Medical Devices and the Public's Health The FDA 510(k) Clearance Process at 35 Years (2011) / Chapter Skim
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5 Postmarketing Surveillance, Compliance, and Enforcement
5 Postmarketing Surveillance, Compliance, and Enforcement
Pages 123-148
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From page 123... ...
It also examines how the FDA communicates information gathered through postmarketing surveillance activities to consumers, such as healthcare providers and the public. The term postmarketing surveillance encompasses a wide array of programs, including medical device reporting by manufacturers and user facilities, third-party safety monitoring, and FDA–academic collaborations.
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From page 124... ...
In an active system, in contrast, the regulator seeks information on adverse events, device malfunctions, and product effectiveness and takes advantage of opportunities to enhance data collection. It is important to note that for most of the programs discussed below there is no reliable information about the number of devices (referred to as the denominator)
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From page 125... ...
. When a medical problem is suspected to have occurred in association with use of a medical device, a bioengineer or risk manager may or may not be available to assist in the assessment of the role and potential responsibility of the device and to take appropriate corrective action.
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From page 126... ...
Physicians increasingly use higher-risk devices, including implantable devices, in their offices where there is no legal requirement for them to report adverse events and device failures to the FDA. Voluntary reports made by healthcare providers have always made up a very small fraction of the reports received by the FDA.
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From page 127... ...
Moreover, the FDA Office of Compliance does not link inspections to the adverse event that may have triggered them. In addition to the previously described system for mandatory and voluntary reporting of adverse events and device malfunctions, summary reporting from industry provides an abbreviated method that relies on established codes for events that are well known and categorized.
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Voluntary reporting of adverse events and device malfunctions
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From page 129... ...
Finding 5-3 Data collected with the current postmarketing surveil lance system is not systematically integrated into the premarket review process. Enhanced Surveillance In addition to the general reporting requirements described above, the FDA conducts postmarketing surveillance via several other mechanisms: tracking of medical devices, the MedSun program, the MD EpiNet program, the Sentinel Initiative, and Section 522 surveillance studies.
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From page 130... ...
The value of the approach is well demonstrated by the fact that 252 of the 350 MedSun facilities reported adverse events in 2007, accounting for 72% of all facilities that reported. In contrast, only 267 of the remaining thousands of other facilities reported adverse events in 2007, and that number has been declining (OIG, 2009)
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From page 131... ...
to include medical devices in the Sentinel system. The Sentinel Initiative helps the FDA to fulfill its mission to "protect the public health by ensuring that .
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Such an investment is expected to provide a rich source of clinical data from a much broader segment of the population and will prove cost-effective in the long term as adverse events associated with device use are identified and reduced (Behrman et al., 2011)
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Advocates for the implementation of UDIs argue that UDIs could substantially improve the FDA's ability to track medical devices once they are on the market. Implementation of a comprehensive UDI system could also reduce medical device–related errors, improve the quality of MDRs, facilitate device recalls and tracking, standardize device nomenclature among administrative databases and clinical registries, identify device use and compatibility issues, and enhance device postmarket surveillance (ERG, 2006)
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The effect of a warning letter varies. If the letter is directing a manufacturer to stop promoting a medical device for a specific indication, it can be corrected immediately.
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Limitations of Recall Data The committee explored FDA recalls of medical devices as potential indicators of their safety. A recall study can be a useful tool for identifying the point in the product life cycle at which a problem is occurring, such as problems with device design or with the manufacturing process.
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. William Maisel (formerly of the Medical Device Safety Institute)
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They are in four major categories: postmarketing surveillance programs, administrative databases, clinical registries, and electronic health records. The FDA has partnerships with academic institutions, federal agencies, and professional medical societies.
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, and clinical registries may enhance the FDA's ability to assess longitudinal device outcomes. Postmarketing Surveillance Programs The Department of Veterans Affairs (VA)
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In addition, registries can provide large samples for detecting rare adverse events and provide an alternative when randomized clinical trials are not practical, ethical, or feasible (AHRQ, 2010)
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In addition to professional-society registries, institutional, regional, and national device registries could be used for collecting postmarket information on medical devices. For example, in orthopedics, there are several totaljoint-replacement registries, such as the University of Massachusetts Global Orthopedic Registry, the Harris Joint Registry, the HealthEast Orthopedic Joint Registry, the Hospital for Special Surgery Center for Education and Research on Therapeutics Total Joint Replacement Registry at Weill Cornell Medical College, the Kaiser Permanente National Total Joint Replacement Registry, the Mayo Clinic joint-replacement database, the MaineHealth Total Joint Replacement Registry, the Rush University Medical Center Joint Registry, and the Virginia Joint Registry (Outcome Sciences, 2009)
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From page 141... ...
Despite the challenges associated with registry development, implementation, and maintenance, several regional and national efforts are under way in the United States to track orthopedic devices, such as total joints. The American Academy of Orthopaedic Surgeons American Joint Replacement Registry, a California state registry effort, and an Agency for Healthcare Research and Quality multicenter registry project may be able to assist the FDA in future postmarket surveillance efforts.
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COMMUNICATING WITH CONSUMERS When a problem with a medical device warrants action, communicating essential information to healthcare providers and the public is challenging for the FDA. Recalls and public-health notices are posted on the FDA's weekly enforcement report (FDA, 2011e)
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From page 143... ...
Volun tary reporting of adverse events and device malfunctions depends on patients, caregivers, and healthcare providers and facilities to identify them, to associate them with medical devices, and to submit reports. • inding 5-2 The inadequacy of the current postmarketing surveil F lance system and the resulting lack of data make it impossible to confidently draw broad conclusions about the safety and effective ness of products that are on the market.
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From page 144... ...
• inding 5-7 The lack of standardization in clinical and device-specific F data among existing non-FDA data sources and insufficient detail in administrative and clinical health records impede the evaluation of the performance of medical devices. REFERENCES AHRQ (Agency for Healthcare Research and Quality)
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From page 145... ...
filters: Initial communication: Risk of adverse events with long term use. http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety AlertsforHumanMedicalProducts/ucm221707.htm (accessed August 30, 2010)
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2009. Adverse event reporting for medical devices.
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2011. Medical device recalls and the FDA approval process.
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