Safety Group ECRI Reminds Hospitals That FDA’s EUA Process A ‘Lower Standard’ For Device Approvals

A well-known independent patient safety group, ECRI, cautions in its 28 January “hazards” report that the US Food and Drug Administration’s heavy reliance on emergency use authorizations (EUAs) for COVID-19 medical devices to fight the virus means the agency was using a “lower standard” than it usually does for medtech approvals.

ECRI added in its 2021 Top 10 Health Technology Hazards executive briefthat to control the No. 1 hazard on its...