The surveillance of medical devices using prospective registries ideally provides critical information to all relevant stakeholders about device safety, long-term product performance, and effectiveness in improving patient outcomes. However, there are several challenges that must be overcome to successfully employ a registry-based post-market surveillance system for medical devices related to the diversity and complexity of medical devices, the iterative nature of product development, the learning curve associated with technology adoption, and the relatively short product life-cycle. Furthermore, novel methodological approaches are needed to manage incomplete ascertainment of adverse events and outcomes and lack of standardization of endpoint definitions, as well as a common method to define the relationship between device, or machine, failure and clinical events. Solutions to these challenges are most likely to emerge from industry, academic institutions, and government collaborations, each bringing their respective strengths and perspectives. Moreover, such collaborations are important for the credibility and integrity of the effort. Accordingly, we propose an industry-academic partnership between Medtronic and Yale, organizations currently collaborating to develop a device surveillance registry network and infrastructure, ideally integrated with other federal efforts such as the Medical Device Epidemiology Network Initiative (MDEpiNet). Over the course of the five-year project, the partnership will convene a series of stakeholder meetings that include methodological experts in post-market surveillance, industry, academics, government, clinicians, and patients to develop the critical methods needed to proactively monitor medical devices as well as the policies that define roles and responsibilities of expert parties engaged in the medical device surveillance ecosystem. This includes policies and procedures to assure integrity of the effort, strategies for sharing of device, clinical and quality data among clinical investigators and others, policies to promote transparency that can be applied to such collaborations, and novel methodological approaches to data collection (including device follow-up and Unique Device Identification compliance) and analysis that address the deficiencies that undermine existing medical device surveillance registry systems.

Public Health Relevance

Determining the effectiveness and safety of medical devices among patients using the products in a real-world setting is difficult to do, but best accomplished using a registration system of all patients that receive the device and follow-up over time. However, there are several challenges that must be overcome to use this system successfully to monitor medical devices, related to the diversity and complexity of medical devices, the fact that the product is constantly improved, the learning curve associated with use of new devices by practicing physicians and clinicians, and the relatively short product life-cycle. We are proposing to engage experts in device safety and effectiveness surveillance, industry, academics, government, clinicians, and patients to develop the critical methods needed to proactively monitor medical devices as well as the policies that define roles and responsibilities of expert parties engaged in the medical device surveillance ecosystem.

Agency
National Institute of Health (NIH)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01FD004585-03
Application #
8731133
Study Section
Special Emphasis Panel (ZFD1)
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Yale University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
City
New Haven
State
CT
Country
United States
Zip Code
06510