Three healthcare organizations have partnered to urge the U.S. Food and Drug Administration to develop medical device registries to help improve patient safety.
The Pew Charitable Trusts, Blue Cross Blue Shield Association and the Medical Device Epidemiological Network Science Infrastructure Center at Weill Cornell Medical College in New York City authored a report containing recommendations and a framework on how to optimize registries.
The organizations' collaboration responds to a 2012 FDA report outlining a strategy for a national medical device surveillance system.
The recommendations in the new report stem from a number of meetings of key stakeholders — including practitioners, regulators, payers, patients and government officials from the FDA and CMS — on how such medical device registries could be utilized to improve patient safety.
"Registries have the potential to dramatically improve our understanding of how medical devices perform in the real world when used by patients and medical professionals outside of a tightly controlled environment," said Naomi Aronson, PhD, executive director of clinical evaluation and policy for Blue Cross Blue Shield Association.
The joint report outlines the following five objectives that would allow medical device registries contribute to the FDA's proposed national surveillance system.
1. Establish criteria to determine if a device registry is the appropriate tool for postmarket surveillance.
2. Ensure registry data are publicly available, including information on a registry's governance and financing.
3. Implement efficiencies to streamline data collection and reduce the time and cost of reporting.
4. Use registry data to bolster device innovation and fulfill regulatory responsibilities.
5. Resolve legal interpretations of provisions overseeing quality improvement activities and research as applied to the registries.
"The successes of established registries in the United States and abroad demonstrate that registries can become a central part of an effective post-market surveillance system for medical devices," said Art Sedrakyan, MD, PhD, director of the MDEpiNet Science and Infrastructure Center at Weill Cornell Medical College. "U.S. registries can also improve their processes and work together to develop a learning network. Implementation of our recommendations can help physicians, patients, manufacturers and the FDA get the needed data on medical devices and build a higher-quality healthcare system."
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