‘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
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.
