The U.S. Food and Drug Administration (FDA) has released new recommendations regarding the use of disposable respirators suggesting “transition away from crisis capacity conservation strategies”.
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The regulator grounds its advice in the fact that domestic supply of the PPE is sufficient enough to make performing decontamination or bioburden reduction on disposable respirators for reuse unnecessary.
Specifically, the FDA recommends to healthcare personnel and facilities the following:
- to limit decontamination to cases when procurement of new respirators is impossible
- to transition away from a crisis capacity strategy for respirators (e.g. decontamination)
- to increase stocks of authorised respirators and prioritise the use of new equipment over reuse.
It is noted that for reuse, organisations should consider obtaining devices reusable by design, such as new elastomeric respirators without an exhalation valve or powered air-purifying respirators.
Since early 2020 till April 2021, the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) has approved for emergency use close to 880 respirator models while the overall number of NIOSH-certified devices is over 6,400 including 600+ FFR models, 5,500+ elastomeric respirator configurations and 360+ powered air-purifying respirator (PAPRs) configurations.
Even though updating its recommendations, the FDA for the time being is not revoking its emergency use authorisation for this type of PPE to support healthcare systems capacity in case of a surge in COVID-19 cases, and keeping respirators, particularly surgical ones, on its device shortage list.
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