New Technique For N95 Respirator Decontamination Gets FDA Approval, Can Cater To 4 Million Daily

N95 Respirator Decontamination Gets FDA Approval, Can Cater To 4 Million Daily
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The Food and Drug Administration (FDA) of the USA has allowed emergency use authorization (EUA) for the decontamination process that was put forward by a company known as Advanced Sterilization Products (ASP). This will result in almost 4 million N95 respirators to get sterilized for reuse daily as per FDA News Release.

N95 Respirator Decontamination Gets FDA Approval, Can Cater To 4 Million Daily

The FDA’s authorization, albeit emergency authorization, can help in countering the increasing shortage of medical supplies that the entire world is facing currently because of the COVID-19 situation. The decontamination process will make it possible for N95 masks designed for only single-use to become reusable.

N95 Respirator Decontamination Gets FDA Approval, Can Cater To 4 Million Daily

The decontamination process is carried by utilizing vaporized hydrogen peroxide gas which is a sterilizing agent. ASP’s STERRAD series sterilization machines that have been granted permission as per the EUA guidelines have already been deployed in roughly 6,3000 hospitals. Their common usage entails sterilizing of clinical equipment and has not been used for N95 masks so far. There are almost 9,930 operations all over the country with each machine capable of cleaning around 480 masks every day.

N95 Respirator Decontamination Gets FDA Approval, Can Cater To 4 Million Daily

Recently, the FDA also gave permission to a similar system for N95 decontamination known as Battelle’s vaporized hydrogen peroxide process. However, this new authorization has increased the potential volume and reach of decontamination and will make other steps become possible as well. Among the first ones to call for this process to be used for the N95 respirators was Duke University that showed that the process was not only safe but also effective and could be applied to a range of equipment that is already being used in biocontainment labs and other medical facilities.

N95 Respirator Decontamination Gets FDA Approval, Can Cater To 4 Million Daily

As of right now, all of the clearances that have been received are EUAs. However, this clearance is part of the group that might become permanent once the COVID-19 outbreak gets under control. This would render our health care systems more prepared for any similar future emergencies. Do let us know what you think of this initiative by the FDA.

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