USA – FDA official warns device makers over supply chain risks

Manufacturers and healthcare providers are reverting to old business practices that could jeopardize medical device supply chains in the event of another public health emergency (PHE), according to a US Food and Drug Administration (FDA) official, who said companies must learn from the pandemic and prepare for potential shortages.

Speaking at the AAMI/FDA neXus medical device standards conference hosted by the Association for the Advancement of Medical Instrumentation (AAMI) on 21 February, Tammy Beckham, associate director of the Centers for Devices and Radiological Health’s (CDRH) Resilient Supply Chain and Shortages Prevention Program, said that stakeholders are reverting to their pre-pandemic habits, which could have dire consequences. She said they need to reconsider how to balance their financial interests against risks to their supply chain…