The preventable deaths of thousands of front-line healthcare workers from COVID-19 was one of the many great tragedies of the pandemic. Their deaths were not just human tragedies, but also a major hit on this country’s public health system as nurses and other front line workers got sick, died, burned out or left for other safer and less stressful occupations.
Even worse, we don’t even really know how many healthcare workers (or any workers) died from COVID-19 contracted at work. No one was required to keep track, aside from illnesses and deaths in long-term care nursing homes.
The main cause of so many preventable healthcare workers deaths and illnesses was a catastrophic shortage of tight-fitting N95 respirators forcing health care workers to wear less effective surgical masks or to re-use worn out single use N95 respirators. To make matters worse, CDC responded to the N95 shortage by changing its policy to tell healthcare workers that N95s were not needed for protection against COVID-19; loose fitting surgical masks would suffice, despite evidence that surgical masks provided inadequate protection.
We now have a chance to learn from that tragic history and make sure it doesn’t happen again when, inevitably, the next pandemic hits — and to ensure that healthcare workers are protected today as COVID-related hospitalizations and deaths continue.
Unfortunately, we seem to be headed in the opposite direction: A little known, but extremely powerful CDC advisory committee, the Healthcare Infection Control Practices Advisory Committee (HICPAC) threatens to make that fatal mistake permanent, repeating one of the most significant and deadly errors of the COVID-19 pandemic.
There have been a number of excellent articles written about this problem (for example, here and here), so instead of going into too much detail, I am going to summarize the debate and focus on the potential impact of bad policy on OSHA’s ability to protect workers from COVID-19 and other airborne infectious pathogens, and suggest an action plan.
What is HICPAC?
According to website of the Centers for Disease Control and Prevention,
HICPAC is a federal advisory committee appointed to provide advice and guidance to DHHS and CDC regarding the practice of infection control and strategies for surveillance, prevention, and control of healthcare-associated infections, antimicrobial resistance and related events in United States healthcare settings.
HICPAC’s work results in CDC’s Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings which is the bible of infection control practices in health care settings in the United States. When hospitals or healthcare workers need to know how to protect themselves (or other patients) against infectious diseases, Isolation Precautions is where they go. This will be the first major update of the Isolation Precautions since 2007.
What’s the problem?
Everyone is familiar with the old recommendation during the height of the COVID pandemic to keep 6 feet away from other people. Some may also be aware of a related change in CDC guidance stating that loose-fitting surgical masks will adequately protect healthcare workers from exposure to the SARS-CoV-2 virus that causes COVID-19. Both of these recommendations are based on the theory that transmission of the virus “most commonly happens during close exposure to a person infected with COVID-19, primarily via respiratory droplets.”
Droplets, the reasoning went, are relatively heavy and quickly fall to the ground. And because they quickly fall to the ground, loose-fitting surgical masks should be adequate to block any droplets that are sneezed or coughed out near a healthcare workers. Anyone out of coughing distance would be fine.
But there was never any reliable evidence that the droplet theory was accurate. In fact, early in the pandemic, growing mountains of evidence from COVID outbreaks, as well as similar previous corona virus outbreaks like SARS, showed that transmission resulted mostly from aerosols. Aerosols are much smaller than the large droplets commonly emitted by sneezing and coughing, and, because they are so small, they can travel further in the air and stay suspended for longer periods than that larger droplets can. As the pandemic progressed, research showed aerosols to be a primary means of SARS-CoV-2 transmission when a non-infected person inhales these small aerosolized particles.
And, according to workplace safety and health experts like University of California, San Francisco, professor and occupational medicine specialist Dr. Bob Harrison, “If a virus is aerosol transmissible, there’s no question that it’s better to wear a fit-tested N95 [than a surgical mask]. There’s just no question. I would be surprised if anyone would argue with that statement.” Surgical masks were designed to protect patients from health care providers, such as surgeons who might accidently cough into a patients open body cavity. They were never designed to protect workers.
“If a virus is aerosol transmissible, there’s no question that it’s better to wear a fit-tested N95 [than a surgical mask]. There’s just no question. I would be surprised if anyone would argue with that statement.” Dr. Robert Harrison
Last April the HICPAC workgroup met to discuss the Isolation Precautions update. Shockingly, a slide deck summarizing the meeting barely mentioned aerosol and airborne transmission, and cited flawed studies suggesting there is no difference in the protection offered between respirators like N95s and surgical masks. The slide-deck also proposed providing significant flexibility to healthcare providers to determine their own protective measures based on a variety of questionable criteria.
More upsetting was the slide deck’s citation of 13 different studies of laboratory-confirmed viral respiratory infections that concluded there is “no difference between surgical masks and N95s in preventing respiratory infections.”
Lisa Brosseau, a national expert on respiratory protection and infectious diseases at the Center for Infectious Disease Research and Policy, and other experts called the studies “just really badly designed and executed” for a variety of reasons. Brosseau called the committee’s literature review “cherrypicked” and “the most ridiculous literature review I’ve ever seen.”
For Brosseau, it’s simply mind-boggling to suggest that surgical masks provide comparable protection to a fit-tested respirator against hazardous aerosols. “We don’t use surgical masks in any other context,” she said. “In any other industry, I’d be run out on a rail if I suggested a surgical mask for exposure to a hazardous aerosol. So why [does HICPAC] think this is a good idea?”
Even the Food and Drug Administration states that
While surgical masks may be effective in blocking splashes and large-particle droplets, they do not provide a reliable level of protection from aerosolized particles because of the loose fit between the surface of the mask and your face. Surgical masks are not respiratory protective devices, such as respirators.
In addition to undermining respiratory protection for workers, HICPAC is ignoring the importance of better ventilation and air filtration to reduce the spread of virus like COVID-19. Former AFL-CIO Health and Safety Director Peg Seminario
was particularly appalled to see the slide deck mentioned almost nothing about ventilation. In the “transmission-based precautions” section, the slide deck simply stated that health-care workers should “take advantage of multiple layers of interventions (e.g., PPE, rooming, ventilation, disinfection) to reduce the risk of transmission.” Yet there is nothing about ventilation in the evidence review.
Seminario went on to call the guidelines outlined in the slide deck
“Really astonishing. And frightening.”
“People are still getting sick and dying from SARS-CoV-2; they’re still getting long COVID,” Seminario said, adding that health-care workers are still significantly more at risk of contracting the virus than the average person.
Despite that, said Seminario, HICPAC’s proposed guidelines are “all based upon trying to minimize protections, rather than being responsive to the science and providing a strong level of protection. We’re talking about health-care workers exposed to suspected and confirmed patients.” “We’re talking about healthcare workers exposed to suspected and confirmed patients.” Seminario was particularly appalled to see the slide deck mentioned almost nothing about ventilation. In the “transmission-based precautions” section, the slide deck simply stated that health-care workers should “take advantage of multiple layers of interventions (e.g., PPE, rooming, ventilation, disinfection) to reduce the risk of transmission.” Yet there is nothing about ventilation in the evidence review.
Brosseau and Seminario said the lack of focus on worker safety indicates a larger problem in health care of putting profit over safety.
Dissatisfaction is broad and deep. Jane Thomason, lead industrial hygienist at National Nurses United, said HICPAC is “weakening existing guidance for infection control and not following the science that has been built over the last several decades about aerosol transmission.” By providing more flexibility, “They said to employers, ‘Here are the minimal standards, and you guys figure out what you need and want to do.’”
Worker advocates warn that such a “flexible” approach, adopted by the CDC during the COVID-19 pandemic, enabled health care employers to use cost considerations to avoid providing necessary protection for health care personnel and patients.
Brosseau added, “Being in health and safety, I know where that goes. It means you get nothing, workers get nothing, no protections. You don’t leave it to the employer to make decisions about workplace hazards.”
What Does This Mean For Worker Protection and OSHA Standards
One might ask why healthcare workers care what guidance CDC is issuing when it’s the Occupational Safety and Health Administration (OSHA) that has authority over worker safety. Unlike voluntary CDC guidance, OSHA standards — such as OSHA’s bloodborne pathogens standard — require employers to comply with the measure mandated in the standard.
OSHA is currently working on a permanent COVID-19 standard that would cover healthcare workers, as well as a comprehensive infectious disease standard that would cover all communicable diseases. (The COVID standard is in the 9th month of a 3-month White House review and seems unlikely to ever see the light of day as concern about COVID wanes.)
But OSHA’s experts tend to differ from CDC’s infection control efforts about how to protect workers. OSHA — whose experts include industrial hygienists, respiratory protection experts and ventilation experts — have always insisted that healthcare workers need N95 respirators (or better) to effectively protect healthcare workers against respiratory pathogens that may be transmitted by aerosols.
Technically, OSHA is an independent agency that can develop its own regulatory requirements independent of CDC. Legally, employers would be required to comply with OSHA standards over CDC guidance. But the federal government generally frowns upon two of its major agencies issuing contradictory guidance and mandates. Health care employers (and employees) may argue that they’re confused about which to follow: CDC guidance or OSHA standards?
The desire to avoid such confusion is somewhat understandable. In fact, part of the reason for White House review of new regulations is to reconcile such disputes between government agencies. Unfortunately, despite OSHA’s unique expertise and authority in worker protections, CDC is generally seen by the White House as the principal expert agency when it comes to communicable diseases.
Should HICPAC decide that surgical masks are adequate to protect healthcare workers, the White House would likely be inclined to favor CDC’s “expert” recommendations over OSHA’s worker protection expertise, leaving the worker protection agency unable to issue standards to adequately protect healthcare workers.
Despite OSHA’s unique expertise and authority in worker protections, CDC is generally seen as the principal expert agency when it comes to communicable diseases.
But that outcome is not inevitable. For example, despite CDC guidance supporting the use of surgical masks during the pandemic, California OSHA’s Aerosol Permissible Disease standard required the use of N95s to protect healthcare workers against COVID-19 and other aerosol pathogens. Somehow the healthcare system of California survived. And workers are better protected.
Flawed Process: Narrow Membership and Lack of Transparency
HICPAC has a long history of opposing stronger healthcare worker protections for TB, SARS1 and other respiratory diseases.
This is partially a result of the committee’s membership. HICPAC includes old-guard infection control specialists, clinicians employers and representatives of health care associations and the largest corporate hospital systems in the county. And as MedPage Today points out, “At least six of nine currently listed HICPAC voting members are affiliated with major hospitals or healthcare systems, including Ascension, Genesis Healthcare, Mass General Brigham, and Beth Israel Lahey Health.”
So health care employers are well represented. But frontline healthcare workers or worker representatives from unions that represent frontline healthcare workers like SEIU, National Nurses United, AFSCME, AFT? None.
And you will look long and hard, and ultimately in vain for industrial hygienists, ventilation experts, patient safety advocates, occupational health nurses, safety professionals or respiratory protection experts.
There are a few “ex-officio” members from various government agencies, but none from OSHA or even NIOSH, the research counterpart to OSHA which is part of the CDC.
Another problem with HICPAC is that working group meetings focusing on guidance updates are not open to the public, nor are the proceedings from the working group publicly posted. Meeting summaries are posted months after the fact. NNU’s Thomason said that “they had submitted a FOIA request for the committee’s evidence review in its entirety and the minutes from the last nine months of working group meetings. These were denied, violating rules under the Federal Advisory Committees Act.”
Lack of transparency and obstacles to participation are major problems because what HICPAC does is important — literally a matter of life and death — for health care workers and patients.
Normally, government agencies that determine the health and lives of millions of Americans set or change policy by developing regulations, comply to the rules of the Administrative Procedures Act and other laws that require documented scientific back-up, robust public input, public hearings and White House review before issuance.
OSHA standards, for example require extensive analysis (which is published in the Federal Register), White House review of its proposals, several weeks of written public comments from any interested party or expert, pubic hearings often lasting weeks, post-hearing comments and briefs, and another White House review before a final standard is issued. During OSHA regulatory hearings, any witness testifying before OSHA is also able to question OSHA or any other witness.
And OSHA isn’t allowed to just receive the comments, smile and file them away. The law requires to them to respond to each comment, and explain in the standard’s preamble why they accepted or rejected it. And after all of that, they have to defend the standard in court after the industry’s inevitable legal challenge
Contrast that open, transparent regulatory process with HICPAC’s closed, secretive process that limits transparency and public input. HICPAC manages to slip through the cracks of all of these requirements because the Isolation Precautions are “just” guidance, not a regulation, even though they impact every health care institution (and worker) in the country, as well as patients.
Letters to CDC
In July, a group of more than 900 experts in infectious disease, public health, industrial hygiene, aerosol science and ventilation engineering signed a letter to CDC Director Mandy Cohen, M.D., asking for more stakeholders to be involved in updating the guidance and explaining how the new draft guidelines weaken protections for healthcare workers and ignore what has been learned about COVID-19 transmission.
The letter expressed the concern that
based on work group presentations at the June 2023 HICPAC meeting, that the revised CDC/HICPAC guidelines will severely weaken protections for health care personnel exposed to infectious aerosols, including SARS-CoV-2. The draft recommendations fail to reflect what has been confirmed about aerosol transmission by inhalation during the COVID-19 pandemic. The draft recommendations do not adequately provide for the proper control measures – isolation, ventilation, and NIOSH-approved respirators – to protect against transmission of infectious aerosols. They are weaker than existing CDC infection control guidelines. The draft recommendations, if adopted, will put health care personnel and patients at serious risk of harm from exposure to infectious aerosols.
The letter also called on CDC to open up the process. As Brosseau explained, HICPAC should publish its recommendations publicly and allowing for a comment period. Instead of having three minutes of public questions at the end, here should be “something like a docket, where they have to be responsive to the comments they receive,” she said. “Why are they not consulting with all the people and all the stakeholders? They are not, and that’s a sort of basic expectation of a federal advisory committee.”
CDC responded to the letter just before the August 22 meeting, claiming that it was dedicated to to “improving healthcare quality” and committed to “to transparency, communication, and stakeholder engagement.” It also claimed that the CDC is meeting the guidelines for transparency required by the Federal Advisory Committees Act. But the letter offered no substantive response to the original letter’s arguments that the new guidance would weaken protection for health care workers.
The same experts sent a follow-up letter to Cohen, again urging CDC to involve key experts and all stakeholders in the development process, citing a two-day 1992 CDC tuberculosis meeting “that together a broad range of experts and stakeholders to seek input on updating the tuberculosis guidelines.” [Full Disclosure: I was a signatory to both letters.]
The letter also questioned CDC’s failure to address “serious problems with the scientific evidence review that concluded that surgical masks were as effective as NIOSH-approved N95 respirators in protecting against transmission of infectious aerosols.” The letter concluded that “We have no confidence that the HICPAC process will produce recommended guidelines that are responsive to these concerns and provide strong protections; and instead, will simply reflect the views of the healthcare industry.”
Why is CDC Failing to Protect Workers?
Why, one may ask, is CDC taking such a narrow, short-sighted and destructive path that is destined to have disastrous results on healthcare workers and our entire healthcare system? To most worker protection experts, it’s a no-brainer that N95s are necessary to protect workers (and others) from airborne pathogens like the virus that causes COVID-19. So why is CDC going the other direction?
Over the past several decades, CDC and OSHA have frequently been at odds over how best to protect workers. Much of this conflict is the result of a turf battle between agencies.
Amber Mitchell, an infectious disease and occupational health specialist and president of the nonprofit International Safety Center, pointed out that…OSHA has “always been at odds with CDC and HICPAC over the years on occupational infection prevention.” According to Seminario, HICPAC and the CDC “don’t like OSHA making requirements for health care and having oversight over health-care workers.”
And we all know that corporate America — including corporate medicine — hates the idea of government agencies like OSHA telling them how to run their businesses and protect their employees.
Aside from the National Institute for Occupational Safety and Health (NIOSH), which is a small, often ignored, agency within CDC, the CDC has little expertise in worker protection. HICPAC’s members are far more interested and knowledgeable in patient protection, rather than worker protection. And HICPAC doesn’t seem anxious to remedy that problem, as we see by HICPAC’s inexplicable failure to include worker representatives, industrial hygienists, ventilation or respirator experts — or even a NIOSH or OSHA representative.
Profit over Safety
Hospitals are big business. They are first and foremost huge corporations seeking to maximize profit. And HICPAC, as mentioned above, is dominated by corporate medicine. And as we see every day, absent strong legal protections and enforcement, corporations put profit over safety.
N95s are more expensive than surgical masks, and to ensure full protection, they need to be “fit tested” for every employee to ensure there is not leakage. Employees who are required to wear respirators must also undergo a medical exam. According to Seminario, “[Hospital administrations] don’t want to spend the money. Fit testing is a big issue you have to do for respirators. That takes time and money. So if they can say, ‘Oh, a surgical mask is just as good,’ they can get around those expenses.”
Upgrading ventilation systems and air filtrations systems is exponentially more costly as well.
National Nurses United, a labor union that represents healthcare workers, stated that:
If the CDC/HICPAC weakens guidance in these updates, it will mean more exposures and infections among nurses, other health care workers, and their patients. Weakening this guidance will exacerbate the current staffing crisis in health care, as more nurses and other health care workers will leave the bedside due to unsafe conditions and health effects from infections.
But from my observations over the years dealing with CDC over H1N1 and COVID-19, there is another, related reason: We seem to never have enough N-95s to protect healthcare workers in a major pandemic.
A little history:
In 2003, in order to avoid the shortages we’ve recently witnessed, the Strategic National Stockpile (SNS) was created “to supplement state and local medical supplies and equipment during public health emergencies.”
In 2009, the world was suddenly faced with what a new strain of influenza — H1N1 — that at first looked like it could develop into a serious pandemic with high mortality rates. The US public health system swung into action. And although 85 million N95 respirators were distributed to hospitals from the SNS, it was clear from the beginning that in the event of a major pandemic, there there would not be enough N95 respirators to protect US healthcare workers.
At the same time, OSHA and CDC were engaged in the same dispute about what type of personal protective equipment (PPE) was needed to protect healthcare workers. OSHA, arguing that influenza was likely transmitted through a combination of droplets and aerosols, advocated for N95s, while CDC argued that loose-fitting surgical masks were perfectly adequate. In order to resolve the issue, OSHA and CDC sponsored a National Institute of Medicine (NOM) study to determine the state of the science. The NOM found that there had never been reliable studies to determine whether the influenza virus was transmitted exclusively by droplets, or also be aerosols.
While the NOM study was underway, the White House convened a meeting between OSHA, CDC and other interested agencies to attempt to resolve the respirator dispute. At that meeting, which I attended, a high White House official, when informed of the N95 shortage, argued that, regardless of the science, the government can’t be telling healthcare workers that they need something that we can’t supply.
In other words, if you’re running a shortage of N95s, it’s better to lie to health care workers about adequate protective measures than to admit that there aren’t enough and figure out how to address the shortages.
In other words, if you’re running a shortage of N95s, it’s better to lie to health care workers about adequate protective measures than to admit that there are supply problems and figure out how to address the shortages.
Is that what happened during the the COVID pandemic? Is that what’s happening now?
We have some history to go by.
When the COVID-19 pandemic hit, healthcare workers were again on the front line and CDC guidance recommended the use of N95s for workers potentially exposed to infected persons. But the SNS respirator supply was never replenished after H1N1 for budget reasons. In 2020, CDC testified that the stockpile contained only around 30 million N-95s, many of which were expired. But CDC estimated that at least 3 to 7 billion N95s would be needed for a major pandemic. And almost all N95s used by American healthcare institutions were manufactured overseas, mostly in China, which was restricting respirator exports because they were having their own COVID problems. Before the pandemic, only 10% of N95 respirators used in the US were manufactured here.
So CDC had a problem. Do you continue to tell healthcare workers that, based on the science, only scarce N95s can provide adequate protection, and then recommend measures for conservation and re-use to stretch the supply? Or do you “solve” much of the the problem by simply changing the recommendations, so that healthcare workers can use surgical masks and only really need N95s in certain high risk procedures?
In March 2000, word leaked that CDC, in order to address the shortages, was preparing to weaken its guidance that at that time recommended the use of N95s for COVID. Congressman Bobby Scott (D-VA), chair of the House Education and Labor Committee, sent a letter to CDC Director Robert Azar stressing that current precautions recommending N95s be kept in place despite the shortage, and that CDC, NIOSH and OSHA collaborate to develop contingency procedures to address protection of healthcare workers in the event of severe shortages.
Instead, CDC weakened its recommendations in early March 2020 to allow the use of surgical masks instead of more effective N95s. And CDC eventually published contingency procedures to decontaminate and re-use N95 respirators.
In the revised recommendations, CDC asserted that only droplet transmission was proven, there was no evidence that the virus could be spread through aerosols, and, therefore surgical masks were perfectly safe. The CDC provided no evidence or citations to support any of the italicized sections below.
Early reports suggest person-to-person transmission most commonly happens during close exposure to a person infected with COVID-19, primarily via respiratory droplets produced when the infected person coughs or sneezes. Droplets can land in the mouths, noses, or eyes of people who are nearby or possibly be inhaled into the lungs of those within close proximity. The contribution of small respirable particles, sometimes called aerosols or droplet nuclei, to close proximity transmission is currently uncertain. However, airborne transmission from person-to-person over long distances is unlikely.
Again, government officials were reluctant to tell health care workers that their health — and even their lives — were dependent on protections that weren’t available.
What Is To Be Done?
The final HICPAC vote has been delayed from August until November, and the CDC (for the first time) posted a recording of the June meeting and presentations. This was something the letter asked for, but CDC has still not opened the Work Group or posted the draft guidance and full evidence review.
There are several things advocates can do to try to head off weakening of healthcare worker protections.
- The fight right now is to convince CDC to open up the process and increase transparency, while taking seriously the strong evidence that COVID-19 is transmitted by aerosols and only N95s will provide adequate protection.
- Should CDC (again) cave in to corporate hospital interests, the battle will then move to OSHA and the White House. Healthcare worker advocates and experts will need to call for OSHA to require the use of N95s in its upcoming comprehensive infectious disease standard (or possibly the shipwrecked COVID standard) — despite the HICPAC recommendations. Workers, unions, industrial hygienists, ventilation experts and others will need to be ready to to concentrate their efforts on OSHA and eventually the White House to issue strong, protective workplace COVID-19 protections.
Workers, unions, industrial hygienists, ventilation experts and others will need to be ready to to concentrate their efforts on OSHA and eventually the White House to issue strong, protective workplace COVID-19 protections.
- And for the long term, the federal government must ensure that there will be an adequate supply of N95s when the next airborne pandemic arrives. That would require the SNS to buy and store billions — not millions — of N95s. And to develop a system to rotate and resupply them so that they aren’t expired when needed.
That, of course, costs money. That adds to the federal budget, and as a CDC official once explained to me, Congress is reluctant to fund supplies that are just going to sit in warehouses in the unlikely event of a major pandemic. Of course, after the last few years, another major pandemic doesn’t seem quite as unlikely as it did pre-COVID
- And, of course, it would help if more N95s were manufactured in the United States. That may also be more costly than manufacturing them in China. This is something Congress and the White House need to push.
On the other hand, if HICPAC determines that N95s aren’t needed and that decision is forced on OSHA, then I guess the problem is solved: we don’t need all those expensive N95s. We’ll just keep on putting healthcare workers at risk and undermining the health care system of this country.