May 21, 2020

NIOSH Issues Alert About Damaged Head Straps on Stockpiled FFRs

Users of previously stockpiled NIOSH-approved filtering facepiece respirators should visually inspect each respirator prior to putting it on due to concerns that the head straps and filtering material may have degraded, the agency said in a notice published to its website last week. The notice states that NIOSH has received several inquiries about replacing damaged straps and notes that any modifications to the device voids the NIOSH approval. Adding new straps may affect the respirator’s fit or filtration performance, according to the notice. Users should consider replacing damaged head straps only when all undamaged respirators have been used.

Respirators whose head straps have been replaced may be used as facemasks but not as respiratory protection, the agency states.

A March 28 Emergency Use Authorization from the Food and Drug Administration (PDF) permits the use of expired NIOSH-approved FFRs in healthcare settings during the COVID-19 pandemic but stipulates that damaged respirators should be discarded.

A NIOSH study (PDF) conducted in 2018­-2019 assessed the performance of nearly 4,000 respirators manufactured between 2003 and 2013 and stored at ten U.S. stockpile facilities. Eleven of the twelve respirator models examined in the study were N95 FFRs. Overall, NIOSH found that 98 percent of the stockpiled respirators maintained their inhalation and exhalation resistance and filtration performance. Nine of the individual respirators tested had damaged straps, but all passed NIOSH performance requirements.

Despite the high pass rate, NIOSH warned that users of expired respirators should “avoid a false sense of confidence” because “these devices may not provide the same level of protection as those that have not exceeded the designated shelf life.”