COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Recommends Healthcare Facilities Transition Away from Use of Decontaminated Disposable Respirators

FDA maze of regulations
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As respiratory supply chain stresses are reduced, FDA issues letter recommending transitioning from using decontaminated disposable respirators

The US Food and Drug Administration (FDA) has issued a letter to healthcare personnel and facilities recommending that facilities transition from crisis capacity conservation strategies, particularly using decontaminated disposable respirators. This recommendation is based on reliable indicators that the national supply chain of respirators no longer requires conservation of disposable respirators.

The FDA letter makes three specific recommendations. These include:

  1. Limiting the decontamination of disposable respirators and only using decontaminated respirators if you are unable to obtain any new respirators;
  2. Transitioning away from a crisis capacity strategy for respirators, such as decontaminating disposable respirators; and
  3. Increasing inventory of available respirators approved by the National Institute for Occupational Safety and Health (NIOSH), such as N95s.

The FDA further recommends, “even if you are unable to obtain the respirator model that you would prefer, the FDA recommends that you obtain and use a new respirator before decontaminating or bioburden reducing a preferred disposable respirator.”

“The FDA and [Centers for Disease Control and Prevention] CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems,” the FDA letter states. “However, the FDA is not revoking the [emergency use authorizations] EUAs for decontamination and bioburden reduction systems at this time.”

Clinical laboratorians or facilities can review the FDA letter in its entirety here.

Related Resource:

FDA: FDA Recommends Transition from Use of Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities

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