The U.S. FDA said in a March 11 letter to health care providers that they can take measures to conserve surgical masks and gowns as the COVID-19 outbreak unwinds, including extended use of surgical masks rather than repeated changings. Gowns used for training purposes can be used beyond the manufacturer-specified shelf life when supplies are limited, while a gown may be used during procedures on more than one patient, assuming the patients present with the same infectious disease diagnosis. Surgical masks may be reused for care of multiple patients when the health care provider is at low risk of disease transmission, and the agency advised providers to beware of counterfeit masks and gowns. In an accompanying FAQ, the FDA said it has heard from some health care providers that distributors of gowns and masks have placed some types of personal protective equipment on allocation based on availability rather than on projected use. This has resulted in shortages at some clinical sites, and the agency is reaching out to manufacturers of products under six product codes in an effort to mitigate shortages. Among the procodes in question are FXX for surgical masks (OUK with antimicrobial/antiviral agents) and FYA for surgical gowns.
The FDA said the Jan. 23 recall of Heartware ventricular assist devices (HVAD) by Medtronic subsidiary Heartware Inc., of Miami Lakes, Fla., is due to the risk that the user will mistakenly insert the battery’s AC charger adapter into the HVAD controller’s power port. The class I recall is applicable to nearly 5,500 devices distributed to a number of nations, but none of which were distributed in the U.S. Patients are instructed to report any persistent, unexpected audibles emanating from the device to their clinical care provider.