As H1N1 pandemic flu stockpiles expire, hospitals turn to reusables
Number of respirators needed during a pandemic would be astronomical’
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.
Education needed for PAPR use
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 too costly for stockpiling
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."
- Simonsen L, Spreeuwenberg P, Lustig R, et al. Global Mortality Estimates for the 2009 Influenza Pandemic from the GLaMOR Project: A Modeling Study. PLoS Med 2013; 10(11): e1001558. doi:10.1371/journal.pmed.1001558
- Wise ME, De Perio M, Halpin J, et al. Transmission of pandemic (H1N1) 2009 influenza to healthcare personnel in the United States. Clin Infect Dis 2011; 52:S198-S204.
- Campbell JA. Spring of Fear: The SARS Commission Final Report, Toronto, 2006. Available at www.ontla.on.ca/library/repository/mon/16000/268478.pdf.
Ebola cases discharged, units remain ready
CDC issues guidelines for all hospitals
The handful of specialized biocontainment units in U.S. hospitals remain on high alert as the Ebola outbreak continues in West Africa and the first two American health care workers were successfully treated and released from Emory Hospital in Atlanta.
In addition, the Centers for Disease Control and Prevention recently issued infection control precautions for any U.S. hospital admitting a suspected or confirmed case of Ebola. The agency also posted Ebola guidelines for environmental cleaning and protection of housekeeping personnel. (See related story, p. 114.)
The two U.S. Ebola cases involved care workers who very nearly gave their lives to helping patients in Liberia during the worst Ebola outbreak in history. A Texas physician and a North Carolina missionary were flown to Atlanta in August, spending several weeks in Emory University Hospital’s biocontainment unit. They received hydration, experimental drug treatment, and other care. By late August, each patient had recovered and was discharged.
The Emory Healthcare team’s experience in treating the two Ebola patients showed how well-trained, well-staffed, and well-equipped hospital units can provide high quality care while ensuring staff remains safe.
"Staff involved in the direct care of these patients received extensive training with demonstrated competency verification," says Nancy R. Feistritzer, DNP, RN, vice president of patient care services at Emory.
But the high profile nature of the rare and dangerous disease has raised concern among the public and health care workers.
"There is anxiety amongst hospital staff in ordinary hospitals about handling Ebola cases," says Philip W. Smith, MD, professor in the division of infectious diseases at the Nebraska Medical Center in Omaha, NE, which houses the nation’s largest biocontainment care unit. The 10-bed Nebraska unit remains prepared to admit Ebola patients should the need arise.
"Before we have a crisis, we have people volunteer to work in the unit and to receive special training," Smith explains. "They’re mentally prepared for something like this, whereas other people are not necessarily ready for Ebola in a hospital ward bed."
The biocontainment units at Emory and Nebraska have had years to train and prepare staff to handle infectious disease cases that might overwhelm the typical hospital. They were designed according to federal guidelines for handling CDC category A diseases, which include Ebola, plague, anthrax, hemorrhagic fever and smallpox.
Since the units are very rarely needed, they are staffed by hospital professionals who are on call 24/7 to shift from their main job when needed.
"Members of the Emory Healthcare team all volunteered to care for these patients," Feistritzer says. "Even so, care of acutely ill patients at their most vulnerable can be stressful under any circumstances."
Emory provided staff and physicians caring for the Ebola patients with support through daily team huddles, leader rounding, and hospital chaplains.
"The staff support team was present throughout these challenging and stressful times in order to provide emotional and spiritual support for staff," she says.
When the Nebraska biocontainment unit sought volunteers from hospital staff before the unit was ready for cases, more than enough health care workers applied.
In fact, even during the ongoing Ebola outbreak, more hospital staff have applied to join the unit, notes Shelly Schwedhelm, MSN, RN, director of emergency department trauma and emergency preparedness.
"People say, Sign me up I want to do this,’" she says. "It’s a professional development opportunity and they see it as an opportunity to enhance their skills in other ways."
Schwedhelm doesn’t hire every person who applies. First, she speaks with their managers to learn more about their clinical skills, energy, and ability to be self-directed.
"We want rock stars on this unit," Schwedhelm says. "We teach them how to care for highly infectious patients."
Volunteers have to be experts in their disciplines because they’ll need to learn special skills involving high level of infection control, notes Kate Boulter, RN, lead nurse of the biocontainment unit in Nebraska.
The ideal employee of a biocontainment unit is someone who is very detail oriented and a critical thinker, she says. Employees have to follow rules and instructions precisely, as shortcuts and mistakes could lead to exposures and injuries. Teamwork is a top priority.
"Each person has a partner who watches them put on their personal protective equipment and take it off," Schwedhelm says. "They hold each other accountable."
From an employee health perspective, the biocontainment team functions as one unit, and everyone involved agrees on decisions and steps taken, says Uriel Sandkovsky, MD, an infectious disease physician and medical director for employee health for Nebraska Medical Center.
Biocontainment team volunteers also have to be eligible to receive the smallpox vaccination in the event of an exposure.
"With smallpox you have a four-day window to get vaccinated after exposure, so if we had a smallpox or monkeypox case we could vaccinate them," Smith adds.
A watchful eye for symptoms
Emory University employee health professionals developed a comprehensive surveillance program consistent with CDC guidelines to monitor physicians and staff caring for Ebola patients, Feistritzer says.
"Inclusion criteria were defined as individuals who were involved in direct patient care or those involved in the handling of contaminated blood or body fluids," she says.
The surveillance protocol includes taking employees temperature twice daily for 21 days the outer limits of the incubation period after their last episode of care for Ebola patients. Also, each employee tracks their symptoms, including headache, joint or muscle aches, weaknesses, diarrhea, vomiting, stomach pain, or lack of appetite. They use a log to document and track results and follow a protocol to report any symptoms.
Informing staff, other patients
Emory also addressed concerns among patients and other employees through hospital-wide education and communication.
"The entire Emory Healthcare community received a series of emails designed to inform and educate throughout the hospitalization," Feistritzer says.
The hospital also educated staff about infection control practices and the Ebola protocols. They held town hall meetings to provide accurate information and to have clinical experts and hospital leaders answer any questions staff might have, she explains.
"Physician and nurse executive teams rounded on each patient care unit to answer questions staff or patients might have had," she adds.
The Emory website posted educational material with frequently asked questions and regular updates, available to both staff and patients.
Be aware of HCW travel destinations
Hospital employee health departments across the country could learn strategies for handling epidemics and even more common infectious diseases from the experiences of the Nebraska and Emory biocontainment units, Sandkovsky emphasizes.
Hospitals should ask employees to notify employee health before taking an overseas trip. There might be vaccinations they’ll need. And when they return, they should be warned to watch for symptoms of illness, he says.
"They could be exposed to malaria or typhoid," Sandkovsky says.
It is a good idea to have employees regularly trained on the use of isolation and personal protection equipment.
"One of our colleagues in the [Nebraska] unit has an innovative educational approach where people get into gowns and take care of mock patients," Smith says. "It’s recorded, and supervisors go over the video with employees to reinforce compliance."
Ebola guidelines to protect workers, patients
Use N95s if aerosols may be generated
Ebola does not spread by the airborne route, but recently issued infection control recommendations recommend that health care workers don at the least N95 respirators if performing a procedure that may generate aerosols with the patient’s blood or body fluids. (http://1.usa.gov/1pvUSQz)
The Centers for Disease Control and Prevention has posted Ebola recommendations to protect health care workers caring for a suspected or confirmed case of Ebola, a highly fatal, hemorrhagic fever virus that is spread via contact with the blood or body substances of an infected, symptomatic patient. The virus does not spread during the incubation phase, which can last up to 21 days. The CDC also recently added Ebola guidelines for cleaning and disinfecting patient rooms while ensuring housekeeping staff can safey perform their jobs. (http://1.usa.gov/1ljxMOM)
The CDC recommends an Ebola patient should be placed in a single patient room containing a private bathroom with the door kept closed. Facilities should maintain a log of all persons entering the patient’s room. Consider posting personnel at the patient’s door to ensure appropriate and consistent use of PPE by all persons entering the patient room. All persons entering the patient room should wear at least, gloves, gown (fluid resistant or impermeable), eye protection (goggles or face shield), and a facemask.
Additional PPE might be required in certain situations (e.g., copious amounts of blood, other body fluids, vomit, or feces present in the environment). These would include but are not limited to: double gloving, disposable shoe covers, leg coverings.
Workers should wear respiratory protection at least to the level of an N95 respirator if they are doing procedures on an Ebola patient or body fluids that could generate aerosols. The CDC recommends avoiding aerosol generating procedures (AGPs) on Ebola patients if possible. If performing AGPs, use a combination of measures to reduce exposures from aerosol-generating procedures when performed on Ebola HF patients.
Conduct the procedures in a private room, ideally in an Airborne Infection Isolation Room (AIIR) when feasible. Room doors should be kept closed during the procedure except when entering or leaving the room, and entry and exit should be minimized during and shortly after the procedure. In addition to a respirator, health care workers performing an AGP on an Ebola patient should wear gloves, a gown, disposable shoe covers, and either a face shield that fully covers the front and sides of the face or goggles. Dedicated medical equipment (preferably disposable) is recommended, with the use of sharps and needles limited as much as possible. All needles and sharps should be handled with extreme care and disposed in puncture-proof, sealed containers, the CDC recommends.
Dearth of data on role of environment
"The role of the environment in transmission has not been established," the CDC conceded. "Limited laboratory studies under favorable conditions indicate that Ebola virus can remain viable on solid surfaces, with concentrations falling slowly over several days.1,2
"In the only study to assess contamination of the patient care environment during an outbreak, virus was not detected in any of 33 samples collected from sites that were not visibly bloody. However, virus was detected on a blood-stained glove and bloody intravenous insertion site."3
Still, there is no epidemiologic evidence of Ebola virus transmission through the environment, the CDC stated.
Simarly, no transmission has been documented from fomites that could become contaminated during patient care (e.g., bed rails, door knobs, laundry), the CDC added.
"However, given the apparent low infectious dose, potential of high virus titers in the blood of ill patients, and disease severity, higher levels of precaution are warranted to reduce the potential risk posed by contaminated surfaces in the patient care environment," the CDC advised.
CDC recommendations for environmental infection control include:
- Be sure environmental services staff wear recommended personal protective equipment including, at a minimum, disposable gloves, gown (fluid resistant/ impermeable), eye protection (goggles or face shield), and facemask to protect against direct skin and mucous membrane exposure of cleaning chemicals, contamination, and splashes or spatters during environmental cleaning and disinfection activities.
- Additional barriers (e.g., leg covers, shoe covers) should be used as needed. If reusable heavy-duty gloves are used for cleaning and disinfecting, they should be disinfected and kept in the room or anteroom.
- Be sure staff are instructed in the proper use of personal protective equipment including safe removal to prevent contaminating themselves or others in the process, and that contaminated equipment is disposed of as regulated medical waste.
- Use a U.S. Environmental Protection Agency (EPA)-registered hospital disinfectant with a label claim for a non-enveloped virus (e.g., norovirus, rotavirus, adenovirus, poliovirus) to disinfect environmental surfaces in rooms of patients with suspected or confirmed Ebola virus infection.
- To reduce exposure among staff to potentially contaminated textiles and cloth products while laundering, discard all linens, non-fluid-impermeable pillows or mattresses, and textile privacy curtains as a regulated medical waste.
- Sagripanti JL, Rom AM, Holland LE. Persistence in darkness of virulent alphaviruses, Ebola virus, and Lassa virus deposited on solid surfaces. Arch Virol 2010; 155:2035-2039
- Sagripanti JL, Lytle DC. Sensitivity to ultraviolet radiation of Lassa, vaccinia, and Ebola viruses dried on surfaces. Arch Virol 2011; 156:489494
- Bausch DG et al. Assessment of the Risk of Ebola Virus Transmission from Bodily Fluids and Fomites J of Infect Dis 2007; 196:S142S147
Hospitals can track, compare needlesticks
Surveillance also tracks other injuries
A hundred hospitals have joined a new system to track needlesticks and other health care injuries, the first such national surveillance since 2007.
The Occupational Health Safety Network (OHSN) enables hospitals to compare their needlestick rates with other, similar hospitals, using an online reporting system that is updated monthly. The system, launched a year ago by the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control andPrevention, also tracks slips, trips and falls, patient handing injuries, and workplace violence.
Slips, trips and falls surpass the other injuries in both number and rate, making them the most common hazard for hospital employees. The OHSN reporting enables hospitals to see where the injuries are occurring and to compare their data with other hospitals nationally, regionally, and of a similar size.
For years, hospitals have faced mandates to report hospital-acquired infections and other patient safety measures. OHSN is voluntary but it represents the most significant tracking of employee health and safety to date.
It is important to have that counterbalance, emphasizing overall safety in hospitals, says Ahmed Gomaa, MD, ScD, MSPH, project offi cer for OHSN. "We believe you cannot achieve patient safety without worker safety," he says.
Demand for sharps surveillance
Previous needlestick tracking systems provided important information about what types of devices led to injuries and which tasks were most hazardous. But most of those systems have been discontinued.
California ceased its surveillance program in 2005, and the CDC’s NaSH system (National Surveillance System for Healthcare Workers) ended in 2007. EPINet, a University of Virginia project that collected information from South Carolina and hospitals in some Eastern and Pacific Northwest states, ended in 2012. By state law, Massachusetts requires its hospitals to reporting sharps injuries each year.
CDC planned to include sharps injuries in its National Healthcare Safety Network (NHSN), but that has focused exclusively on patient safety.
OHSN hopes to fill that gap. The system will collect information on the device used, the task involved, where and when the injury occurred similar to the previous tracking systems. The denominators will include fulltime employees, bed size and monthly patient admissions. "There is a big need for a surveillance system [in sharps safety]," Gomaa says.
Users of OHSN can download comparison reports at any time and can submit data through existing occupational health software programs.
Reporting helps boost support for workersafety both nationally and within hospitals, says Bobbi Jo Hurst, MBA, BSN, COHN-S, manager of employee and student health and safety at Lancaster (PA) General Health. Lancaster is a member of the Voluntary Protection Program (VPP), a safety recognition program of the U.S. Occupational Safety and Health Administration, and was one of the first hospitals to report data to OHSN.
"All executives want to know how you’re doing and what your benchmarking is," she says. "The more information that your leadership sees, the more support you gain."
Slips, trips and falls are hospital-wide
OHSN is constantly adding hospitals, so the database is growing.
The data come from hospitals of varying size: 48 small (<200 beds), 38 medium (200-499 beds) and 16 large (>500 beds).
They span the country, with 55 in the Midwest, 33 in the South, 6 in the Northeast and 5 in the West.
As of June 2014, the network reported the following preliminary data:
- Injuries from slips, trips and falls (3,401) outnumbered patient handling injuries (3,053). There were 1,577 incidents of workplace violence involving nurses and nursing assistants among the 100 hospitals.
- Slips, trips and falls also had the highest incidence rate as measured per 10,000 worker-months (0.52), per 100 licensed bed-months (0.18), and per 1,000 admissions (3.2).
- Many slips, trips and falls occur outside of patient care areas. Patient handling was the No. 1 injury in patient care areas.
- Patient handling injuries also were the most common OSHA-recordable event.
- Most injuries were among employees between 45 and 64 years of age (7,041), followed by 30- to 44-year-olds (6,069) and 18- to 29-year-olds (3,436).