This week the folks at the independent testing organization ECRI published Medical Device Hazard Report on certain N95-style masks. A wide variety of imported (into USA) N95-style respirators (face-filtering respirators [FFRs]) that lack NIOSH certification were shown in testing to be less than acceptable for filtration of airborn materials, here more specifically COVID-19 and related materials. To be clear, here, this does not mean that ALL MASKS are bad, but that some masks aren’t as good as they should be for healthcare workers and patients at risk during the COVID-19 pandemic.
The ECRI released a report this week with the title “Use of Imported N95-Style Masks, without NIOSH Certification or Independent Lab Validation, May Put Healthcare Workers and Patients at Risk during the COVID-19 Pandemic.” This report suggests that ECRI’s own testing shows 60-70% of tested imported non-NIOSH certified respirator alternatives “currently exhibit filtration performance significantly inferior to NIOSH-certified N95s.”
NIOSH testing released on September 2, 2020 showed 53% of a total of 358 FFR models tested did not meet N95 filtration requirements. ECRI warned healthcare workers that “you cannot judge the authenticity of a respirator by its appearance, labeling, or packaging.” A pair of masks was shown, one legitimately tested with NIOSH standards, the other a counterfeit (on the left, top and bottom).
On the right you’ll see a couple more examples of counterfeits. You can also find a giant list of known counterfeit NIOSH masks. That is to say, masks that appear to be NIOSH-certified, but haven’t actually been certified by NIOSH at all.
Per the report, the ECRI recommends that buyers in the healthcare industry request samples before purchase, ask for ISO/IEC 17025 accredited laboratory test reports demonstrating the filtration efficiency for the FFR, and check the NIOSH Certified Equipment List (CEL). You can see the full list now at the CDC.
IMPORTANT NOTE: If you’re an everyday average human being and you’re heading out into public, you should wear a mask. The more offically certified, the better, but any level of filtration – any block between your lungs and the materials going in and out of other lungs – is better than no protection at all. Please, for the good of humanity, wear a mask if you’re able.
The ECRI Institute is an independent organization (and a nonprofit) that focuses on health and safety practices for health patients in the United States. The United States Department of Health and Human Services lists the ECRI Patient Safety Organization as a federal patient safety organization as part of the Patient Safety and Quality Improvement Act of 2005.