FDA Recommends Shift from Use of Non-NIOSH-Approved & Decontaminated Disposable Respirators

Everything You Need to Know About the Lastest Mask Guidelines from FDA

The US Food and Drug Administration is making new announcements for health care professionals and equipment use in the wake of an increase in supply. While concerns regarding health and safety-related to COVID-19 remain at the forefront with healthcare professionals and their associated facilities, the National Institute of Occupational Safety and Health is providing new guidance to medical workers on the use of respirators and decontamination practices:

The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities shift from crisis capacity conservation strategies, such as using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s. This recommendation is in follow-up to the April 9, 2021, letter in which the FDA recommended a transition away from decontamination or bioburden-reduction systems for cleaning and disinfecting disposable respirators, which were being reused by health care personnel.

As a result of an increase in the domestic supply of new respirators approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) and consistent with CDC’s updated recommendations, the FDA has concluded that health care professionals and associated facilities can now pivot away from utilizing non-NIOSH-approved respirators as well as the use of decontamination and bioburden reduction systems. While these crisis strategies were necessary in the past, their use to address respirator shortages during the COVID-19 outbreak is no longer relevant.

According to FDA recommendations, health care personnel, and facilities are recommended to:

• Limit decontamination of disposable respirators. Decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new filtering facepiece respirators (FFRs) or when any new respirators are unavailable.

• Limit the use of all non-NIOSH-approved respirators, including imported respirators, to only when there are insufficient supplies of new NIOSH-approved FFRs or when any new respirators are unavailable.

• Transition away from a crisis capacity strategy for respirators, such as the use of non-NIOSH-approved respirators and decontamination of N95 and other FFRs.

• Increase inventory of available NIOSH-approved respirators, including:

• N95s and other FFRs

• Elastomeric respirators, including new elastomeric respirators without an exhalation valve that can be used in the operating room

• Powered air-purifying respirators (PAPRs)

Furthermore, in the event health care personnel and facilities are unable to obtain the exact respirator model that they prefer, the FDA strongly recommends utilizing a new NIOSH-approved respirator before using a non-NIOSH-approved respirator or decontaminating or bioburden-reducing a selected disposable respirator.

At WeShield we are committed to sourcing the highest quality products and addressing your needs as changes like this occur. We understand that this is not always easy and are here to help you with bulk pricing, reoccurring orders, and one-to-one consultations. We look forward to working with you and meeting these needs as you continue to keep your employees and the surrounding communities safe.

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