Finally — HCWs will get a better respirator
Comfort, tolerability are NIOSH priorities
Memories are still fresh of the challenges of respiratory protection during pandemic flu: Inadequate supplies, stockpiles with the wrong size or model, massive fit-testing. But good news is on the horizon. A better N95 respirator for the health care environment may be on the market within the year, and safety officials are developing new design criteria for a sleeker powered air-purifying respirator (PAPR) for health care workers.
The National Institute for Occupational Safety and Health (NIOSH) is testing prototypes of newly designed filtering facepiece respirators (N95s) with improved comfort and tolerability, says Maryann D’Alessandro, PhD, director of NIOSH’s National Personal Protective Technology Laboratory (NPPTL). Health care workers have complained about discomfort from prolonged use of respirators.
"It’s possible to have products with improved comfort by the end of the calendar year," she says.
NIOSH also hopes to expedite the process of approving new respirators, which would make it easier to introduce new designs. "Hopefully, we can get a better process to get them into the market and into the hands of users," says Roland BerryAnn, deputy director of the NPPTL.
In a Federal Register notice, NIOSH sought input on a proposal that would streamline the dual approval of NIOSH and the Food and Drug Administration, which clears respirators and surgical masks used in the surgical setting.
"How do we make the process as federally efficient as possible so you don’t have to have FDA clear every [new] respirator? That’s what we’re working toward," says D’Alessandro.
Meanwhile, NIOSH is on a fast track to develop performance requirements for a PAPR designed for health care. The agency is sponsoring a workshop in Washington, DC, to gather feedback about health care needs. (The workshop was tentatively set for August, but a date had not been finalized at presstime. More information is available at www.cdc.gov/niosh/npptl.)
PAPRs currently must be able to run for at least four hours; 30 to 60 minutes may be sufficient for many health care uses, says D’Alessandro. The flow rate also may be decreased, which would allow for lighter, more efficient and less costly units, she says.
Many hospitals have begun to integrate reusable respirators into their respiratory protection programs because they do not require fit-testing. A survey of occupational health professionals found that about 10% of hospitals use elastomeric respirators and 30% use PAPRs. Almost all hospitals (90%) use filtering facepiece (N95) respirators, she says.
NIOSH is continuing to move forward on new fit criteria for N95s, called the "total inward leakage" rule. It would result in better-fitting respirators overall and more information on fit for buyers. Some N95 models have had low passing rates in fit-testing.
NIOSH is working with The Joint Commission and the Occupational Safety and Health Administration on documents that will provide information about best practices in respiratory protection.
And although pandemic concerns have diminished, NIOSH is researching the shelf life of N95s and how best to set expiration dates. Aging stockpiles may need to be replaced, says BerryAnn.
"The immediacy of need may have subsided, but there’s still a drive to have a viable solution [to building a stockpile of respirators]," he says.