The CDC challenged sent to the agency for approval from the Healthcare Infection Control Practices Advisory Committee (HICPAC), asking for clarification on key issues including N95 masks and transmission of pathogens by air.
In a , the CDC asked for answers to a number of questions before they would submit the document -- an update to guidance last updated in 2007 -- to the Federal Register for public comment.
"We feel these questions, largely related to when masks and respirators (such as N95) are recommended in healthcare settings, reflect concerns or areas of confusion that continue to be raised by stakeholders in response to the draft guideline," Alexander Kallen, MD, MPH, HICPAC's designated federal official, wrote to the co-chairs of the workgroup within HICPAC responsible for the draft.
The response was "based on the significant interest in the draft recommendations," the CDC wrote in an . It follows criticism from healthcare providers and other experts who have argued the guidelines fail to protect them and patients adequately from the spread of disease in healthcare settings, and instead protect the interests of hospital employers looking to cut costs.
"It was really exciting to see the CDC finally listen to many of the concerns -- not all, but many -- of the concerns NNU has been raising," Jane Thomason, MSPH, lead industrial hygienist for National Nurses United (NNU), told Ƶ. "It's really a positive step to see the CDC finally listening to what folks have to say outside of the infection prevention and the hospital industry interests that are currently what are represented on HICPAC." Six of the work for hospitals or hospital systems.
On the other hand, Tom Talbot, MD, of Vanderbilt University Medical Center, and president of the Society for Healthcare Epidemiology of America (SHEA), told Ƶ in an email, "Many of the experts on HICPAC are healthcare epidemiologists/medical directors of infection prevention as well as SHEA members. These individuals have specialized training, knowledge and professional experience in the prevention of infectious disease transmission in healthcare settings."
"This makes them the right experts to address these concerns and adjust the guidance," Talbot said.
Among the clarifications are whether HICPAC should recommend N95 respirators for all pathogens spread by air, not just the broader "masks" for some respiratory pathogens, which would include surgical masks. In the current draft guidelines, N95 or more protective respirators are only required for "special" or "extended" air precautions, but not for "routine" airborne pathogens, terms defined by HICPAC.
Accordingly, the CDC asked HICPAC to clarify its "special precautions" category, which requires N95s only for "new and emerging" pathogens. The agency questioned if the guidelines were sufficient for healthcare organizations allowing "voluntary use" of N95 or higher-level respirators, in a nod to , Thomason said, that require employers to allow employees to use N95 or other respirators voluntarily.
CDC also asked if the guidelines should include broader use of source control (i.e., masking to contain respiratory secretions, rather than protect against them) in healthcare settings. In the current draft, source control is recommended only when a patient leaves their room, at all levels of transmission-based precautions.
In another win for organizations that have asked for expanded input from stakeholders, the CDC also wrote in its letter, "Additional subject matter experts will be added to the workgroup to assist with preparing responses." Thomason said NNU has not learned anything further, but hopes to be invited on as subject matter experts.
CDC said in its blog post that the updated HICPAC workgroup will discuss these considerations at its next meeting, "which is open to the public" -- but the date of that meeting remains "to be determined."
In the lead-up to a HICPAC meeting in August after a preview of the draft guidelines was shared, groups including NNU, along with occupational health experts and patient advocacy groups, sent a petition to the CDC and HICPAC. In it, they called for stronger language around aerosol transmission, and rejected the inclusion of surgical masks as adequate protection at certain levels of transmissibility, a recommendation they said was based on a flawed review of evidence.
In November, HICPAC voted unanimously to approve the draft guidance, amidst an outcry from NNU and other critics for failing to include healthcare workers, patients, ventilation engineers, occupational health experts and others in their drafting process, and allowing minimal time for public comment.
to CDC director Mandy Cohen, MD, in December asked the agency to reject the draft guidelines.
"I think the existing the 2007 guidance, which is what is still in effect, really does need updates, and so we're glad that the CDC is taking those steps to update that," said Thomason. "It just needs to be based in the most up-to-date science, and needs to take into account all of the perspectives and expertise because ultimately, the goal here is to save healthcare workers and patients."