The Centers for Disease Control and Prevention on Thursday published an interim final rule to allow for the development and use of smaller, lighter weight powered air-purifying respirators, or PAPRs, for use by healthcare workers.
The agency started working on the rule as a deregulatory measure in 2018, but the COVID-19 outbreak caused the CDC to fast track its regulatory approval process by skipping the usual public notice and comment period.
"Recently, some manufacturers have notified (the government) that they are ready to submit approval applications for (new respirators) that would be employable in the current public health emergency as soon as the effective date of this interim final rule," the CDC wrote.
Officials expect that the new devices will be more cost-effective than existing models because, unlike N95 respirators, they don't require test fitting and are reusable.
"Because these PAPRs are reusable, it is likely that 1% of the stock of PAPRs would be required compared to that of single-use items such as the N95 filtering facepiece respirator, assuming the ability to reuse a PAPR one hundred times," the CDC wrote.
That's a conservative estimate because providers report being able to clean their filters for many years before replacing them, according to the agency.
The Trump administration has been looking for ways to address widespread shortages of critical personal protective equipment, or PPE, like N95 masks. And as with other issues like testing and telehealth, it's hoping that deregulation will help take care of the problem.
While PAPRs have been available for decades, their large size and weight limited their adoption by the healthcare industry because they were uncomfortable and made it difficult to deliver care.
Efforts to create a new class of more nimble and comfortable PAPRs were set in motion in 2004 following the 2002 SARS outbreak, which led to an uptick in the use of the respirators by providers. The 2014 Ebola pandemic prompted a second wave of PAPR usage, reviving interest in making more appropriate respirator designs available to healthcare providers.
