The US Food and Drug Administration (FDA) has provided updated recommendations for one of the surgical N95 respirators listed among those the agency said earlier this month posed a risk of protection failure.
The recommendations enable the use of existing inventory of the O&M Halyard FLUIDSHIELD Surgical N95 Respirator Masks, Orange (Regular), Level 3, (Model 46727). If necessary, this model may continue to be used for respiratory protection when fluid barrier protection against splashes, sprays, or splatter is not needed, such as in non-surgical settings where exposure to liquid, bodily, or other hazardous fluids is not expected, according to the FDA in a safety communication.
When fluid barrier protection against splashes, sprays, or splatter is needed, such as in surgical settings where exposure to liquid, bodily, or other hazardous fluids may occur, the FDA recommends:
- Consider alternative options and seek an alternative surgical N95 respirator, if possible.
- In the absence of alternative options, the risk of fluid exposure can be mitigated by wearing a face shield over the respirator to prevent fluid penetration.
The FDA continues to recommend that the FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, (Model 46827) by O&M Halyard not be used due to concerns with particulate filtration and fluid resistance identified through laboratory testing.
The FDA says that the recommendations come in response to questions about existing inventory that it has received from healthcare provider organizations that rely upon O&M Halyard surgical N95 respirators and are informed by testing results available to the FDA.
“This is an evolving situation, and we will continue to keep the public informed as new or additional information becomes available about these and other O&M surgical N95 respirators,” says the FDA in the update.
Earlier recommendations for certain surgical masks (including procedure masks) and pediatric face masks by O&M Halyard have not changed.