First hospital joins FDA’s medical device information sharing and analysis initiative

Editor’s Note

Charlotte, North Carolina-based Atrium Health is the first hospital to join the Medical Device Information Analysis and Sharing (MDIAS) public-private partnership (PPP) between the Food and Drug Administration (FDA) and private sector stakeholders. The news was announced December 12 by Mitre, a nonprofit research organization and the independent trusted third party for the MDIAS PPP.

By collecting and analyzing data from a wide variety of medical device sources, the initiative aims to improve patient outcomes and provide new and better insights into both public health trends and systemic quality issue. Launched in 2020, MDIAS completed two Phase I Proof of Concept (POC) studies in September 2021. The first identified root causes of recalls. The second, evaluating whether medical device reports are predictive of recalls, found that using a predictive model could detect 72% of recall events. Phase 2 studies will involve non-public data from MDIAS Early Adopters.

Atrium is part of one of the largest nonprofit health systems in the US, Advocate Health, a leader in mobile medicine, and provided $2.6 billion last year in free community care. As the first health system to join MDIAS, Atrium Health’s participation is expected to provide real benefits to the entire ecosystem impacted by medical devices—including patients, regulators, and manufacturers.