Chinese-made N95 masks and respirators with exhalation tubes among banned types.
Editor’s note: This article was originally published in the newsletter Briefings on Accreditation & Quality. Briefings on Accreditation & Quality is published through the HCPro Accreditation & Quality Compliance Center.
On June 7, the FDA announced that it was changing what types of respirators can be decontaminated for reuse. Faced with a national shortage of these items, the agency had given the healthcare industry emergency authorization during the coronavirus pandemic to decontaminate single-use respirators and facemasks..
The FDA now says that decontamination systems can only be used on non-cellulose-compatible N95 respirators. Banned from reuse are any respirators that have exhalation tubes, or N95 masks made in China. The latter has been banned due to quality control issues. And, as always, the FDA stressed that decontaminated respirators should only be used when new respirators are unavailable.
These changes are in response to new information from the Centers for Disease Control and Prevention (CDC) and from pushback from healthcare workers worried about the safety of reused personal protective equipment (PPE).
"In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the agency is reissuing certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination. Based on the FDA's increased understanding of the performance and design of these respirators, the FDA has decided that certain respirators should not be decontaminated for reuse by health care personnel,” states the FDA news release.
This reversal was cause for celebration for members of the Massachusetts Nurses Association, which petitioned for the right of nurses to refuse to use decontaminated PPE during the COVID-19 pandemic, citing safety concerns.
"Government officials and healthcare executives wasted time and resources and put frontline workers at risk chasing the unproven and dangerous dream of mask decontamination. Nurses and healthcare professionals caring for patients during this pandemic knew all along that these processes lacked rigorous evidence, could damage N95 masks and may create lasting health problems,” said MNA President Donna Kelly-Williams, RN, in a press release response to the FDA reversal.
In April and March, the FDA issued two EUAs stating that single-use N95 masks could be decontaminated to make up for the shortage of these products during the pandemic. The most common method used involved spraying masks with vaporized hydrogen peroxide and letting them dry.
Brian Ward is an associate editor for HCPro who writes about hospital accreditation and patient safety.
Photo credit: Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA. / Editorial credit: JHVEPhoto / Shutterstock.com