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Center for Devices and Radiological Health 2002

Anesthesiology

Recall of Infant Apnea Monitor

Possible Failure of Infant Monitoring Device Results in Class I Recall

FDA’s New England District Office reported that CAS Medical Systems, Inc., Branford, Connecticut, voluntarily recalled three models of Infant Apnea Monitors. The firm initiated the recall on December 17, 2001, because the infant apnea monitor might shut down and the audible alarm might fail to sound. Monitors effected in the recall were: AMI 9700 Apnea Monitor, AMI 9700A Apnea Monitor, and AMI Plus 9700B Infant Central Apnea/Heart Rate Monitor. The devices were manufactured between 1997 and 2001.

Deviations from QSR Result in Warning Letter

FDA’s New Orleans District Office issued a Warning Letter to Honeywell, Inc., Minneapolis, Minnesota, a manufacturer of Class I humidifiers and vaporizers, on April 1, 2002. An inspection of their Newbern, Tennessee facility on March 4 - 8, 2002, disclosed deviations from the Quality System Regulation (QSR). These deviations included the following: failure to validate the blow molder and plastic injection molding machines; incomplete and/or no Device History Records and Standard Operating Procedures; and no QSR training of firm personnel.

Firm Agrees to Pay $7 Million in Settlement Agreement

Firm Fails to Investigate and Document Failure of Devices Sold to U.S. Government

United States v. Hewlett-Packard (D. Mass.). On July 26, 2002, the United States District Court for the District of Massachusetts approved a Settlement Agreement settling civil claims against the Hewlett-Packard and Agilent Corporations for submitting false and/or misleading claims to the United States in connection with the sale of medical devices to the government. Under the agreement, HP/Agilent agreed to pay $7,000,000 to settle these claims. This case was first initiated by an employee who brought this matter to the attention of the government by reporting his concerns about HP's safety practices to FDA.

In response, FDA inspected HP and required substantial corrective action. The employee also filed a qui tam lawsuit. He provided substantial assistance to the government in the pursuit of this case and, as the law governing qui tam actions permits, will receive 23% of the proceeds.

The United States Government alleged that from 1991 through 1997, HP sold to the United States Government patient monitors, anesthesia gas modules, and pulse oximeters which were defective and/or adulterated, and that HP failed to comply with FDA regulations requiring the firm to investigate and document device failures. The settlement amount was based upon a $5,000 to $10,000 penalty for each claim submitted for these devices to the government during the designated time. The Court has approved the settlement as fair, adequate, and reasonable under the circumstances.

Bioresearch Monitoring

Application Integrity Investigations
Manufacturer of In Vitro Devices Receives AIP Letter

Firms Receives AIP Letter Due to Concerns with Reliability of Data

FDA’s Center for Devices and Radiological Health (CDRH) placed Micro Detect, Inc., Tustin, California, under the Agency’s Application Integrity Policy (AIP) due to data reliability concerns in its 510(k) submission for an in vitro diagnostic device. On November 5, 2001, CDRH issued an AIP Letter to Micro Detect, Inc., Tustin, California, a manufacturer of in vitro diagnostic (IVD) devices. Issuance of the AIP letter defers scientific review of pending applications and any new or supplemental applications filed thereafter, until CDRH is satisfied that the data is reliable.

This enforcement action was the culmination of a series of events that began when CDRH’s Office of Device Evaluation reviewers voiced concerns about data reliability in the 510(k) submission. The Division of Bioresearch Monitoring (DBM) issued “for cause” inspection assignments for the study sponsor and several clinical investigators involved with this and other Micro Detect 510(k) submissions under review at that time.

Inspections by FDA’s Los Angeles District investigators revealed that Mehdi Alem, Ph.D., President and CEO of the company, was unable to supply source documentation for the device’s pivotal studies. Field investigators also determined that studies conducted to establish the performance characteristic of another assay were not performed according to the instructions in the package insert, and that materials used for the assay were other than those included in the assay kit.

Moreover, investigators from FDA’s Los Angeles District Office uncovered evidence to show that Dr. Alem altered the test results of a study for a third assay in which three laboratories assayed the same set of samples. This finding was verified during a limited inspection of one of the testing laboratories involved. Micro Detect is currently working with DBM and the District on an acceptable Corrective Action Plan.

AIP Letter Issued for Study of Orthopedic Prosthesis

In February 2002, CDRH Placed Endotec, Inc., South Orange, New Jersey, under the Application Integrity Policy (AIP) due to data reliability concerns in its investigational device study of an orthopedic prosthesis. On February 14, 2002, CDRH issued an AIP Letter to Michael J. Pappas, Ph.D., President, Endotec, Inc., South Orange, New Jersey, a manufacturer of orthopedic prosthetic devices. This enforcement action resulted from well coordinated inspections by three Districts (i.e., New Jersey, Florida, and New York) that revealed a system-wide failure by the study sponsor to ensure the integrity of data collected in support of their research application.

The Division of Bioresearch Monitoring (DBM) received information that Endotec’s study of the orthopedic prosthesis may be compromising the safety of research subjects. After careful evaluation, DBM issued “For Cause” inspection assignments for the study’s sponsor, the clinical investigator with the majority of study subjects (Mark H. Feldman, DPM), and the clinical investigator recently dropped from the study by the sponsor, Mark Figgie, M.D. The field conducted the first two inspections simultaneously.

During the sponsor inspection, FDA’s New Jersey District investigators found that Endotec had no standard operating procedures in place for either study monitoring or oversight of data collection and failed to adequately train their clinical investigators. Furthermore, reports submitted to FDA prior to the inspection lacked information on critical adverse device effects, and a significant number of subject case report forms and medical histories were incomplete. CDRH placed Endotech under the AIP and DBM issued comprehensive Warning Letters to each Clinical Investigator (see Drs. Feldman and Figgie below). Endotech is now working with DBM and the District on an acceptable Corrective Action Plan.

Warning Letters Issued to Clinical Investigators

  • On December 21, 2001, CDRH’s Division of Bioresearch Monitoring (DBM) issued a Warning Letter to clinical investigator, Dr. Mark H. Feldman, DPM, located in Miami Lakes, Florida, as a result of a comprehensive inspection by FDA’s Florida District Office. Deviations included the following: failure to obtain informed consent from several study subjects; failure to provide study subjects with a copy of their signed and dated informed consent document; protocol deviations; lack of device accountability records; inadequate subject records; and commercialization of an investigational device.

Protocol violations included the following: treatment of ineligible subjects; performance of auxiliary surgery at the time of the implant; failure to perform all required tests at all visits; failure to return explanted devices; and failure to maintain copies of case report forms submitted to the sponsor.

Dr. Feldman responded in writing to CDRH. He promised immediate corrective actions and also included copies of informed consent documents subsequently signed by a number of the study subjects who had not previously signed one.

  • On March 21, 2002, CDRH’s Division of Bioresearch Monitoring issued a Warning Letter to clinical investigator, Dr. Mark P. Figgie, as a result of New York District Office’s inspectional findings. The findings included: starting the research prior to institutional review board (IRB) approval of the study; obtaining informed consent documents after the subject’s surgery; treating research subjects after IRB approval was rescinded; failing to report to the IRB an unanticipated adverse device effect; protocol deviations; no device accountability records; and inadequate subject records. Protocol deviations included the following: treatment of ineligible subjects; bilateral implantation; and follow-up visits outside of the prescribed windows.

Dr. Figgie’s official response to FDA’s New York District Office’s inspectional observations did not include any planned corrective actions. In the Warning Letter, DBM requested Dr. Figgie to describe the corrective actions he had taken or planned to take in response to the inspectional observations, within15 working days of receipt of the Warning Letter.

Dr. Figgie responded in writing listing the corrective actions he planned and implemented. In addition, the Hospital for Special Surgery where he practices has taken steps to enhance regulatory compliance, establishing a Clinical Trials Office in their Research Division which includes a new Assistant Director for Clinical Trials.

This office is mandated to assist investigators in the conduct of clinical trials and to conduct periodic audits to ensure compliance with IRB and regulatory requirements.

  • On March 5, 2002, CDRH’s Division of Bioresearch Monitoring (DBM) issued a Warning Letter to the Ochsner Clinic Foundation IRB in New Orleans, Louisiana. FDA’s New Orleans District investigators uncovered objectionable practices during their inspection including the IRB’s failure to have and follow adequate written procedures for conducting initial and continuing review of research; to conduct review of research as described in the written procedures; and to prepare and maintain adequate documentation of IRB activities.

As a result of the New Orleans District Office’s findings, DBM effectively suspended Ochsner Clinic Foundation’s authority to approve new research studies of FDA-regulated products and to add new research subjects to ongoing FDA regulated studies. This suspension continued until the IRB was in full compliance with FDA’s IRB regulations as determined by implementation of an adequate Corrective Action Plan, and a future FDA inspection.

DBM required representatives from Ochsner to discuss their Corrective Action Plan during a conference call, to which DBM invited officials with the Department’s Office for Human Research Protections. Ochsner Clinical Foundation was required to develop a Corrective Action Plan that included the following items:

  • contract with an independent IRB to perform re-review of previously approved research and to review new studies;
  • ensure that all previously approved investigational studies are adequately reviewed in accordance with FDA requirements, including the applicability of an IND or IDE submission;
  • revise current policies and procedures so that the functions and operations in the procedures manual comply with all pertinent federal regulations (include the date of revision, signatures of approval officials, and the date of implementation);
  • ensure that all IRB members and staff are appropriately educated, on a continuing basis, about the regulatory requirements for review of research projects and the protection of human subjects; and,
  • ensure that the IRB (or the institution) prepares and maintains adequate documentation of the IRB’s activities.

Ochsner Clinical Foundation implemented an adequate Corrective Action Plan and had a satisfactory follow-up inspection by the New Orleans District Office. In June 2002, DBM removed the IRB’s suspension.

Disqualification Letter Issued to Clinical Investigator

FDA Inspection Discloses that Investigator Repeatedly Violated FDA Regulations

CDRH issued a Notice of Disqualification Letter to Leon C. LaHaye, M.D., Lafayette, Louisiana, Sponsor/Investigator, for an Investigational Ophthalmic Laser Study. On June 18, 2002, CDRH’s Division of Bioresearch Monitoring issued its first “Notification of Disqualification of Entitlement to Receive Investigational Devices” letter to Dr. LaHaye. This clinical investigator disqualification was based upon inspections by FDA’s New Orleans District Office that found Dr. LaHaye repeatedly and deliberately violating FDA regulations governing the conduct of clinical research and the use of investigational devices. The New Orleans District Office also established that Dr. LaHaye repeatedly and deliberately submitted false information in reports to FDA for studies of investigational devices.

Cardiovascular

Contract Manufacturer Receives Warning Letter

FDA Inspection Discloses that Manufacturer of Balloon Catheters Is In Violation of QSR for Devices

FDA’s Minneapolis District Office issued a Warning Letter on March 29, 2002, to the President and CEO of Minnesota Extrusion, Inc., Maple Grove, Minnesota. An inspection of this firm was conducted from January 23 through 30, 2002. The firm manufactures dilators, balloon catheters, sheaths and catheters for use in diagnostic, therapeutic and interventional applications. The inspection revealed that the devices were in violation of the Quality System Regulation for devices. The Warning Letter cited deficiencies in the areas of management responsibility, management reviews, quality plan and audits, validation of manufacturing processes, and in corrective and preventive actions.

For example, management with executive responsibility had not ensured that an adequate and effective quality system had been fully implemented and maintained at all levels of the organization; a quality plan had not been established; management reviews were not conducted at defined intervals; quality audits were not conducted as prescribed by internal procedures to verify that the quality system is effective; the corrective and preventive action procedures addressing the analysis of quality data and potential causes of nonconforming product or other quality problems were not implemented; and the manufacturing process for the measuring balloon catheter had not been validated and approved according to established procedures.

Warning Letter Issued to Manufacturer of Electrocardiographic Monitors

FDA’s Florida District Office issued a Warning Letter dated February 6, 2002, to the CEO of Medicomp, Inc., Melbourne, Florida. An FDA inspection of the firm from December 10 - 12, 2001, disclosed deviations from the Quality System Regulation (QSR) in the manufacture and distribution of electrocardiographic monitors.

The QSR violations included: failure to validate significant manufacturing processes; failure to establish, document and maintain procedures for the monitoring and control of validated process parameters; failure to fully document corrective and preventive actions; failure to implement and record changes in methods and procedures needed to correct and prevent identified quality problems; and failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

Firm Recalls Defibrillators

Defibrillators Recalled Due to Possible Failure to Deliver a Charge

FDA’s New England District Office reported that Zoll Medical Corporation, Burlington, Massachusetts, voluntarily recalled Zoll M Series Advisory Defibrillator Serial Numbers: T98F00046-T01K27762 and Zoll M Series AED Defibrillator T98F0092-T01J27533 both with System Software Version below 30.00. Defibrillators were recalled as they may fail to detect ventricular fibrillation and fail to deliver a charge. Zoll Medical Corporation notified consignees by certified letter on December 8, 2001. The firm mailed software kit upgrades beginning on December 12, 2001, with instructions to install a 30-second software upgrade to be completed at the customer site.

Class I Recall of Band Ligator

Band Ligators Recalled Due to Possible Failure to Deploy

On January 31, 2002, FDA’s Center for Devices and Radiological Health (CDRH) issued a Class I recall for Bard RapidFire Multiple Band Ligator (Item No. 000608). The recalling firm was Bard Endoscopic Technologies, Division of C.R. Bard, Inc., Billerica, Massachusetts. The band ligator is used for binding or tying off veins, arteries or lymph vessels abnormally dilated and twisted. This product is intended for use by physicians during surgical procedures. The recall was initiated because inadequate chlorination of the ligature bands caused them to become tacky and not deploy properly during application. FDA’s New England District monitored the recall. FDA considers there to be a risk of death since the band ligator may fail to deploy and prevent or control of bleeding.

Ear, Nose and Throat

Class I Recall of Bronchoscopes

Bacteria Found Growing in Video Bronchoscopes

On November 30, 2001, Olympus America, Inc., of Melville, New York, initiated a voluntary recall of its bronchoscopes after a medical facility reported that bacteria growing in video bronchoscopes may have been responsible for a patient infection requiring medical treatment. A bronchoscope is a flexible tube with a small light and camera used to evaluate the airway and lungs to diagnose or rule out respiratory problems such as pneumonia and lung cancer.

Olympus issued a recall notification letter to hospitals and medical facilities on November 30, 2001, requesting the return of the suspect bronchoscopes to Olympus for modification. The biopsy port on the video bronchoscope is not intended to be removed from the bronchoscope. However, the medical facility, which reported one illness among patients treated with the bronchoscopes, discovered that the biopsy ports on the bronchoscopes had become loose, and could be removed by twisting. Olympus America repaired the bronchoscopes by applying adhesive to the biopsy port, and replaced the plastic biopsy port with a port made from stainless steel.

On February 27, 2002, Olympus issued a second recall notification letter to facilities that did not respond to their first letter. The following are the Olympus Bronchoscope Models that were recalled: BF-40, BF-P40, BF-IT40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF-IT240, BF-6C240, BF-160, BF-P160, BF-IT160, BF-3C160, BF-XT160.

The bronchoscopes were distributed nationwide and to Canada, Mexico, Dominican Republic, Argentina, Brazil, Panama, Chile, Peru, Ecuador, Columbia, Venezuela, Paraguay, Uruguay, Costa Rica, and El Salvador. FDA worked with Olympus on this recall.

General Hospital and Personal Use

Warning Letter Issued to Manufacturer of Wound Care Products

FDA Inspection Finds Numerous Violations of QSR Which Could Have Adverse Effect on Product Quality

FDA’s Center for Devices and Radiological Health issued a Warning Letter to the President of Dumex Medical, Toronto, Ontario, Canada, on January 24, 2002. The firm manufactures Class II medical devices including operating room sponges, wound dressings, wound care products, and gauze, cotton and synthetic bandages. FDA conducted an inspection of the firm on July 23 - 26, 2001. This inspection revealed that the devices were in violation of the Quality System Regulation.

The violations noted in the Warning Letter included: failure to establish and maintain adequate procedures for finished device acceptance; failure to establish and maintain adequate procedures for the receipt, review, and evaluation of complaints; failure to establish and maintain adequate procedures for implementing corrective and preventive action; failure to ensure that all personnel are trained to adequately perform their assigned responsibilities and to document the training; failure to have quality audits conducted by individuals who do not have direct responsibility for the matters being audited; failure to establish and maintain requirements for the health, cleanliness, personal practices and clothing of personnel if contact between such personnel and product or environment could reasonably be expected to have an adverse effect on product quality.

Class I Recall of Infant Bassinet

On March 20, 2002, FDA announced the recall of bassinets with a drop leaf work surface, models 248 and 121. The recalling firm was Hill-Rom, Inc., 1069 State Route 46, East Batesville, Indiana. FDA noted that – although the drop leaf shelf is not included as a support shelf for infants, when used in this manner – the drop leaf shelf support mechanism will fail to support the infant. The infant could fall causing head or other bodily injury. FDA considers there to be a risk of serious injury from continued use of this device unless correction is made.

In Vitro Diagnostic Test Kits

Gonorrhea Test Kits Recalled by Abbott Laboratories

On August 30, 2002, FDA announced that Abbott Laboratories, Inc., Abbott Park, Illinois, initiated a worldwide recall of 32 lots of laboratory kits used to diagnose gonorrhea. These test kits were distributed to hospitals and laboratories from January 11 to June 24, 2002.

Gonorrhea is a serious, highly contagious sexually transmitted disease that affects both men and women. Women primarily suffer severe consequences from infection that is not detected and treated. Untreated gonorrhea in women can cause pelvic inflammatory disease that can lead to sterility. In pregnant women, infection can cause abortion, premature delivery, or infection in the baby. If undetected and untreated in men, it can cause an infection of the urethra that makes urination painful and difficult. In both sexes, infection can spread through the bloodstream and infect the joints, skin, bones, tendons and other parts of the body.

"FDA is alerting the public to this recall to help protect the public health," said FDA Deputy Commissioner, Dr. Lester M. Crawford. "We want to make sure laboratories that have purchased these test kits, physicians who have ordered these tests, and people tested for gonorrhea since January 2002, receive this information so they can act upon it."

FDA advised that people who have had a negative gonorrhea test since January 11, 2002, may wish to ask their physician if they should be re-tested for gonorrhea. Abbott notified its customers (clinical laboratories) to discontinue use of all test kits and to destroy any remaining product.

Abbott also advised the laboratories to contact the health care providers served by their facility and have them determine if their patients need to be re-tested. The physician should offer a re-test to patients whose test results were negative and who were not already treated. Repeat testing should be performed on a fresh specimen and not on retained specimens. Abbott Labs will reimburse expenses associated with repeat testing.

Abbott voluntarily recalled 32 lots of its gonorrhea test kits after learning through routine internal testing that certain lots did not meet specifications and, as a result, could report positive test results as negative. Upon further testing, Abbott determined that only 16 of these 32 lots did not meet internal release criteria. Abbott is continuing to investigate the cause of the problem.

The 16 lots that failed to meet specifications when tested by Abbott were: 84073M400; 84075M400; 84142M300; 84146M300; 85487M200; 87007M400; 87103M400; 87243M100; 87377M200; 87899M200; 87905M200; 88097M300; 88105M300; 88107M300; 88439M200; and 88439M201. Approximately 750,000 tests were affected.

Civil Money Penalty Case for In Vitro Test Kit

Firm Fined $250,000 for Promoting“ Professional Use Only” Product Over-the-Counter

On May 30, 2002, Worldwide Medical Corporation and its first president agreed to a $250,000 civil money penalty plus interest. Under the name First Check Home Drug Tests, Worldwide Medical marketed a line of “drugs of abuse” test kits that had been cleared for professional use only. Earlier, a different company had received marketing clearance to sell this same test for professional use (in a laboratory setting); it was never intended for over-the-counter (OTC) sale to a lay person. Nevertheless, Worldwide Medical promoted the product OTC. The firm was able to undersell their competition because their kits did not include confirmatory laboratory testing of presumptive positive results.

FDA began an investigation after receiving complaints from other companies that Worldwide Medical’s products were being sold without having premarket clearance. CDRH issued a Warning Letter to Worldwide Medical on July 7, 1999, for failure to have premarket approval or clearance. Despite numerous meetings and letters from FDA, the firm continued to market the test kit. Several FDA District offices collected documentary samples covering numerous shipments of the devices. On May 30, 2002, the firm and its president agreed to a Civil Money Penalty of $250,000.

Mammography

Congress enacted the Mammography Quality Standards Act (MQSA) in 1992 in order to ensure that all women have access to quality mammography for the detection of breast cancer in its earliest, most treatable stages.

On December 21, 1993, FDA published interim regulations for mammography facilities and accreditation bodies, effective February 22, 1994. Development of the final regulations began with the first meeting of the National Mammography Quality Assurance Advisory Committee in February 1994. Proposed rules were published on April 3, 1996, with a 90-da y comment period. FDA analyzed over 1,900 letters and considered approximately 8,000 comments during this development process. On October 28, 1997, FDA issued the more comprehensive final regulations that became effective on April 28, 1999.

Since 1994, FDA has issued guidance documents designed to help facilities comply with the regulations. The Agency has had these documents incorporated into the Policy Guidance Help System (a computerized search engine) that is available on CDRH’s web site. FDA continues to update its guidance in response to facility and consumer inquiries 1/.

1/ http://www.fda.gov/cdrh/mammography/robohelp/finalregs.htm.

Warning Letters Issued for Violations of MQSA

  • On August 14, 2002, FDA’s New Orleans District Office issued a Warning Letter to the Administrator of the Imaging Center-Baton Rouge Radiology Group, Baton Rouge, Louisiana. An inspection of the facility on May 29, 2002, by the State of Louisiana, acting on behalf of FDA, revealed that the interpreting physician did not hold a valid state license to practice medicine. The interpreting physician did not meet the continuing experience requirement. In addition, the firm did not have the required personnel qualification documents available during the inspection.
  • On July 31, 2002, the Florida District issued a Warning Letter to the Administrative Director, Imaging Services for the Osceola Regional Medical Center, 700 West Oak Street, Kissimmee, Florida, and the Osceola Imaging Center at 3501 W. Vine Street, Kissimmee, Florida. The District issued the Warning Letter for MQSA violations observed during the inspections on June 18, 2002. The inspection was conducted by the State of Florida on behalf of FDA. The inspection revealed serious violations of the MQSA.

    Both facilities failed to produce documents verifying that interpreting physician(s) met the initial requirements of being certified in the appropriate specialty by an FDA approved board or that they have two (interim) or three (final) months of initial training. In addition, the firm failed to produce documents showing that the physician(s) met the initial requirement of having interpreted or multi-read 240 mammograms in 6 months, and failed to produce documents showing that the physician(s) met the initial requirement of having 40 (interim) or 60 (final) hours of category I medical education in mammography as required by FDA regulations.

  • On August 13, 2002, FDA’s New Orleans District Office issued a Warning Letter to Thomasville Infirmary, Thomasville, Alabama. The State of Alabama, acting on behalf of FDA, conducted an inspection of the facility on July 26, 2002. The inspection revealed the following findings: processor quality control records failed to document a processor performance test on each day that clinical films were processed, before any clinical films were processed that day, and failed to document a weekly image quality evaluation test, using an FDA approved phantom. In addition, the system to communicate results was not adequate for the Thomasville site because there was no system in place to provide timely medical reports; and there was no system in place to provide timely lay summaries.
  • On April 19, 2002, FDA’s New Jersey District Office issued a Warning Letter to the President of Medical Park Imaging, Wayne, New Jersey. An inspection conducted by a representative from the State of New Jersey under contract to FDA inspected the facility on March 26, 2002. The inspection revealed that the facility failed to document that phantom image quality control testing was performed. Phantom image quality control records were missing for two weeks in April 2001, and one week in May, July, August, and December 2001, and January 2002.
  • On March 6, 2002, FDA’s Seattle District Office issued a Warning Letter to Manilaq Health Center, Kotzebue, Alaska, for a violation of the Mammography Quality Standards Act (MQSA). A representative from the State of Alaska on behalf of FDA conducted an inspection of the facility on February 20, 2002. The inspection disclosed that the facility had no system in place to notify each patient as soon as possible of assessments of "suspicious" or "highly suggestive of malignancy" categories.
  • On July 16, 2002, FDA’s New England District Office issued a Warning Letter to the President and CEO of Mount Auburn Hospital, Cambridge, Massachusetts. An inspection of the facility was conducted on May 28, 2002, by a representative of the Commonwealth of Massachusetts, on behalf of FDA. The inspection disclosed that the firm’s records revealed that image quality evaluation tests, using an FDA-approved phantom were missing for at least four weeks. During the inspection, the inspector observed that there were no weekly phantom quality control charts or films between the date of the firm’s last inspection on April 11, 2001, and July 8, 2001. However, the firm’s records showed that mammography examinations were performed during that time period.
  • On May 9, 2002, FDA’s Minneapolis District Office issued a MQSA Warning Letter to the President and CEO of Divine Savior Healthcare in Portage, Wisconsin. The firm had a repeat violation, in that there were eight random mammography reports reviewed that did not contain an acceptable assessment category. The firm also failed to produce documents verifying that the interpreting physician met the initial requirement of 40 hours of medical education in mammography prior to April 28, 1999.
  • FDA’s New Jersey District Office issued a Warning Letter to Diagnostic Imaging of Clifton, Clifton, New Jersey. A representative from the State of New Jersey under contract to FDA inspected the facility on March 8, 2002. The inspection revealed a serious regulatory problem – failure to document that processor quality control testing was performed. This facility was also cited for darkroom fog density that exceeded the allowed optical density limit of .05. In addition, random review of reports revealed that their reports did not contain acceptable assessment categories.
  • FDA’s Detroit District Office issued a Warning Letter, dated April 1, 2002, to St. Vincent-Williamsport Hospital, Williamsport, Indiana, for violations of the MQSA. The inspection, conducted by the State of Indiana on March 14, 2002, revealed that there was no documentation to show that the technologist met the minimum requirement of having taught or completed continuing education units. In addition, the facility did not have adequate written procedures for the collection and resolution of consumer complaints including the resolution of serious complaints and reporting or referral of serious complaints to the American College of Radiology.
  • On August 7, 2002, FDA’s Seattle District Office issued a Warning Letter to TRA Medical Imaging Centers, Tacoma, Washington. On July 25, 2002, a representative from the State of Washington, inspected that facility on behalf of FDA. The inspection revealed a serious regulatory problem in that processor quality control records were missing at least 30% of the operating days in November 2001. In addition, there was no documentation verifying that the radiologic technologist met the continuing experience requirement.

Administrative Civil Money Penalty

Firm’s Failure to Pay Civil Money
Penalty Results in Collection Action

United States v. Miller (N.D. Ill.). On January 31, 2002, a United States District Judge entered a default judgment of $26,182.63 against Thomas Miller. In 1997, FDA had brought an administrative civil money penalty action against Mr. Miller and others for violations of the Mammography Quality Standards Act of 1992 (MQSA), 42 U.S.C. § 263b. In August 1998, Mr. Miller entered into a Consent Decree with FDA under which he agreed to pay a civil money penalty of $25,000 in twenty-four monthly installments. He last made a payment in January 1999, after making only six payments. In June 1999, FDA served Mr. Miller with a Notice of Default.

The Justice Department brought this collection action and the district judge awarded the government the outstanding balance plus interest calculated from June 1999.