FDA issues guidance on using certain dry heat systems to support respirator reuse

The Food and Drug Administration last week released enforcement policy guidance for health care providers and others using dry heat systems to reduce bioburden on certain N95 and other respirators in limited supply to support reuse by health care personnel during the COVID-19 public health emergency.
FDA has not issued any emergency use authorizations for such systems, but said it does not intend to object to using them to support single-user reuse of certain otherwise disposable filtering facepiece respirators during the emergency.
System manufacturers should follow both the FDA enforcement guidance and the Centers for Disease Control and Prevention’s existing reuse recommendations, FDA said.
Related News Articles
Headline
The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations…
Headline
The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial…
Headline
The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following…
Headline
The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore…
Headline
COVID-19 infections are growing or likely growing in 45 states and not changing in five states, according to the latest data from the Centers for Disease…
Headline
The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium…