The workshop concluded with several discussion sessions, including an audience discussion and an opportunity to hear from speakers who were asked to provide a summary of the workshop and to identify priorities for next steps.1 While the perspectives varied and included those of health care workers and managers, respirator manufacturers, staff from professional associations and unions, federal agency staff, and emergency management administrators, the suggestions for improvement in powered air purifying respirator (PAPR) design and use greatly overlapped. What follows is a summary of the views expressed, categorized into three main themes:
- Improve PAPR design and standards: assess the risks and protective factors, identify design attributes, and drive the market to meet health care needs;
- Increase education and training; and
- Strengthen implementation and use of PAPRs in health care.
IMPROVE PAPR DESIGN AND STANDARDS: ASSESSING THE RISKS AND INCORPORATING HEALTH CARE NEEDS
As noted throughout this summary, numerous workshop participants said that respirator standards relevant to PAPRs could be revised and
1This section summarizes the discussion session after the Panel 5 presentations, the Audience Discussion session, and the issues raised by Panel 6 speakers who were asked to summarize the workshop.
expanded to allow for PAPRs that better meet the needs of health care workers. Current PAPR certification standards, developed primarily for industrial applications, are not always appropriate for the health care work environment.
Assessing the Risks and Protection Factors
James Johnson and other respiratory researchers emphasized that it is clear from aerosol physics research that for the purposes of assessing respirator filter performance, all particles are the same, regardless of whether they are biological particles, radioactive particles, or toxic material particles.
The challenges for ensuring health care worker safety lie in quantifying the infectious dose and in determining the level of protection that needs to be achieved with respiratory protection. Much remains to be learned about acceptable risk and the inoculum amount necessary for specific infectious diseases. Lewis Radonovich noted that one of the goals in respiratory protection for health care workers is to know more about the exposures. He said that information is needed that can provide a characterization of risk for health care workers that is similar to the characterization of risk used in the industrial hygiene approach to chemical exposures. However, “if we cannot define the risk, we should base our decisions on the precautionary principle,” Radonovich noted.
In an earlier discussion Deborah Gold had emphasized that PAPR design for health care workers should aim for an assigned protection factor (APF) of better than 25 and include a specific APF range, as confirmed by the National Institute for Occupational Safety and Health (NIOSH) in the respirator certification process. She said that PAPRs should be labeled for the various worker postures for which they are certified to maintain airflow and protection.
Identifying Design Attributes
Because the way in which health care workers use personal protective devices such as PAPRs can differ significantly from how workers in industrial settings use the same equipment (e.g., numerous interactions with a variety of patients, exposures that are difficult to quantify, intermittent or infrequent use of personal protective equipment [PPE], and
reduced workload and subsequent airflow demands), there are design features that could be improved to meet the specific needs of health care workers. Any such changes would need to be incorporated into PAPR certification regulations and processes.
Maintaining the Sterile Field
In his summary remarks, Craig Colton reemphasized the need to explore the design parameters of PAPRs that would allow for surgeons and others to maintain a sterile environment. Currently, PAPRs use an externally venting air exhaust system. Various approaches to filtering the exhaust air could be explored and then tested in the certification process.
Visibility and Communication
Health care work inevitably involves interaction with others. As Karen Anderson pointed out, PAPRs need to be patient friendly. In addition to the need for facial visibility, health care workers need to communicate with patients, including listening to them or to their vital signs. The noise of a PAPR fan can interfere with this aspect of their work. Reductions in the requirements for high-flow systems could significantly reduce the noise levels, noted Larry Green.
In a comment on the NIOSH docket, Jennie Mayfield noted, “We have concerns that the use of PAPRs impedes health care workers’ ability to observe and communicate with the patient and other members of the health care team, which affects patient safety.”
Ease of Donning, Doffing, and Cleaning
A number of participants commented on the need to better measure and train for donning and doffing. Philip Harber suggested that laboratory- and health care facility–based tests could be used to assess and improve a number of the design attributes, including donning and doffing procedures.
Multiple Flow Rates
A multiple flow rate PAPR was suggested by several speakers, including Johnson. Having a switch or sensing device that changes the airflow rate depending on the work rate—low, such as when taking vital signs, and high, such as when helping to move a patient—could provide
increased comfort and workability features for health care workers. Jim Chang noted that it might be hard to determine the appropriate flow rate for sporadic users of PAPRs, but automatic adjustments could be helpful.
Other Design Enhancements
Other enhancements suggested by workshop participants included
- Reduced size and bulkiness;
- Improvements in battery charge/drain times and filter efficiencies for longer-term use in field situations in the event of a pandemic;
- Interchangeable batteries and filters between models, which would simplify and extend their use;
- Better equipment-related feedback for wearers, such as flow pressure and power monitoring; and
- Improved training materials that are also a part of the requirements for the certification process.
Many workshop participants noted that cost is a key barrier to the use of PAPRs by health care organizations. Some of the costs may be due to the requirements to meet the specifications of the silica dust test performed for NIOSH certification, said Green. Cost savings may be achievable, according to Green and other speakers, by revising the specifications to meet health care needs.
Testing is an integral part of the NIOSH certification process for PAPRs. A number of participants expressed the opinion that testing standards should be based on the activities in which the user is engaged. Colton stated, “As a manufacturer, we would argue for performance orientation versus specification to allow us to make it do what it needs to do rather than be restricted to minimum flow rates and a battery that has to last this specified mandatory time to get through the tests. Get away from the specifications and go to performance.”
Driving the Market to Meet the Needs of Health Care Workers
Changing the design and standards for PAPRs to meet the needs of health care workers will require concerted efforts. Several presenters, including Edward Sinkule, pointed out that health care workers do not currently have an organization that is focused on providing the momentum for change in respiratory protection for the health care work environment. The changes leading to improved firefighter protection resulted in large part from the unifying and energizing force that the National Fire Protection Association and the International Association of Fire Fighters brought to the world of fire protection. Roland Berry Ann and Radonovich noted that Project BREATHE (discussed in Chapter 3) assembled a collaboration of federal agencies and other organizations to put together a list of performance attributes for N95 respirators for health care workers. A similar effort could be done for PAPRs for health care workers.
During the workshop, a number of representatives from various respirator manufacturing and health care PPE companies expressed their willingness to listen to what is needed for respiratory protection, including PAPRs, and to develop products based on those specialized needs, using health care performance requirements to drive specifications.
Determining the extent of the health care market is challenging, said James Zeigler. He noted that a large number of nonsurgical N95 respirators are being used in the health care industry, which adds to the market share but may not be included in market assessments. He also said that the health care industry is viewed as a valuable and growing market space. As Richard Metzler stated, “The health care community across the United States is huge. You would really be able to demand almost anything you want if you got together and identified what those specifications were and laid them out for the manufacturers. You specify it, and they will come.”
INCREASE EDUCATION AND TRAINING
A number of workshop participants, including Trish Perl, noted that while the one-size-fits-all design of loose-fitting PAPRs is appealing to providers because it negates the need for costly and time-consuming fit testing, the design does not negate the need for education and training.
Health Professional Education
Very little attention is being paid to teaching about respiratory protection in nursing and medical schools, said Bonnie Rogers. She said that end users need to be engaged in respiratory protection and worker safety training early on in their education and pointed out that one particularly neglected but important segment of provider education is certified nursing assistant (CNA) education. CNAs provide much of patient care both in hospitals and outside hospitals in nursing homes and the home health care environment. In responding to inquiries about respiratory protection training, administrators in community colleges in North Carolina have indicated that there is no time for this training in the CNA curriculum. Practitioners will do what they are taught, Rogers noted. Kerri Rupe, University of Iowa, concurred and noted the lack of emphasis on worker safety and respiratory protection in nursing education. She stated that “nurses want to protect themselves, and they certainly want to protect their families.”
Throughout the workshop, speakers mentioned the need for training health care workers on the use of PAPRs. Mark Catlin noted the importance of ensuring that training is done in advance of use, with hands-on practice in donning, doffing, and working while wearing a PAPR. Anderson pointed out that just as there is extensive education on the use of N95 respirators during fit testing, there needs to be a similar emphasis on PAPR training. She noted that health care workers who frequently use PAPRs, such as respiratory therapists, would have the expertise to train others. Also important to remember, as pointed out by Rupe, is that health care workers may not use a PAPR every day or even every week or month. The use is intermittent and more likely to occur in a surge situation. This means that there may be large gaps of time—6 months to 1 year—between when workers are trained to use a PAPR and when they actually use it.
Currently, NPPTL reviews the user instructions for respirators as part of the certification process but does not review training and maintenance manuals. Maryann D’Alessandro noted that this could be something to consider going forward and asked the workshop participants if the review of instructions and training on donning, doffing, and use of
PAPRs should be part of the NIOSH certification process. Several participants thought PAPR use could be improved by requiring manufacturers to provide training materials to purchasers. Gold noted that the written materials included with respirator certification should include clear, plainly written statements to help employers select the most appropriate devices for their needs and to train employees on the use, advantages, and limitations of specific equipment.
Green pointed to the requirements that the Food and Drug Administration (FDA) has for obtaining 510(k) approval for isolation gowns, which include instructions and training videos on how to don and doff the gowns. NIOSH could have similar requirements for training materials for PAPR certification. Melissa McDiarmid noted that the inclusion of user training information could be a recognized standard of practice for manufacturers, similar to the information required by FDA on package inserts for pharmaceuticals.
STRENGTHEN IMPLEMENTATION AND USE
Compliance with regulations for use of PAPRs and other respiratory PPE in health care can be quite different than in other industries, noted Catlin. In other industries, such as asbestos abatement, he noted, the industry determined what was needed and then “workers wore what they were provided to wear and told to wear and trained to wear” for their protection. In health care the exposures may be unknown and difficult to quantify, and the work culture is more independent. Chang noted that health care is often outcomes based, and respiratory protection is not an issue until a patient has an infectious disease.
Metzler pointed out that health care institutions are fighting the status quo and the beliefs by health care workers that surgical masks are “almost good enough” and thus an N95 respirator may not be needed. Anderson provided the perspective of a nurse manager in infection control and prevention and suggested that many health care workers believe that the fact that they have been using a surgical mask for 30 years without a problem is evidence that they do not need additional respiratory protection.
Ensuring that PPE is a priority and that its use is a core competency was a theme echoed by many participants. Rogers pointed to the value of having an individual or individuals designated as the “practice champions” on health care units; these individuals provide guidance and answer
questions regarding PPE. Frank Califano noted that accountability by an organization such as the Joint Commission would be key to driving change in the worker safety culture in health care. Furthermore, research is needed that can bolster the quantitative evidence of the effectiveness of PAPRs and of specific donning and doffing protocols. Workers and administrators need to be convinced that PAPRs can protect health care workers, their families, and their patients.
In concluding the discussion, Linda Clever noted that there are many more voices that need to be a part of the discussion, including health care workers and administrators who work in home health care, in clinics, in small or rural hospitals, and in nursing homes.