FDA Releases National Medical Device Evaluation System Recommendations

The Medical Devices Epidemiology Network (MDEpiNet) Pubic Private Partnership's Medical Device Registry Task Force held a public meeting at ACC's Heart House on Aug. 24 to discuss the creation of a National Medical Device Evaluation System, as outlined in a draft report unveiled at that meeting. The report, which aims to provide stakeholders with better, faster system for evaluating medical devices, outlines recommendations on how strategically coordinated registry networks can be used to bridge clinical care and research. MDEPiNet is an effort of the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiologic Health (CDRH) operated in conjunction with external stakeholders aimed at bringing together leadership, expertise and resources to build and operate a national device ecosystem supporting the development, regulation and use of innovative medical devices.

During the meeting, Jeffrey E. Shuren, MD, JD, shared CDRH's vision for a medical device evaluation system, stressing the need for flexible regulation, knowledge commons, a national evaluation system and appropriate reimbursement policy. Representatives from a diverse array of stakeholder groups, including the the Pew Charitable Trusts, Harvard Medical School, Galileo Analytics, the Brookings Institute and the Office of the National Coordinator for Health Information Technology, also shared their perspectives on a National System, addressing topics such as patient-centered research and interoperability. Kathleen Hewitt, RN, AACC, who leads the NCDR and ACC's quality improvement solutions, moderated a panel on stakeholder perspectives.

Given the novel nature of a National System, the Task Force recommends taking a "scalable system architecture" and "staged implementation" approach so that lessons learned from a few core medical device areas can be applied down the line as the system expands. "The principle tool of this approach is a portfolio of pilot projects that have both immediate impact on specific device-related issues and that provide predicates for more generalizable principles that can be applied in other device areas," the report notes. The Task Force also underscores the importance of consistent and flexible architecture to "accommodate the pace of new, emerging electronic health information systems."

The Task Force's version of a National System creates Coordinated Registry Networks (CRN) to shift the "analytical paradigm through emphasis on the development of strategically partnered electronic health information systems that support both 1) the implementation of structured device identifiers, core minimum data elements and definitions, and 2) the ability to share complementary data across information systems." This CRN approach would rely on existing data obtained through device registries, electronic health records, administrative data and potentially social media and mobile devices.

The report pointed out the fact that there is significant "fragmentation and distrust" in the current medical device system, but "with transformation of the current landscape into one of good will and trust, the actual timelines and cost of doing business could be substantially mitigated through partnered CRN architecture..." Furthermore, the CRN model could be applied to "disease-based and other health information systems emerging outside of medical devices..."

According to Ralph G. Brindis, MD, MPH, MACC, a member of the Task Force, "the NCDR and the ACC are enthusiastic partners in the MDEpiNet public-private initiative in developing strategies for the use of registries to support premarket approval and post market device surveillance. The NCDR and the ACC are well positioned in helping MDEpiNet identify medical devices in need of registries and contribute in device quality assurance and data quality practices." John S. Rumsfeld, MD, PhD, FACC, also serves on the Task Force, as does James Tcheng, MD, FACC.

Comments from the public on the draft report are due on Oct. 26. The ACC intends to respond to this request.

Keywords: Academies and Institutes, Electronic Health Records, Medical Informatics, Pilot Projects, Quality Improvement, Radiologic Health, Registries, Research Design, Schools, Medical, United States Food and Drug Administration

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