be that apparent when they get in there.So I would put that up as a cautionary note before we completely discard the idea of looking into wire loc.

††††††††††† DR. BARR:Thank you.

††††††††††† MEMBER MONTICCIOLO:Debbie Monticciolo.I would just say that I think there is data on the miss rate on stereos.There have been many papers put out looking at miss rates and they have been found to be equivalent to the surgical miss rate which is often quoted at less than two percent.So there is that data.

††††††††††† The second thing I would add and I think Penny point this out is that we're not required when we're accredited for stereotactic to give data on our misses and complications but it's requested.You feel pretty awkward submitting that document without that information and we do it.Obviously it's a voluntary program, but we always look at it and we have data on all of the things that we felt were discordant or we missed a lesion.

††††††††††† It's very unusual for us to miss a lesion actually.With experience, that doesn't happen very often.But we do get discordant results and we keep track of all of that because it's been suggested by the ACR that we do that.So I think most accredited facilities, Penny, you could probably tell me, if they voluntarily give that information.I know you're not gathering it as a big database yet but we were asked to give it and we do.

††††††††††† MS. BUTLER:Penny Butler, ACR.Yes, most of the facilities that do apply will provide us with the information, but we have not put it into a database that we can analyze it.We've told them that we're voluntarily requesting it from them with the thought about going back at a later date and reevaluating whether it should be mandatory or not.

††††††††††† DR. BARR:Penny, do you have any idea when you might get that information in an analyzable form?

††††††††††† MS. BUTLER:In a database?I can't give you an estimate right now.

††††††††††† DR. BARR:Thank you.

††††† ††††† CHAIR HENDRICKS:I have a comment.Carolyn Hendricks, Panel Chair.In our community, the exact reverse of what Dr. Williams alluded to is occurring in that the very small number of breast surgeons are shifting almost all of their procedures to the radiologist, a higher level of confidence, wanting to spend more time in the OR.It's technically difficult to get access to stereo machines in our communities.The busiest breast surgeons are shifting their interventional work exclusively and just confidence in the radiologist.

††††††††††† So the exact reverse is occurring with the surgeons focusing on the primary breast surgery, allowing the interventional radiologists to establish the diagnosis of breast cancer which brings me to my comment.I'm hopeful that we really learn from the demonstration project from the MQSA data that possibly as the ACR accreditation data matures and you're able to compare the collaborative track with the individuals and facilities that are on the independent track that we might be able to compare those two and really determine whether the collaborative approach is the best approach and whether the data is going to be superior in that track.

††††††††††† That is where we know there is an interaction between the radiologists and the surgeons as opposed to the physicians, either surgeon or radiologist that's operating independently to provide data for accreditation with a comparison between those two groups, the two sets of data.I'm not sure.The dataset looks small but it seems that you might be able to look at some of these quality indicators and some of the audit data and the complication rates and compare those two tracks.

††††††††††† DR. BARR:Dr. Hendricks, would you in your opinion then be in favor of waiting for that type of comparison and analysis to be done or going ahead and doing a regulatory program right now where we don't have a lot of that information?

††††††††††† CHAIR HENDRICKS:Carolyn Hendricks, Panel Chair.I do think as I'm listening to the discussion this morning that there is a difference that this advisory committee should take as we approach mammography as opposed to the stereotactic procedure itself and the skill and to hold it to a little different standard.So I think the survey data is very important and that really is the only data that, other than anecdotal data, we've been able to look at.We need good outcomes data but I think we also need to acknowledge that significant deficiencies do exist even in the very select group of radiologists and surgeons that have agreed to participate in the accreditation process as it exists right now.

††††††††††† DR. BARR:So in your opinion, there's enough to proceed with a federal regulatory program.

††††††††††† CHAIR HENDRICKS:As we've heard from the speakers, from the representatives from ACR, it's very interesting of course to look at the audit data as it correlates with the pathology of the breast disease that's being diagnosed and it does sounds like that data is being collected and that would be very helpful.Dr. Monticciolo.

††††††††††† MEMBER MONTICCIOLO:Debbie Monticciolo.I would just say that there is a tremendous body of literature on stereotactically guided biopsy and the successful rate of that procedure.Now what you're speaking of I think, Dr. Hendricks, is a little bit different in looking at sites that go for accreditation and why they fail, etc.I think that's worth looking at, but there is a body of data to show that this procedure can be done well and very accurately.That's been established in the literature for quite some time.

††††††††††† CHAIR HENDRICKS:Yes, I agree.Dr. Ferguson.

††††††††††† MEMBER FERGUSON:Yes, I'm asking for the sense of the committee and I've taken this all in and tried to read all of this.I agree with Debbie that on the wire localization, I believe, the equipment shouldbe accredited.I think that you ought to be doing wire locs on equipment that you can do mammography on.

††††††††††† Also I have struggled with the mandatory accreditation for stereotactic and I think I come down on the side it should be required based on personal experience, based on Melissa's comments that would be the mirror of mine at home and we saw this with MQSA. The people who don't go for accreditation are going to fall out or they're going to update their equipment and their education and their training and their quality control.I think that's what we want to see.

††††††††††† When Debbie mentions the volume of literature on stereotactic, I would bet a lot of money that that literature is coming from accredited facilities who have gone through voluntary accreditation and you won't see the information that you're looking from missed stereotactics because those facilities aren't doing the high quality of work that she's talking about.So I, as a sense of at least me on the committee, would favor regulation and on the issue of needle loc, I would say the equipment should meet the same standards.

††††††††††† CHAIR HENDRICKS:Any other comments from the panel before we break for lunch?

††††††††††† MEMBER MONTICCIOLO:A quick comment because we're waiting for lunch.With due respect to Dr. Williams' remarks about needle localization, as some of you know, I've had several jobs because my husband has moved me all over the country.So I've practiced at Emory and Mass General and in private practice in smaller towns as well as in Texas and California and I have to say I've never seen wire localizations be an issue.What Dr. Williams is talking about is you can't get the wire close enough, you have to converse with your surgeon about how to operate.

††††††††††† But I've really never seen the actual placement of wire and obtaining a specimen if the surgeons and radiologists work well together that being a tremendous issue.I just want to reiterate. I think the equipment is an issue.We would really want to use certified equipment.But having an entire regulatory program for wire localization would be very onerous and I don't think it would be that productive.

††††††††††† DR. BARR:It's fine.I would like to perhaps continue a small bit after lunch with some more questions.

††††††††††† CHAIR HENDRICKS:Absolutely.I would like to thank the panel and the audience and all the participants for the discussion.We'll break now and then reconvene at 1:00 p.m.Off the record.

††††††††††† (Whereupon, at 12:03 p.m., the above-entitled matter recessed to reconvene at 1:04 p.m. the same day.)


















†††††††† A-F-T-E-R-N-O-O-NS-E-S-S-I-O-N

†††††††††††††††††††††††††††††††††††††††† 1:04 p.m.

††††††††††† CHAIR HENDRICKS:On the record.Okay.Our meeting is back in session for the afternoon session.We're going to start out with a continuation by Dr. Helen Barr of our discussion of the Institute of Medicine Recommendations Regarding Interventional Mammography.Dr. Barr.

††††††††††† DR. BARR:Thank you.One thing I have neglected to do although I've thanked all of you is I did want to mention that this is Dr. Hendricks first time chairing this committee and I think she's an absolutely excellent job.

††††††††††† I'm going to try to lead the remainder of our discussion time by trying to summarize things I've heard and trying to conclude some discussions on them.One thing that I heard is that we should consider accrediting the mammography equipment that wire localization are performed on that there should no longer be an exemption that if you only use equipment for those procedures that it is exempt from accreditation.

††††††††††† Dr. Finder, do you have any comments on what that would entail and what that would mean and perhaps we need some further clarification on what people's idea on that are.

††††††††††† EXEC. SECRETARY FINDER:Okay.I would like to ask the question when people said that they felt that equipment used for needle localizations should be accredited and I'm not exactly sure what they mean by that.It's one thing to use a piece of equipment that is also used for mammography where patients are going through that machine and you can actually generate enough images that can be sent for the standard accreditation.

††††††††††† But what do you do with a unit that is used strictly for needle localizations?Those machines under the current situation are not being used for general mammography.How would you accredit that type of unit?

††††††††††† CHAIR HENDRICKS:Yes, Carol.

††††††††††† MEMBER MOUNT:Carol Mount.You always do your post films to show that your wire is in place.Couldn't you use those to view the two-view mammogram you do as your post wire position films as your films that you would send in and then your phantom image?Otherwise it could be the same.

††††††††††† EXEC. SECRETARY FINDER:Big difference in that at least the standard procedure, now you have to submit a bilateral mammogram, two views, of a normal examination or benign examination.That would require a change in the current accreditation process and review process and maybe we could get some comments from the ACR if they would be able to do something like that for those types of units.

††††††††††† MEMBER MONTICCIOLO:Could I make a comment also before we ask for comment from Penny?This is regarding a wire localization and how you would submit films from a unit that is being used only for wire localization.It would be difficult to use wire localization films because you couldn't achieve the same positioning.Getting the amount of pectoralis muscle on a patient that has a wire in her breast is not as easy.So there would have to be some other accommodation.

††††††††††† MS. BUTLER:Sorry for coming in late.Penny Butler with the American College of Radiology.If I think I caught what you were talking about is asking for these dedicated wire loc units how would we test them under an MQSA approved accredited process?

††††††††††† CHAIR HENDRICKS:Yes.

††††††††††† MS. BUTLER:Let me ask our physicians on the panel.It's my impression that some of these may also be used for diagnostic films.

††††††††††† MEMBER MONTICCIOLO:In my place, we don't have any distinction.We only do our locs on accredited machinery.So the issue that Dr. Finder brought up was that if we decide to include machines that are only used for localization into the accreditation process how would they go about it because how do you submit films from that unit?

††††††††††† MS. BUTLER:It would be very difficult to do that because we really wouldn't have a process to evaluate it because we look at adequate film size and other kind of things.But it may be possible under existing system if they also do diagnostic images there rather than just screens and not just MAGs but regular diagnostic images.They could send us the diagnostic images and then in that case they would follow that particular process that we allow in special cases.

††††††††††† DR. BARR:And I suppose if we simply said that these procedures had to be on an accredited mammography unit then the procedure would be the same.It would the same as it is now.

††††††††††† MS. BUTLER:Right.

††††††††††† DR. BARR:There would no longer be able to be a dedication of a machine solely for that purpose.

††††††††††† MS. BUTLER:That would have to be a decision that would have to be made.

††††††††††† MEMBER MARTIN:Melissa Martin.I would like to bring to your attention the fact that I know at least we have at least three surgery centers which have dedicated mammography units in it solely for localization procedures.They do not do anything else except wire locs in them.

††††††††††† I thought the suggestion was made that this be accredited for equipment only.So it would be very straightforward to require that these units pass the physicist annual evaluation.That's what I was hearing is that everyone was in support.That eliminates you having to evaluate the films.But it would still require to have a full physicist evaluation on the equipment.

††††††††††† DR. BARR:And it would require a change in the current accreditation procedures.

††††††††††† MS. BUTLER:Correct.

††††††††††† EXEC. SECRETARY FINDER:It's Dr. Finder.I just want to clarify.Everybody is listening to the same words and coming out with different ideas of what they mean.Accreditation is a defined process in a statute and the regulations and it involves the review of clinical images.

††††††††††† If you're talking about just meeting the equipment requirements and doing certain QC, that's not accreditation.That's something that doesn't exist right now but something that could be looked into.But again, when you use the terms these units then should be accredited, it means something very specific that may not applicable to all the units that are out there and may not applicable to the current accreditation process that exists.I just want to make people aware of that.

††††††††††† DR. BARR:That's a good point.

††††††††††† MEMBER MOUNT:Just a comment about the films on a regular unit being used for wire.When we accredit stereo units, we're not doing the same positioning, the MLO and CC, to get all the anatomy on the film.You're positioning to get the area of interest. So if you were using a machine for wire localization, then too couldn't that just be you're looking at the image for the area of interest and image quality?

††††††††††† DR. BARR:Certainly, that's possible.The difference is that currently there is an accreditation program for stereo and there isn't for wire loc.So one would have to be developed if you were to go that way or as some other people are saying, are we simply interested that the equipment passes a physicist's survey and that's our bottom line of interest there?

††††††††††† CHAIR HENDRICKS:Dr. Monticciolo.

††††††††††† MEMBER MONTICCIOLO:Just two comments.One is, I don't want to speak for Dr. Ferguson, both of us intended that the equipment pass the physicist's QA/QC.That's what we recommended for the wire localization.It's not a full accreditation process.We didn't understand that difference.Thank you, Dr. Finder, for that.

††††††††††† And the second I would just comment on what Carol Mount just said.The images that are submitted for the stereotactic accreditation program, and Penny can correct me if I'm wrong, are not assessed for positioning and they're not assessed the same way a clinical review is done.When we submit, we just want to indicate that we know where the lesion is and what the lesion is that we're going after.So the films are viewed differently.They accept copy films, not originals.So it's not held to the same standard as those that are used for diagnostic purposes.

††††††††††† CHAIR HENDRICKS:Yes.Dr. Williams.

††††††††††† MEMBER WILLIAMS:And furthermore, a lot of the stereo biopsy machines are small field of view.So they can't possibly visualize the entire breast anyway.

††††††††††† MEMBER MONTICCIOLO:The images that she's talking about that we submit, we do submit mammograms with our accreditation but they're copies and they're not judged the same way as clinical mammograms for accreditation.

††††††††††† DR. BARR:So, Charlie, if we would determine that a physicist survey is what we're interested, is there a way of incorporating that into inspection procedures without an accreditation program?

††††††††††† EXEC. SECRETARY FINDER:That's a very interesting question which we would have to talk with our lawyers about.We are bound by what the statute says and what regulations we would write.I'm not 100 percent sure that you can have something that gets certified without being accredited in some manner and how we would write that I don't know at this point.But it's something we would certainly be able to look into.

††††††††††† DR. BARR:But it seems at least that we're hearing that it's the equipment itself and not the skill of the localizer that would be under evaluation.

††††††††††† MEMBER FERGUSON:That's how I see it.I would agree with what Debbie says.

††††††††††† DR. BARR:Okay.Thank you.For stereotactic, a couple things in summary.There is an existing accreditation program.There is a failure, a fairly significant failure rate, at this point, although we don't seem to know exactly what that failure rate means.We should be mindful and take into account of that.There does seem to be a body of literature that seems to indicate that this procedurecan be done well and accurately and at least in the published reports is being done well and accurately.

††††††††††† So where does our interest lie in stereo?Is it the equipment?Is it the user?Is it the team?Where is our interest there?

††††††††††† MEMBER FERGUSON:I think it's the entire team.I think it's the technologist.I think it's the physician.I think it's the equipment.I think it's the same as MQSA.I think we should be holding it to the same standard.

††††††††††† MEMBER MONTICCIOLO:It's Dr. Monticciolo.I agree with Dr. Ferguson.I think the program that's been begun in collaboration between the American College of Surgeons and American College of Radiology is a good one.It's the kind of things I would want to do anyway to insure quality.So I would support including that in regulation.

††††††††††† MEMBER MARTIN:I agree with Dr. Ferguson and Dr. Monticciolo.The program has been developed in collaboration with both the radiologists and the surgeons and it includes all aspects of the program, personnel, machines and procedures.

††††††††††† EXEC. SECRETARY FINDER:This is Dr. Finder.I have a question because there are a lot ofsimilarities but there are differences between mammography and stereotactic biopsy.One of the major differences that I see at least is the ability to obtain outcomes data in the sense of the audits that are currently being done in mammography and are being recommended to be increased by the IOM.They're trying to focus in on outcomes to a greater degree than we have in the past.

††††††††††† And a lot of the big problem with that is the difficulty in facilities being able to obtain the results from patients who they may have seen.That is not a big problem or shouldn't be a big problem in patients who are undergoing biopsies.So presumably for every biopsy done or attempted, there is a result whether cancer was found, whether it wasn't, where the results were concordant or discordant.Is that something that we should be looking at if we decide to go ahead with regulation in that program to a greater degree than we have in the mammography program?

††††††††††† MEMBER MONTICCIOLO:This is Dr. Monticciolo.While I don't agreed that the additional audit that's been recommended for mammography would be very useful simply because I don't think there's any evidence to indicate it's going to change quality and it's going to be a burden.

††††††††††† On the other hand, I think you're right, Dr. Finder.For a stereotactic biopsy, I think we can be expected to get the biopsy results.I mean we're performing the biopsies and I don't know who else is going to get those results if we don't.Obviously, it can go the patient's primary care physician, but I check all the pathology as I think any person that does biopsies should be doing is checking their biopsy results.

††††††††††† And I think if you look at the American College of Radiology's accreditation program, the data that they're asking for, requesting but not requiring right now, is a very good way to audit those programs.It's a reasonable request.They ask for rebiopsy rates, discordance, hematoma formation, those type of things.It's very minimal.It's the type of thing that you would want to do to insure what you're doing is accurate and correct anyway.

††††††††††† So I think we could make that a mandatory data collection without much difficulty.I wouldn't have much heartburn about it.I think it would probably be a good thing.

††††††††††† MEMBER FERGUSON:And I would agree.I think that information is readily available and it's right there on the spot and you should be checking it.I don't see where that would be an undue burden.

††††††††††† DR. BARR:And, Dr. Ferguson, who would bechecking that?The accreditation body would require it.An inspector would look for it.

††††††††††† MEMBER FERGUSON:It would gathered by the person performing the biopsy and then submitted to the accrediting body.

††††††††††† DR. BARR:Would there be an audit that the inspector, like for MQSA, would look at?Do we envision an inspection procedure for stereo?

††††††††††† MEMBER FERGUSON:I would envision the audit data being collected and submitted and you're going to have a fabulous data bank with accurate information.

††††††††††† DR. BARR:I wish we had that now.

††††††††††† MEMBER FERGUSON:Yes.

††††††††††† DR. BARR:Does anybody have comments about inspection in stereo?Do we envision that?What do we envision that looking like?

††††††††††† MEMBER MONTICCIOLO:I'm not sure if I can envision what it would look like.I would say thatit would be nice if the inspection process itself were minimally disruptive on the practices because it does take a lot of time to prepare for inspections and to set the room aside and to do those types of things.It's the same issue with mammography of course.

††††††††††† I would envision the data for biopsy success to go to the accrediting body to be assessed.It seems like an inspection probably could be done with minimal disruption though.

††††††††††† DR. BARR:Thank you.Any other?Charlie, do you have any other, since you are always good at raising the issues, issues on the stereotactic side either to accreditation, certification, inspection that you would like some discussion on?

††††††††††† EXEC. SECRETARY FINDER:Yes.Actually I had sent around a question or a series of questions before the meeting to the committee members and I just want to make sure that we've actually answered some of these questions.And my first question there was have we clearly defined what we consider the problems with interventional stereotactic because I do think that if we believe that the problems are diffuse, we have to have a diffuse type of program where we look at everything and not focus on any one area.If we believe that the problems are more focused in one area whether it be equipment or personnel or audit or whatever, then if we plan a accreditation inspection and certification program, we should try and focus inon those areas.Just my own personal opinion in the mammography program, we focus a lot on equipment and I think while there were some problems there where now getting a state of diminishing returns on that and maybe we would be better focusing on some of the other areas as recommended by IOM.

††††††††††† I'd like to go with that same type of philosophy if we're going to regulate stereotactic.So my first question would be what do people here on this committee really think the problems are and then that will help us direct our focus on what we should do about them.So if anybody has any idea of that.

††††††††††† MEMBER RINELLA:Diane Rinella.Can someone from the ACR let us know as far as the facilities that failed accreditation what percentages of what they failed, films they sent in or what the failure rates were?I mean we got the overall percentage but was it broken down?

††††††††††† MS. BUTLER:Penny Butler, ACR.We did break it down between clinical, phantom and dose.I don't have a further breakdown at this time with regards to calcs versus mass or fibrous specs masses on the phantom.

††††††††††† MEMBER RINELLA:With regards to the necessary requirements of the technologists and what not to perform stereo with the radiologist and all the continuing education and all that, is that listed in here?

††††††††††† MS. BUTLER:No, it's not reflected in there because they don't proceed unless they meet the personnel requirements.

††††††††††† MEMBER RINELLA:So that's not an issue with accreditation for stereo units.

††††††††††† MS. BUTLER:It's not an issue because if they provide a name of an individual and that person does not meet the requirements, we tell them they cannot proceed with accreditation and use this individual to perform the stereo procedures and be accredited.So sometimes they actually shuffle people around on their staff in order to proceed with accreditation.

††††††††††† MEMBER RINELLA:Okay.So then to get to that point then, it always has to be something clinical.

††††††††††† MS. BUTLER:Right.

††††††††††† MEMBER RINELLA:Or with the phantom.

††††††††††† MS. BUTLER:Right.It's the testing we call it.

††††††††††† MEMBER RINELLA:Okay.So the machine.

††††††††††† CHAIR HENDRICKS:Yes.Carolyn Hendricks.I have a follow-up question please.Just for the panel that as a panel if we could hear in terms of the background of the development of this accreditation program.Dr. Finder was concerned about the balance and the emphasis on the technical aspects as opposed to the clinical.So I'm curious in your instances you were accrediting these facilities whether there was a waiting and whether the clinical failure had a higher weight than for example the technical failure.†† As you guys were developing this procedure, how did you weigh those two features of this accreditation process, clinical and technical?

††††††††††† MS. BUTLER:There is not a waiting.Basically you have to pass all aspects in order to pass accreditation.So you may not pass in the phantom which may be considered a technical aspect and pass in the clinical and we would not grant accreditation.You would have to take corrective action and repeat the test so all aspects pass.

††††††††††† CHAIR HENDRICKS:Thank you.

††††††††††† EXEC. SECRETARY FINDER:This is Dr. Finder.  I just want to ask a question.In terms of personnel qualifications, my understanding, and correct me if I'm wrong, is you basically accept an attestation that these people meet or do they actually have to submit documentation of the qualifications?

††††††††††† MS. BUTLER:They have to submit an attestation.But we also do do site visits and they have to be able to show us the documentation once we show up.

††††††††††† CHAIR HENDRICKS:Thank you.Yes, from the audience.

††††††††††† MS. WILCOX:Pam Wilcox, ACR.I think going back to your question about personnel while it's not a pass/fail criteria because they're not even eligible to apply if they don't meet it, that still raises the bar.Those people as we saw in mammography, some people got out of the business because they didn't want to go through the training or they didn't want to buy adequate equipment.So it does have an impact before they can even get into the process.Thank you.

††††††††††† MEMBER MARTIN:Melissa Martin.Again being a consulting physicist, we see all ranges of the equipment and it is a state requirement that there be a physicist evaluation in California annually.It is not uncommon that a unit is pulled out a hospital, a major medical center, and bought by another person and reinstalled in their office.

††††††††††† That equipment definitely would not meet state-of-the-art requirements.So your question as to what is the problem, I think it is a range of problems and that's what you will find when you start going and evaluating all the facilities.

††††††††††† I would highly recommend too that the requirement that it be a mammography trained technologist be the technologist used in this procedure.The biggest problems I have seen are those facilities that do not have a mammography technologist working with particularly the surgeons.If you don't have a radiologist and you do not have a mammography technologist, you basically have people that are very untrained or just not cognizant of dose requirements or dose problems and the idea of what significance it may be if you repeat that film or that image many times.

††††††††††† DR. BARR:Thank you.Yes, we see similar issues with interventional fluoroscopy procedures and lots of other areas.Do you want to keep going with your questions, Charlie?

††††††††††† EXEC. SECRETARY FINDER:I guess the major question has been answered, what problems exist, and it sounds like everything a problem in terms of equipment, personnel, audit.So we can't focus on any one area.At least that's the impression I'm getting from the committee.

††††††††††† DR. BARR:How come the data is so good if everything is a problem?

††††††††††† MEMBER MONTICCIOLO:Can I just make a comment to that?

††††††††††† DR. BARR:Yes.

††††† ††††† MEMBER MONTICCIOLO:While I support this as you know, I'm sorry, it's Dr. Monticciolo, I don't think we know how serious a problem it is.We don't have that data.  I think we do stereo pretty well where I'm at and I know a lot of people who do it well. So I would say that the reason I support these standards is to make sure that everyone who is doing it can meet a certain standard.I agree with the comment about having a mammography technologist involved.That would be crucial, I think, to make sure these procedures go well.

††††††††††† DR. BARR:Thank you.

††††††††††† EXEC. SECRETARY FINDER:I have a question about that and maybe somebody from ACR can address it.We have heard in the past about technologists who have gone into the stereotactic field who spent a lot of their time doing stereotactic and they have the issue about keeping up with requirements if they're also going to be MQSA certified mammo techs.Is there any comment or enlightenment from your experience in the voluntary program if that's a problem or not?

††††††††††† MS. BUTLER:Penny Butler, ACR.So your question is regarding a mammo tech who does stereo and staying up with mammo qualifications?

††††††††††† EXEC. SECRETARY FINDER:Right.

††††††††††† MS. BUTLER:We actually brought this issue up to our committee a couple years ago after receiving a request from I think it was just one facility regarding a stereo dedicated technologist who didn't want to maintain mammo and the committee felt that it was very strong for the individual's qualifications to maintain the small number really of examinations that MQSA requires for mammography in order to really put the entire examination together.So they did not want to change the requirements.

††††††††††† EXEC. SECRETARY FINDER:Thank you.

††††††††††† MEMBER MONTICCIOLO:This is Debbie Monticciolo.I would just reiterate or support what Penny says.The minimum number of films a technologist has to do is not that onerous and I think if the technologist is going to do a good job at doing stereo they have to be familiar with how to image and continue to do standard imaging.I would be interested in what the technologists have to say about that but I would think you would want to be able to do both to keep your skills up.

††††††††††† MEMBER RINELLA:Diane Rinella.I absolutely agree with you.It is a minimal amount, number of examinations, to do per year and you need to know how to manipulate the breast correctly and if the only thing you're going to be doing is stereo, I don't feel it's enough as far as your technical expertise.

††††††††††† MEMBER MOUNT:Carol Mount.I totally agree with that.I think they should be able to keep up their minimal 200 and continue to do stereo.They should be able to do them both.It's very important like Diane said to be able to do both.

††††††††††† DR. BARR:Thank you.

††††††††††† MR. FLATER:Don Flater with Iowa.If you want to refer back to the Iowa rules, it does show how much they have to do plus we also require that they be a general diagnostic radiographer in the State of Iowa.So they don't have any trouble meeting those.We chart 12 and then three every year thereafter.So it has not been difficult for our technologists to maintain the requirements.We didn't have any that dropped out up to that period of time.

††††††††††† One other point that I didn't bring upthat I think is germane and that has to do with the issue of suits against radiologists and folks like that.We have had none in the stereotactic area and I know that for a fact because that comes through our board of medical examiners and those kind of things since the program started nor have we had any lawsuits against radiologists as with regard to our mammography program.

††††††††††† DR. BARR:So we're talking about the technologist.Then we would be requiring, if we required a person to be a technologist and they were hired by a surgeon, that they would have to find some way then to perform the number of mammograms that are needed and presumably the surgeon would have to allow them time to do that.Dr. Harrison, are you there?I would be interested in hearing a breast surgeon, another breast surgeon's point of view.

††††††††††† I think this is an important issue because this would bring surgeons into the realm of federal regulation which nobody but a radiologist has heretofore had the privilege of.So I think it's important to get some of these opinions.

††††††††††† MEMBER HARRISON:Yes, I am.I'm sorry. I was talking to you on mute.I'm here.

††††††††††† DR. BARR:That's the way we generally like our surgeons to talk to us.

††††††††††† MEMBER HARRISON:I was trying to figure out why no one could hear my response.Can you please repeat the question?The audio is very -- I can hear very well sometimes and not so well others.

††††††††††† DR. BARR:Yes, we so appreciate you trying to do this and bear with us.If we go ahead and lift the exemption for stereo, then surgeons would become part of a federal regulatory process which heretofore they have not been.So I'm interested in getting as many opinions from surgeons, particularly breast surgeons, as to how this would affect their practices, what they think about this.

††††††††††† We just discussed that if there was a requirement that a mammography technologist be involved with stereo that they would still have to keep up their mammograms.  So if a surgeon hired a technologist, he or she would have to --

††††††††††† MEMBER HARRISON:May I comment?

††††††††††† DR. BARR:You go ahead.Shoot.

††††††††††† MEMBER HARRISON:I personally am in a very comfortable situation.My hospital has a breast center where I work very heavily with the technologist and the radiologist.So I do my own stereotactic core biopsies but clearly all the films are read pre and post and the post biopsy film is read by the radiologist.

††††††††††† I don't believe that those of us who have committed to this in practice will have any problem whatsoever being regulated at all.As a matter of fact, I think we'd welcome it.We all wanted to be more involved and tied to the radiologist because there was a time when this was a turfing battle and it should not be a turfing battle.So I would welcome that and I think all of us who are committed to being "breast surgeons" would certainly comply and welcome it.

††††††††††† DR. BARR:Thank you very much.

††††††††††† MEMBER HARRISON:Hello.Are you there?

††††††††††† DR. BARR:Yes.Thank you very much.That's very helpful.Thank you.Charlie, did you have any more questions on your roster?


††††††††††† DR. BARR:I did hear one of our public speakers talk about the whole chain of not only breast imaging and breast treatment as quality.I just wonder where do we draw the line.Is the line overdrawn?Where are the pathologists?Do we need to make sure under federal regulation that they know what they're doing?Do we need to involve the surgeons not only in stereo but in excisional biopsy?How about the oncologists who are treating the patients?How far do we go along this chain of diagnosing and treating breast cancer with federal regulation?Dr. Ferguson.

††††††††††† MEMBER FERGUSON:Ferguson.I think Dr. Finder set out in the beginning that our panel, we strictly deal with imaging of the breast.And so I don't think pathologists and oncologists are going to fall into the purview of what we're looking at here. I think he made that very clear to me at least.Is that right?

††††††††††† EXEC. SECRETARY FINDER:Right.It's Dr. Finder.That is correct and it does bring up another interesting point.Because while the IOM recommendations talk about a breast imaging quality standards act, that does not exist at the present time.So it is an issue that I think we should maybe touch on very briefly what people think might be the consequences of regulating stereotactic procedures, mammographically guided stereotactic procedures, in an environment where there is no control over ultrasound or MRI biopsy and again the regulation of even needle localizations wouldn't be as comprehensive as for stereotactic.

††††††††††† Does anybody think that what we might end up doing is just moving people over from the stereotactic into either ultrasound biopsy or moving them out of needle guided biopsies back to open biopsies using needle localization?Could we actually be pushing things in the wrong direction if we can't control everything?Just a point for discussion.

††††††††††† MEMBER MONTICCIOLO:Dr. Monticciolo.I think it's hard to tell.It's the unintended consequences of making these types of decisions.I don't think that you'll move many people from stereo into ultrasound or MR guided biopsies simply because calcifications are not very readily seen on those modalities and we use stereotactically almost exclusively for calcifications now because we tend to see masses pretty well on ultrasound.

††††††††††† But the issue of moving probably primarily surgeons doing these techniques if they can't qualify for stereotactic back to open biopsy is probably a read concern.Radiologists don't do open biopsies.So they're not going to be pushed in that direction.They're either going to get pushed out of it or they're going to do it to meet the regs.But I would say it probably is a legitimate concern, but I don't know the extent of the problem or what the extent of the problem would be.

††††††††††† CHAIR HENDRICKS:From the audience.

††††††††††† MS. WAGNER:Judy Wagner.

††††††††††† CHAIR HENDRICKS:To the microphone please and then reintroduce yourself to all of us.

††††††††††† MS. WAGNER:Judy Wagner, R.N.  That is exactly why I am speaking to women's groups next week.Next month, I have four meetings with women at a bank that has contacted me to talk to their women.That's why when women hear they need a biopsy, they're going to say, "I want a needle."And I've given you some documentation of a questionnaire that I handed out and when I gave my talk those women got that message and I hope that all of them will tell 20 other women.

††††††††††† CHAIR HENDRICKS:I'll comment, Carolyn Hendricks, Panel Chair, on the concern that regulation of a stereotactic biopsy procedure might drive radiologists and surgeons to perform fewer stereotactic biopsies in favor of open biopsies.I think that won't occur for the fact that we have not been able to make a dent in the open biopsy rates in the United States for some time even with the advent of the stereotactic procedure.

††††††††††† What I think it might do regulating this procedure because it is hinging on breast imaging which is our mission is that it might make radiologists and surgeons more selective.We really want a good candidate for a stereotactic biopsy.Once that decision is made, that's when the process gets started.So if a regulatory piece makes physicians scrutinize that initial decision, "Is this woman a good candidate for a stereotactic breast biopsy" then we would have achieved that goal and improved that quality of the procedure.

††††††††††† MEMBER MARTIN:Melissa Martin.I thought the other item of consideration was the recommendation from the IOM report that the ultrasound guided procedures also be required for accreditation which if you do them in conjunction with each other, then you're not going to be necessarily driving patients from one to the other.It's the radiologist's choice for the performance of the biopsy procedure because both units would be required to be accredited.

††††††††††† EXEC. SECRETARY FINDER:It's Dr. Finder.The difference is that under the current situation, under MQSA, we do have the ability to regulate stereotactic biopsy.We do not have the ability to regulate ultrasound.In order for that to occur, Congress would have to change the law and then we could work on it.

††††††††††† If you're saying they'd have to be done at the same time, then we'd have to wait until Congress does something before we do anything.But there will be this asymmetry if we decide to go ahead with this just because of the way our current authority is created.

††††††††††† DR. DOWLATSHAHI:This is Dowlat from Chicago.I think you are moving very fast for me.I don't want to go back and be killed as a messenger.There are a lot of surgeons in the country and especially the American breast surgeons who would like to hear your opinion before you come to a definite decision.As I said, I didn't have enough time to search around to get the opinion from everybody but it would be good if you gave the College of Surgeons as well as the Society of Breast Surgeons a chance to come up with some ideas or suggestions that don't come to me right now.That's No. 1.

††††††††††† The other caveat that I wanted to mention is that the speaker said we want needle and not knife.Well, that has now become very debatable because some of the big needles these days require an incision and we even go in with a radio frequency device and carve out the piece of breast tissue.

††††††††††† So technically the needle is not what it used to be.A small 16 or 18 gauge is now eight or nine and as I said, sometimes you have to make an incision.So the difference between the needle and the knife is not that well defined and I just wanted to tell you as a person who does these biopsies to let you know that there are a variety of issues which I would like to take back to the people who are practitioners in this field.

††††††††††† CHAIR HENDRICKS:Any other questions from the panel or the audience on this topic of the IOM?Yes?

††††††††††† MR. MOURAD:Wally Mourad, FDA.I don't want to jump the gun on inspections before we even write regulations but as Dr. Monticciolo mentioned be easy on the inspections, do not make it onerous and laborious.What do you mean by that?Should we cut down on the scope or minimize the questions?Could you explain a little bit more?

††††††††††† MEMBER MONTICCIOLO:This is Dr. Monticciolo.I'm a veteran of these inspections in different states as I indicated before and sometimes it's very smooth.We've generally been in compliance. That's not been the issue but sometimes it just takes longer for inspectors to get through all the equipment, records and we have satellites that have to close down for a full day.So they lose all those patients.They can't do patients.

††††††††††† So it's just a matter of taking it into account and the cost of doing this.For the facilities, it can be extremely difficult and we've had inspectors at our site especially if it's an inexperienced inspector for a couple days for the five units and it's very disruptive when you're trying to do 100 patients a day and procedures and you have to run around and get everything ready and close down andit can be onerous.

††††††††††† It's only once a year.That's the good news, but it can be difficult.So if one more thing is added to that, it's just a lot for the technologists to have to prepare and for the patients that we're also trying to service that day.That's what I meant.

††††††††††† DR. BARR:I think you raise some good points and it's interesting that we've heard a lot don't give us anymore regulatory burden, don't spend anymore time in the facility than you've already been spending and here we're talking about additional regulatory burden and then additional time in the facility.  So it's interesting.It goes against some of the other things that we've heard.

††††††††††† MEMBER MOUNT:Carol Mount.I think the difference is none of us want any more work.None of us want any more burden, but I think we all want good patient care and the bottom line is quality not so much the burden.Yes, we don't like it but we will accept it if we can raise the bar.

††††††††††† DR. BARR:Thank you.

††††††††††† MEMBER MONTICCIOLO:Dr. Monticciolo.Just along those lines, I would say that's a very reasonable assessment, Dr. Barr, that when we go for accreditation we have time to gather things and the clock start running and you have to get the films but you can spread that over.If you have three days when you have a lot of patients cramming into your center, you can maybe do some of your ACR accreditation paperwork on a day that's not as busy.

††††††††††† But for inspection, there's no give and take.It's there and so that is a little bit different issue, accreditation versus inspection for our time.

††††††††††† CHAIR HENDRICKS:Thank you.Yes, from the audience.

††††††††††† MS. WILCOX:Pam Wilcox, ACR.I wonder if the state inspectors and the physicists could talk to the inspection process for stereo in terms of the inspector having to have access to the unit.There's a difficulty in mammography when you have to not do patients.But if a woman is scheduled for a biopsy and has to be cancelled, I think the implications are more significant.

††††††††††† MEMBER MARTIN:Melissa Martin.I would like to think that the process that would be developed for inspections will be more allowing the proposed line of what I think is coming along for all the mammography inspections where it will be basically more of an inspection of the physicist report if the physicist report is current and there would be more minimal time, if any, for that inspector to be on the actual machine.

††††††††††† The only thing I can see an inspector actually ever doing in a biopsy unit is having the technologist take a phantom film because that would not even require the inspectors to be trained to operate the stereotactic units.And that should be minimal.It might even be a recommended procedure that if the technologist could take a phantom film the morning of the inspector's arrival and have it available for review, that would be acceptable.It's just a suggestion, but that way it wouldn't impact patient care.

††††††††††† DR. BARR:Thank you.

††††††††††† MEMBER PASSETTI:I think you're already moving in the right direction as far as the inspections go.You're looking at not taking dose measurements.You're looking at simplifying the CE so the inspectors, it's easier for them to check.I think if we're going to add some regulatory requirements in the high risk areas, you just need to consider continually looking at your inspection process to make sure you're looking at the important areas and cut back on those areas like you said the inspector doesn't need to do while they're in there or they can do off to the side looking at physicist's reports and those types of things.So I think you're starting to head in that direction and I'll just encourage you to keep going in that way.

††††††††††† DR. BARR:Thank you.

††††††††††† CHAIR HENDRICKS:From the audience.

††††††††††† MEMBER WILLIAMS:Thanks.But, no, this is Mark Williams.I just wanted to agree 100 percent with what Melissa said.It think that's exactly the right approach and the way that things are going already and I think that with the physicist report in hand it's going to alleviate essentially all of the physical tests that the inspector would have to do.

††††††††††† MR. FLATER:Don Flater from Iowa.It may do that but what we're going to have to be very careful of is the legal aspect of this and what's going to happen relative to our records and what the state is attesting to and the responsibility that they're taking on.So we have to be careful.

††††††††††† I'm not saying that we can't do that.But all of a sudden, do physicists want to become state inspectors and have that legal problem that they may have to deal with if we have to go in and have to actually enforce our regulations and what kind of a liability does it put on them?Are they now state employees?We have to ask some attorney generals questions and ask whether or not they come under the umbrella of the state being the regulatory.If somebody makes a mistake who's responsible for it?

††††††††††† I think there are a lot of questions you have to be careful in the inspection process and what we're going to do.I'm not disagreeing with what you're saying.I'm just saying be careful because as we know, our attorneys can make different decisions and when you have 50 state attorney generals to deal with plus you have the federal folks to deal with on the legal side, there are some questions that probably really need to be considered very closely.

††††††††††† CHAIR HENDRICKS:Carolyn Hendricks, Panel Chair.I have a quick follow-up question, Mr. Flater, related to how you handle in Iowa the mandatory program currently in place.How do you handle the down-time and the inspection time when you're taking a stereo unit off-line to inspect it and accredit it?

††††††††††† MR. FLATER:We call our facilities five days ahead of time even though our stereotactics don't fall under.We do the same thing that we do on our MQSA.If there is a problem, then we adjust our schedule to fit their schedule so that they don't have down time.There are facilities that doctor referred to that have 100 patients per day.We go into them at night and we actually do the inspections at night so we do not disturb the patient flow.

††††††††††† That's one thing that the Department of Public Health gets really excited about is if we get a call from a facility and say we're doing something that's a problem with health.  So we make adjustments for our schedules.Our people are not on an 8:00 a.m. to 4:00 p.m. basis.If they have to go in at 9:00 p.m. they have to go in 9:00 p.m.That's just the way it works.That's the way it's been for all our regulatory programs even our NRC programs and our inspections and those kinds of things.

††††††††††† CHAIR HENDRICKS:Thank you.

††††††††††† DR. BARR:I think we're all, as several people have commented, our goal here is quality.I have just as a public health person need to continually raise the question about whether federal regulation is the only way to achieve that quality.How about in the area of breast ultrasound and I sort of disagree with the statement that we don't need to look at the whole chain.To me if we're ever going to make the ultimate dent in breast cancer, it's the whole chain that needs to be looked at.

††††††††††† I wonder why we concentrate on certain pieces of it.We do because the moon and stars gave us MQSA and that's what we do at the moment.But since it is in the IOM recommendation, what about breast ultrasound?What about breast MRI?What about a statutory change to include all of breast imaging or perhaps beyond?

††††††††††† CHAIR HENDRICKS:Carol Hendricks, Panel Chair.I think from the information that we've heard for the past two days it seems that it is premature to incorporate MRI imaging or MRI guided breast biopsy procedures into any form of regulations at this point in time.

††††††††††† DR. BARR:What do you think about breast ultrasound where there is an accreditation program in existence?†† Although I don't know.ACR, is a breast ultrasound non interventional?Does it deal with any interventional, breast ultrasound?

††††††††††† MS. BUTLER:Penny Butler, ACR.It is both non interventional and interventional.There is a module that they can apply for for interventional.

††††††††††† DR. BARR:Thank you.And I certainly agree from what I've heard.The MRI issue seems to be off the table for the moment, but the breast ultrasound, one of the arguments I've heard for stereos we have an accreditation program.Therefore, we climb Mt. Everest because it's there.We have this accreditation program.What do we do with it?

††††††††††† MEMBER RINELLA:As far as breast ultrasound is concerned, there is just so much variability out there throughout all the facilities that I've seen and I feel very strongly that it should be an accredited modality because there just isn't enough consistency from how they're done and who is actually doing examination because in some facilitiesthese are not even ultrasound technologists that are doing the exams.

††††††††††† DR. BARR:Thank you.

††††††††††† MEMBER PASSETTI:Bill Passetti.I'm not sure how many states you contract with to do the MQSA inspection.I don't know if you have that right off the bat.

††††††††††† DR. BARR:Basically, from moment to moment, I don't know but I think there's maybe four or five states that we do not contract with.

††††††††††† MEMBER PASSETTI:I guess my only caution or concern with ultrasound is not all states have the authority or the ability to do inspections under contract in that area.So that would fall more into the FDA's responsibilities.I just don't know.Currently in Florida, we have authority in the non-ionizing area but we don't have any regulations or inspection authority.So that could be an issue if you got into the inspection of those types of units.

††††††††††† DR. BARR:If it were an MQSA type program, you would have the authority.You wouldn't need state authority.But are you more saying that since there aren't many states that probably inspect ultrasound, the expertise wouldn't be there.

††††††††††† MEMBER PASSETTI:The expertise and maybe the willingness to get into that area.

††††††††††† DR. BARR:Thank you.That's a good point.Linda.

††††††††††† MEMBER PURA:Linda Pura.I would think if we're using the gold key of quality then we are moving from the MQSA to breast imaging mammography regulations and ultrasound would certainly fall under there because there are many variants in how it's done and who does it from what I see out in my particular practices in the community. So I would very much like to see not only stereotactic but I would like to see ultrasound also under regulation.

††††††††††† DR. BARR:Thank you.Don Flater.

††††††††††† MR. FLATER:Don Flater from Iowa and I just want to emphasize what Bill said.The magic line for us in the State of Iowa at the current time is non-ionizing versus ionizing.We do not cross that barrier.Dr. Barr, I would not be able to inspect them because if they don't have the authority to go in the facility even if there's a federal law, it doesn't make any difference.We cannot cross that barrier.So we would have to get new legislation not that it's not that difficult to do but we would have to do that.

††††††††††† DR. BARR:Thank you.

††††††††††† CHAIR HENDRICKS:Carolyn Hendricks, Panel Chair.If I could put Penny Butler from ACR on the spot for a moment because I feel like we've not been using some of the information from your very important survey data on your accreditation on stereotactic procedures.But I feel like I really don't have adequate information on where we stand in terms of ACR and the ultrasound process.Where do we stand right not in terms of accreditation for ultrasound procedures under ACR?

††††††††††† MS. BUTLER:Penny Butler, ACR.Unfortunately, I didn't come prepared like I did for stereo with all the numbers and don't quote me and I'd certainly be happy to provide this information to you later.But I think it's on the order of 300 to 400.Does that ring a bell?Okay.Three hundred to 400 facilities that we accredit.

††††††††††† By the way, we don't accredit, it's not unit based like we have in stereo but it's facility based.So they may have multiple units but we would accredit the entire facility's practice.Unfortunately, I cannot break it down right now into the number that we accredit for interventional.Certainly, not all facilities going through breast ultrasound accreditation will also accredit in interventional but my gut feeling right now is it's most of them.

††††††††††† Pass rate, again, I'd have to go back and look at the numbers.  It's probably about the same order but I really can't tell right now.So what else do you want to know?

††††††††††† CHAIR HENDRICKS:Thank you.

††††††††††† DR. BARR:Perhaps at the next meeting we could have a presentation on breast ultrasound.

††††††††††† CHAIR HENDRICKS:Yes.Carolyn Hendricks, Panel Chair.I think that that would be, I know that you want information from this panel as we sit on our opinions related to ultrasound.But I don't feel that we have an adequate information base at this point in time.Thank you.

††††††††††† MS. BUTLER:May I ask a question now?

††††††††††† DR. BARR:Yes.

††††††††††† MS. BUTLER:Thank you.One of the questions I have is obviously MQSA refers to x-ray and Breast Imaging Quality Standards Act would apply to a change in the legislation in order to grant anybody authority to take that next step.Does this body here have the, is there an intent from this body to provide Congress with a recommendation one way or the other or is this on the table?I'll be quiet now.

††††††††††† DR. BARR:You're absolutely right, Penny.It would require a statutory change which logisticallyat the time of reauthorization would be the easiest time to get that.I think I heard Dr. Hendricks say that we probably don't have enough information to make a full recommendation on ultrasound at this point.

††††††††††† CHAIR HENDRICKS:Yes.Carolyn Hendricks.I welcome input from the other members of this panel of course on it especially the diagnostic radiologists.

††††††††††† MEMBER FERGUSON:I'd like to say I think that we need to be moving towards an accreditation program in ultrasound.I don't think we have all the pieces yet.What I wouldn't want to do is to somehow be distracted from the stereotactic issue we've been talking about and say, "Let's do ultrasound and do it all at one time and put off what we're moving towards."I feel very strongly we need to move towards the stereotactic process.We need to moving towards the ultrasound accreditation process as well would be my feeling.

††††††††††† CHAIR HENDRICKS:Dr. Monticciolo, comment?

††††††††††† MEMBER MONTICCIOLO:Yes.Dr. Monticciolo.In my experience, the comments that Diane made are accurate.Ultrasound is really all over the map and we see a lot of use of ultrasound that's inappropriate and miss diagnoses all the time.It's in variable hands.It's not done by people who are trained to do it and they think because the breast is an external appendage it ought to be easy and it's not.So I think that some type of improvements certainly would be welcome.

††††††††††† I'm a little bit hesitant only because as a breast imager I already feel overburdened.So I'm little bit concerned about that.But I think Dr. Ferguson's comments are good ones and I am in favor of quality and I don't see another way around it.I think we're moving in that direction.

††††††††††† The ACR Breast Ultrasound Accreditation Program is a good one.I will say I'm on that committee.So you should know that.The committee members are really good, but I also review for that program.So I'm familiar with it, but it's a difficult issue.I don't know that we have enough to go ahead to make that mandatory yet.Obviously we can't because it requires a change in the law.But certainly there is a tremendous variability in breast ultrasound right now and it really does need a look.

††††††††††† MEMBER MOUNT:Carol Mount.I totally agree that breast ultrasound is an area that should be accredited.It's probably not quite ready yet as there are some things that have to be put into place.The only question I have and since you are on the committee is we accredit as Penny said the facility and one facility may have several ultrasound units.So if they are sending in their picture from their best unit, they still may be using substandard units to do full breast ultrasound or whatever.So that might be something that could be addressed and maybe the committee is looking at that as well.

††††††††††† MEMBER MONTICCIOLO:This is Dr. Monticciolo.I'm sorry I mentioned I was on the committee because it's letting Penny off the hook now for answering these questions.That might be an issue but I suppose we would have to look at that.In my experience, the reason people fail is there's some poor image quality but that's controlled by the operator.And my experience shows that if the operator doesn't know what they're doing, they need to change their game and they're just submitting images that obviously would be poor for diagnosis and it's pretty apparent.But I suppose it's possible for somebody to do really well on one ultrasound machine and not do well on another.But I tend to see peopleif they don't know how to scan on one machine, they're going to do poorly on different types of machines.So I'm not sure how much we need to do with that.

††††††††††† DR. BARR:Is it reasonable to sum the ultrasound discussion to say that perhaps we should be moving in that direction but that at future meetings, we should plan some presentations and further discussion?

††††††††††† MEMBER MONTICCIOLO:I would agree with that.

††††††††††† DR. BARR:I'm interested to know if the voluntary accreditation program if all of a sudden people see the writing on the wall for regulation and a much larger percentage of the stereotactic units out there were to get accredited and the failure would go down, we haven't seen a voluntary accreditation program work very well yet.If we saw that, would that make any difference in your recommendations related to stereo?

††††††††††† MEMBER MONTICCIOLO:I'm not sure I understand the question.You're saying would that make me feel like it's working?Is that your question?

††††††††††† DR. BARR:Right.Would you still think you need federal regulation if we were seeing a voluntary accreditation program that had a large percentage of the units applying and passing accreditation.

††††††††††† MEMBER MONTICCIOLO:Oh.It's Dr. Monticciolo.That's a very good point.I think if we saw a large percentage doing it voluntarily, it probably would not need regulation.I just want to make a comment that Melissa mentioned earlier that a lot of programs use the materials but don't apply for accreditation and I am wondering and maybe Penny would have some information on this.A lot of places don't want to spend the extra money for a voluntary program especially in the breast imaging section.

††††††††††† For example, when I came to Texas, I said we're going to get accredited for ultrasound and stereotactic and the administrator said, "How much is that going to cost?We don't need to do it so we're not doing it."  I said, "We're doing it."And we had this little discussion with the chairman and I got my way.That was mainly because I was new.There's that little honeymoon period there.

††††††††††† But I think my administrator was not opposed to us having high quality stereo.They wanted that but they didn't want to spend the money.So I'm not sure how many units.People might be doing good work but just getting that little stamp because they're trying to avoid paying.

††††††††††† CHAIR HENDRICKS:From the audience.

††††††††††† MS. WILCOX:Pam Wilcox, ACR.I'm sorry that we don't have the numbers of people who bought the stereo manual that didn't apply for accreditation.I couldn't pull it out of my hip pocket.

††††††††††† But just going back historically, and Dr. Barr's probably going to shoot me for this, but I'll take my chances.When the Mammography Quality Standards Act was passed at the time it was actually passed, it wasn't implemented for two years.About 70 percent of the facilities doing mammography in the U.S. had applied voluntarily.My guess is that other 30 percent probably never would have.

††††††††††† And in fact, although they knew that there was a two year deadline to get accredited, in the last six months before the law went into effect and they had to be accredited, we had a huge bolus of sites that waited until the very last minute and we had to work closely with FDA to have all kinds of extension procedures so people didn't have to shut down because they waited until the day before the deadline.

††††††††††† We also heard before this committee when it was composed of other individuals that if 90 percent of all the stereo sites in the country voluntarily got accredited, then we wouldn't need to regulate that.As I recall, that is now nine years ago.So my perspective is it's not going to happen unless there's a mandate.

††††††††††† DR. BARR:No, I'm not going to shoot you because as I've said we haven't seen a voluntary program that that's happened.Just as a federal regulator, I'm trying to get to the point of if we ever saw that, would we still need federal regulation or would that be good enough for us?Thank you.Very helpful.

††††††††††† CHAIR HENDRICKS:We have time for one or two more comments and then we'll move on.

††††††††††† MR. FLATER:Flater with Iowa.I've been in this business now 41 years and looked at every side of radiological health that there is and I can tell you that the good people are going to work the programs.The ones that are going to provide nasty services are not going to do it unless you hit them with a big hammer and you force them to do it.So the question that you have here is do we want to let the ones that are going to give the bad services and everything go ahead and do it.

††††††††††† You don't need to talk about the good guys that are going to go and I'll bet you every one of these people on this panel are ones that would fall right into the voluntary system.But the bad guys will not.Ninety-five percent of the people that we set a regulation for qualify for it, do everything they can to meet it.It's that nasty five percent that gives you the bad time.

††††††††††† CHAIR HENDRICKS:Thank you.One final comment from the audience?

††††††††††† MS. WAGNER:Judy Wagner.In response to your question about ultrasound accreditation, in my article that I handed you out this morning, I believe I took out north, south, east and west and I compared stereotactic accreditation with ultrasound saying in your area of the country, how do you fit.The reasonbeing is in Wisconsin there are ten hospitals or facilities that are accredited for stereotactic and six for ultrasound.So in my article that I wrote, I said, "Where do you fit?"†† You can look those answers up on the wonderful under Facilities.

††††††††††† My other question, and Dr. Finder has brought it up to me and I've heard it from other people, if you mandate stereotactic, then they're going to take people across the street to their little clinic and they're going to do ultrasound.So are you really doing the patient a service?

††††††††††† That is why I believe and I've talked Senator Mikulskiís aide about this is that we need to make the umbrella BIQSA and as soon as possible give standards for ultrasound so this doesn't happen because how is the patient going to know when the doctor says, "Honey, come here.I can cut that out for you."You say, "Yesterday."

††††††††††† DR. BARR:I wonder about appropriated money for all this and what the interest from Congress is going to be in appropriating money.I also had another thought but go ahead, Debbie, since I can't think of it.

††††††††††† MEMBER MONTICCIOLO:Dr. Monticciolo.With all due respect to the member from the audience,if I have a choice between doing an ultrasound guided biopsy and a stereotactic biopsy on a patient, I'm going to pick ultrasound every time.It's more comfortable for the patient.She's laying on her back instead of on her stomach.It's easy.You can see the needle moving real time.It's a tremendous advantage.  It's the reason that we don't have enough masses to submit on our accreditation and we have to struggle to get it because if I can see on ultrasound, I'm going to do it on ultrasound.

††††††††††† So I don't believe that there'll be a competition between if stereo is regulated and people can't do stereo, that they're going to take the patient and do an ultrasound guided biopsy.If they're going to that, they're probably going to do the patient a favor.Because if you're doing a stereo when you could do an ultrasound, you're not doing it the easiest way.

††††††††††† The concern that Dr. Finder raised that people who can't do stereo will then take the patient to open biopsy, I'm concerned about that because I wouldn't want to see things go in that direction because the minimally-invasive technique I do think is better for women.

††††††††††† DR. BARR:Does anyone have any, because I know Congress will ask us this, thoughts or ideas or even information about we did see a certain percentage of the population drop out when mammography accreditation and certification became mandatory, that at least at the time, did not affect access.Does anybody have any thoughts on with the number of units out there whether 3,000 or 5,000 if a percentage dropped out of the stereo business with federal regulation are we affecting access because I know this is always off the top of Congress's mind?

††††††††††† MEMBER MONTICCIOLO:That's a very good point.This is Dr. Monticciolo.I actually think there are more stereotactic tables than we need.Now I only say that because our table is not booked solid.And when we had an equipment problem, we actually had a power surge that blew the tube apart, luckily it happened at night, we had to shift our stereo patients to a satellite site and they were easily able to accommodate it.

††††††††††† It's very expensive equipment and in fact, I don't like to have it sitting still.So whena neighborhood hospital lost their stereo unit, we took their patients without any problem.Now that's just localized and it's very anecdotal obviously, but I can't imagine there are many stereotactic units that are fully utilized morning to night.I would be surprised if that were the case.

††††††††††† CHAIR HENDRICKS:Thank you.Any other final comments about the IOM recommendations?Dr. Barr?

††††††††††† DR. BARR:No.Thank you.

††††††††††† CHAIR HENDRICKS:Thank you very much.It was very interesting.Thank you very much.So we'll move to the final item on our agenda this afternoon which relates to a discussion of recently issued guidance documents and other related topics to be led by Dr. Finder.

††††††††††† EXEC. SECRETARY FINDER:Okay.It's Dr. Finder.I want to go back to an issue that was brought up yesterday briefly and it deals with certification and an issue that is coming up before us very quickly.I want to frame the issue right now.

††††††††††† For those who aren't aware, one of our initial requirements for interpreting physicians is that they either be board certified or have two or three months of training depending on when they qualified.Relatively recently, the board that we accept for interpreting physicians have begun issuing time-limited certificates.In the past, those certificates were issued for life.But starting in 2001 for one group, the Royal College of Physicians and Surgeons of Canada started issuing five year certificates and in 2002, the ABR, the American Board of Radiology and the American Osteopathic Board of Radiology started issuing ten year certificates.

††††††††††† The question that we have is in the past for all these years we've been looking at those certificates as a static being in the sense of once you got that certificate you had it.We didn't have to recheck it at all during the inspections.

††††††††††† The real question that we have now is should we in light of the fact that new people and this only applies to new people, the people who were issued certificates before these dates, their certificates are permanent, whether we should start inspecting against and checking these certificates and we'd have to check them actually for everybody because we don't know who has a time-limited one and who doesn't have a time-limited one.So it becomes an issue of logistics and burden and paperwork and time.So I bring it before the committee to ask their opinion about should we basically accept the certificate once it's issued as permanent or should we go and start checking the expiration dates for all these certificates.

††††††††††† CHAIR HENDRICKS:I'll start the response.Carolyn Hendricks, Panel Chair.This is an issue that all hospitals are dealing with, all the health care systems, ABIM and I think that recertification should be required including documentation of recertification of the staff.

††††††††††† EXEC. SECRETARY FINDER:One other issue, one with a little caveat to this.As I said, our requirement is that you either be board certified or have the training.One of the situations that we could encounter, let's say, in five or ten years is somebody who was initially board certified, then decided not to take the board certificate or failed the test or whatever it is at that time when then have to fall back on the other alternative which would be the two or three months of training.Actually, in this case, it would be the three months of training in mammography.

††††††††††† We have from past experience learned that the longer it is the time from your residency program the harder it is to get anybody to get documentation for you of what you actually did during your residency program.So we could have a situation where somebody goes out, is board certified, uses that certificate for proof of meeting that requirement, never get additional documentation about the three months of training in ten or twenty years.When their certificate expires and they don't renew it, we then go and ask them, "Now you have to show us that you've had three months of training ten or twenty years ago" and that is a problem or can be a problem.

††††††††††† CHAIR HENDRICKS:From the audience.

††††††††††† MR. MOURAD:Wally Mourad, FDA again.There is another issue that you should keep in mind and that is for the initial qualifications of the interpreting physicians we equate the three months training with board certification.So if you got one or the other, you're good.You've met it.

††††††††††† Now if you start checking on the expired certificates, you're basically treating them differently from those who have acquired or provided the three months training because we don't recheck that.It's good for life.

††††††††††† MEMBER MONTICCIOLO:This is Dr. Monticciolo.That's a good point.I think it would be unfair to ask somebody to meet the higher standard of passing their board in radiology and then giving them a hard time ten years later when you've let somebody read who only had three months of training and didn't pass their boards.

††††††††††† But I also think we should check because I believe the current standard for board eligibility is, well, I guess you don't have to complete a residency training program but residency training programs not require three months of training in mammography.So I don't think we had any board examiners sit who did not have that training.So if they initially passed their boards, I think they had to have had three months of training in residency.Maybe that's not true for people who are not passed repeatedly.I guess that's possible.

††††††††††† EXEC. SECRETARY FINDER:One would make the assumption that they have the three months of training.I will tell that for whatever reason in some specific instances we do have difficulty in people willing to sign that statement.

††††††††††† MEMBER MONTICCIOLO:I see.That's just information I lack.

††††††††††† EXEC. SECRETARY FINDER:But it really comes down to a question of how we should proceed on this question and it's going to be coming up actuallynext year because I don't know how many interpreting physicians we have who were certified by the Canadian board but their board is going up in 2006.

††††††††††† MEMBER FERGUSON:My thought would be that right now we accept the board certification and only since 2002 are the boards going to have to ten years later go back.We have continuing education requirements.We have work requirements.I think once you're initially qualified, you're initially qualified would be my thought.You would hope everybody would go back and recertify but should that disqualify you for something that you've been doing very well for ten years, I don't think I would side there.

††††††††††† EXEC. SECRETARY FINDER:I will add, I want to make the topic more interesting, we have talked to some states and some of the states appear to have taken the stance that if you do not have an active, valid certificate they will not allow you to practice mammography.So some of the states at least are taking that stance at this point.They may be waiting for a lead from us to go in a different direction but we've heard back from some of the states and that's their position as of today.

††††††††††† MEMBER MONTICCIOLO:Could I ask a question about that?This is Dr. Monticciolo.So are you telling me there are states that are going to say the three months aren't good enough?

††††††††††† EXEC. SECRETARY FINDER:Correct.Some states actually have a requirement that you have to be board certified.They have a more stringent requirement than we do.

††††††††††† CHAIR HENDRICKS:Melissa.

††††††††††† MEMBER MARTIN:I guess my question is I would be really surprised why it would be acceptable for a radiologist not to renew their certification and still continue to do mammography when at that point they would not be allowed to do CT or MR or any other imaging modality.And maybe I'm missing something.

††††††††††† MEMBER MONTICCIOLO:†† First of all, you do not have to be board certified to read CT or any other modality.So that's not regulated at all and you can read CTs until the cows come without being board certified.But the issue I can see happening, Melissa, is what if you have a radiologist who is 59 years old or 60 and is very good reader and now he comes up against or she comes up against recerting and feels "I'm going to retire in three years.I'm not going to go through the recertification process but I think I'm a good practitioner and I want to continue."

††††††††††† There's other reasons other than trying to sneak through the system that people may not want to recert.So we are going to come up against this I think.

††††††††††† EXEC. SECRETARY FINDER:I'm trying to get at least a feel for how the committee feels about this because again we have to make some decisions pretty quickly on this.  So one alternative is to treat this as an initial requirement that never goes away that we would not look at again.The other is basically to say if you have a certificate that does expire, we're going to expect that certificate to be valid and current.So those are your basic two alternatives.

††††††††††† MEMBER MARTIN:And just to play Devil's advocate, I don't see, or I guess to play the other side of the coin, the inspection process treats the technologist as having to have current continuing education, current certification.So I guess if I'm playing the other side of things, I would think I would expect the same thing of a radiologist that I would of the technologist and I don't see why the inspection procedure would be any different.The technologists already have to provide that documentation at every place they work and we expect that of the technologist.

††††††††††† So I can see where you could do it either way but it is required of all the technologist.At this point, you're setting a very different standard if you grandfather in and say you do not have to have a current qualification as the radiologist.

††††††††††† EXEC. SECRETARY FINDER:That is correct.We do require that the technologist show a current status on their certification.Again, I just want to throw in this point to make it more interesting.The American Board of Radiology is not only doing this to interpreting physicians.They are also doing it to medical physicists.

††††††††††† MEMBER MARTIN:Oh yes.

††††††††††† EXEC. SECRETARY FINDER:It is an issue that affect them too.

††††††††††† MEMBER MONTICCIOLO:While I appreciate the remarks Melissa has made, I agree with Dr. Ferguson.Right now, we're saying that somebody's is not board certified they are qualified to read mammography if they have three months of training.So it is setting a different standard if we force our board certified to recert and there is a continuing CME requirement.So I guess I would be in favor of allowing that to be the initial criteria for it and just leaving it at that.

††††††††††† CHAIR HENDRICKS:Carolyn Hendricks, Board Chair.I have a different take on it because I do agree that this is something all hospitals, all payers, are going to be scrutinizing.Every hospital in the United States does not know what to deal with their medical -- Every medical staff obviously in the country is dealing with this across all specialties.But the issue here might be to permit some grandfather process of the current population of interpreting physicians.

††††††††††† But I do think that we need to scrutinize the new interpreting physicians and set maybe that higher standard and indicate that if they come in board certified that continuous board certification will be required because that's not the same as a 50 year old physician that's looking at one more year of active practice.This is the new generation of interpretative radiologists and we do want to set the bar quite high.

††††††††††† DR. BARR:Helen Barr, FDA.And, Dr. Hendricks, what you bring up certainly goes to what we've been talking about recruiting and retaining physicians in this field.Is this just one more thing if we change what is now an initial requirement to a continuing requirement?Are we just creating more problems for people entering and staying in our field?

††††††††††† CHAIR HENDRICKS:From the audience.

††††††††††† MR. MOURAD:Wally Mourad, FDA.I just want to comment on Melissa's point regarding the radiologic technologist.It's true that their board certification or state licensing if you will also has time limitations but it has been like this from day one and they're used to it.That's how they always expected it.So there's no change for them.But this is a new requirement that affected basically the interpreting physicians and now possibly the medical physicists.So that's one different area.

††††††††††† MEMBER MARTIN:Melissa Martin.But I think it is a change that has happened in all aspects that these people are going to be practicing in.Thisis a change and it's a change that the ABR has made.So it's nothing different about maintaining current status to read mammography than it is the current status to practice the profession of either radiology or medical physics.The qualifications are the same and it's going to effect everybody and everything we do.

††††††††††† MEMBER MONTICCIOLO:I was just going to say we still have that initial requirements allow you to read if you have three months training and are not board certified.So you still have that.Why would you take somebody who met the higher standard and then penalize them by constantly looking at them?They can just fall back on the three months if they can get the documentation.So what we are doing there?

††††††††††† MS. WILCOX:Pam Wilcox, ACR.Going back to the issue of the technologists, the techs on the panel can correct me if I'm wrong but it's my understanding you renew your certificate as long as you have your CEUs.But you don't have to take another exam.We're talking about for the radiologists and the physicists is reexamination.It's more comparable to their medical license as opposed to the board certification.

††††††††††† CHAIR HENDRICKS:Carolyn Hendricks, Board Chair.What is ACR's position on this dilemma of the physicians whose board certification is expiring?

††††††††††† MS. WILCOX:We have not taken a position.The ACR has not taken a position on this.One of the requirements for membership in the ACR is board certification.So we have a committee that will be looking at what position we're going to take.

††††††††††† EXEC. SECRETARY FINDER:All right.Next, I wanted to address some guidance documents and one of the public comments that we heard in the morning dealt with the issue of our guidance document and how it deals with full field digital mammography.I think the issue is extremely important because some of the guidance that we put out will have a big effect on the future use of digital mammography.

††††††††††† Just to refresh everybody's memory, the first comment from Dr. Murray Reicher this morning was related to Guidance Document No. 9 which you all have. It's page 15 and according to him, it's question no. 5.Unfortunately because of the difference in printers, we don't have the exact same marker but I believe that what he was talking about was question no. 5 on page 14 on the versions that you have.Let's see what he talks about.He talks about --Maybe 13.

††††††††††† (Discussion off microphone.)

††††††††††† EXEC. SECRETARY FINDER:Right.Fourteen is No. 5.Let's look at page no. 14, question no. 5.That's a charge one.So that's not it.

††††††††††† (Discussion off microphone.)

††††††††††† EXEC. SECRETARY FINDER:Let's go through one of his topics though.Basically it's a question of can a facility, and this is on page 13, question no. 5, copy or digitize a film screen mammography and use that copy or digitized image for retentional final interpretation?The guidance that we put out is no for the reason that's listed there.And his comment basically is he wants to be able to show or making the claim that he can show that digitized or copied films can be used for final interpretation and should be allowed for final retention purposes.

††††††††††† This is a question that was brought up before the committee last time and we just want to bring it up again because it is so important and to get your feeling on this business about copying original mammograms and then discarding that original and just keeping the digitized image.Any comment?

††††††††††† MEMBER PURA:What happens to the digitized?

††††††††††† EXEC. SECRETARY FINDER:I identify yourself.

††††††††††† MEMBER PURA:I'm sorry.Linda Pura.What happens to that because I'm not familiar with the process?What happens to that digitized film when you say you go to reproduce it?Is it a good production?

††††††††††† EXEC. SECRETARY FINDER:That's the entire issue.

††††††††††† MEMBER PURA:Yet I don't know.

††††††††††† EXEC. SECRETARY FINDER:Let me give somebackground.

††††††††††† MEMBER PURA:Because I haven't seen any of those done.So I would like to know what the comments are.

††††††††††† EXEC. SECRETARY FINDER:With film screen mammograms before full field digital came along, the statute and the regulations specifically precluded the use of copying of films.And the reason behind that was is the feeling was is that no matter how you tried to copy that film it would never be the same as the original and we had huge problems with facilities that were being sent copies for comparison purposes or for biopsy purposes being sent films that they felt were of suboptimal quality.So in the regulations we were very strict about it and said that when the patient requests her examination that the originals be released.

††††††††††† With the advent of full field digital mammography, there is now a question of what is the original mammogram.How do you display it?How do you transport it?How do you retain it?With that, now comes the issue of can I take a film screen mammogram and put it in a digitizer, scan it in, and take that digital data and use that for various purposes and then he's asking discard the original.It makes it easier to store in some cases, easier to retrieve, certainly easier to send them to other facilities.

††††††††††† So there is a functionality that is gained by digitizing these film screen mammograms.The question is should we allow this process and under what conditions and under the guidance that is currently out there, we have given basically a blanket no to it for the reasons we've stated here.The question is does anybody on this committee have any comments about that.

††††††††††† MEMBER MONTICCIOLO:Debbie Monticciolo.†† I'm not sure how good the digitizers are that this person who asked the question is talking about but I've never seen a digitized film screen product that was as good as the film screen image itself.There's going to be image loss.It's different if it's an acquired digital image and then you're talking about printing it out.That's a whole different issue.

††††††††††† But if you take a film screen mammogram and run it through a digitizer, you're going to lose information.I've never seen one that didn't lose some information.So I would think it would not be a good idea to destroy an original film that was taken with film screen because you're never going to be able to duplicate that just like you can't copy well.That's why they don't copy well.I've tried to scan in an awful lot of mammograms because I lecture and I try to make images that look just like the film and it's a horrendous problem.You just lose detail.

††††††††††† MEMBER WILLIAMS:This is Mark Williams.I was going to say exactly the same thing and I don't know many research studies that use digitized film or copied films for that very reason.There's always some loss in those processes and the original film is always insisted upon.I don't see why it should be any different for patient care.

††††††††††† MEMBER FERGUSON:I was actually going to say what David did and I saw Mark's hand up and I was afraid he was going to stump us with a physicist's answer.I agree.I've never seen a film of any typedigitalized that is as good as the original film.

††††††††††† EXEC. SECRETARY FINDER:My next questionor actually his next question is what would it take you to convince you that you're wrong.

††††††††††† MEMBER WILLIAMS:Mark Williams.I guess a big reader study.

††††††††††† EXEC. SECRETARY FINDER:Okay.So that's what you would recommend that before we would do something like this that a significant size reader study be done and would you be looking at end result or would you be looking at comparison of films because there are two different standards in one sense.You may be able to get the same diagnosis but still recognize that the film isn't the same and that you've lost something.So which one of those two standards do you think you would need or both?

††††††††††† MEMBER WILLIAMS:Mark Williams.If you set up the study so that you were just looking at correct diagnosis of images where there was a known lesion, then I'm not sure you would get the answer you wanted.

††††††††††† MEMBER MONTICCIOLO:Could I comment?It's Dr. Monticciolo.I don't think you would because once you know something's there or certain lesions would stand out regardless of if the film is diminished in quality.  I know that because we often get copied films from older years from other facilities and I can use those minimally but you really can't that film screen that's acquired the way it is and digitize it without losing something.

††††††††††† Now the question is is that something important.Isn't the modulation transfer function known for these devices or not?That's a physics question as you could tell.I'm amazed I can say that.MTF, modulation transfer function.

††††††††††† MEMBER WILLIAMS:This is Mark Williams and I think the answer to that is that the modulation transfer function is certainly characterizable for these systems.So you could measure the MTF prior and after.In reality, I don't think that data is very well known or studied very broadly across manufacturers simply because it's not a really straightforward, easy measurement to make like if you had a digitally acquired mammogram.

††††††††††† MEMBER MONTICCIOLO:Can I make one last comment?Sorry.We're going to be here all day if I keep this up.This is Dr. Monticciolo.I would just say even if we did a study we'd have to do a pretty large users' study to convince me that there's a good reason to throw out an original film.

††††††††††† MEMBER HOLLAND:Jackie Holland.I'm thinking the same thing and I'm wondering from a legal standpoint and especially when you're looking at from the patient's angle to get rid of anything that was the original, what kind of problem are you going to have standing in a court of law?I just don't see that that's going to be possible.

††††††††††† EXEC. SECRETARY FINDER:Now as I say, I keep trying to make things more interesting.That's digitization of a film screen mammogram.Now we go to the next real issue that he brought up which is suppose you take a full field digital mammogram and compress the data and we in our guidance basically have said that we will accept the original data as the original or if it is compressed using a lossless compression algorithm such that when you regenerate that data it brings back the full data.We will accept that as the original.

††††††††††† His feeling in his statement was that he can compress using lossy compression, so there will some loss of data, fairly large amounts of compression and he is using a term about visually lossless so that in some manner to the eye.And I tried to get him to pin this down through other correspondence but really wasn't able to get a firm definition of what he meant.But the general concept here is that if you looked at the image, you would not be able to see a difference.He's saying that if you can establish that why wouldn't you allow that type of compression?

††††††††††† MEMBER HOLLAND:Jackie Holland.I think though as Mark Williams there would have to be some kind of study done for me to accept that.

††††††††††† MEMBER MONTICCIOLO:Debbie Monticciolo.This is a slightly different issue is that there are images that have more information than the, I don't know how to say this except than to say that the eye can detect.Let me give you an example and maybe Dr. Williams can help me with this.

††††††††††† When I do slide presentations, I acquire the images of very high resolution but the projector can only project so much information.So what I do to make my talk smaller is I compress them and there's no change in the image.The image looks identical to me and believe me, I'm really picky about my images.So if there were a change, I wouldn't accept it.

††††††††††† But you can go down to a resolution that's what can be projected and you can't detect the difference between a 50 megabyte image and 5.So if they could prove they were doing that, I really wouldn't have a problem with it.The question is how to prove that.It really would have to be completely apparent because I really wouldn't want to take a chance with losing pertinent information.

††††††††††† MEMBER WILLIAMS:This is Mark Williams.The other thing that complicates it is that different compression algorithms produce different results.When you uncompress the image, bring it back, then they have different tendencies to produce degradations.Some of them result in visible artifacts and it may be that a visible change equates to being able to see little isolated artifacts.That's very different than of a more smooth but nevertheless very nonnegligible loss of image quality.

††††††††††† MEMBER MONTICCIOLO:I guess my opinion at this point would be unless there's information to the contrary I would not allow someone to use lossy technology.It would have to be lossless.

††††††††††† EXEC. SECRETARY FINDER:Okay.That's what the guidance says right now.He's coming back and saying what do I have to prove to you to get you to change your mind.

††††††††††† MEMBER WILLIAMS:Mark Williams.The other thing that I would add to the discussion is that I'm on another committee right now that's looking at the question of just image quality and digital mammography all together and one of the things that we did was an analysis of the pros and cons of various degrees of compression and one of the conclusions that popped up very quickly is that from an image storage standpoint there really aren't very strong arguments anymore like there originally were when digital mammography came about from the standpoint of space.Storage space is relatively inexpensive and the only arguments, the strong arguments, for compression such as they are now would be in transmission.So I think that we should keep that in mind that some of the original impetus for trying to somehow make this work are not quite as strong anymore.

††††††††††† EXEC. SECRETARY FINDER:So you would say no.

††††††††††† CHAIR HENDRICKS:Carolyn Hendricks, Panel Chair.Just a comment.So then do we go to the vendor and mandate that?How will you be able to move forward if you don't have good clinical or technical data right now and this individual physician may not be able to create a dataset that is acceptable to change this guidance?Go back to the vendor?What steps could be taken to try to resolve this issue?

††††††††††† EXEC. SECRETARY FINDER:That's a very good question.This is not just a physician.This is the chair of a company who is actually interested in this.

††††††††††† CHAIR HENDRICKS:The vendor.

††††††††††† EXEC. SECRETARY FINDER:As it stands right now under our current guidance, and this is draft, we're waiting for other public comments, if this goes into effect, some of the things that he wishes to do would not be allowed.Part of his question though is what would it take to get people to see it his way and provide the proof that he feels he already intrinsically believes.

††††††††††† I guess that's a question that I'm hearing would require a clinical trial of some kind but even there the parameters of that clinical trial would have to be fairly well established in order to make sure that we're talking about the same thing.I will just for Devil's advocate talk about some of the other issues that were brought up by this person.

††††††††††† With certain full field digital detectors, there's actually more data than can be presented on the monitor.So while right now, the standard is that use of five megapixel, five million pixel, monitors depending on the machine you're using you may actually have more data than can actually be presented on that screen.What he's basically saying is if you can't see it in the first place, why are you requiring me to store it and use it and keep it when I didn't make the diagnosis using that data to begin with?These are the types of questions that are being raised and they raise certain good issues.Go ahead.

††††††††††† MEMBER WILLIAMS:Mark Williams.I think the simplistic answer to that is that radiologists can use that information.They may not be able to visualize the entire mammogram in one view but if you zoom and roam, you certainly can get down to the level at which the image was originally acquired.So I don't think that necessarily the argument that you can't see it all in one view is grounds for throwing away information.

††††††††††† EXEC. SECRETARY FINDER:Okay.Very good.Part of his other question is right now the standard or the de facto standard for monitors is the use of the five megapixel monitor.One of his questions deals with the fact of why can't I use a lower resolution monitor and do exactly what you just said, basically roam and scan over the image and look at the entire image at three megapixels and then scan each component of it at the full resolution.Do you have any comments about that?

††††††††††† MEMBER WILLIAMS:This is Mark Williams.I really think that's a question for the radiologists because the problem that you get if you have a smaller monitor with fewer pixels is that you have a lot more manipulation to do and so I think the tradeoff is going to be in through-put and ease of use.

††††††††††† MEMBER FERGUSON:I was just telling her you're just not going to do it.It's just not going to happen.

††††††††††† EXEC. SECRETARY FINDER:Well, never say never.Part of the rationale behind this is that a lot of facilities are going fully digital and while the monitors and the program setup for full field digital may have a five megapixel monitor, all the other monitors in the department may be of three or two or four, whatever, megapixel capabilities.

††††††††††† What one of his arguments is that in orderto make this process smoother, make the adoption of full field digital easier and less expensive is instead of having to view these on five megapixel monitors allow them to go through PACS systems and be viewed on three megapixel or other lower resolution monitors and then do the scanning of the full image at full resolution.Part of the issue that comes up is yes, this may take a little bit longer but there is a savings then.The decrease in efficiency may be made up for in the lower price that you would pay.

††††††††††† I will tell you that in our guidance because of the authorities that we have and the authorities we don't have we have actually said that while we recommend that you use the monitors specified by the FFDM manufacturer, we do not have the authority to require it and that as long as the monitor you use meets the quality control procedures as recommended by the FFDM manufacturer we cannot stop you from using that monitor.So if you as an end-user want to use a lower resolution monitor, we cannot stop that.

††††††††††† We can at this point tell a manufacturer that they can't advertise and sell a lower resolution monitor at the present time for that purpose.But as an end-user because of practice of medicine issues and our current limitations of regulatory authority, an end-user can use a lower resolution monitor.So that's part of the argument that he makes is you're allowing it under that circumstance.Why are you preventing these other activities such as digitization and lossy compression?So it's a very complicated issue and that's why I bring it up for the physicists.

††††††††††† MEMBER WILLIAMS:This is Mark Williams.I think that of the, I could be wrong on this, current FFDM units out there I think there may only be one where you can view the image at full resolution even on a 2.0 X 2.5 K monitor and that's just because the matrix size of the detectors is just larger than that.So I guess that means there's nothing really magic about 2.0 X 2.5 K.It's just that's reasonably affordable and out there.

††††††††††† EXEC. SECRETARY FINDER:Let me just for other people around here.A 2.0 X 2.5 K monitor is a five megapixel monitor.

††††††††††† MEMBER WILLIAMS:Right.But I think maybe I gave the impression in what I said a minute ago that it's a continuously sliding scale and if you had a two or four pixel monitor and you wanted to take enough time, you could read a mammogram.I think, and I would like to get the comments from the folks here, that many radiologists also like to have a sort of gestalt where they do see the whole mammogram at some acceptable level to compare it with a left/right or a current prior.And then you have to draw the line someplace although right now, I don't think we know exactly where that is.

††††††††††† MEMBER MARTIN:Okay.Melissa Martin and I'm going to put my two cents in.Everything Mark has said I would agree with and I guess from what I have seen and just watching the way the radiologists are reading, and obviously we have the two radiologists can speak up here at the end, the comment I consistently get at this point already is the digital acquisition is much faster for the technologist and it is already "slower" for the radiologist.

††††††††††† We were in a group or we've been with a couple of groups and one of the radiologists blatantly made the statement "If it takes me more than 45 seconds to read an image, I'm losing money."I think Dr. Ferguson was right.The idea that they're going to scan and pan and spend five minutes looking at every image is not reality.But they're basically going to be doing is reading that image in a much lower resolution.So at this point, I have a real difficult time saying decrease the monitor resolution because most radiologists from what I've seen want to see that overall picture and then scan in on it.

††††††††††† MEMBER FERGUSON:I agree.

††††††††††† MEMBER MONTICCIOLO:It's Dr. Monticciolo.I think what Dr. Williams said was right that I don't think we know how it would affect the image quality to look at a four versus five monitor.But Dr. Finder is also right that there is a significant barrier to entering into the digital realm because of the cost of the monitors.They're extremely expensive and that's one of the reasons my administrator is just loathed to do that.My experience with digital is from Massachusetts General but I think you really have to see it.

††††††††††† Every radiologist I think needs to get a gestalt just like Dr. Ferguson said, but I don't know what effect of a four versus a three versus a two.I just don't know where it is I would want to stop.I certainly would like the highest resolution possible.That would be the best of all worlds but that is a complicated issue because that is a huge expense for the system.

††††††††††† MEMBER MARTIN:Dr. Finder.I'm Melissa Martin.The other thing I would just add is the comment at least I'm hearing consistently for the radiologist we are in there using the digital systems of biopsy.They are using the monitor that is in the acquisition mode or in the room that the technologist usually uses which is a lower resolution monitor and it is not infrequent that I get complaints that they cannot see on that monitor what they see on their review workstation which is the 5.0 K workstation.So several times, they've had to walk down the hall, look at the image on the 5.0 K workstation and then come back in.It's like "Oh, yeah.Now I can see on the lower resolution monitor because I know where to look."

††††††††††† In fact, I thought the request was almost going to go the other way.For those that are doing biopsies, they wanted the 5.0 monitors on the acquisition station so that they had the same resolution in the acquisition station if they're going to use it for biopsy procedures.At that point, I've heard it several times that there is a very different perception looking at that low resolution monitor.

††††††††††† MEMBER MONTICCIOLO:What's the resolution of the acquisition monitor?

††††††††††† MEMBER MARTIN:Is it a 2.0 K?The vendors would know more than I do.One K?

††††††††††† PARTICIPANT:One meg.

††††††††††† MEMBER MARTIN:I mean not 1.0 K, 1.0 meg.

††††††††††† MEMBER MONTICCIOLO:That's a pretty significant difference, isn't it?

††††††††††† MEMBER MARTIN:One or two depending on the vendor.So it's a significant difference.But if that's what we're talking about doing, I do know it is definitely a noticeable difference between the acquisition monitor and the review monitor.

††††††††††† MEMBER MONTICCIOLO:This is Dr. Monticciolo.I don't think anybody would want to go down to a one, but I don't know if there's a huge difference between five and four.I think we don't know.Certainly, if there is, then I would want to stay with the five but I don't think we have enough information to know that.

††††††††††† EXEC. SECRETARY FINDER:Okay.  That makes me feel good.Next question that came up should be little easier and it deals with the use of cushion pads so that you don't have to worry about all this mathematical stuff.Basically for those people who are not familiar with it, there are some pads that are available that can be placed either on the Bucky or on the compression paddle itself or both and they're used to minimize the discomfort from the compression during the mammographic procedure.

††††††††††† We have recently heard and I want to try and find out if this is anybody else's experience that the use of these pads may under certain circumstances cause a certain type of artifact.I just want to know if anybody's heard about this.I did ask this question before the committee met.I sent it out to them to see if they or any of their colleagues were aware of this type of artifact being produced.

††††††††††† MEMBER MARTIN:Melissa Martin.I did part of the original testing on these and that's why I'm looking.What kind of artifact are we looking for because I didn't find any at least from the physics mode?But that's not a clinical question.So is it an artifact that's showing up clinically?

††††††††††† EXEC. SECRETARY FINDER:Yes, it's an artifact that's been reported to show up during clinical examinations of patients with fatty breasts where they're using high speed film cassette combinations or with FFDM, full field digital machines.And I'm not sure again what the cause of this is and I'm trying to get some information from people if anybody's heard of it.

††††††††††† MEMBER RINELLA:Diane Rinella.A couple different things here.I don't really remember quite when the pad came out.Maybe it was 2000, something like that.1999.I was a supervisor of a prominent breast imaging center in California at the time and I tested the pad myself before allowing it to be utilized on our patients if they chose to use it.

††††††††††† And I was always under the foundation and taught and positioning in mammography that we always want the best as close to the image receptor as possible.Even though the pad may be just this thick, to me it was against everything that I worked so hard to try to do and that is to try to get as much information on the receptor detector as possible.So right there and the fact that it was raised bother me when I used it.

††††††††††† The second issue with the pad is that they provide two pads, one for the bottom and one for the top.And the one for the top covers the actual compression plate from underneath.So if you were use the top pad on the compression plate and bring that plate down, you are no longer able to see your breast basically.It covers the whole area.So you can't see as far as positioning is concerned, if your nipple is tracking straight, if you have lymph nodes that you've pulled over that you're trying to make sure you have the axillary area on or if you have any skin folds.

††††††††††† So the only way to really use the pad at that point was to only use it on the bottom.And in using it for myself, I found that because I tested it on my own body that the only thing that it provided for me, it wasn't more comfort, but that it provided warmth on the plate and that was basically it.There was a very slight, and I don't remember because this was a long time ago, increase in dose.So I thought at that point I'm not going to allow this to be used at my facility and I did not.

††††††††††† So I have not had any experience with it myself since that time.But in my travels throughout, I hear from technologists that are using digital equipment that they are seeing artifacts when they use the pad.So they have stopped.They haven't told me what specifically but they said that they are seeing artifacts.

††††††††††† MEMBER MONTICCIOLO:Dr. Monticciolo.I just wanted to ask a question.When this was originally approved for use, I'm assuming that digital wasn't in use at the time.So we probably don't have that data.But didn't the company have to provide data showing that it doesn't interfere with the image to get approved?And what data do we have?I don't know.

††††††††††† MEMBER MARTIN:But it was tested basically on a standard film screen system, not the ultra fast film screen systems and it certainly wasn't digital.That's why I was asking the details of why is it showing up.And that does make sense that if you're going to see it that's where you would see it.The original breast standard Kodak or Fuji film system, it was not showing up and the dose difference was certainly less than one percent.So at that time, it was not a problem.I think you have a different set of parameters now and it would be a clinical based decision.If it's giving you artifacts, obviously you wouldn't use it.

††††††††††† MEMBER MOUNT:Carol Mount.I agree with Diane.When the pad first came out, I too was not in favor of it and we used it very sparingly.However we do use it on patients that are very apprehensive.It might just get them to have a mammogram.We would rather that they have a mammogram than not.So we will use the pad on the bottom.Putting it on the top does also as Diane said cause a problem because you end up repeating films because you can't see where the breast is on the receptor.

††††††††††† We've used them ever since they came out again sparingly with film and the only time we see an artifact is when it's misaligned and you can see the line of the edge of the pad because there's a difference in density.On our digital unit, we are not seeing an artifact and we are using the pad.

††††††††††† EXEC. SECRETARY FINDER:Thank you for that information.Does anybody have any comments or questions about the guidance document especially no. 9?Guidance document no. 11 deals only with one topic and that is an issue that we discussed actually earlier and it deals with the fact that we will not be enforcing the requirement for continuing education in each specific mammographic modality and is consistent with our earlier discussions about the IOM recommendations.

††††††††††† The reason we put it out as a guidance document at this point was that since the requirement went into effect in 2002 we have continually been delaying implementation of this.We went from 2002 to 2004 to 2006 and 2006 was coming up quickly and people were starting to ask us questions and now with this advice that we've gotten from earlier advisory committees as well as the IOM, we put out a guidance document that said that we would indefinitely delay enforcement of that specific regulation.So that's document no. 11.

††††††††††† That leaves us again with any comments or questions about no. 9 if anybody had any.I surprised somebody hasn't asked me about where is document no. 10.Okay.So there are no other comments, questions or anything.It's good to go, document no. 9.Everybody thinks it's fine as is.Okay.Good.Thank you.

††††††††††† CHAIR HENDRICKS:Any other discussion related to guidance or any other issues?

††††††††††† EXEC. SECRETARY FINDER:Let me just check one thing.

††††††††††† CHAIR HENDRICKS:We have one item of business for our advisory committee and that is to say goodbye to four current members who will be departing from the panel after serving four years.

††††††††††† EXEC. SECRETARY FINDER:I do want to extend my personal thanks and also the thanks of the Food and Drug Administration to the following people who have served on the committee:Alisa Gilbert, Melissa Martin, Linda Pura and Miles Harrison who is on by phone.Their terms will end on January 31, 2006 and I doubt that we're going to have another meeting before then.So I did want to extend my thanks to all those people for all the effort and the years that they put into this committee and the advice that they've given us which has been very helpful.

††††††††††† While you'll still be officially committee members till January 31th, chances are we will not be having another meeting before then.I wanted to say goodbye to you and wish you luck and it's been a pleasure having you on the committee.Thank you.

††††††††††† CHAIR HENDRICKS:And with that, barring any other business to discuss --

††††††††††† EXEC. SECRETARY FINDER:No.Can't leave just yet.Summary minutes.  Do we have any summary minutes?Those of you who have seen the summary minutes from last meeting, does anybody have any comment on those minutes?Okay.I will take it that there were no comments to the summary minutes for the previous meeting.

††††††††††† CHAIR HENDRICKS:And with that, unless any panel members or members of the audience have any other comments that they would like to submit to the record, we thank everyone for their participation and this meeting is adjourned.Off the record.

††††††††††† (Whereupon, at 3:08 p.m., the above-entitled matter concluded.)