FDA Medical Device Safety Tracking System Reform

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The Los Angeles Times reports that in recent years, several devices, including certain reusable medical scopes, metal-on-metal hip replacements, transvaginal meshes, and lead wires in heart defibrillators have been recalled.  Most recently, Olympus Corp., the manufacturer of 85 percent of the duodenoscopes used in the United States, announced that it would recall and redesign its duodenoscope.  Olympus’ recall was prompted by a Senate Report, issued by Senator Patty Murray (D-Wash), which criticizes device manufacturers, hospitals, and the FDA for contributing to “superbug” outbreaks stemming from such scopes.  250 patients were infected in the United States and Europe, alone.

The LA Times reports that although the first outbreak caused by the duodenoscope occurred in late 2012, it was not until 2015 that the FDA began warning hospitals about the risks of using the device.  According to the LA Times and Senator Murray’s report, that delay was caused in large part by the FDA’s “losing a key adverse event report and missing relevant international adverse event reports.”  Senator Murray, and others, point to this situation as highlighting the serious shortcomings in the antiquated national database used to monitor the safety of medical devices, which even the FDA has long admitted is flawed.

The Albuquerque Journal reports that the Senate Report calls for a new medical device tracking system, which would, among other things, require unique device identification numbers (e.g., bar codes) to be included on every instrument.  This could allow for real-time tracking of incidents, and is intended to supplement the industry’s injury reports, which are “often cursory and filed months late.”  In theory, tracking device IDs, like the VIN number on a car, may allow regulators to identify patients across the country coming into an emergency room or developing infections after a procedure.

Deborah Kotz, an FDA representative, has stated that the FDA is already working on the Senate Report’s recommendations:

The FDA is committed to establishing a national medical device evaluation system that leverages real-world evidence to help us more quickly identify safety signals.

The LA Times notes that, as a first step, the FDA now makes a disclaimer that data extracted from its database to evaluate medical device safety may be “incomplete, inaccurate, untimely, unverified, or biased.”  Additionally, FierceMedicalDevices reports that the FDA has just signed off on two out of the five manufacturers making automated endoscope reprocessors that are labeled for use with duodenoscopes as well as a new version of Olympus’ duodenoscope.

David G. Kim
David Kim is an IP Litigation associate in the firm’s Los Angeles office. David’s practice focuses on patent litigation, including Hatch-Waxman litigation, and trade secret litigation. He has handled matters involving a broad range of subject matter, including pharmaceuticals, medical devices, antennas, and solar cells. He has also represented clients in proceedings before the Patent Trial and Appeal Board, as well as the International Trade Commission.
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