WORKER EXPERIENCE IN USING PAPRs IN HEALTH CARE SETTINGS
Both N95 respirators and powered air purifying respirators (PAPRs) are used in health care settings. Information was presented from two respirator research studies that quantified the differences in respirator use around the country. Representatives of two hospitals and one union shared what they have learned from health care workers about PAPR use and preferences.
Translating Research Findings into Clinical Practice
Debra Novak, National Personal Protective Technology Laboratory
The National Personal Protective Technology Laboratory (NPPTL), along with partnering organizations and universities, conducted two studies to better understand the use of respirators in health care: the Prevalence of Respiratory Protection Devices in U.S. Healthcare Facilities Survey (2014) and REACH II Public Health Practice Study—Respirator Evaluation in Acute Care Hospitals (2010–2012).
Prevalence of Respiratory Protection Devices in U.S. Healthcare Facilities Survey (2014)
This survey was undertaken with the American Association of Occupational Health Nurses (AAOHN) to fill a gap in research about what types of respiratory protection devices are being used daily in clinical
practice. The 11-item, online survey was disseminated to members of AAOHN and the Association of Occupational Health Professionals in Healthcare. In all, 322 completed surveys were received from 47 states. Device use varied by geographic region. N95 respirator use was most prevalent in the Northeast, while PAPR use was most prevalent in the Midwest. Respondents in the Midwest (88.0 percent) and West (86.7 percent) were more likely than respondents in the South (67.0 percent) and Northeast (65.1 percent) to have employees who had used a PAPR at least once in the past year. If follow-up studies on PAPRs are needed, this information could be useful for determining where to conduct those studies.
REACH II Public Health Practice Study—Respirator Evaluation in Acute Care Hospitals (2010–2012)
The REACH II Study evaluated hospitals’ respiratory protection programs and respirator usage in six states/five regions across the United States: California, Michigan, Minnesota/Illinois, New York, and North Carolina. Data were collected from 1,500 hospital managers, unit managers, and health care workers from 98 hospitals and included 300 demonstrations of donning and doffing protective equipment. More than 85 percent of hospital managers and unit managers who participated said their facilities had PAPRs available for use when employees needed them, with only 10 percent or fewer saying they did not know if PAPRs were available. In contrast, nearly 30 percent of the health care workers themselves—those working closest to the patient bedside—did not know whether PAPRs were available for use in their facility. Furthermore, nearly 40 percent of health care workers did not know what would happen at their facility if an employee could not be successfully fit tested for a respirator. More than 40 percent of health care workers did not know whether their program evaluations included a determination of whether respirators were being properly maintained. In each case, health care workers reported much more uncertainty about the respiratory protection program than did hospital managers or unit managers.
Although caution should be taken in generalizing the results, the REACH II Study provides several findings:
- Respiratory protection program plans exist on paper.
- Health care workers may provide different responses to questions about respiratory protection than hospital or unit managers.
- Health care workers are unclear about when to use respiratory protection, what type of protective device should be used, and how to properly don and doff the equipment.
- The focus is on fit testing rather than training. Health care workers usually receive less than 15 minutes of respiratory protection training per year.
Unit-based champions of personal protective equipment (PPE) are important resources, and respiratory protection training needs to be a hospital-based, practice-based competency within an organization. Respirator instructions should provide guidance for use and be easily understood by the end user. Practice performance specifications need to be developed through field studies, feasibility analyses, and greater understanding of how PAPRs are being used in practice, including how they are used as part of a protective ensemble.
PAPR use is increasing. Novak noted that this is demonstrated not only in the study results she presented, but also in several comments on PAPRs that were in response to the published request for information through the National Institute for Occupational Safety and Health (NIOSH) docket (CDC, 2014b). Jennie Mayfield, Association for Professionals in Infection Control and Epidemiology, stated, “Based on experiences in the facilities of some of our members, we anticipate that, as PAPRs become cheaper and lighter, health care employers may consider expanding PAPR use to alleviate the burden of N95 fit testing, rather than from any appreciable benefit of employee protection.” Similar comments were submitted by Dan Diekema, Society for Healthcare Epidemiology of America, and Barbara Murray, Infectious Disease Society of America, who noted, “Many facilities with low incidence of [tuberculosis]—and therefore infrequent need for respirators for routine care—have opted for PAPR-only policies as a cost-effective alternative to cumbersome annual fit testing of hundreds of employees enrolled in their respiratory programs.”
PAPR Use at OSF Saint Francis Medical Center Peoria, Illinois
Jo Garrison, OSF Saint Francis Medical Center
In 2010, OSF Saint Francis Medical Center, like other health care facilities around the United States, had an H1N1 influenza crisis. With limited supplies of N95 respirators, the health system turned to its PAPR program, which was already in place. However, “What we found out is we weren’t really as prepared as we would like to have been,” stated Garrison. Recognizing that this was an opportunity to improve processes, the medical center’s management instituted a Six Sigma project to establish a standard process to make sure that all employees would be protected and there would be an adequate supply of respirators. Administrators had to determine which workers could have potential hazardous exposures and needed to be included in the respiratory protection program to ensure worker protection and effective patient care. OSF Saint Francis Medical Center has large departments but very few exposures, so its employees do not use respirators very often. They have approximately 2,400 employees in the respiratory protection program.
Health care workers have to complete a two-page questionnaire about their health histories. Those who are in the respiratory protection program complete a mandatory computer-based respiratory education module. The employees who are identified as candidates for N95 respirator use attend a fit testing. The employee health department tracks fit testing compliance with a goal of 80 percent compliance each year. This program is very labor intensive.
“Everybody wants to be part of the PAPR program because then they don’t have to do the N95 fit test, which takes 20 minutes,” said Garrison. From a manager’s perspective, the advantage to using PAPRs is that employees do not have to be taken away from work and patient care in order to complete N95 respirator training. From the employee’s viewpoint, the advantages to PAPRs are that they are less restricting and more user-friendly, and they accommodate facial hair. Furthermore, patients can see the worker’s face more easily when the worker is wearing a PAPR than when the person is wearing an N95 respirator, so patients are not as frightened.
The biggest challenge to using PAPRs is financial. Each PAPR costs about $1,800, which comes out of departmental equipment budgets. Currently the hospital’s 35 PAPRs are kept in individual departments rather than in one central location. Once a department purchases PAPRs, it is
not eager to share them with other departments. Every department leader is responsible for assuring that the department’s employees are trained.
A second challenge is that PAPRs can be difficult to keep track of because the equipment is compact and can fit in a file cabinet or drawer. Sometimes a PAPR cannot be found when needed, and when the PAPR is found, sometimes it is missing certain pieces. This may be an argument in favor of having PAPRs in a central location and available to be checked out as needed.
“I do not see us ever trying to get away from the N95 or the PAPR,” Garrison said. “We will continue to use both because there are different needs.”
PAPR Use at California Pacific Medical Center San Francisco, California
Karen Anderson, California Pacific Medical Center
Any discussion of PAPRs inevitably draws comparisons with N95 respirators, which are very much in use but not the topic of the current workshop. Anderson described an informal survey conducted in several California hospitals that found a mixture of respiratory protection devices being used, although the use was heavily weighted toward N95 respirators.
According to Anderson, the biggest disadvantage to using N95 respirators at California Pacific Medical Center is the annual fit testing needed by the approximately 3,500 employees who either have contact with patients posing an airborne infection risk or who engage in other high-hazard procedures. The four hospital campuses have a total of more than 600 stations that conduct fit testing, which occurs over a 1.5-month period each year. The fit testing and educational components combined take approximately 30 minutes per employee. The cost to the medical center for the personnel who conduct the fit testing is more than $60,000 per year. There are other institutional costs as well, such as the time each employee spends in training and not seeing patients. Because nurse-to-patient ratios must be maintained when a nurse does fit testing, each nurse has to have his or her work covered by someone else while being tested. In addition, reminding people to complete N95 respirator fit testing, and keeping track of who has completed fit testing and who has not, is quite complex from a bookkeeping perspective.
Health care workers need to have meaningful evidence to be persuaded to do something they do not want to do. Even though California’s
Division of Occupational Safety and Health Administration (Cal/OSHA) regulations are law in California, some health care workers are not compliant with respiratory protection. They are not convinced of the importance of the fit testing for N95 respirators. The law requires fit testing to be done every year, whether or not there is facial change, but employees do not understand that. In addition, because nurses must be fit tested but doctors are given the option of either fit testing and wearing an N95 respirator or wearing a procedure mask, nurses complain that a double standard is being applied. “If we can convince people that this is really going to improve their health then I think they will buy into it, they will do it. But we have to have a really convincing argument.”
California Pacific Medical Center uses a particular model of PAPR that employees find easier to use than other PAPR models. It is lighter in weight, the air comes through the helmet of the device so there is no tubing on the wearer’s back, and the battery can fit in one’s pocket. There are also indicator lights to show airflow and filter status. An added benefit of using the PAPR, as opposed to an N95 respirator, is that patients can see the health care worker’s whole face. Although there had been a concern that the respirator would scare pediatric patients, medical center workers have found these patients are not frightened by PAPRs. On the other hand, there are some challenges to using PAPRs. In addition to their high cost, PAPRs can be heavy to wear and are noisy. A designated location for recharging and storing is also needed.
Respiratory therapists are in charge of the PAPRs at California Pacific Medical Center. They bring them to a care unit and take them back to storage, clean them, charge the batteries, and rotate the stock. One of the challenges related to infection prevention and occupational health is that they are not revenue-generating departments. Reducing infections and protecting employees from needle sticks and hepatitis C (and a possible liver transplant later) may save millions of dollars over time, but these efforts rarely interest a chief financial officer in advance of the event. This is an area where outcome measures could be invaluable for gathering appropriate attention.
Given the high cost per unit, PAPR availability will always be a problem in the event of a major outbreak or act of bioterrorism. Health care facilities need to have dual systems for N95 respirators and PAPRs, and they need to train health care workers to use both. Anderson suggested that the priorities for improving the use of PAPRs in health care settings are to
- Have meaningful evidence to convince hospital staff and administration that the use of respirators is necessary and not just the law;
- Make PAPRs more affordable;
- Have a system for storing and recharging PAPRs; and
- Have sufficient training so that employees are prepared in advance of an outbreak or a bioterrorism event.
An Employee Union Perspective
Mark Catlin, Service Employees International Union
Service Employees International Union (SEIU) has more than 2 million members, with more than half of them working in the health care field, including tens of thousands of physicians and nurses. A survey of about 150 SEIU members who are health care workers showed stronger support for using PAPRs than for using N95 respirators. SEIU members thought they got a higher level of protection from PAPRs. They also liked the fit of PAPRs and said that PAPRs were cooler to wear and more comfortable. PAPRs were reported to be used primarily for contact with known and suspected tuberculosis patients and during the H1N1 influenza pandemic. Occasionally they are used during surgeries.
Many of the survey respondents said they wore PAPRs rarely—only once every few months or once per year. Few people use them routinely, so remembering how to use the PAPR effectively is a challenge. However, even if a worker goes to use a PAPR and remembers how to use it properly, there can be a problem with the batteries not being charged or with parts of the PAPR missing or being worn out. Facilities often do not have a good system in place for PAPR maintenance. Although other challenges to PAPR use were reported, such as the devices being heavy and awkward to wear and the noise they produce interfering with communication, workers reported that they were able to overcome these challenges with some practice.
Catlin suggested that actions could be taken to improve the use of PAPRs by health care workers, including
- Modify respirator design to fit the hospital environment
- Reduce noise that interferes with communication
- Reduce weight and awkwardness for wearing
- Modify for less strenuous but more extended use
- Increase ease of disinfection
- Modify exhaust airflow for use in sterile environments
- Improve training
- Provide hands-on practice with donning, doffing, and working while wearing the equipment
- Minimize use of slides or videos, which are not helpful in training people how to wear respirators
- Institute clear employer policies and emphasize the need for and use of respirators, including PAPRs
Often an employer does not have a clear policy about when and how to use the equipment. Sometimes, despite the existence of a corporate or hospital-wide policy that requires using respirators in certain areas, an immediate supervisor may tell a health care worker that wearing a respirator is not necessary. Later, the worker may be blamed for not wearing the respirator. There is a need for clear policies for health care workers to follow, and workers need their supervisor’s support in following those policies.
Discussion on Health Care Worker Experiences Using PAPRs
During the discussion session, the workshop participants considered how PAPR use in health care should be measured and how proper respiratory protection should be extended to non-hospital health care settings. James Johnson reminded workshop participants that N95 respirators and PAPRs are respiratory protective devices that are used for different hazards. N95 respirators are used in circumstances where the hazard is low. The advantages to using them are that they are low cost and easy to wear, and many employees can be protected easily. On the other hand, PAPRs are used for a higher level of protection, but they are expensive.
Philip Harber, University of Arizona, raised the issue of what outcomes could or should be measured in studies of PAPR effectiveness and use. Anderson said a tuberculosis skin test is one outcome that could be watched for because a positive skin test might indicate that the employee did not follow proper respiratory protection protocols. Work is being done to examine outcomes, noted Lewis Radonovich. He commented that the Department of Veterans Affairs (VA) is involved in the Respiratory Protection Effectiveness Clinical Trial (ResPECT), which is comparing the effectiveness of N95 respirators to the effectiveness of
surgical masks in protecting health care workers from respiratory infections. However, this study does not include a comparison to PAPRs, and even though these types of studies are essential, they are very expensive. Radonovich added that there is a need to address the confusion among health care workers about what they should be doing to properly protect themselves and to address the fact that there are some workers who do know what they should be doing but who do not always comply with the guidelines.
Harber noted the importance of enhancing respiratory protection in ambulatory care settings where patients often go with symptoms that may signal presence of an infectious disease. Catlin concurred and observed that health care is moving away from big hospitals and becoming decentralized. He said he has found that many outlying facilities are doing little in the way of respiratory protection, noting that “it is not even on their radar screen.” Edward Sinkule, NPPTL, added that private hospices and ambulance services also need to be considered. He pointed out that small business owners will have a lot of information to wade through to have a successful and effective PAPR program.
Another issue raised by Sinkule was the need for instructions on how to clean and disinfect a PAPR; these instructions are often lacking. He said, “Half the PAPRs in their user instructions just say yes, they can be cleaned and disinfected. I called to talk to the reps at the manufacturers. They had to get back to me because they did not know exactly what type of disinfectant I should be using.” He added that it is also important to know how to inspect a PAPR before donning it. He stated that he was concerned that if clear instructions are not included with a PAPR, the users will probably not ask for clarification. Given the fast pace of health care, directions need to be very clear and easy to understand.
EMPLOYER EXPERIENCE IN USING PAPRs IN HEALTH CARE SETTINGS
This panel focused on the employer’s perspective on PAPR use in health care settings. Speakers were asked to discuss the reasons behind their institutions’ respirator choices, criteria, and use procedures and practices. Specifically, presenters were asked to discuss any challenges they had encountered in regard to PAPR storage, distribution, cleaning, and use.
PAPR Use at the University of Maryland Medical Center Baltimore, Maryland
Jim Chang, University of Maryland Medical Center
In the center of Baltimore, the University of Maryland Medical Center (UMMC) is an academic medical center with several thousand staff members plus more than 1,000 faculty members from the various professional schools of the University of Maryland Baltimore. Challenges to respiratory protection at UMMC include tuberculosis, hazardous medications and chemicals, and novel pathogens such as H1N1 influenza, MERS-CoV (Middle East Respiratory Syndrome Coronavirus), and Ebola. When the H1N1 influenza pandemic occurred in 2009, UMMC managers found that N95 respirators were difficult to procure despite the considerable purchasing power of the 13-member health system. They were told by their primary vendor that other entities had priority for distribution. In response to this sudden shortfall of respiratory protection devices, UMMC developed a mixed protection strategy that emphasized the use of stockpiled reusable elastomeric air purifying respirators, a handful of N95 respirators, and approximately 400 PAPRs (of two different models). In addition, another 100 PAPRs were purchased. Fit testing for the elastomeric air purifying respirators involved unit-based fit testers and educators as well as centralized fit testing services. Selective deployment of PAPRs in their facilities made respiratory protection available to all staff and helped minimize the need to potentially fit test and supply tight-fitting respirators to all staff. This helped to alleviate staff concerns and allowed employees who were ineligible for fit testing to still have respiratory protection.
Learning lessons from the H1N1 influenza experience, UMMC has refined its respiratory protection strategy by identifying high-risk care units and services—for example, general medicine units, the medical intensive care unit, and services such as pulmonology, emergency medicine, and pediatrics. All new employees in these units and services are fit tested for an elastomeric air purifying respirator at the time of hire, and current employees are fit tested annually by unit-based fit testers. PAPRs are pre-deployed to high-risk units. For all other units, PAPRs are maintained and deployed by an equipment distribution group that is part of the clinical engineering function. Any care unit that asks for a PAPR gets a package of five PAPRs, head covers, and a five-pack battery charger from the central depository. UMMC also learned that the instructions
provided with PAPRs were inadequate, which prompted it to create its own guidelines for how to wear and remove PAPRs.
To advance the effective use of PAPRs in health care settings, there are three areas in greatest need of improvement, said Chang. First, manufacturers should match the equipment design with the functional needs of the different users. Bedside-care staff require different functionalities to meet their respiratory protection needs than maintenance staff. Second, respirators should be designed to be easy to use, assemble, clean, and test by a health care worker. For example, one model UMMC uses requires a battery pack clipped to a web belt, a turbo blower with breathing tube, three filter cartridges, and a hood. A simplified design, where components are housed internally, would be easier to use and less prone to user error. This is important, as some health care workers may use a PAPR only a few times per year. Last, the standardization of consumable items such as head covers should be encouraged. For example, in an emergency there are mask cartridges used for chemical, biological, radiological, and nuclear (CBRN) air purifying respirators that can be interchanged between different manufacturers’ masks, although this may be in violation of certification.
PAPR Use and Research at the Department of Veterans Affairs
Lewis Radonovich, Department of Veterans Affairs
PAPRs are used in most medical centers across the VA health care system, which includes outpatient clinics and hospitals. Approximately 60 percent of VA medical centers use PAPRs routinely during clinical care; however, fewer than 5 percent rely solely on PAPRs for respiratory protection.
Acknowledging that large infectious disease outbreaks may result in a shortage of N95 respirators, VA plans to rely on elastomeric respirators as a last resort, so they are held in reserve in a national stockpile. One respirator and two sets of cartridges are available for each health care worker who sees patients, amounting to some 180,000 respirators. Elastomeric respirators are not currently used in routine clinical care.
Based on data from several studies, VA researchers have shown that employees find PAPRs more comfortable than half-face elastomeric masks or N95 respirators. However, among a variety of respirators studied, none of the tested devices were well tolerated for an entire 8-hour shift by all test participants. In one 2009 study, half of the study subjects
had removed their respiratory protective device by the end of an 8-hour work shift, regardless of the type of respirator used. VA researchers found that PAPRs were primarily disliked not because they were uncomfortable but because they might interfere with occupational activities and might be somewhat challenging to use in certain situations. In another study, when an individual was wearing a PAPR that allowed airflow to go past the ears, there was about a 15 percent decrease in the wearer’s ability to repeat the words he or she heard. VA research teams also have found that the rechargeable batteries available for use with PAPRs often malfunction or are unable to be adequately recharged. Because of these concerns, the use of non-rechargeable batteries might be preferable, even though they are usually more expensive.
PAPRs are much more expensive than their counterparts. In one study, the cost for a PAPR was $768.20, compared with an N95 respirator, which cost approximately $1.50, and an elastomeric respirator, which cost about $20. Assessments conducted for stockpiling respirators for an influenza pandemic showed that VA would need approximately 18,343 PAPRs (at a total cost of more than $14 million) to care for a population of 1 million people, making PAPRs 20 to 30 times more expensive to stockpile than any other type of respirator.
Representatives from nine federal departments and agencies participated in Project BREATHE (Better Respiratory Equipment Using Advanced Technologies for Healthcare Employees) to make recommendations for future development of respirators for health care workers (Radonovich et al., 2009). The project identified 28 desirable characteristics for health care worker respirators, which fell into four broad categories:
- Safety and effectiveness;
- Support for, and no interference with, occupational activities;
- Comfort and tolerability; and
- Compliance with health care system policies and practices.
The major challenge with respirators lies not in designing an effective one, but in persuading people to wear it and to wear it correctly. Respiratory training is not taken as seriously as blood-borne pathogen training, but both promote a safe health care workplace.
PAPR Use at Johns Hopkins Health System Baltimore, Maryland
Trish Perl, Johns Hopkins University School of Medicine
Johns Hopkins Health System has six hospitals plus clinics and outpatient settings serving much of the city of Baltimore, as well as a children’s hospital in Florida. In 2003, the Johns Hopkins system established a two-tiered respiratory protection program using both N95 respirators and PAPRs. Staff members working in high-risk areas are trained on how to use PAPRs and also are fit tested for N95 respirators. The Department of Health, Safety, and Environment performs the fit testing and maintains the PAPRs. Staff members are trained to use respirators and must pass a medical screening examination before they are allowed to treat patients posing a risk of airborne infection, perform aerosol-generating procedures on high-risk patients, or administer certain hazardous aerosolized drugs. PAPRs are present in all care units that have potential high-risk patients. If a PAPR is not available, staff can request one from the central stores. However, the delay between request and delivery may create a period during which a patient is not seen or a health care worker is not protected. The Johns Hopkins system has approximately 1,000 PAPRs in its stockpile, 600 of which are in the care units and available for use at any given time. Department of Health, Safety, and Environment staff members check and perform maintenance on PAPRs twice per month for those that are in use and once every 6 months for devices in storage.
Health care workers at Johns Hopkins are expected to know how to don and doff a respirator without contaminating themselves, so that they do not put themselves or their patients at risk. Furthermore, the workers need to know when the PAPR headpiece can be reused and when it has to be discarded due to exposure to certain infections. Instruction on how to clean the respirator is important, as is training employees to make sure that the PAPR is returned to its charger so it will be ready for the next user. As noted by other speakers, the package instructions provided for PAPRs are quite complicated and difficult to understand.
In 2011, Johns Hopkins conducted a simulation of a pediatric resuscitation during the H1N1 influenza pandemic. During the simulation, 19 percent of the involved staff members did not wear any kind of respirator, 6 percent used PAPRs, and 75 percent used N95 respirators. Making the PAPRs easier to use and making sure the workers know how to use them will increase their use (Watson et al., 2011). Some of the reluctance to use PAPRs may be the result of the institution’s relatively complicated
policy on trouble shooting problems and on the maintenance of the devices. If a problem is noticed, a member of the Department of Health, Safety, and Environment has to evaluate the device before the PAPR is used again.
Barriers to the use of PAPRs also include the time required to don the PAPR, which lengthens response times in emergencies. The devices are cumbersome and impede the health care worker’s ability to care for patients, and to take a patient’s vital signs in particular; also, the devices can be intimidating to patients. Often the PAPRs cannot be found when they are needed or parts are missing. The decontamination process is arduous and requires a fair amount of time both to train the workers and for workers to complete the process.
The cost of PAPRs is a definite drawback to their use: a PAPR costs around $900; the battery costs $130; and a charger for 10 PAPRs can cost from $1,700 to $2,000. This is in addition to the cost of the Department of Health, Safety, and Environment staff needed to deploy and maintain the PAPRs.
Perl stated that health care workers do see advantages in using PAPRs, as the equipment makes them feel safe; does not require them to breathe through a facepiece, which can be taxing for workers who are older or have underlying respiratory problems; and can be more convenient, because the PAPRs used in their facilities do not require fit testing and are reusable. She identified the top opportunities for overcoming barriers to the effective use of PAPRs in health care settings: decreasing noise, simplifying the cleaning and storage requirements, and improving battery life. Two research avenues suggested for improving NIOSH certification of PAPRs are (1) clarifying the cleaning requirements and (2) verifying that the improved filtration efficacy translates into enhanced health care worker safety.
PAPR Use at the Mayo Clinic Rochester, Minnesota
Jeffrey Nesbitt, Mayo Clinic
The Mayo Clinic health care respiratory program uses a blend of tight-fitting respirators (two models, seven sizes) and one type of PAPR. On average, the program fit tests 1,370 health care workers per year. It has 200 to 300 PAPRs in a rotating stock that is always available, and the PAPRs are cleaned, maintained, and distributed through the linen and
central services units at the hospitals. Some offsite locations may have their own PAPRs, which are on a monthly rotation schedule with the stock at the hospitals. Mayo Clinic also has a separate supply of respirators in a stockpile to be used in case of an epidemic. Mayo Clinic tracks its workers’ fit testing, training, and medical clearance through a centralized electronic system that requires unit managers to update the workers’ status monthly.
The Mayo Clinic does not use PAPRs in surgical sterile fields, and clearer guidance is needed on how and if this could be done, stated Nesbitt. Another barrier to PAPR use is the question of cleaning and decontaminating PAPRs when they are being used by staff members who are treating multiple patients and moving between multiple rooms. The communication barrier is also of concern. Comfort and functionality are also limited by various PAPR design issues, such as the device’s weight and bulk; critical switches being located on the back of the unit, making them susceptible to being turned off inadvertently; and occasional faults in the monitors for airflow and pressure. The opportunities to improve NIOSH certification for PAPRs include clarifying the issues regarding the use of PAPRs in a sterile field, providing guidance on the appropriate use and decontamination of PAPRs for novel infectious diseases, and advancing the evidence that respiratory worker safety translates to safer and healthier workers and patients.
Discussion on Health Care Employer Experiences with PAPRs
The group discussion began with a focus on respiratory protection training. Perl noted that respiratory protection training may not be as effective as it could be because it is one of many mandatory trainings. Moreover, training may be provided through slide shows or Web-based educational modules, rather than by hands-on application. Chang agreed and said the University of Maryland has similar types of training. However, because training had been highlighted as a potential weakness in UMMC’s program evaluation, the medical center plans to add respirator training to its “nursing marathons,” which include more hands-on and practical training. Nesbitt stated that the Mayo Clinic provides training every year through quizzes, as well as part of incident follow-up and investigation. He added that it looks at compliance rates annually. Bonnie Rogers, University of North Carolina at Chapel Hill, commented on the very low rates at which workers retain information from their respiratory
protection trainings and the quite brief amount of time that is spent on providing information on respiratory protection to health care students while they are in school.
Linda Clever added to this discussion by asking the speakers to compare their institutions’ respiratory protection training with blood-borne pathogen training. Radonovich said that he thought both of these topics were covered during employee orientation at VA, as well as through annual training processes with, in his opinion, more effort put into on-the-job blood-borne pathogen training. He noted that respiratory protection may not be covered as much during trainings because it is not used as often in practice. Chang agreed but noted that this trend might improve with face-to-face respiratory protection training and hands-on practice. Nesbitt said fit tested groups probably receive better respiratory protection training, because during that training the workers are tested and observed donning and doffing the respirator. He stated that because the PAPRs used in the Mayo Clinic facilities do not need to be fit tested, the PAPR training is usually a show-and-tell format with little or no hands-on practice. An opportunity for hands-on training, noted Chang, is when an airborne isolation patient enters the University of Maryland’s tracking system. When this occurs, either a safety or an infection control staff member will visit the unit that is caring for the patient to make sure the equipment is in working order and to offer just-in-time hands-on training.
The discussion also covered the need for standardized, interchangeable consumable parts as well as specific barriers and opportunities for the design of PAPRs. Frank Califano said, “Every time we buy a new PAPR, we are buying a new filter, a new battery, a new charging system.” Because of the cost of replacing these items, he said there is a real need for generic, off-the-shelf batteries and chargers that could help reduce health care costs. Nesbitt reiterated that the bulk and weight of the respirators is always mentioned when he asks his workers for feedback. He also wondered if the bib length might pose a problem if PAPRs are eventually approved for use in sterile environments and if the reusable head covers, which some manufacturers offer, might have potential infection control issues, such as the spread of head lice. Chang suggested that the one-size-fits-all solution should be examined. While it offers versatility, he said he believes it does so by compromising the design. When the provider and end user are given choices in filter and breathing tube options, the likelihood of failure increases, he said. Chang also described an incident where a PAPR breathing tube was compromised because the reinforcement piece, made of plastic, had been crushed.
In response to questions about respirator performance requirements and user instruction booklets, D’Alessandro said NIOSH is moving away from prescriptive requirements and moving toward performance requirements (i.e., how a unit would have to perform to meet the needs of health care workers). She added, “It would be up to the health care workers to tell the manufacturers that ‘this is the type of thing that we need.’ And then we would be able to certify it. There is nothing prohibiting these types of certifications. It is just that the users are not demanding these types of products.” She also explained that unlike user instructions, which are reviewed as part of the certification process, NIOSH does not review training or maintenance manuals for the respirators until an issue or event is being investigated. D’Alessandro noted that NPPTL needs to explore how to incorporate the feedback and desires of an end user into the NIOSH certification process. Although it has been suggested that different prototypes should be distributed and evaluated in the field, D’Alessandro explained that it is difficult to get institutional review board approval to test prototypes for health care purposes. She noted that user feedback data are needed and that NPPTL should devise a way to standardize that type of research in the future.
PAPRs AND EMERGENCY PLANNING
The respirator needs of “first receivers”1 can be different from those of first responders. Five speakers at the workshop addressed the use of PAPRs and other respirators in the context of emergency response.
Use of PAPRs in Hazardous Materials Response
Massachusetts Department of Fire Services
The hazardous materials response teams of the Massachusetts Department of Fire Services use an array of respiratory protection, from a full face air purifying respirator (APR) to a 4-hour chemical re-breather (the latter is used in the maritime environment). However, it is estimated
1“First receivers” are hospital employees who are the first to care for individuals presenting at their facility who may have been exposed to hazardous substances or infectious diseases. They are distinguished from first responders such as firefighters, law enforcement, and ambulance service personnel, who typically respond to an incident site.
that some 90 percent of the time, hazardous materials technicians use a self-contained breathing apparatus, or SCBA. These technicians choose the SCBA because, as firefighters, they are familiar with the equipment and confident in the high level of respiratory protection that SCBAs provide. These two factors—familiarity and confidence—seem to be missing from respiratory protection in the health care field.
Since 1999, Massachusetts has deployed mass decontamination units to fire stations protecting every acute care hospital in the state—now some 92 in all. The firefighters who would respond to a mass contamination event are trained to use SCBAs and are comfortable doing so.
The health care field “has failed to develop a respiratory protection strategy.” A layered approach should be considered with multiple types of respirators. In addition to N95 respirators and PAPRs, devices that provide higher levels of protection need to be considered, including full face APRs. This is especially important when dealing with a highly contagious or highly lethal disease. In these cases, it may be necessary to use a full ensemble that covers a person from head to toe. The biggest risk to health care would be to lose the confidence of health care workers.
“Three factors have to be met in order to provide protection: proper equipment, properly worn, by a properly trained individual.” Training is critical, and teaching health care professionals how to properly use PPE should be a core element of their education. A final necessity is a sustained market that builds respirators to meet the needs of health care workers.
The National Preparedness Perspective
Biomedical Advanced Research and Development Authority
The Biomedical Advanced Research and Development Authority is an advanced development organization for public health medical emergency preparedness within the Office of the Assistant Secretary for Preparedness and Response in the Department of Health and Human Services. The agency is interested in ways to improve respiratory protection devices.
When considering PAPRs for the nation’s preparedness for a pandemic, consideration is given to three questions: What is affordable? What is available? And what is acceptable? There are a suite of protective devices to choose from: surgical masks to reduce the spread of infec-
All respiratory protection devices have advantages and disadvantages. As other workshop presenters have underscored, the major advantage of PAPRs is that many types do not require fit testing. It is estimated that close to 10 percent of workers cannot be fitted for an elastomeric or N95 respirator due to facial hair or other reasons. Another advantage to using PAPRs is their reusability. The major disadvantages are maintenance and cost. Disposable N95 respirators, while costing much less for an individual respirator, are not so economical if workers need to use respirators day after day for weeks during a pandemic.
In prior work in a select agent laboratory, lab staff worked while wearing PAPRs day in and day out and became quite familiar with them. Challenges to using PAPRs that were identified in the laboratory work included a relatively short battery life, difficulties in hearing due to the noise of the blower, and to a lesser extent, difficulties in seeing due to the hood. The dedicated laboratory staff who were wearing PAPRs did weekly equipment checks, had a battery cycling schedule, and determined the cleaning procedures. They also used a two-man rule so that when the equipment was donned and doffed there was always someone else there to ensure that it was done correctly.
Emergency Services at North Shore–Long Island Jewish Health System New York City Metropolitan Area
Frank Califano, North Shore–Long Island Jewish Health System
North Shore–LIJ Health System has 18 hospitals in the New York City metropolitan area. It is one of the largest employers in the state of New York. Each hospital in the system has 20 to 30 PAPRs, primarily in its cache for emergency response and infectious disease management.
Long Island Jewish (LIJ) Medical Center, a part of the North Shore–LIJ Health System, was involved very early on in the 2009 H1N1 influenza pandemic in the United States. One of the biggest challenges was educating staff on how to don and doff their PPE. The health system posted door-sized instructions in every care unit to explain the proper procedures for entering and exiting a unit.
The hospital system stocks more than 500,000 N95 respirators and 250,000 pairs of goggles. However, PAPRs “are the best personal protec-
tive equipment available to hospital workers in the event of trying to protect them from some type of airborne contaminant.” The health system has found that the best strategy is a tiered approach in which strike teams of specific people in designated areas are trained to use the PAPRs and act as a team in response to an outbreak or other emergency. Because of their cost, PAPRs are not a feasible option for protecting all of the system’s workers in the case of an emergency. At approximately $1,000 per PAPR, the cost is a major factor in decisions on changing or updating respiratory protective equipment. “Our initial response until we figure out what it is going to be is N95s. That is why we stock over half a million of them.”
One of the key characteristics that is taken into account when planning for respiratory protection is the protection factor of the devices. Efforts should focus on the development of PAPRs and PAPR certification processes that provide for increased protection capabilities. An improved PAPR would be one that works with the flip of a switch and signals the user that it is ready for use. It would be useful if filters were interchangeable among devices. In addition, although a good, high-efficiency filter is needed for health care, there is no need for chemical-resistant filters. Other desirable features include hoods that provide better visual clarity, a flow meter and an alarm to notify the user of changes in flow rates, a low-battery indicator, and improved ability to decontaminate the PAPRs. Furthermore, in times of emergency, it is important to have clear and transparent directives on what PPE is needed.
Association for Professionals in Infection Control and Epidemiology
Association for Professionals in Infection Control and Epidemiology
The Association for Professionals in Infection Control and Epidemiology (APIC) has more than 15,000 members, most of whom collect, analyze, and interpret health care–associated infection data and work to reduce such infections. During the H1N1 influenza pandemic, APIC disseminated a position paper on extending the use of or reusing respiratory protection in health care settings during disasters.
In California, the California Aerosol Transmissible Disease Standard covers not only PPE but also requires immunization for all aerosol-transmissible infections such as measles, mumps, rubella, chicken pox, diphtheria, and pertussis. PAPRs are required for high-hazard activities
such as sputum induction, bronchoscopy, aerosolized administration of medications such as pentamidine or other nebulizer-type treatments, pulmonary function tests, autopsies, and certain surgeries.
As noted by other speakers, the advantages of PAPRs include comfort, eye protection, and not having to do a fit test for certain models. Disadvantages include hearing and communication challenges, patient fear, and decontamination, as well as higher storage and battery costs. Respiratory protective equipment has both administrative costs and capital costs. Training is needed for all types of respirators. Although loose-fitting PAPRs do not have the same fit testing costs that N95 respirators have, they do have higher capital costs.
One challenge for health care is that it is difficult to show cause and effect. Health consequences of particular behaviors are not always immediate and may present days or weeks later. For example, it can be difficult to determine whether increased infection rates are due to health care workers not washing their hands adequately as they go from patient to patient or due to workers not wearing N95 respirators. Facilitating the use of PAPRs by health care workers requires equipment that is easy to use and has clear directions for its use. Ideally, PAPR design and NIOSH certification of PAPRs would consider the specific needs of health care workers.
Preparedness and Response in the Chicago Department of Public Health
Chicago Department of Public Health
The Chicago Department of Public Health oversees clinical and nonclinical emergency responders. It is prepared in an emergency to help in providing triage and care to people outside the clinical setting in order to keep hospitals from being overwhelmed. The Joint Commission requires each accredited hospital to have an alternative treatment protocol and a plan to move clinical operations into the field in order to increase surge capacity.
In response to the Joint Commission’s mandate and also to serve as a storage site for 35 city hospitals, the Chicago Department of Public Health maintains a warehouse inventory of pharmaceuticals, countermeasures, and PPE in a temperature- and humidity-regulated environment. The PAPRs that are stored are seen as an important part of the PPE inventory because anyone can wear them, fit tested or not. Chicago uses
PAPRs to expand its PPE options for its traditional first-response workforce. The city maintains PAPRs at an average cost of $1,200 each, which includes an extra battery and extra filters. When deployed, the PAPRs are sent out with two batteries, a charge station, and two filters, all of which is projected to allow for 16 hours of running time. The battery maintenance program tests the batteries on a cyclical schedule to ensure all PAPRs are fully charged when they are sent into the field.
The Chicago Department of Public Health tracks its PPE and pharmaceuticals from point of purchase to point of receipt in the field, all the while controlling the temperature and humidity of the secure environment in which they are stored. Given the extraordinary maintenance measures taken, the city received manufacturer approval to extend the expiration date of its inventory. This level of control and monitoring is believed to be unique outside a military environment.
Improvements needed for PAPRs include increases in filter efficiencies and increasing the battery capacity. The Chicago program emphasizes life-cycle testing. Respiratory protective device certification should specify operational and performance qualifications so that the equipment can be retested after sale or during field deployment to determine whether it meets manufacturing specifications.
Discussion on PAPR Use in Emergency Response
The discussion began with participants voicing an overarching concern about performance requirements for PPE for health care workers. Bill Kojola raised the issue of the uncertainties about what is an infectious dose for each of various pathogens. Richard Metzler agreed and went on to highlight the need to determine a permissible exposure level and relate that to the assigned protection factor (APF) of the respiratory protective device. He also noted that particle filtration is the same regardless of whether a particle is biological or inorganic. Roland Berry Ann pointed out that although exact infectious doses may not be known, it is possible to use the APFs to assess the relative efficacy of respirators.
James Zeigler, J.P. Zeigler, LLC, and Linda Clever discussed issues related to the hierarchy of controls and the other non-PPE measures (including engineering controls) that should be in place prior to determining the type of PPE needed in a given situation. Hernando Perez, Drexel
University, brought up the subject of control banding,2 which can provide some general assessments regarding ranges of exposures and the protective controls that are needed, and Maryann D’Alessandro stated that NIOSH is writing a document about control banding in health care environments. David DeJoy, University of Georgia, noted two things to consider when determining what is an acceptable level of risk: (1) the ability to objectively measure risk and (2) the social and political assessments of how much risk is acceptable.
An additional topic of discussion was the training and maintenance manuals for PAPRs. D’Alessandro noted that NPPTL reviews user instructions as part of the respirator certification process but does not require training or maintenance manuals and does not review those materials when they are available. Melissa McDiarmid, University of Maryland, suggested that similar to the way the Food and Drug Administration requires that certain information be included in medication package inserts, respirator package inserts could be required to include training and maintenance instructions. Zeigler suggested adding instructions on the donning and doffing of respirators. Ensuring that the end users have access to the information provided with the respirators was an issue raised by Mark Catlin. He noted that the package inserts are often not seen by the employees themselves.
A question was raised about the nation’s Strategic National Stockpile, and D’Alessandro noted that PAPRs are not currently a part of that stockpile effort.
2The Centers for Disease Control and Prevention defines control banding as “a technique used to guide the assessment and management of workplace risks. It is a generic technique that determines a control measure (for example, dilution ventilation, engineering controls, containment, etc.) based on a range or ‘band’ of hazards (such as skin/eye irritant, very toxic, carcinogenic, etc.) and exposures (small, medium, large exposure)” (CDC, 2014c).
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