FDA Updates Use Recommendations for Halyard Surgical N95 Respirators
Source: aha.org
In response to questions from the American Hospital Association and others, and informed by testing results,
the Food and Drug Administration has announced that health care providers without alternative options may continue to use a certain version of the O&M Halyard FLUIDSHIELD Surgical N95 Respirator Mask for fluid barrier protection if they wear a face shield over the respirator.
On April 12,
the agency announced that health care providers and consumers should not use certain N95 respirators made by O&M Halyard because they do not meet quality and performance expectations, and should not use certain surgical masks and pediatric face masks made by the company for fluid barrier protection. The FDA continues to evaluate quality and performance information for these products and will provide updates as more information becomes available. The agency said it also continues to work with providers to assist with challenges and can help them find alternative sources and products.