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FDA Issues Green Light to Sterilize N95 Respirators

April 14, 2020
Pulling out all stops to increase the availability of the critical medical devices.

A dire shortage of N95 respirators compelled the U.S. Food and Drug Administration to issue an emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by healthcare workers in hospital settings.

The EUA was issued on April 10 and provides access to about 4 million N95 or N95-equivalent respirators per day to frontline healthcare workers in the United States.

N95 respirators are generally used as a single-use protective device, according to FDA regulations. Tested against NIOSH Standard 42CFR 84, N95 masks block at least 95% of very small (0.3 micron) test particles.

The FDA’s chief scientist, Denise M. Hinton, noted that the authorization is limited to the use of the Advanced Sterilization Products STERRAD Sterilization Systems for use in decontaminating compatible N95 respirators contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms.

There are about 9,930 STERRAD Sterilization systems in 6,300 hospitals across the United States. Sterilization systems vary in reprocessing times from 24 to 55 minutes, and each system can reprocess approximately 480 respirators per day.

The FDA noted that the decision to decontaminate compatible N95 respirators for single-user reuse by healthcare professionals is based on the totality of scientific evidence available, and that the course taken will outweigh known and potential risks.

As of Feb. 4, the U.S. Department of Health & Human Services issued liability immunity for activities related to medical countermeasures against COVID-19.

President Issues DPA Order

The shortage of N95 respirators have left government and hospitals scrambling to secure extra resources for several weeks.

President Trump invoked the Defense Production Act on April 2, specifically ordering 3M Company and other manufacturers of N95 masks to ramp up production and prioritize orders from the Federal Emergency Management Agency (FEMA).

The U.S. administration also requested that 3M cease exporting respirators to the Canadian and Latin American markets. 3M responded in a statement that the company had already been working with the U.S. Administration and, in addition, had secured approval from China to export to the U.S. 10 million N95 respirators manufactured by 3M in China.

In addition, 3M warned against the implications of a request made by the Administration for ceasing all export of respirators produced in the United States. As a major supplier of respirators in Canada and Latin America, 3M noted there would be significant humanitarian ramifications for ceasing respirator supplies to healthcare workers in those countries. 

Price Gouging

The multinational also reported that it was working to counter price gouging and unauthorized reselling related to 3M respirators. According to a lawsuit filed by 3M on April 10, New Jersey-based Performance Supply LLC allegedly offered to sell $45 million in N95 respirators to New York City officials at prices 500-600% over 3M’s list price.

3M noted the prices for respirators have not changed as a result of the COVID-19 outbreak. The company is working with online retailers and technology companies such as Google, Amazon and Facebook to identify and remove counterfeiters and price gougers from their sites.

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