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Decontaminating Personal Protective Equipment: Here Are The New Rules

The Centers for Disease Control states that certain guidelines must be met for implementing standards of safety when reusing PPE and masks.

Disposable filtering facepiece respirators (FFRs) are not approved for routine decontamination and reuse as standard of care. However, FFR decontamination and reuse may need to be considered as a crisis capacity strategy to ensure continued availability. Based on the limited research available, ultraviolet germicidal irradiation, vaporous hydrogen peroxide, and moist heat showed the most promise as potential methods to decontaminate FFRs.” – (CDC)

What once was disposable is proving to be healthcare’s greatest weapon against COVID-19. In early April, the U.S. Food and Drug Administration (FDA) shared an emergency use authorization (EUA) that showcased the potential decontamination and reuse of millions of N95 respirators in the United States. The FDA mandated new guidelines just last week on decontaminating personal protective equipment (PPE), such as N95 masks and disposable filtering facepiece respirators (FFRs) to help guide healthcare personnel and organizations on sound hygiene and safety best practices. 

A study completed by Battelle Memorial Institute from 2014 to 2016 showcased proper protocols when decontaminating N95 masks after a health emergency that was cited by the FDA. In the study head researcher, William Richter shared, “The project successfully demonstrated the feasibility of a test approach to evaluate FFR reuse and establish testing methods for future investigation of additional decontamination technologies.” Cited in the current COVID-19 crisis and as a precursor to the EUA, the study laid important groundwork for understanding decontaminating respirators and masks.

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Stephen M. Hahn, M.D., FDA Commissioner explained the FDA’s decision, saying, “This authorization will help provide access to millions of respirators so our healthcare workers on the front lines can be better protected and provide the best care to patients with COVID-19.” (Their full Q&A on PPE and safety procedures can be found here.)

The FDA’s newest EUA gives permission to decontaminate Advanced Sterilization Products (ASP) using the  STERRAD Sterilization Cycles (STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle) which can sanitize an average of 480 respirators a day.
Decontaminating Personal Protective Equipment: Here Are The New Rules
Photo by Jonathan J. Castellon via Unsplash

The Centers for Disease Control (CDC) — via their partner site, the National Institute for Occupational Safety and Health (NIOSH) states that certain guidelines must be met for implementing standards of safety when reusing PPE and masks. The CDC advised using caution on reusing respirators as, “there is no way of determining the maximum possible number of safe reuses for an N95 respirator as a generic number to be applied in all cases.”

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The CDC recommended: 

  • Minimizing the number of individuals who needed to use masks
  • Considering alternatives to N95 respirators, (including half-masks and full facepiece air purifying respirators
  • Allowing extended use and limited reuse of N95 respirators
  • Prioritizing N95 respirators for those at the highest risk of contracting the disease

To learn more about the EUA or see other FDA COVID-19 resources, the FDA has you covered.

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