The prestigious Institute of Medicine (IOM) earlier this month opined concerned that most medical devices are cleared for sale without sufficient evidence that they are safe and effective -- even though we tend to delay approvals of devices far longer than the EU, Canada and most of the developed world. IOM’s assessment should give everyone pause -- particularly because they declared the current regulatory approach (related to the FDA 510K approval process) to be so messed up that we should scrap it and start over. FDA reacted immediately that they disagreed, stating they would instead work to fix the problems acknowledged in the 510K regulatory system.

The IOM committee found no major new horror stories related to existing devices on the market, but worried that FDA and the public have no good way to determine where risk may exist because there is virtually no good clinical data to rely on. Hello. The NCDR has the clinical data they seek; and if we could get the feds to offer incentives to help us diffuse the PINNACLE Registry across more outpatient practices, we could track post-approval performance and look for even low-signal adverse events incredibly effectively!

The IOM committee commented specifically on what they termed "highest-risk" CV devices, such as implantable defibrillators and replacement heart valves. They noted that clinical trials with relatively few enrolled patients are used to demonstrate safety and effectiveness of such devices, deeming that they afford only a “moderate risk,” based on having the manufacturer show that they are “substantially equivalent” to devices previously cleared. The added concern is that those devices in turn may have been cleared because they were “substantially equivalent” to earlier devices that may no longer be in use -- a ‘house of cards’ process.

IOM deserves credit for spotlighting the issues. But, not only the FDA objected to IOM’s recommendations: the device industry, already frustrated with the cumbersomeness of the 35-year old 510K process, are yet even more worried about and opposed to completely scrapping the process. They want to see it streamlined instead. What we need to do is show FDA, IOM and industry what the broad use of registries could do to carefully track ALL patients who are device recipients. That’s what needs to happen! Upcoming FDA hearings on the IOM recommendations and the future of the 510K process will give us an opportunity to promote this potential of using our registries to provide more rigorous and effective surveillance of CV devices after they are on the market.

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