FDA Warns Against Using Incorrect Sterilization Procedures For Certain N95 Masks

Amid continued shortages of personal protective equipment among medical personnel on the front lines of the COVID-19 pandemic, federal health officials are urging those with highly sought after N95 masks or other devices to follow proper decontamination and sterilization procedures to ensure the performance of the products are not compromised.

In a letter to healthcare providers issued on Wednesday, the FDA highlights the importance of following the correct decontamination cycles for reusable N95 or equivalent respirators, warning that some models are only compatible with certain sterilization systems.

As the number of deaths and infections from COVID-19 continue to spread, reaching over 1.6 million cases in the U.S. and more than 100,000 deaths, the demand for particulate-filtering N95 respirators continues to increase. However, if the reusable devices are not properly cleaned it can impact performance.

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At issue are the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems, which use vaporized hydrogen peroxide to decontaminate medical equipment. However, only specific combinations of STERRAD systems and decontamination cycles should be used to decontaminate certain N95 masks, the FDA warns.

This is because some N95 masks contain cellulose, which is essentially paper. Vaporized hydrogen peroxide is incompatible with devices containing cellulose, the FDA warns.

“Using the correct decontamination cycle is necessary to avoid potentially compromising the performance, fit, and breathability of decontaminated compatible N95 respirators,” the FDA warning states. “Using the correct cycle also helps preserve the electrostatic properties (such as leakage resistance) of the polypropylene filter in these respirators. These electrostatic properties play a vital role in the respirators’ filtration efficiency.”

In addition to listing the proper decontamination systems and cycles, the recommendations also call on healthcare facilities to recognize that new N95 and N95-equivalent respirators should always be the first choice for health care personnel, if available, and to confirm these respirators do not contain cellulose.

Officials have also explicitly stated that N95 masks being decontaminated for reuse should only be done so for single user reuse, and masks that are decontaminated should never be given to another individual to use afterwards.

Globally the coronavirus pandemic has infected more than 5 million people and has led to over 300,000 deaths. To date, officials are continuing to search for a reliable means of treating the virus until a vaccination can be produced.


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