CREDIT: REBECCA NOBLE VIA GETTY IMAGES
SUPPLIER DIVERSITY
Robert F. Kennedy Jr. with US President Donald Trump
“ We know from experience that reliance upon voluntary notifications to the FDA about device supply chain disruptions has not been effective,” Michelle adds.“ We are often the last to know and by then the consequences are already being felt in neonatal intensive care units( NICUs) and children’ s hospitals.”
To improve matters, the FDA created the Office of Supply Chain Resilience( OSCR). The OSCR performs risk assessments, collaborates with manufacturers and coordinates emergency production efforts. When tracheostomy tubes ran short, the OSCR used the Defence Production Act to expedite raw material supply and issued guidance to help hospitals identify safe alternatives. However, without stronger regulatory tools, these interventions happen after the fact.
“The FDA recognises that early awareness of supply chain disruptions is essential to mitigating the impacts of potential medical device shortages”
MICHELLE TARVER, DIRECTOR, FDA’ S CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, US FOOD AND DRUG ADMINISTRATION
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