Even as PPE shortages persist, FDA revises authorizations for certain respirators

Nearly half of the primary care physicians who responded to a Primary Care Collaborative, Larry A. Green Center and 3rd Conversation weekly survey “continue to lack” personal protective equipment.

Ann Greiner, president and CEO of the Primary Care Collaborative, called that finding “abominable.”

“We're now about 3 months into this pandemic, and we don't have a public health system in this country that is adequately resourced to make sure we have the equipment we need to safely take care of patients and keep our workforce safe,” Greiner said. “There's no excuse for that.”

The personal protective equipment (PPE) shortage could be exacerbated by the FDA’s recent announcement that certain respirators should not be decontaminated for reuse.

“The FDA has learned from the Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health [NIOSH] testing that authorized respirators manufactured in China may vary in their design and performance,” the agency said in a press release. “As such, the FDA has determined that the available information does not support the decontamination of these respirators and has accordingly revised the relevant [emergency use authorizations (EUAs)].”

The FDA also stated it was “revising relevant EUAs to no longer authorize decontamination or reuse of respirators that have exhalation valves. ... Decontaminated respirators should only be used when new FDA-cleared N95 respirators, NIOSH-approved N95 respirators or other FDA authorized respirators are not available.”

A list of respirators that the FDA says should not be decontaminated for reuse can be found on the CDC’s website.

Greiner did not blame the FDA for the lack of reusable PPE. Instead, she said that the responsibility for chronic under funding for public health, PPE specifically, was shared by many, including the White House. She insisted that greater effort should be made to ensure that primary care physicians can do their job and that health care workers are kept safe.

“The FDA is trying to do what they can with a very unfortunate situation that could have been avoided,” she said. “Organizations and individuals are doing the best that they can in trying to keep the workforce safe, but without PPE, that is very hard to do. This is a storyline that has not changed, 13 weeks into our survey. We need to reinvest in public health and in primary care so that when the next wave of the coronavirus hits, we're better prepared to deal with it.”

The FDA did not return Healio Primary Care’s request for comment for this story prior to its posting. In the release, Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs, said that the need for PPE cannot eclipse the need for safety.

“While we continue to support efforts to meet the urgent need for respirators, we are also doing everything in our authority to ensure health care personnel are adequately protected,” Shah said.

References:

• FDA. Coronavirus (COVID-19) update: FDA reissues emergency use authorizations revising which types of respirators can be decontaminated for reuse. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reissues-emergency-use-authorizations-revising-which-types#:~:text=According%20to%20CDC's%20recommendations%2C%20decontaminated,non%2Dcellulose%20compatible%20N95%20respirators. Accessed June 17, 2020.