The U.S. FDA’s emergency authorization of medical devices—meant for temporary use when the COVID-19 pandemic began 18 months ago—is still in effect. That’s a major issue for healthcare safety insider, Marcus Schabacker, MD, PhD, president and CEO of ECRI, who sees the potential dangers posed to patient safety.
“We’re not arguing for universal revocation of emergency use authorizations,” Schabacker says. “We are saying there are risks associated with EUAs. We believe the FDA definitely, but also the hospital, has an obligation to manage this proactively.”
The FDA granted emergency device EUAs at a time when many essential devices needed to treat the pandemic, such as ventilators, were in short supply. Inventors stepped forward, devising makeshift ventilators and related devices to address the shortage.
And yet, these devices have gone through a massively abbreviated authorization process, not having had to demonstrate safety and efficacy in the same rigor as the FDA’s two main authorization mechanism, the 510(k) Premarket Notification, and the Premarket Approval (PMA).
Read the full story at Health Leaders.
