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Five years after the H1N1 flu pandemic, hospitals and public health authorities are dealing with a difficult aftermath: Stockpiles of N95 respirators are expiring. Rebuilding pandemic stockpiles could cost many millions of dollars and still might not provide enough protective devices.
That reality is now reshaping pandemic planning across the country.
Based on estimates from the Centers for Disease Control and Prevention, "the number of [disposable] filtering facepiece [N95] respirators that would be needed during a pandemic would be astronomical, so we’re looking at reusable devices," says Maryann D’Alessandro, PhD, director of the National Personal Protective Technology Laboratory of CDC’s National Institute for Occupational Safety and Health (NIOSH).
Hospitals are purchasing reusable respirators that were previously mostly used in industrial settings, and the federal government is rethinking its stockpile strategy. The Veterans Administration purchased 180,000 elastomeric half-face respirators to protect its health care workers in a pandemic.
While the world is riveted by the Ebola outbreak in West Africa, occupational health experts remain concerned about the risk from respiratory diseases. MERS-CoV (Middle Eastern Respiratory Syndrome) had led to at least 291 deaths among 837 lab-confirmed cases by late July, according to the World Health Organization. An outbreak of H7N9 avian influenza in China caused alarm in 2013. As of June, there had been 450 lab-confirmed cases and 165 deaths.
H1N1 was considered a "mild" pandemic, but researchers estimate that it killed as many as 203,000 people worldwide, most of them under age 65.1 In the first six weeks of the pandemic in the spring of 2009, CDC identified 35 health care workers who became infected at work. Lack of compliance with infection control guidance as well as an inadequate supply of N95 respirators, were cited as factors. 2
"We knew after H1N1 that we needed to improve preparedness, but the pace [of the efforts] increased in the past two years," says D’Alessandro.
NIOSH is studying the use of powered air-purifying respirators (PAPRs) and elastomerics in hospitals and the cost and logistical issues involved in switching from N95s to reusable respirators for emergency preparedness, she says.
Today’s trends are reverberations of the headaches of H1N1. When hospitals ran short of N95s, they were sometimes forced to switch to a different brand or model. That meant new rounds of fit-testing.
PAPRs became appealing because they can be reused and they don’t require fit-testing. They also are often used by health care workers who have a beard or can’t pass a fit-test for other reasons.
In the wake of the H1N1 pandemic, OSF St. Francis Medical Center in Peoria, IL, created a quality improvement project that focused on respiratory protection and pandemic preparedness. The hospital provides PAPRs on every unit that has a negative pressure room, in addition to fit-tested N95s.
As part of quality measures, occupational health reports the percentage of health care workers who completed medical questionnaires and the annual educational modules for N95s and PAPRs. Employees are included in the program based on their potential for contact with infectious patients.
"We wanted to make sure we met our goal that everyone was adequately protected in case there was a pandemic," says Jo Garrison, MSRN, director of business and community health.
The Johns Hopkins Health System in Baltimore began using PAPRs in its respiratory protection program in 2003. The PAPR units are inspected twice monthly while they are in use and every six months in storage, senior epidemiologist Trish Perl, MD, MSc, said at an Institute of Medicine workshop on "The Use and Effectiveness of Powered Air-Purifying Respirators in Health Care" in August. Employees using the devices also receive education.
"The health care worker has to know how to don and doff this without contaminating themselves and putting themselves at risk," she said. "As they walk out of the room, they have to know what to do, how to clean it, and then the unit has to be recharged to make sure it can be used by the next health care worker."
PAPRs present some challenges that prevent the respirator from being the sole solution for a pandemic stockpile.
First, PAPRs are expensive. A battery costs $130 and a battery charger costs $900, said Perl, who noted that Johns Hopkins recently ordered 100 additional batteries.
Lewis Radonovich, MD, director of the national Center for Occupational Health and Infection Control at the Veterans Health Administration, estimated that it would cost 20 to 30 times more to stockpile PAPRs for a pandemic than any other type of respirator.
PAPRs are not approved for use in surgery, and some health care workers complain that they affect communication with patients.
The University of Maryland Medical Center turned to half facepiece elastomeric respirators during the H1N1 pandemic. They are reusable but must still be fit-tested.
"We couldn’t reliably get all of the disposable N95s that were needed," says Melissa McDiarmid, MD, MPH, director of the University of Maryland Division of Occupational and Environmental Medicine. "Our outpatient clinics made the decision to get the individual fit-testing for the elastomerics and assign a personal respirator to the people in their clinic network."
VA facilities use PAPRs and N95s on a regular basis, but elastomerics are a key part of pandemic preparedness, Radonovich said at the workshop.
"We anticipate that as soon as we have recognition nationally or globally that there is a [pandemic] outbreak, there will be no N95s to sell, and as soon as we run out we will be on our own," he said.
The Institute of Medicine will issue a report based on the August workshop, which included feedback from both hospitals and health care workers. Manufacturers are still working on N95s and PAPRs designed specifically for use in health care.
The device-oriented discussion should be part of a new commitment to worker protection, Radonovich said.
"We need a fundamental shift in the approach to respirator protection in this country," he said. "If a patient shows up with an unknown disease and they have respiratory symptoms, we should give health care workers protection from getting sick."
That is the foundation of the "precautionary principle," to err on the side of protection when scientific evidence is lacking a major conclusion from a review of the Severe Acute Respiratory Syndrome (SARS) outbreak in Canada. A doctor and two nurses died of SARS in Toronto and 45% of the Canadian cases were among health care workers.3 Respiratory protection needs to be a priority for hospital leadership, says McDiarmid. "The acceptance of workers to any employee health intervention has a lot to do with how the leadership presents it and the professionalism with which a program is carried out," she says. "If there is a begrudging leadership that is resentful of having to have a respiratory protection program, then that is going to be telegraphed to the workers.
"If the leadership and infection control and employee health community are all of one mind and present it as part of a comprehensive infection control program that protects patients and workers, the whole thing is much more smoothly executed."