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FDA reverses course on healthcare worker re-use of N95 masks

For decades, the N95 filtered mask has been a vital piece of personal protective equipment for frontline medical workers. But for months, shortages of that precious item which was previously taken for granted left countless health care workers defenseless from exposure to the coronavirus. The good news is that the N95 shortages have finally abated, with surplus stockpiles enough to last three to 12 months. As a result, federal regulators are beginning to unwind some of the health and safety shortcuts they authorized labs to take to deal with the lack of adequate N95 supplies.

The FDA calls for ending N95 recycling & sharing

National Institute of Occupational Safety and Health (NIOSH) standards dictate that N95 masks be used once and then thrown away. But as an emergency response to the N95 shortage, the federal government relaxed those restrictions by giving providers a temporary green light to reuse, recycle and even allow workers to share N95s, provided that proper cleaning, inspection and fit testing measures were performed. Similar temporary compromises were made for other disposable equipment in short supply, including aprons, gowns and swabs.

With some degree of normalcy restored, the government has made moves to go back to the one mask per worker rule. In its mid-April letter, the Food and Drug Administration (FDA) indicated that it’s “recommending that healthcare personnel and facilities transition away from crisis capacity conservation strategies.”

But labor unions and others concerned about health workers’ safety were less than impressed and noted that “recommending” is the operable word. The letter isn’t an order and labs are still legally allowed to reuse N95s.

But federal officials suggest that this may change soon. Suzanne Schwartz, director of the FDA’s office of strategic partnership and technology innovation says that “the ability to decontaminate was purely a last resort, an extreme measure.” Schwartz said we “need to move back towards contingency and conventional strategies, which is, you use the respirator for the interaction, and then you dispose of it and get a new one.” She also suggested that NIOSH and the Occupational Safety and Health Administration (OSHA) feel the same way on this.

The N95 reuse and recycle rules are clearly on borrowed time. Still, it’s a headscratcher why the peel back of such a dangerous policy adopted as an expediency in response to a crisis that apparently no longer exists, namely, the N95 mask shortage, is taking so long.

CDC tweaks N95 mask guidance

The U.S. Centers for Disease Control (CDC) made a subtle but significant adjustment to its N95 medical mask guidelines that you might not have noticed. Previously, when N95s were in desperately short supply, the CDC said that they should “be reserved” for healthcare workers. But on April 9, the CDC modified its position by indicating that N95 masks should be “prioritized” for healthcare workers but also giving the nod to bulk sales for use at other high-risk workplaces, such as schools, travel and retail.










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