KN95 masks may not meet quality standards, report says

September 22, 2020

The ECRI Institute found that between 60 and 70 percent of imported KN95 masks provide less filtration performance than promised.

Physicians should think twice before using imported KN95 and other masks not certified by the National Institute for Occupational Safety and Health (NIOSH) or validated by an independent laboratory.

According to a hazard report from the ECRI Institute, physicians should only consider using KN95s or other masks not certified by NIOSH as a last resort when N95s or other NIOSH-certified respirator are not available due to questions about their quality. An ECRI test of imported KN95s found that between 60 and 70 percent provided only sub-95 percent filtration performance while a September 2 NIOSH test found that 53 percent of 358 tested filtering facepiece respirators met N95 standards.

The report cites reporting from The New York Times showing that 67,000 companies registered with China to make or distribute masks and a “high percentage” of those companies are start-ups or repurposed manufacturing companies. While China’s filtration efficiency regulations on KN95 masks are nearly the same as those used by NIOSH for N95 masks, theirs is no guarantee that what physicians buy from offshore suppliers meet these requirements.

ECRI recommends that when assessing a foreign face mask manufacturer, practices should determine whether other healthcare facilities have purchased from the manufacturer and what their experience was. The organization also recommends contacting the company if information is available and ask for things such as: how long they have been making the masks, names and contact information of U.S. purchasers, whether the manufacturer is a NIOSH-approval holder, whether they can share accredited laboratory tests, photos of the product, and request samples for evaluation.

If using non-NIOSH-certified masks, physicians should ensure they’ve been properly tested and evaluated before use when treating a patients positive for COVID-19 with particular attention to their filtration efficiency and proper fit, the report says.