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US health systems call for universal recall communication platform

by John R. Fischer, Senior Reporter | February 27, 2024
Health IT Risk Management
Novant Health, BJC HealthCare, and Munson Healthcare, and other U.S. providers are demanding the adoption of a universal, centralized communication platform by manufacturers, supply chain companies, and hospitals to immediately and electronically address concerns and supply chain disruptions in the medical technology recall process that threaten patient safety.

In letters to their medical equipment and resource suppliers, the organizations are advocating for the adoption of NotiSphere to facilitate “a single point of communication for all necessary updates and alerts” in place of “the current manual and fragmented systems” they use. NotiSphere facilitates real-time, two-way communication and includes recall management software that provides up-to-date information on such events.

"Right now, we receive a lot of paper notices from several different channels regarding recalls, and we have to send back a lot of paper notices to confirm receipt. We also receive a lot of recall broadcasts, some of which don't even apply to us. As a result, our facility spends a lot of time and resources just to figure out whether or not every last recall applied to us," Mark Welch, senior vice president of supply chain at Novant Health, told HCB News.

With adverse events rising, Welch expects a likely increase in the frequency of recalls, adding to the challenges that he and other providers face now. A digital platform would allow suppliers to issue alerts electronically and to only those affected. Providers could acknowledge receipts immediately in the same way and address any questions or issues in less time.

Last month, the Government Accountability Office launched an inquiry into FDA oversight of medical device recalls after it was revealed the agency failed to provide warnings about safety risks in Philips' breathing machines, reported ProPublica. Congress also recently enacted the Medical Device Recall Improvement Act, which would require the FDA to create an electronic format for communicating medical device recall alerts.

While these efforts could potentially pave the way for a mandate dictating for a platform like NotiSphere, the time for this to happen is too long for an industry that requires change now, says Tracy Cleveland, vice president of supply chain at Munson Healthcare.

"We do not need to wait for legislation to drive something that is needed today. Again, it's in our own best interests," he told HCB News.

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