Post Market Surveillance: Medical Device Adverse Event Reporting
- Adverse Event Reports
During Fiscal Year 2000, we received almost 50,000 individual medical device adverse event reports from manufacturers, user facilities, and importers. Additionally, 3,000 voluntary reports came in from health care professionals and the public. Our staff analyzes these reports to determine if the use of particular product is resulting in unexpected problems or risks, and to identify trends that can improve risk management and reduce user error. Additionally, manufacturers reported over 42,000 incidents via the new Alternative Summary Reporting program.
- Alternative Summary Reporting (ASR)
We continue to enhance the ASR program. This program allows device manufacturers to submit abbreviated reports on certain adverse events in a summarized, line-item fashion. Thirty-eight device manufacturers, representing 48 different classified products, are currently participating, and they started to submit their new abbreviated reports in January 2000. To date, the reports cover a period of October 1, 1999, to October 1, 2000, and are being entered into a new database designed especially for the ASR program.
A guidance document describing the ASR program and providing instructions for completing and submitting reports was recently published on the FDA website under Medical Device Reporting.
- Medical Products Surveillance Network (MedSuN)
The FDA Modernization Act of 1997 (FDAMA) directed FDA to change the current MDR regulation pertaining to user facilities from a required universal reporting system to a system comprised of a subset of user facilities. FDA has titled this new effort MedSuN, and under a Phase 1 pilot conducted testing to discern current barriers to reporting and incentives that may help overcome those barriers in the new system.
In preparation for Phase 2 of the MedSuN pilot, which will evaluate various aspects of this new reporting program, an internet based adverse event reporting system is being developed by the University of Maryland’s Office of Academic Computer Services. The University’s Survey Research Center is conducting research to ensure that the system is user friendly for both the future participating clinical facilities and FDA. A contract modification has been awarded to begin the process of planning and implementing the Phase 2 pilot, including the recruitment and training of 25 hospitals to participate in the initial phase of the program.
- International Postmarket Vigilance Reporting
FDA and others participating in the Global Harmonization Task Force Study Group 2 (SG2) (Medical Device Vigilance and Postmarket Surveillance) developed a process for the global exchange of vigilance reports between National Competent Authorities (NCAs). The language in the US/EU Mutual Recognition Agreement (MRA) or SG2 documents provided the initial basis for the development of FDA’s vigilance reporting criteria and procedures. Most of the postmarket vigilance reports exchanged thus far involve recalled devices with a potential for adverse events in countries where the product is distributed. The pilot portion of the program was recently concluded. The program is now fully operational with expansion to other NCAs planned.
- MDR Network
We are working with an industry group to evaluate the feasibility of using the Failure Mode Effects Analysis (FMEA) as a basis for MDR Summary Reporting instead of reporting each malfunction separately. At present, our industry partners are comparing the costs of submitting individual medical device malfunction reports versus using summary reporting based on FMEA.
Post Market Collaborative Efforts
"Leveraging" is the creation of relationships and/or formal agreements with others outside the FDA that will ultimately enhance FDA's ability to meet its public health mission. The Office of Surveillance and Biometrics, in collaboration with the Office of Systems and Management, has continued to increase leveraging activities to support the use of partnerships and alliances. The Center coordinates with other FDA centers to learn about leveraging successes and share lessons learned. We have been particularly well placed to provide leadership to the Agency since we began our leveraging efforts two years ago when we conducted a seminar and workshop on what we called, "Outside Leveraging." Our experience since then, including documenting these activities has put us in an unusually strong position to work with our colleagues both within the government, industry and the public health community. Some examples include:
- FDA/NIH Clinical Center Interagency Agreement
A five year agreement to conduct studies of thermal ablation, combining the clinical strengths of the National Institutes of Health (NIH) Clinical Center and the computational, engineering and animal research capabilities of our Center. Both the FDA and the NIH are concerned about safety and effectiveness issues that arise from the application of radiofrequency energy (RF) or other extreme thermal techniques for the treatment of soft tissue tumors and other disease states.. This cooperative research project will investigate the physics of ablative technologies, including their methods of application and potential new applications, and should result in clinical refinements in the application of the techniques as well as new imaging-guided techniques.
- NASA/FDA Cooperative Agreement
Early cataract detection has advanced under a cooperative agreement coupling dynamic light scattering (DLS) technology from NASA-Lewis with a unique animal model maintained by FDA. Animal studies have shown that the optical technique can detect changes in the lenses of diabetic animals long before the cataracts are apparent via standard clinical examination. This has provided a means for NASA to assess the capabilities of their optical instrumentation. Our scientists have benefited by being able to expand their investigations of the progression of the disease in this model. The project has also enabled us to investigate the capabilities of DLS and other optical technologies that will ultimately find their way into new medical devices.
- ONR/AFOSR/FDA Cooperative Agreement
Funding from the Office of Naval Research (ONR) and the Air Force Office of Scientific Research (AFOSR) has been used to conduct investigations of optical fibers used for delivery of laser and optical radiation for diagnostic and therapeutic purposes. In the last decade, optical techniques for the diagnosis and treatment of diseases have rapidly evolved into an area of intense medical interest. This program has made possible the evaluation of new sources of laser light, new optical sensors, and new fiber and wave guide delivery systems. This research is helping to develop the knowledge needed by the Agency as applications for new devices utilizing these techniques are received.
- Cell Phone Standards
We are leading the development of a draft voluntary international standard for evaluating the radiofrequency (RF) radiation dose to users of hand-held wireless handsets. These handsets include cellular and personal communications service (PCS) telephones. The Institute of Electrical and Electronics Engineers (IEEE) Standards Coordinating Committee 34, Subcommittee 2, chaired by one of our engineers, is completing a detailed technical document that recommends experimental protocols for the measurement of the Specific Absorption Rate (SAR) in a realistic model of the human head. It also specifies SAR measurement techniques, instruments, calibration techniques, measurement uncertainties, and the establishment of validation methods. The intended users of this Recommended Practice will include wireless handset manufacturers that are required to certify to the U.S Federal Communications Commission (FCC) and other foreign government agencies that their products meet maximum allowable SAR radiation dose criteria. We are also developing a measurement and quality assurance test laboratory for instruments that measure the SAR delivered to human head models by cellular phones and other wireless handsets.
Reuse of Single-Use Devices Issue -see Regulatory Science and Standards
- Systematic Technology Assessment of Medical Products (STAMP)
Through the STAMP program, CDRH shares its knowledge of marketed medical devices with clinicians, consumers, and industry. A committee is selected for each device chosen for review through the STAMP program. The members of the committee, specially selected for their expertise in the particular device area, identify the issues related to the device, the public health impact of the device, and the best vehicle for disseminating relevant information regarding the use of the device. Three STAMPs were conducted this year: Liposuction; Electronic Fetal Monitors; and LASIK. The Liposuction STAMP resulted in the publication of an article in FDA Consumer. Changes to the labeling for Electronic Fetal Monitors are currently under review. A website is now available for the LASIK STAMP.
- Safety Notifications
Notifications, in the form of Safety Alerts, Public Health Advisories and Public Health Notifications, are the primary means for CDRH to communicate to medical device users important information regarding postmarket safety issues.
In 2000, we issued notifications on the risks of electromagnetic interference with medical telemetry systems, injuries from microwave thermotherapy for benign prostatic hyperplasia, the potential for injuries from circumcision clamps, and the recall of Clinipad sterile products used in prepackaged procedure kits and trays. To view these notifications see the CDRH Safety web page.
- Hospital Bed Safety
We led a multidisciplinary group representing the federal government, national health care organizations, manufacturers of hospital beds, patient advocate groups and medical researchers to address the safety issues of hospital beds and the vulnerable patients in all patient care settings--nursing homes, hospitals and at home. The group has been working in partnership to improve the safety of hospital beds for patients at risk for entrapment. The FDA developed a web site to report on the work of the Hospital Bed Safety Work Group, increase awareness of the entrapment issue and educate the public on the problems associated with hospital beds and bed rails. In addition, the participating organizations produced a brochure, A Guide to Bed Safety, to educate caregivers, patients and families in the risk and benefits of bed rails. The brochure and other items are available on the FDA web site for bed safety.
- Global Medical Device Nomenclature (GMDN)
The first phase of the three-year project to create an international device nomenclature is complete. The GMDN was created from six existing nomenclatures (including FDA’s). The resultant nomenclature contains approximately 11,000 terms, most of which are preferred terms, but also includes synonyms to preferred terms as well as templates (higher order "root" terms). In addition, definitions are provided for all preferred terms and template terms. We helped to create GMDN, participating in the steering committee, the expert advisory team (set naming rules and conventions and oversaw process), and the device expert task groups (experts in particular categories of devices). Early in 2001, the GMDN (considered a technical report) will be presented to appropriate European and ISO standards representatives to begin the process for formal comment and vote. In the interim, FDA will review the GMDN for its suitability to meet FDA nomenclature requirements.
Post Market Epidemiology
- Our epidemiologists conduct applied epidemiological research using a variety of methods and databases and provide consultative services to ODE and others on issues requiring epidemiological expertise, from systematic reviews of the literature, to risk assessments, to the design and conduct of observational studies. Major epidemiological research during the past year, resulting in publications in scientific journals and presentations at national professional meetings include: a study of factors associated with mammography screening in disadvantaged women; a study that assessed adverse events associated with breast implants; and a study which showed how medical device tracking can be useful in facilitating public health interventions when safety problems are discovered with implanted medical devices.