Making PPE? Did you know it may require certification?

These unprecedented times are calling on all of us to be our best selves, and to step away from what we were doing, to the pressing needs of now. We’ve been hearing from and about several organizations who are shifting their technologies to produce personal protective equipment (PPE) that can protect health care workers and others exposed to COVID-19 in their work.

From 3D printing to home sewing machines, we are seeing a diversity of innovations from small companies to large ones, to individual entrepreneurs. While we applaud these efforts, we feel compelled to explain that there are legal requirements for manufacturers of N95 respirators. That’s right – while we have all heard decision makers like our governors or hospital CEOs talk about ‘PPE’ and N95 masks, those masks need to be NIOSH Certified here in the USA, or similarly certified elsewhere to ensure they are adequately protective for health care workers or others looking to use them for respiratory protection against viruses.

The US National Institute for Occupational Health and Safety (NIOSH) National Personal Protective Technology Laboratory (NPPTL) conducts testing of all respirators in the USA and certifies they are compliant with federal regulations (42 CFR 84) for their purpose. If masks will be worn in surgical settings, FDA also must certify their use. One special consideration is that the COVID-19 virus, like most viruses, is very small, in fact, is nanoscale. Thus it is critically important to ensure that masks can adequately protect wearers from exposure to the virus. One part of this is by ensuring masks are fitted to the face. There is other testing too that ensures they perform as they are labeled. Be safe everyone, and ensure you are protecting yourself and others.