U.S. FOOD AND DRUG ADMINISTRATION

 

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GENERAL HOSPITAL AND PERSONAL USE DEVICES PANEL

 

OF THE

 

MEDICAL DEVICES ADVISORY COMMITTEE

 

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THIRTY-FIFTH MEETING

 

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TUESDAY,

 

AUGUST 9, 2005

 

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            The above‑entitled matter met in Salons A, B, and C of the Hilton Washington, D.C. North, 620 Perry Parkway, Gaithersburg, Maryland, at 8:00 a.m., Charles E. Edmiston, Jr., Ph.D., Chairperson, presiding.

 

PRESENT:

CHARLES E. EDMISTON, JR., Ph.D, Chairperson

MATTHEW J. ARDUINO, D.Phil, Voting Member

RICHARD O. BUTCHER, M.D., Voting Member

YARDIN B. DAVID, Ed.D., Voting Member

BONNIE M. WORD, M.D., Voting Member

TERRY LAYTON, Ph.D., Industry Representative

CAROLYN N. PETERSEN, M.S., Consumer Representative

CHIU S. LIN, Ph.D., Director, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices

SCOTT A. COLBURN, BSN, RN, LT, USPHS Executive

      Secretary                                  

 

 

 

FDA PRESENTERS:

 

THOMAS GROSS, M.D., M.P.H., Director, Division of

            Postmarket Surveillance, Office of

            Surveillance and Biometrics

SHEILA MURPHEY, M.D., Chief, Infection Control

            Devices Branch

ANTHONY D. WATSON, M.S., M.B.A., Chief, General

            Hospital Devices Branch

JASON F. LIPMAN, Lead Reviewer, General Hospital

            Devices Branch

SHEWIT BEZABEH, M.D., M.P.H., Medical Officer,

            Division of Anesthesiology, General

            Hospital, Infection Control, and Dental

            Devices

DAYAWANSA G. RANAMUKHA-ARACHCHI, Ph.D., Molecular

            Biologist/Genomics, Office of Science

            and Laboratories, Division of Biology

 

INVITED GUEST PRESENTER:

 

MARTIN FRIEDE, Ph.D., Initiative for Vaccine

                        Research, World Health Organization

 

INDUSTRY PRESENTERS:

 

DARIN LEE ZEHRUNG, Program for Appropriate

      Technology in Health (PATH)

 

MARK KANE, Program for Appropriate Technology in

      Health (PATH)

 

LINDA D'ANTONIO, D'Antonio Consultants International

 

KATHLEEN CALLENDER, Genesis Medical Technologies

 

 

PUBLIC SPEAKER:

 

HARRY HOOKS

HCVets.com

                    A-G-E-N-D-A

INTRODUCTIONS................................... 5

      Executive Secretary Colburn............... 6

CONDITION OF APPROVAL STUDIES:  RECENT CHANGES IN CDRH

      Dr. Gross................................ 13

DIVISION/BRANCH UPDATE

      Dr. Lin, DAGID Division Director......... 21

      Dr. Murphey, Chief Infection Control

            Devices Branch..................... 23

      Mr. Watson, Chief, General Hospital

            Devices Branch..................... 27

PUBLIC HEARING SESSION

      Harry Hooks, HCVets.com.................. 38

PRESENTATIONS BY FDA

      Introduction and welcome,

            Mr. Watson......................... 50

      Mr. Lipman............................... 51

      Dr. Bezabeh.............................. 59

      Dr. Ranamukha-arachchi................... 72

      Questions by Members to FDA presenters... 86

PRESENTATIONS BY CDC AND WHO

      Dr. Friede, WHO......................... 102

PRESENTATIONS BY INDUSTRY

      Dr. Zehrung, PATH....................... 134

      Dr. Kane, PATH.......................... 154

      Ms. D'Antonio, DCI...................... 179

      Ms. Callender, Genesis Medical

            Technologies...................... 180

PANEL DELIBERATIONS........................... 181

OPEN PUBLIC HEARING                            246

      Dr. Kane, PATH.......................... 246

               P-R-O-C-E-E-D-I-N-G-S

                                         8:06 a.m.

            CHAIRMAN EDMISTON:  Good morning.  I'd like to welcome to the 35th meeting of the General Hospital and Personal Use Device Panel. 

            I also want to request everyone in attendance at this meeting to sign in on the attendance sheet that is available on the table outside the door.

            I will note for the record the voting members present constitute a quorum as defined by 21 CRF Part 14.

            At this time I would like each panel member at the table to introduce him or herself and state his or her specialty position, title, institution and status on the Panel. And I'll start with my left, Dr. Lin.

            DR. LIN:  Hi. Good morning.  My name is Chiu Lin.  I'm the Director of Division of Anesthesiology, General Hospital, Infection Control and Dental Device in FDA.

            MS. PETERSEN:  My name is Carolyn Petersen. I'm a web editor at Mayo Clinic in Rochester, Minnesota.  And I'm here as the consumer representative.

            MR. DAVID:  Good morning. My name is Yardin David. I'm Director of Biomedical Engineering Department at Texas Children's Hospital in Houston and Assistant Professor at Baylor College of Medicine, Department of Pediatrics.

            EXECUTIVE SECRETARY COLBURN:  Good morning. My name is Lieutenant Scott Colburn. I am the Executive Secretary to the General Hospital and Personal Use Devices Panel.

            CHAIRMAN EDMISTON:  My name is Charles Edmiston.  I am a faculty member at the Medical College of Wisconsin and hospital epidemiologist.

            DR. WORD:  Hi.  My name is Bonnie Word.  I am on faculty at Baylor College of Medicine also at Texas Children's Medical Center where I'm the Chief of the infectious disease clinic and travel medicine clinics.

            DR. ARDUINO:  Hi.  My name is Matt Arduino, and I'm the lead microbiologist in the epidemiology and laboratory branch at the Division of Health Care Quality and Promotion at the Center for Disease Control and Prevention.

            DR. BUTCHER:  I'm Richard Butcher, a physician a San Diego, general practice with Care View Medical Group.

            DR. LAYTON:  Good morning. I'm Terry Layton, a biomedical engineer. I'm industry representative on this Panel.  And I'm from Laytech, Incorporated out of Chicago, Illinois.

            CHAIRMAN EDMISTON:  Thank you.

            Lieutenant Scott Colburn, the Executive Secretary, would like to make some introductory remarks.

            Lt. Colburn?

            EXECUTIVE SECRETARY COLBURN: Before I start the remarks, I'd like to introduce Ms. Mary Ann Killian from the Ethics Integrity staff to read the conflict of interest statement for the members of the Panel.

            MS. KILLIAN:  Thank you.

            The Food and Drug Administration is convening today's meeting of the General Hospital And Personal Use Devices Panel of the Medical Device Advisory Committee under the authority of the Federal Advisory Act of 1972.  The Advisory Panel meeting provides transparency into the Agency's deliberative processes. With the exception of the industry representative, all members of the Panel are special government employees or regular federal employees from other agencies and are subject to the Federal Conflict of Interest laws and regulations. Consequently, in the interest of transparency and the spirit of disclosure, the following information on the status of this Advisory Committee Panel's compliance with the Federal Ethics and Conflict of Interest laws covered by but not limited to those found at 18 USC 208 and 21 USC 355(N)(4) is being provided to the participants in today's meeting and to the public.

            FDA has determined that members and consultants of this Panel are in compliance with Federal Ethics and Conflict of Interest laws.  Under 18 USC 208 Congress has authorized FDA to grant waivers to special government employees who have limited financial conflicts when it is determined that the Agency's need for a particular individual's service outweighs his or her potential financial conflict of interest.

            Members and consultants who are special government employees at today's meeting have been screened for potential financial conflicts of interest of their own as well as those imputed to them including those of their employers, spouse or minor child related to the discussion of today's meeting. These interests may include investments, consulting expert witness testimony, contracts grants, creative teaching, speaking, writing, patents, royalties and primary employment.

            Today's agenda involves a discussion on methods to assess the potential of disease transmission by multi-use nozzle jet injectors; that is jet injectors for which the fluid path for the injection is used more than once. The discussion will also include premarket testing, recommendations to address this issue.  This is a general matters meeting during which the topic of discussion is limited to recommendations or considerations of broad legislative proposals, regulatory initiatives or policy developments that affect an industry, group of manufacturers or health care providers. So any conflict of interest waivers granted for this meeting are broad and general in nature.

            A copy of the written conflict of interest waiver statement may be obtained by writing to the Agency's Freedom of Information Office, 12A30 of the Parklawn Building.

            Based on the agenda for today's meeting and all financial interests by the Panel participants it has been determined that all interests in firms regulated by the Center for Devices and Radiological Health present no actual or appearance of conflict of interest for today's meeting.

            The following Panel participants have not received a conflict of interest waiver to participate in today's meeting:  Dr. Charles Edmiston, Dr. Matthew Arduino, Dr. Richard Butcher, Dr. Bonnie Word, Dr. Yardin David and Ms. Carolyn Petersen.

            In addition, Dr. Terry Layton has been invited to participate as the industry rep acting on behalf of all related industry, and is employed by Laytech, Incorporated. 

            With regard to FDA's guest speakers, the Agency has determined that the information provided by these speakers is essential.  The following interests are being made public to allow the audience to objectively evaluate any presentation and/or comments made by the speakers:

            Dr. Bruce Weniger, who is a guest speaker with us today, has acknowledged that his employer, the Centers for Disease Control and Prevention, has financial interest in firms at issue. The financial interests and professional relationships are in the form of research contracts and educational projects involving multiple-use jet injectors.

            Dr. Martin Friede, who is also a guest speaker with us today, has acknowledged that his employed the World Health Organization has interest in today's topic in the form of pending clinical trials.       As guest speakers, these individuals will not participate in Panel deliberation.

            Members and consultants of the Committee are reminded that if the work of the Committee moves from matters of general applicability to matters that are more specific, for example product or firms identified, the FDA shall end the discussion promptly and each special government employee's financial interest will be reexamined in relation to the particular matters so that a determination may be made on whether exclusion from further discussion is required.  All exclusions will be noted for the record.

            Finally, in the interests of public transparency with respect to all other participants, we ask that they publicly disclose prior to making any remarks any current or previous financial involvement with any firm whose products they may wish to comment upon. This statement will be available for review at the registration table during this meeting and will be included as part of the official meeting transcript.

            Thank you.

            EXECUTIVE SECRETARY COLBURN:  Thank you, Ms. Killian.

            The FDA seeks communication with industry and the clinical community in a number of different ways.  First, FDA welcomes and encourages premeetings with sponsors prior to all IDE and PMA submissions.  This affords the sponsor an opportunity to discuss issues that could impact the review process.

            Second, the FDA communicates through the use of guidance documents.  Toward this end, FDA develops two types of guidance documents for manufacturers to follow in submitting a premarket application.  One type is simply a summary of the information that has historically been requested on devices that are well understood in order to determine substantial equivalence.  The second type of guidance document is one that develops as we learn about new technology.

            The FDA welcomes and encourages the Panel and industry to provide comments concerning our guidance documents.

            I'd also like to remind you that the tentative dates for the next meeting on the General Hospital and Personal Use Devices Panel is scheduled for September 27, 2005.  You may wish to pencil in this date on your calendar, but please recognize that this date is tentative at this time.

            The first item on our agenda is a presentation by Dr. Tom Gross from the Office of Surveillance and Biometrics. He will discuss the conditions of approval studies and recent changes in CDRH.

            Dr. Gross?

            DR. GROSS:  Good morning.

            As was stated, I'm Tom Gross.  I'm the Director of the Division of Postmarket Surveillance in our Office of Surveillance and Biometrics.  And I'd like to take a few minutes of your time today to talk bout recent changes in our conditions of approval study program.

            Before I do that, I'd like to touch based on some of the essential functions that our office serves for the center. And those are presented in this slide here.

            First and foremost, we provide support for premarket review.  We have a large group of statisticians who address all statistical aspects of premarket submissions.  We also have a group of epidemiologists who are involved in PMA review teams and help design condition of approval studies. 

            We are also responsible through our nationwide passive surveillance systems to detect signals of potential public health problems. That's our Medical Device Reporting system or MDR system.  And our network of user facilities throughout the United States for our MedSun network.

            Thirdly, we're responsible for risk characterization and analysis of these potential public safety issues.  This is done primarily by our epidemiology staff doing everything from systematic literature reviews to de novo studies.

            We also coordinate our center response on these public health issues.  We convene committees of center experts to deliberate these issues and to present their recommendations to center senior staff for action.

            And lastly, we have a staff who interpret our medical device reporting regulations; what needs to be reported under what circumstances, and also to follow-up on violations of those reporting requirements.

            Now let's turn to our condition of approval study program.  As most of you know, these studies are ordered as a condition of approval of our PMA products.  And the regulations clearly stipulate the following:

            That post approval requirements can include continuing evaluation and periodic reporting on the safety, effectiveness and reliability of the device for its intended use. This regulation gives us our broad authority in ordering these post approval studies.

            Next slide.

            Now about the middle of 2002 our office took a snapshot of the center's activities with regard to the condition approval study program to see how well the center was doing.  And the study basically involved looking at PMAs that were approved from 1998 through the year 2000. All tolled, there were 127 PMAs that were approved during that period of time.  45 of those had clinical condition of approval study orders.

            At the end of the day what did we find?  That CDRH had limited procedures for tracking study progress for results, that our IT and other systems were wholly deficient in this regard.

            There's large turnover of lead reviewers that resulted in lack of follow-up.  Up to 40 percent of individuals who are lead reviewers at the time the PMA came in the door were no longer associated with that PMA when we did this study.

            And lastly, there was lack of premarket resources. Those resources were devoted to premarket submissions and there was little left for oversight of condition approval studies.

            Next slide.

            So based on these results and based on an ongoing pilot we had of epidemiologists involved with PMA reviews we decided there was need for a change. And the goal for that change basically focused on the following:

            To obtain useful, timely and quality postmarket information on the safety and effectiveness of devices as they move into the marketplace;

            To better characterize the risk and benefit profile of these devices.  For instances, their long term performance, and to add to our ability to make sound scientific decisions based on these timely and high quality studies.

            So what did we do in terms of change?  The next two slides speaks to this. We transferred the condition of approval study program from our premarket side of the house, the Office of Device Evaluation, to our postmarket side of the house, the Office of Surveillance and Biometrics.  We did that effective January of this year.

            We did that for two reasons.  One, our office has the resources to oversee the program and we also have the resident expertise in epidemiologists to be part of this program.

            We developed and instituted an automatic tracking system for these studies so we could acknowledge receipt of the protocols and interim study reports, and follow-up when reports were not received.

            Next slide.

            Most importantly, we added epidemiologist to all the PMA review teams for all the five review divisions within the Office of Device Evaluation.  The epidemiologists were tasked with the development of postmarketing monitoring plans during the premarket review.  These plans spoke to the best means of monitoring the safety of these products in the postmarket period.

            Epidemiologists assumed the lead in developing and formulating postmarket questions, the lead in the design of condition approval study protocols and tracking those study results over the period of the study.  And throughout this process we collaborated very closely with all members of the PMA review team.

            Next slide.

            In addition, we addressed motivation for study conduct, meaning how best can industry do these studies and how best can FDA participate in these studies.  And first and foremost, obviously it's important to address the important postmarket questions:  What are the essential questions that need to be addressed in these condition approval studies and to develop a good study protocol to address those questions and objectives.

            We had to acknowledge the receipt of these protocols and study reports in real time, providing real time feedback to the industry.

            As part of a guidance document we hope to issue soon, we hope to be transparent with regard to these studies by posting the status of these studies on CDRH's website.

            And lastly, there are other authorities that we can levy if companies do not perform these studies with due diligence.  And those other authorities give us leeway in terms of misbanding the product or levying monetary penalties if the companies continue to fail to do those studies.

            Next slide.

            And lastly, what's the impact on the Advisory Panel?  We will attempt to lay out the important post approval public health questions for the Panel's deliberation and possible considerations. And we will also inform the panel, that is FDA and industry, on a periodic basis about the results of these studies that were approved.

            Thank you very much.

            EXECUTIVE SECRETARY COLBURN:  Thank you, Dr. Gross.

            Before I turn the meeting back over to Dr. Edmiston, I'd like to ask that all cell phones and pagers be turned off or placed in the silent mode, please, so they do not interrupt the business during the time of this meeting.

            Dr. Edmiston?

            CHAIRMAN EDMISTON:  Thank you.

            At this time we have several presentations from representatives of the Division of Anesthesiology, General Hospital Infection Control and Dental Devices.

            Our first presenter will be Mr. Lin, Director of the Division of Anesthesiology, General Hospital Infection Control and Dental Devices.  He will provide a very brief update of the Division's activities.

            Dr. Lin?

            DR. LIN:  Good morning.

            I thought I will spend a few minutes to talk about what the current update.  I know that since the last Panel meeting the Division has changed significantly. So I will spend a few minutes to talk about what the Division, and following my presentation the two branch chiefs are going to give you an update what each branch chief's activities.

            As you probably may know, the Center for Device and Radiological Health composed of at least six office, and because of the time I don't want to go into the detail, but next slide, please.

            Office of Device Evaluation, where that's most of us work in the Office of Device Evaluation, is composed of five divisions. And division is divide according to product line that we are responsible for reviewing.  And the divisions of Anesthesia, General Hospital and Infection Control and Dental Device are one of those divisions in the Office of Device Evaluations.

            Next one.

            Currently the Division has myself is Division Director.  And then we have Dr. Ginette Michaud who is sitting in the audience.  Dr. Michaud, can you -- she's my Deputy Director.

            Next. 

            From the Division's name imply that we are responsible for four product lines.  One is the Anesthesiology and Respiratory Device branch.  And at current the branch chief is Ms. Ann Graham.  And some of you probably already met.  We have a panel meeting not long ago.

            And then we have a Dental Device branch, and the chair of the branch is Dr. Susan Runner.  Some probably also met. We also had panel meeting a few months ago.

            And then the General Hospital Device branch is headed by Mr. Tony Watson.  Is right here.