News Feature | August 27, 2015

FDA Task Force Proposes Coordinated Registries For National Medical Device Evaluation System

By Jof Enriquez,
Follow me on Twitter @jofenriq


A task force commissioned by the U.S. Food and Drug Administration Center for Devices and Radiologic Health (CDRH) is proposing a national medical device evaluation system based on coordinated registry networks (CRN) that would pool real-world device data from disparate sources into a single reference for patients, physicians, payers, manufacturers, and regulators.

According to a draft report of recommendations from the Medical Device Registries Task Force (MDRTF) and the Medical Devices Epidemiology Network (MDEpiNet), "A broad range of medical device technologies continue to emerge and iterate at a far more rapid pace than most pharma and biologics. Device evaluations often need unique information, such as device identifiers and operator proficiency. In such a complex and fast-moving universe, the need for a more efficient, partnered National System for device evaluation has been advanced by FDA’s CDRH."

The MDRTF believes such a system should be built on a structure called a coordinated registries network, or CRN, that links both complementary registries and non-registry data sources (electronic health records, or EHRs, administrative claims data, or mobile device outputs), which support fast and robust device evaluation over the total product life cycle of medical devices by relevant stakeholders, according to a summary published in the Journal of the American Medical Association (JAMA).

The JAMA article states that the proposed CRN must have:

  • The ability to uniquely identify medical devices
  • Implementation of standardized clinical vocabularies and dictionaries
  • Reusable interoperability solutions linking diverse, strategically complementary data sources
  • Partnered, inclusive governance
  • Value-based, incentivized sustainability

According to a white paper authored by The Pew Charitable Trusts, the Blue Cross Blue Shield Association, and the Medical Device Epidemiology Network, “Patients rely on the Food and Drug Administration to ensure the safety and efficacy of new medical devices. However, recent high-profile failures of these technologies, including metal-on-metal hips and implantable cardiac defibrillators, are a reminder that this country lacks a robust system for assessing the safety and effectiveness of medical devices once they enter the market.”

Because the proposed CRN-based evaluation system includes real-world device performance after medical devices hit the market, conveniently collected in a single location, the FDA task force believes this would serve public health better.

"The ultimate beneficiary of the CRN is the patient," said author Dr. Art Sedrakyan, director of MDEpiNet's Science and Infrastructure Center, and professor of healthcare policy and research in cardiothoracic surgery at Weill Cornell, in a statement. "Conceptually, this is the best way for us to make sure that physicians and patients get up-to-date, near real-time information about the performance of medical devices to be able to make informed choices about what works best for individual patients."

Furthermore, such a system would help manufacturers assess products under development and hurdle regulatory pre-market and post-market requirements faster. 

"Device manufacturers will also benefit from the CRN because it will enable assessment of information from more diverse groups of patients exposed to devices in more diverse treatment settings, ultimately providing critical information about device benefits and risks," added author Dr. Sharon-Lise Normand, who leads the MDEpiNet Methodology Center

and is professor of healthcare policy and of biostatistics at Harvard University, in the statement.

CDRH first laid out a strategy for a postmarket surveillance system in 2012, then fleshed out plans to create a National Medical Device Postmarket Surveillance System (MDS) in 2013, according to an FDA blog post.  However, the MDRTF, in its recent report, recommends changing from a dedicated postmarket surveillance system to a National Medical Device Evaluation System better suited to address optimal pre-market and post-market balance.

"FDA continues to promote collaborative efforts to create our national medical device evaluation system in order to help the agency strengthen its ability to understand the performance of devices throughout their life cycle," said Dr. Danica Marinac-Dabic, director of the division of epidemiology at CDRH, who contributed to the JAMA paper. "Registries linked to other electronic health information including unique device identification are the core foundation of such a system."

The draft report is open for public comments for 60 days, beginning Aug. 24, 2015.