Quantity Not the Only Concern About N95 Masks; Quality Also Matters

Most of the news about N95 respirators deals with quantity: There’s a shortage, and too many healthcare workers enter the battle against COVID-19 unarmed. That shortage still exists but, thanks to recent rulings by the US Food and Drug Administration (FDA) that approves decontamination processes for the masks, quantity will hopefully become less of a pressing problem as the battle against COVID-19 moves forward and the curve flattens. 

The FDA on Sunday approved an emergency use authorization (EUA) to Advanced Sterilization Products (ASP), a Johnson & Johnson affiliate located in Irvine, California, which could lead to the sterilization of as many as 4 million N95 respirators a day. That followed an EUA that the agency issued last Friday to STERIS Corporation, based in Ireland, whose sterilization process can decontaminate about 750,000 N95 masks a day. Both utilize vaporized hydrogen peroxide in their decontamination process. 

It’s been known that hydrogen peroxide can decontaminate N95 masks since 2016, but that was never followed by widespread adaptation, because earlier studies did not account for fit testing, which would affect efficacy. Research by Duke University investigators showed that the decontamination process works in the real world. 

But a lot of issues surround N95 masks. For instance, there’s also price gouging on the part of companies that would take advantage of the COVID-19 crisis. New Jersey-based Performance Supply LLC is accused of trying to sell the N95s manufactured by 3M at 500% to 600% above 3M’s marked prices to New York City officials; price hikes that would make Performance about $45 million. 3M wants an injunction to make Performance Supply cease its alleged illegal activities and is also seeking an undisclosed amount of damages, the money from which to be donated to COVID-19 relief efforts.

There’s also the issue of quality. 

Project N95, launched in March, comprises healthcare volunteers who vet N95 masks and other personal protective equipment (PPE) to see if they measure up in terms of quality. But there’s a limited number of volunteers vetting a seemingly unlimited amount of PPE. Forbes reports this morning that “only 1.6 percent of products submitted have successfully completed their vetting process.” 

Project N95 lists the PPE that’s needed by healthcare workers. In addition to N95s, needed supplies include hand sanitizers, ventilators, surgical gloves, face shields, triple layer surgical masks, disinfecting wipes, Cpap or BiPap machines, and isolation gowns. 

As Forbes reports, Project N95 also takes aim at the black market for PPE; that’s one of the reasons for the list of vetted products. “One of the key partnerships announced is with Amazon, to coordinate with and enable suppliers to distribute PPE, at no profit through their business marketplace, to healthcare workers and those on the frontlines,” Forbes reports, adding that the data will be shared “with all federal, state, and city governments as well as hospitals, charitable organizations, and influential organizations who support their COVID-19 relief initiatives.”