FDA Allowing Modifications To Ventilator Equipment To Bolster Supplies During COVID-19 Crisis
The US agency says it will not object to medtech manufacturers making minor modifications to the motors, tubing or software of medical ventilators – or even to pressing CPAP (continuous positive airway pressure) equipment into service to use as ventilators – during the COVID-19 public health emergency.
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The US agency has not received any adverse event reports associated with the use of the accessories to treat COVID-19 patients. But the medical literature has raised some grave concerns.
Manufacturers of devices granted emergency use authorization (EUA) status during the COVID-19 crisis are fully responsible for filing any adverse events about the products to the FDA, the US agency says on a new FAQ page.
‘Have Some Level Of Fear’: How Scrapped FDA Inspections, Hastily Made Ventilators Could Portend Product Problems
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.