FDA authorizes monkeypox test, issues update on recalled ventilators

The Food and Drug Administration Friday authorized for emergency use a real-time polymerase chain reaction test to detect mpox (formerly known as monkeypox) in lesion swab specimens from individuals whose health care provider suspects they have the virus. Only laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high or moderate complexity tests may perform the test. For more, see the fact sheet for health care providers.

In other news, FDA last week released an update on medical device reports associated with certain Philips Respironics ventilators, BiPAP machines, and CPAP machines recalled in June 2021, which include 346 deaths reportedly associated with the breakdown or suspected breakdown of polyester-based polyurethane foam used in the devices.