Building Medical Device Supply Chain Resilience With the US Food and Drug Administration

Abstract

Medical device supply chain shortages have the potential to negatively impact patient care when patients and caregivers are unable to obtain the medical devices they need. The US Food and Drug Administration (FDA), specifically the Center for Devices and Radiological Health, received expanded authorities requiring medical device manufacturers to notify the FDA of any interruption or discontinuance of medical devices during or in advance of a public health emergency. The clinical community, in particular, healthcare technology managers, can provide additional information and perspective to the FDA by voluntarily reporting any device availability concerns. This will provide the FDA with more data about the current supply chain landscape and drive communication about the issue. Ultimately, improved information sharing will help ensure devices are available when and where they are needed to protect the health of the nation's patients and healthcare workers into the future.