Tens of millions of medical devices are used daily in the U.S so it is important for providers, patients, manufacturers, and others to have access to better information concerning the performance of these devices.
A briefing on February 23rd held at the Engelberg Center for Health Care Reform at Brookings www.brookings.edu discussed the “Future of Medical Device Safety and Innovation: The National Medical Device Postmarket Surveillance System”. Mark McClellan, Senior Fellow and Director, Health Care Innovation & Value Initiative, at the Engelberg Center for Health Care Reform at Brookings, led the discussion.
In 2012, FDA’s Center for Devices and Radiologic Health (CDRH) developed an action plan to strengthen the nation’s postmarket surveillance. FDA took the first step and signed a cooperative agreement with the Engelberg Center for Health Care Reform to form the “National Medical Device Postmarket Surveillance (MDS) System Planning Board”.
In 2014, MDS was formed to work with a multi-stakeholder groups that included CMS, NIH, AHRQ, and the Office of the National Coordinator (ONC), plus the Veterans Administration to plan and design the system, identify governance policies and priorities, and develop business models needed to develop a sustainable system.
As Jeffrey Shuren, M.D., J.D, Director of FDA’s Center for Devices and Radiological Health (CDRH) and Thomas P. Gross M.D state in their February 23 blog posted by FDA Voice www.fda.gov, “New tools and systems are able to present real-time data on what happens to patients in clinical practice. With this information, poorly performing devices will be discovered, device approvals and clearances will move faster through the system, postmarket data collection for manufacturers will be reduced, and better informed healthcare decisions will be made by providers and patients.”
Mark McClellan announced the release of the Planning Board’s report “Strengthening Patient Care: Building an Effective National Medical Device Surveillance System” outlining recommended steps to take towards achieving the goals of the planning board.
Jodi Daniel, JD, MPH, Director, Office of Policy, ONC at HHS, is in total agreement that electronic sharing of information with healthcare providers, patients, and caregivers is essential. It is also important to strengthen feedback loops between the scientific and healthcare communities in order to translate evidence into clinical practices and other settings.
As Daniel commented, “It is important to make certain a system is developed that is complementary with HIT exchanges, has effective standards in place, includes patients in the system development phase, and addresses future data capture systems.
The report also suggests that it may be possible to learn from and coordinate with CDC’s national electronic disease surveillance system that transfers data from the healthcare system to public health departments. Several states are developing all-payer claims databases that compile data from private and public payers to assess healthcare utilization.