A Key Step To Build Resilience In The Medical Device Supply Chain

Health Affairs May 22, 2023
Suzanne Schwartz, Tammy R. Beckham

In September 2022, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) began hearing from patients and clinicians about difficulties obtaining pediatric tracheostomy tubes. These tubes are commonly used to keep airways open in children recovering from surgery or who have a serious medical condition. They are frequently lifesaving. But the CDRH had not previously been aware of the magnitude or timeline of the crisis, which was brought on by a labor shortage resulting in a shortage of the silicone used to make the tubes. Providers, unable to access the required tubes, were forced to keep children on ventilators for extended periods of time.

This incident is not the first time the CDRH learned about a...

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