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‘Have Some Level Of Fear’: How Scrapped FDA Inspections, Hastily Made Ventilators Could Portend Product Problems

In the haze of COVID-19, deadly ventilator failures could go undetected, ex-agency official warns

 
• By Shawn M. Schmitt

Two former US FDA officials tell Medtech Insight they’re concerned about product problems down the line as automobile manufacturers make critically needed medical ventilators amid the COVID-19 crisis, and as device makers quickly scale up manufacturing on items like masks and gowns. Compounding problems is the agency’s decision to stop conducting quality systems inspections domestically and abroad.

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Kwame Ulmer is troubled about makers of automobiles contract manufacturing complex medical ventilators as the world struggles with the COVID-19 pandemic.

“It worries me. I can't lie,” the former US Food and Drug Administration official told Medtech Insight.

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More from Policy & Regulation

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• By Ashley Yeo

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