Use of a respirator will be compromised if it does not pass a user seal check, if breathing resistance is unacceptable, or if there are obvious defects in the respirator’s structure. The choice of a fluid-resistant cover (faceshield or medical mask) should be dictated in large part by functionality and availability.

MEDICAL MASKS AND IMPROVISED PROTECTION

In its discussions with manufacturers, the committee was told that currently marketed disposable medical masks are made of materials that are likely to degrade with standard means of disinfection (e.g., chemicals, heat, radiation). Because medical masks are intended for disposal and are submitted to the Food and Drug Administration (FDA) with that labeling, manufacturers have no reason or incentive to develop methods for decontamination or reusable masks. However, manufacturers with whom the committee spoke noted that several disposable devices currently on the market can be used repeatedly by the same wearer until they become damaged, moist, difficult to breathe through while wearing, or visibly soiled. The length of use is, in general, related to the durability of the mask, and its ability to withstand moisture. Because reuse of the same device by infected patients is unlikely to increase the risk of contamination, medical masks can be reused by patients until the masks are no longer useable due to moisture or damage.

FDA informed the committee that it has not cleared any medical mask/ N95 filtering facepice respirator or medical mask as a reusable device. The agency also indicated that if such a device became available it would perform an expedited review of the premarket submission to meet the public health need. Thus, FDA recommends that without manufacturing modifications, current medical (surgical and procedure) masks commonly used in the United States cannot be effectively cleaned and should therefore be discarded after a single use.

Finding 5: Any method of decontaminating a medical mask must remove the viral threat, be harmless to the user, and not compromise the integrity of the various elements of the mask (e.g., tear or deform the filter, stretch the elastic attachments, bend the nose clip). The committee found no validated method of decontamination that meets these criteria.



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