‘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.
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
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