Report Issues Recommendations for National Medical Device Evaluation System

The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that a new draft report urges the development of a series of coordinated registry networks (CRNs) to help monitor the performance of medical devices—especially those implanted in individuals—and to provide manufacturers, patients, clinicians, regulators and payers with better data on these products.

Collectively, the CRNs would constitute a National Medical Device Evaluation System, which would provide “customized, informative data, and thereby a truly unique value, to all stakeholders in the medical device ecosystem.” according to the report issued by the public/private Medical Device Registry Task Force and the Medical Devices Epidemiology Network. More than two dozen professionals served on the task force that drafted the paper, including medical doctors, federal regulators, academics, and executives from the medical device industry.

The report builds on earlier paper released by the Food and Drug Administration (FDA) which had called for a national system for the postmarket surveillance of medical devices. This new report, which was developed with the support of the agency, is called Recommendations for a National Medical Device Evaluation System. Instead of focusing solely on postmarket surveillance, this report emphasizes the need to consider the entire life cycle of devices, and to approach a “‘balance’ between pre- and postmarket evidence.”

“To improve both the quality and efficiency of medical device evaluation fundamentally requires eliminating gaps in and fragmentation of device-related data,” says the report, adding that “one of the largest gaps is in the segmentation of research efforts that separates premarket from postmarket studies.”  The report advocates a mindset of “continuous accrual of benefit/risk and safety knowledge.”

Another key component of the 141-page report is its emphasis on leveraging existing resources and registries, building on those successes through pilot programs, and coordinating these disparate efforts to deliver something that functions as a national system. It described the approach as “small steps to big changes.”

In terms of registry development, the report said high-risk devices should be the primary focus. “Registries can provide information on the long-term performance of the device and the health impact on patients,” the report says. The report cited implanted devices—such as those used for hip and knee replacement, ophthalmic or spinal needs, or items such as coronary stents and surgical mesh—as registry priorities.

The FDA posted a summary of the report on the Federal Register and is seeking public comments on it until Oct. 26, 2015. A complete copy of this new report, along with the earlier 2013 FDA report, Strengthening Our National System for Medical Device Postmarket  Surveillance: Update and Next Steps, is available HERE.

Source: AAMI

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