A new report (PDF) containing recommendations for the creation of a national registry system for evaluating and monitoring medical devices has been released for public comment today. The report, a joint project of the Medical Device Registry Task Force and the Medical Device Epidemiology Network (MDEpiNet), is available on boh the US Food and Drug Administration (FDA) website and on the MDEpiNet website.
The report reflects the results of a year-long effort, prompted by the FDA’s Center for Devices and Radiological Health (CDER), that is focused on fostering a national system for monitoring the use of medical devices in the “real-world” setting of patient care, once the devices have been approved for the market (known as “postmarket surveillance”).
The term “medical devices” encompasses a wide range of technologies, including implantable pacemakers, cardiovascular stents, robotic surgical devices, and artificial joint replacements, among many others. At present, information about the use of these devices in routine care settings, including safety issues reported by doctors and patients, is collected in a variety of registries and health record systems. A networked national system, such as the one described in the task force report, would be able to unite and build upon both existing and novel data resources, thereby improving safety monitoring and accelerating the development of new devices:
“Task Force recommendations for [Coordinated Registry Network] CRN architecture, and thus for the National System, center on leveraging existing, self sustaining electronic resources, such as device registries, electronic health records, administrative data and even social media and personal mobile device sources.”
The Task Force Report offers recommendation in several key areas, including:
- Establishing a national dialog about medical device evaluation that includes all stakeholders;
- Leveraging existing efforts in the arena of device registries and electronic data systems;
- Describing the desired characteristics of a national Coordinated Registry Network (CRN) for medical devices;
- Outlining priorities for developing and refining medical devices in multiple therapeutic areas;
- Identifying and improving methods for analyzing data on medical devices; and
- Addressing network governance and issues related to patient privacy and informed consent.
Each of these key areas also features suggested pilot projects designed to inform ongoing efforts.
A related perspective article summarizing the National Registry System project has also been published online in the Journal of the American Medical Association.
- Task Force Report (full document; PDF)—Recommendations for a National Device Evaluation System
- Federal Register address for public comment—Medical Device Epidemiology Network Registry Task Force Report; Availability, Web Site Location and Request for Comments (comment period ends on 10/26/2015)
- FDA website—National Medical Device Postmarket Surveillance System
- MDEpiNet news—Medical Registry Device Task Force Report Released
- JAMA Online First—Bridging Unmet Medical Device Ecosystem Needs with Strategically Coordinated Registries Networks