A device for devices: Developing a national medical device surveillance system

A nationwide medical device surveillance system would be most effective if developed from existing health information systems, data registries, and health records, according to the recommendations of the Medical Device Registries Task Force (MDRTF), in a August 24, 2015 report. The MDRTF was tasked with identifying objectives, operations and architecture for such a national medical device surveillance system. The MDRTF report, which contains the task force’s recommendations for that national system, acknowledged that the task force did not recommend a de novo system, but instead, one that takes advantage of extant data systems to develop a nationwide network. The MDRTF report explained the importance using alongside existing systems and infrastructure to reach a public domain with an important data store of medical device information.

Goals

An article published in the Journal of the American Medical Association (JAMA), addressed the MDRTF’s recommendations and outlined the specific goals of the hypothetical network:

  • provide continuously updated benefit/risk and safety data on priority medical devices;
  • provide customized analyses supporting both regulatory and other key stakeholder decisions;
  • 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;
  • 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;
  • pursue stepwise system development, sharing of lessons learned, and solutions use/reuse across device areas;
  • pursue sustainability through a progressive demonstration of value across stakeholders;
  • leverage international efforts; and
  • promote a portfolio of pilot programs capable of creating momentum toward this vision.

CRNs

According to the JAMA article, current systems, including electronic health records (EHRs) and data sources, are inadequate from a medical device registry standpoint because they “do not contain all the elements necessary for device evaluations, including device and procedural details, patient descriptors, or long-term outcomes.” The MDRTF recommended that the ideal network would get around such limitations through interoperability—linking several registries in order to achieve a more comprehensive data collection than one single source would allow. The MDRTF called this hypothetical interoperable network a “coordinated registries network” (CRN). A series of CRNs would then serve as “the foundational architectural construct for the national system.” The five priority principles for CRN functionality that the MDRTF recommended include: “(1) the ability to uniquely identify medical devices; (2) implementation of standardized clinical vocabularies and dictionaries; (3) reusable interoperability solutions linking diverse, strategically complementary data sources; (4) partnered, inclusive governance; and (5) value-based, incentivized sustainability.”

Benefits and Challenges

If a functional CRN or system of CRNs were developed, the benefits for patient safety and device development could be significant. Such a system could provide faster and more comprehensive post market information about device risks and benefits over the total product life cycle of medical devices. CRNs could facilitate better access to device information including information about the device itself, operator and user experience, procedure, and patient profiles. A national network could be used to profile medical devices based upon specific characteristics, in order to identify devices with higher risks. Some important device characteristics that could lead to such profiling include:

  • serious public health consequences of device failure;
  • new technology with safety and effectiveness concerns that are not well understood;
  • devices with significant design variations; and
  • devices with costs that are higher than current therapy costs.

However, the MDRTF acknowledged that an interoperable data system like a CRN also presents challenges in the form of privacy and ethical dilemmas. The MDRTF recommended that CRNs address privacy and ethics problems by engaging patients in a way that allows for patient control of personal health data.

Impact of CRNs

The report explained that CRNs “are well-positioned to inform premarket study designs and post market performance, and hence positively impact the total product lifecycle for related devices.” The proposed network would benefit from the wealth of information held in a variety of different data stores to allow for a more comprehensive and more helpful surveillance system. The JAMA article acknowledges that although the coordination effort necessary to make CRNs possible would be complex—due to the intricacy of data sharing and standardization—the article also suggests that “doing so could allow more effective, low-cost, real-time, rich safety and research opportunities.”