Infectious disease experts ask President Obama to end H1N1 influenza respirator debacle
'We are concerned about patients dying because of this mandate'
A misguided federal mandate that health care workers don N95 respirators to treat known or suspect H1N1 influenza A patients is critically undermining the medical response to the first pandemic in four decades, clinicians tell Hospital Infection Control & Prevention.
In a classic case of good intentions gone awry, an effort to protect health care workers has left them no safer while compromising patient care, they argue. As a result of the federal action, a relatively arcane debate about whether to wear standard surgical masks — the longstanding practice with flu — or respirators has now metastasized into a national patient safety issue.
"We are concerned about patients dying because of this mandate," says Kim M. Delahanty, RN, PHN, MBA, CIC administrative director of infection prevention at the University of California in San Diego.
The federal requirement to have health care workers wear fit-tested N95s for even suspect cases of H1N1 is delaying discharge and transfer of patients to facilities that do not have the gear to comply, she explains. As a result, mildly ill patients are taking up much-needed hospital beds, backing up hard-pressed emergency departments as unintended consequences of the mandate ripple through a besieged health care system.
"It's tumultuous — very difficult to manage, but we are complying," she says. "Some hospitals are complying better than others based on actual resources of having enough N95s to meet the surge of H1N1 patients. The concern that we have — infection preventionists who base all of our decisions on evidence and research — is that this mandate has been given with no science or evidence to support it."
Making a similar point to the highest office in the land, the nation's leading infectious disease associations are urging President Barack Obama to halt federal enforcement of the mandate by the Occupational Safety and Health Administration (OSHA). The federal guidance and OSHA requirements are "deeply flawed" the letter to the president states. "Due to their disconnect with scientific evidence, these documents have engendered significant confusion among health care professionals and facilities' administrators; the misallocation of scarce resources to the detriment of both patient and health care worker protection; and the creation of skepticism toward federal public and occupational health decision making."
The letter from the Association for Professionals in Infection Control and Epidemiology (APIC), the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA) strongly questioned the lack of science behind the decision.
"Public health policy decisions should be based on sound scientific evidence," says Neil Fishman, MD, president-elect of SHEA. "Right now, it appears that one of the major pieces of evidence that was used to guide the recommendations was based on flawed science." Therein lies another entire dispute, as one of the principal but unpublished studies supporting the use of N95 respirators over masks has been brought into question over the researchers' reanalysis of some of their findings at a recent meeting of the IDSA.1 Another study recently published in the prestigious Journal of the American Medical Association (JAMA) found that health care workers are equally protected by standard surgical masks as with N95s, a finding specifically cited in the presidential letter.2 For their part, the Centers for Disease Control and Prevention and the Institute of Medicine panel that advised the CDC on the issue said neither study was considered in making the controversial recommendation for respirators.
"The current recommendation [for N95] respirators is based on the unique conditions associated with the current pandemic, including low levels of population immunity to 2009 H1N1 influenza, availability of vaccination programs well after the start of the pandemic, susceptibility to infection of those in the age range of health care personnel, increased risk for complications of influenza in some health care personnel (e.g., pregnant women), and the potential for health care personnel to be exposed to 2009 H1N1 influenza patients because of their occupation," the CDC said in a statement posted on the web after the Obama letter was issued.
Given the CDC clarification and reaffirmation of its decision, a health worker union rep accused the infectious disease groups of attempting "a disinformation campaign" in appealing to the president to reverse the mandate. "[The letter is] disingenuous and intellectually dishonest because they don't want to spend 50 cents to protect health care workers," says Bill Borwegen, MPH, health and safety director for the Service Employees International Union (SEIU).
The CDC is under considerable pressure from health care unions and worker safety advocates since at least four nurses nationally have reportedly died of complications related to H1N1. What is not known is whether the infections were acquired in the community or occupationally, and if the latter, whether respiratory protection levels were a contributing factor. Current H1N1 surveillance systems do not provide occupational data, so the National Institute for Occupational Safety and Health (NIOSH) is asking for more information on health care worker H1N1 illnesses and deaths. (Editor's note: Information can be e-mailed to [email protected].) "Once we get that information, we can make decisions about whether we want to do a more thorough investigation, whether it is a Health Hazard Evaluation or another kind of study," says Christina Spring, health communications specialist with NIOSH in Washington, DC.
Given this backdrop, which is about as serene as a painting by Hieronymus Bosch, the CDC opted to hold fast to its recommendation for workers to use N95 respirators in a verdict rendered Oct. 14. That same day, OSHA stepped in, codifying CDC recommendations that always are issued as voluntary guidelines. The agencies acted on a recommendation by the IOM panel charged with reviewing the evidence and reporting findings to the CDC. "[T]here is evidence that work-related exposures to patients infected with H1N1 virus result in health care workers becoming infected," the IOM report stated.
It should be noted that in making the final decision, the CDC ignored the advice of its own standing group of experts, the Healthcare Infection Control Practices Advisory Committee (HICPAC). That committee endorsed the use of surgical masks rather than respirators. Among the real-world issues HICPAC considered in its decision are that surgical masks are cheaper, widely available, less restrictive and more likely to be actually used by workers. Indeed, the subsequent review process was somewhat undercut at the onset by the IOM panel's charge, which was to review the evidence and render a recommendation without regard to costs or logistics. This apparent desire for the purity of science to prevail, led down a road of unseen, adverse consequences. The CDC has declined comment on the decision, referring HIC inquiries to its NIOSH branch that oversees respirators.
"Hospitals are spending a lot of time trying to comply with this guidance or at least developing the information in a formal plan [explaining] why they can't comply," Fishman says. "That has actually detracted from their ability to do things that are more important to prevent transmission. I truly believe that forcing N95 respirators for the care of these patients really has the potential to impact negatively on care. People don't like to wear them and they won't go into rooms if they have to put them on. I am very concerned that this guidance will end up hurting patients more than helping them. We have evidence now [the JAMA study] that it certainly won't help health care workers."
In the letter, the nation's leading infectious disease groups told the president that requirement for respirators could lead to the "unnecessary referral of patients to already overloaded emergency rooms and the exacerbation of the existing shortage of respirators, thus potentially precluding their use in situations where they are needed."
Such situations include the treatment of patients with tuberculosis and during aerosol-generating procedures (e.g., bronchoscopy, open suctioning of airways) on a patient that may have H1N1 or other diseases. These types of procedures heighten transmission risk by creating aerosols that may be inhaled by the health care worker. "N95s are appropriate for aerosolized procedures because you are more at risk," Delahanty says. "[A sufficient supply of N95s] is a concern because we don't know what the surge is going to look like. Everyone is looking to materials management, but we have to remember that the manufacturers were not ramped up for this either."
As a result, hospitals attempting to avoid OSHA citations and fines are now scrambling to find N95s, which are normally purchased only in small outlays sufficient to treat patients with TB and conduct the aforementioned high-risk procedures. Complicating the situation, demand for respirators from other health care sectors that never stock N95s will only make it harder for hospitals to maintain adequate supplies to protect workers conducting procedures that could put them at risk, says Stephen Streed, MS, CIC, member of the national board of directors of APIC and system director of epidemiology at Lee Memorial Healthcare System at Fort Meyers, FL.
"There is predicted to be a huge shortfall of N95s," he says. "Hospitals and clinics, skilled nursing facilities and long-term care facilities that have had nothing to do with TB suddenly have a need for respirators for H1N1. That's going to completely compromise the supply for the traditional needs that we still have for those N95s, which are TB and aerosol-generating procedures."
Indeed, the specific problem of discharging patients to nursing homes has contributed to the back up at Delahanty's hospital in San Diego. "You can't discharge these patients back to long-term care because they don't have the personal protective equipment or the CAL-OSHA required fit-testing programs in place to protect employees from H1N1," she says. "Then people who are acutely ill in the emergency department can't get in an acute care bed because those beds are full with people who could be discharged to long term care. We have this backup in our infrastructure with this surge of influenza."
The elderly are generally thought to have preexisting immunity to H1N1 — thus their low priority to receive vaccine — but that doesn't mean you can rule out individual cases that present with flu symptoms. Though they are less likely to acquire H1N1 than younger people, the elderly can have more severe infections once they acquire the pandemic strain.
"The problem is that influenza-like illness could be anything, but unless we can rule it out in a timely fashion through rapid PCR or rapid culture we still have to act as if [it's H1N1] until we know," Delahanty says. "Unfortunately, we don't have the kind of diagnostic tests that are that quick. So, you are still having that backup."
Amid the logistical challenges the pandemic continues to spread. "We are seeing about 100 cases a day of influenza-like illness," Streed says. "Some of those get ruled out because of other illnesses, but we are seeing about 100 a day in our emergency rooms and we have at any given point in time probably 50 to 60 cases in our four hospitals that are still on the influenza watch list. We have had four [patient] deaths."
The situation is expected to worsen as the winter months set in, but the ebb and flow of H1N1 has proven unpredictable. Most hospitals have to assume for planning purposes that a major surge of cases still is to come as 2010 begins. "Not all hospitals plan equally," Delahanty says. "Some have enough N95s, some don't, some have a mixture."
Facing such situation, hospitals in California and other states are tapping into the CDC's Strategic National Stockpile to get allotments of millions of N95s. Still, Borwegen argues that hospitals are overplaying the shortage angle to leverage their argument to repeal the mandate. "Every time employers tell us they can't get a hold of respirators we help them find them," he says. "They need to look beyond their traditional sources. I think they want there to be a shortage so they don't have to do what the government is telling them to do."
Hospitals and health care systems may be locked into agreements with distributors, but even if they seek out new supplies they can run into a Catch-22 that requires burning a mask to fit-test it. "The problem with that is with any N95 that you use — if you change the manufacturer you have to refit," Delahanty says. "In order to refit, you have to use up a mask. If I have to refit everybody to a new mask I would use up 7,000 masks just to do the fitting. That is Cal-OSHA law: If you don't have the same manufacturer, you have to refit every mask you have."
How did we get to such an impasse, where protecting workers and patients are at cross- purposes? When the pandemic began in early spring, the CDC viewed the novel virus with an appropriate abundance of caution and recommended N95 respirators, a step beyond surgical masks long used for seasonal flu. The current debate is about protecting health care workers from H1N1, but occupational health experts and infection preventionists have been wrangling over this issue since TB resurged in the 1990s. Somewhere at the heart of the current controversy is the question of whether flu virus can be transmitted via the airborne route (thus warranting respirators) or is only spread at short range via droplets (masks are sufficient).
"The evidence for aerosol transmission is laboratory-based," Fishman argues. "There is no clinical evidence for airborne transmission. The CDC guidance acknowledges that to a certain extent because they do not mandate negative-pressure [rooms for H1N1 patients]. Although they are mandating the use of N95s, it is not true airborne precautions."
Given such skepticism in the infectious disease community, it was not particularly surprising that shortly after it became clear that the vast majority of cases in the United States were relatively mild, hospitals in the field broke ranks, dropped the N95s and began treating H1N1 like seasonal flu.
"Most infectious disease experts have felt there was not a reason to go to the N95s in the first place vis-à-vis traditional influenza, which has always been droplet transmission," Streed says.
Entire state health departments made the same decision, including the one in Albany, NY, then headed by current CDC director Thomas Frieden, MD. However, Frieden could not be so bold after assuming leadership at CDC in May with the pandemic under way and the potential for a health care worker revolt on his hands. The answer, he decided, was to use respirators but to limit their use through other measures. "Use a scarce resource carefully," he said in a briefing on the guidance. "Follow a hierarchy of controls and limit the number of people who are potentially exposed and would need a higher level of protection."
The CDC is no longer recommending contact precautions — the use of gowns and gloves for H1N1 patients — but Frieden noted that influenza is spread through droplet, fomite, and aerosol transmission. "It is an unfortunate fact that we do not have definitive evidence on the portion of transmission that occurs from each of those three routes," said Frieden, noting that "the preponderance of belief" was that droplets were the most common route.
The CDC is in a lose-lose situation. If lifting the N95 pandemic measures is followed by health care worker infections, it will be lambasted by worker unions and proponents of occupational health measures that favor respirators when dealing with a novel virus. Indeed, one of the underlying confounding variables in all of this is that H1N1 — though it can certainly result in severe infections and deaths — is not in the same league as highly virulent H5N1 avian influenza A. Though it still is sputtering to achieve effective transmission in humans, the "bird flu" — not "swine" — was the pandemic the government was planning for, meaning N95 respirators were a foregone conclusion in the response plan.
"Mother Nature doesn't read our guidelines," observes Eddie Hedrick, BS, MT(ASCP), CIC, emerging infections coordinator at the Missouri Department of Health and Senior Services in Jefferson City. "This stuff doesn't come at us the way we anticipate, so this may turn out to be a Category 1 pandemic when we planned for a Category 5."
References
- Macintyre, CR, Wang Q, Cauchemez S, et al. The first randomised, controlled clinical trial of surgical masks compared to fit-tested and non-fit tested N95 masks in the prevention of respiratory virus infection in hospital health care workers in Beijing, China. Abstract 1247. Presented in Philadelphia at the Infectious Diseases Society of America; Oct. 29-Nov. 1, 2009.
- Loeb M, Dafoe N, Mahony J, et al. Surgical mask vs. N95 respirator for preventing influenza among health care workers: A randomized trial. JAMA 2009; 302(17):1,865-1,871.
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