The End—a Good Place to Start

In the life of a medical device, the information gathered after a product has been approved or cleared by the U.S. Food and Drug Administration (FDA) is just as important as the data gathered to support the device’s premarket submission to the FDA. But unlike the coordinated and monitored methods for gathering premarket data, means of collecting information after the fact from a varied number of sources has proved to be much more cumbersome. It’s not that the sources of data don’t exist—in fact, there are plenty—but they don’t exactly always play well together.

Millions of patients undergo surgery each year and require some type of medical device during the procedure. Information on thousands of medical devices is readily available in registries, electronic health records (EHR) and claims data, among other sources, but—according to experts—the disparate locations make it difficult for regulators, doctors and patients to understand and use it efficiently.

At the end of August, while most of Washington, D.C., was enjoying the peace and quiet of Congress’ summer recess, the National Medical Device Registry Task Force (MDRTF) released the findings of a year-long study to evaluate how the industry can better monitor medical products’ performance after they become commercially available. The report is titled: “Recommendations for a National Medical Device Evaluation System: Strategically Coordinated Registry Networks to Bridge Clinical Care and Research.”

The National Medical Device Registry Task Force consists of key stakeholders under the FDA’s Center for Devices and Radiological Health’s Medical Device Epidemiology Network (MDEpiNet) program, which is working to build a national medical device evaluation and surveillance system by improving and integrating the infrastructure for real-world data, developing methodologies and conducting studies. MDEpiNet is a “public-private partnership bringing together leadership, expertise and resources to build and operate in a national system that supports the development, regulation and use of innovative medical devices.”

The MDRTF report includes eight recommendations to serve as the foundation for a national medical device evaluation system. The following points were summarized in an article in the Journal of the American Medical Association:

1. Provide continuously updated benefit/risk and safety data on priority medical devices;
2. Provide customized analyses supporting regulatory and other key stakeholder decisions;
3. Integrate broad electronic patient access infrastructure with implementation of standardized data elements and dictionaries, moving currently heterogeneous data into more structured domains reflecting the multidimensional aspects of device use, procedures, patients and outcomes in clinical practice;
4. Actively engage stakeholders to transform the medical device landscape from one of fragmentation, redundancy and distrust to one of goodwill, inclusiveness, efficiency, continuity and partnering;
5. Pursue stepwise system development, sharing of lessons learned and solutions use/reuse across device areas;
6. Pursue sustainability through a progressive demonstration of value across stakeholders;
7. Leverage international efforts; and
8. Promote a portfolio of pilot programs capable of creating momentum toward this vision.

The MDRTF outlined that most existing registries and other sources of data such as EHRs do not contain all the elements necessary for device evaluations, including device and procedural details, patient descriptors, or long-term outcomes. To overcome this challenge, the group advocated the creation of a coordinated registries network (CRN) to solve interoperability problems and link complementary registries and data sources to produce networks of data to support improved device evaluation. Because EHRs, administrative claims data, or mobile device information are not formal registries, CRNs—the task force claims—would provide the foundation for a national system that would add to national registry development and the unique device identifier system.

“The success and sustainability of CRNs, and of the national system itself, will depend on the actively promoted transformation of the contemporary medical device innovation ecosystem from a landscape of fragmentation, skepticism and distrust to a culture of goodwill and partnering in every aspect of the CRN and national system’s development and operations,” the report’s authors wrote. “CRNs and the national system will require responsible financial support, but their sustainability will depend on the overall ability to provide processes, engagement and deliverables of such value that stakeholders will share the perception of the system as a truly priceless healthcare resource.”

For a more in-depth look, the complete report can be found in the medical device section of the FDA’s website: www.fda.gov/MedicalDevices/default.htm. Public comments on the draft report’s findings will be gathered until Oct. 26.

Christopher Delporte
Editorial Director