Public Health Effectiveness of the FDA 510(k) Clearance Process Measuring Postmarket Performance and Other Select Topics: Workshop Report (2011) / Chapter Skim
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2 Food and Drug Administration Postmarket Surveillance Activities and Recall Studies of Medical Devices
2 Food and Drug Administration Postmarket Surveillance Activities and Recall Studies of Medical Devices
Pages 5-22
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FDA's surveillance activities are focused on identifying potential safety issues with devices currently on the market. If safety concerns are identified through surveillance activities, FDA can take several different types of actions, including recalling devices.
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Mandatory Reporting For all device classes, FDA regulations require manufacturers to report deaths, serious injuries, and malfunctions to FDA within 30 working days of their becoming aware that a device may have caused or contributed to those events. User facilities are required to report deaths to FDA within 10 working days of recognition of an event and deaths and serious injuries to the manufacturer within 10 working days.
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• Device malfunction (for example, ventilator power is lost because of limited power supply capacity in power surge) • Use error (for example, tissue is retained in arthroscopic shaver handpieces because of human factors or design issues)
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There is no dynamic way to identify individual devices uniquely, for example, by serial number or by lot number and expiration date. Accurate identification is challenging, Gardner noted, given the variety of devices that FDA regulates, including software and implantable devices.
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gives FDA the authority to require a manufacturer to conduct postmarket surveillance studies for class II and class III devices if failure of the device is reasonably likely to have serious adverse health consequences or is expected to have substantial use in pediatric populations, is implanted for longer than 1 year, or has life-supporting or life-sustaining use outside the device user facility. In accordance with Section 522, FDA asks a company questions about a device, the company returns to FDA with a protocol for answering the questions, and then FDA goes through a process of approving or not approving the protocol.
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The Sentinel Initiative is an effort to develop a national, integrated infrastructure of electronic healthcare data systems for medical-product safety surveillance. It will augment, not replace, existing functionality, Gardner noted.
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Maisel, former director of the Medical Device Safety Institute,3 provided an overview of an independent analysis of FDA recall data that he was commissioned to perform for the committee.4 The ideal measure of the success of the device approval or clearance processes, he said, would be the performance and reliability of each individual approved or cleared device. Analysis would need to be done for many thousands of devices, so it would be extremely difficult and impractical.
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applications, which are for modifications of products that conform to design control standards, make up about 16%, and abbreviated applications, which are for devices that can be cleared on the basis of standards or special controls, make up about 3%. About 25% of the devices cleared during that period were implantable devices.
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Determining recall rates presents a variety of challenges, Maisel said. For example, how should one account for the fact that some devices have been on the market longer than others?
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Some of the devices with very high numbers of predicates cited are in vitro diagnostics, such as a laboratory analyzer that might perform multiple tests and require multiple predicates. If there were multiple predicates, the age of the newest predicate cited was less than 5 years in more than 75% of the 510(k)
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Devices assigned to the anesthesia, chemistry, and cardiovascular advisory committees, for example, are generally higher-risk devices and had higher recall rates; but dental, immunology, and microbiology devices were less likely to be recalled. Maisel suggested that this information may be useful in deciding how to allocate resources to the fields in which recalls are more likely (see Box 2-2)
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process lead to greater or lower risk.5 Methods There are three classes of FDA device recalls, which, Hall noted, with regard to risk are in reverse numerical order from device classification itself. Class I recalls involve the most serious safety issues -- situations in which there is a reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death.
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The study included data derived from FDA databases, including databases of recalls, 510(k) cleared devices, PMA devices, product classification, and the Total Product Life Cycle; the 2009 Government Accountability Office (GAO)
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, including bench testing and design controls to identify design issues without endangering patients. TABLE 2‑1 Primary Reason for 118 Class I Recalls Other or Primary Reason for Recall PMA 510K Class I Unknown TOTAL Manufacturing 6 31 2 1 40 Labeling error 0 4 0 0 4 Design issue 6 25 1 0 32 Software design 1 9 0 0 10 Software manufacturing 0 2 0 0 2 failure Supplier issue 2 5 0 0 7 Failure to identify clinical risk 0 0 0 0 0 Failure to warn or inadequate 0 8 0 0 8 instructions Missing parts 0 0 0 0 0 Sterilization 1 4 2 0 7 Regulatory violation 0 1 1 0 2 Packaging or handling 0 0 0 0 0 Other (such as counterfeit or 0 6 0 0 6 sham)
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Overall, about 7% of the recalls were attributed to unidentified clinical issues. Those data suggest, Hall said, that conducting additional human clinical trials would have very little effect on the number of class I safety recalls.
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• The data do not clearly support the need for a fourth device class. rates of premarket issues.
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. He stressed that QSR is extremely important given the prevalence of design issues and is probably more important than additional human clinical studies.
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