Throughout the COVID-19 pandemic, the demand for disposable N95 respirators has outpaced supply.
The U.S. Centers for Disease Control and Prevention has laid out strategies to optimize the supply of personal protective equipment, including the limited reuse of N95 respirators in certain crisis circumstances.
While 3M is accelerating its global production of respirators to achieve a run rate of 2 billion annually over the next 12 months and is additionally importing 166.5 million to the United States over the next three months, it is also helping to mitigate the immediate shortage of the supply of respirators. In general, decontamination of disposable N95 and other filtering facepiece respirators is not recommended due to the potential negative impact on fit and filtration of the respirator.
That said, 3M has collaborated with several decontamination companies to help evaluate whether or not their proposed decontamination systems could be used in connection with limited respirator reuse during critical shortages without having a negative impact on fit and filtration.
Over the past several weeks, 3M sent respirators to decontamination companies to run them through the companies’ decontamination systems. Upon the return of these respirators, 3M evaluated them on filtration and properties related to fit. If the evaluation led to a “pass” result on both fit and filtration, and the company recommending the decontamination method completed its own due diligence to ensure treated respirators were properly decontaminated, then that company was able to apply for a U.S. Food and Drug Administration Emergency Use Authorization (EUA) to use its decontamination system on disposable filtering facepiece respirators, such as N95s.
3M has published its review of these decontamination systems. Company names, decontamination methods and 3M results are available here.
To date, three companies have passed both 3M’s fit and filtration tests after decontamination and have also received, following FDA’s analysis, EUAs that permit emergency use of their systems to decontaminate respirators during the pandemic.
Steris, Advanced Sterilization Products (ASP) STERRAD Sterilization System, and Battelle have each received an FDA EUA for their decontamination system.
3M will continue to perform testing to support performance verification and has recently expanded efforts to do likewise for other decontamination systems being evaluated by relevant governments or other authorities around the world.
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