Medical device groups call on FDA to advance registries

The Pew Charitable Trusts, the Blue Cross Blue Shield Association and Weill Cornell Medical College's Medical Device Epidemiology Network (MDEpiNet) have issued a series of recommendations to advance device registries as part of a national surveillance system.

“Registries can support patient care decisions and improve outcomes by providing healthcare professionals with reliable information on the performance of a technology, and can highlight factors that affect the data collected, such as patient selection or operator experience,” according to the groups.

Their new report, “Medical Device Registries,” follows the 2012 release of an FDA report that outlined four specific steps for creating a national surveillance that would quickly identify poorly performing devices:

• Establish a unique device identification system and promote its incorporation into electronic health information
• Encourage the development of national and international device registries for selected products
• Modernize adverse event reporting and analysis
• Develop and use new methods for evidence generation, synthesis and appraisal.

With these goalposts in mind, the groups convened meetings with a range of stakeholders during the past year to discuss objectives for optimizing the use of registries that can collect data over time on patients who are exposed to a specific medical device or type of device.

The report lays out the following five objectives that could quickly be adopted by FDA, registry owners and other stakeholders:

1. Establish criteria for determining if a registry is the appropriate tool for postmarket surveillance.
2. Deliver timely, actionable information from registries to all stakeholders, including the public.
3. Streamline registry data collection through efficiencies that reduce the time and cost of reporting.
4. Gain additional value from device registries by using them to accelerate device innovation and to fulfill other regulatory responsibilities.
5. Provide clarity for registry owners, providers and patients by resolving varying legal interpretations of the HIPAA privacy rule and the Federal Policy for the Protection of Human Subjects, as they apply to registries

“The FDA-sponsored MDEpiNet Medical Device Registry Task Force and all U.S. registries should implement these recommendations to better understand the safety and effectiveness of medical devices,” concluded the report. “Only then will registries play a central role in a robust national surveillance system that quickly identifies poorly performing devices, provides information to patients and clinicians for shared decision-making and supports device innovation.