In early 2020, the magnitude of the COVID-19 pandemic was already becoming visible to the public and creating a strain on healthcare and public safety industries, making it clear that supply chain issues were imminent. In response to supply chain issues for personal protective equipment (PPE), the Centers for Disease Control and Prevention developed PPE optimization strategies.1 Additionally, temporary emergency use authorizations from the Food and Drug Administration permitted the use of reusable respirators such as NIOSH Approved® elastomeric half-mask respirators (EHMRs) in health settings.2 Consequently, many healthcare and public safety organizations turned to these optimization strategies, including the procurement and integration of reusable respirators.
LifeLine Ambulance, a full-service ambulance company offering pre-hospital emergency medical services as well as emergency and non-emergency interfacility patient transport, was having difficulty and became concerned with procuring PPE and associated decontamination supplies. Typical vendors either did not have the supply or procuring those supplies was cost prohibitive. By the middle of 2020, it was a scavenger hunt for surgical masks and N95® filtering facepiece respirators (FFRs) with many small to mid-level EMS companies – like LifeLine – scrambling to find an alternative to disposable N95 FFRs. Specifically, the COVID-19 response plan mandated by the State specified that respiratory protection with N95 filtration efficiency should be the minimum filtration efficiency when providing patient treatment regardless of whether a respiratory illness was present. In other words, a disposable N95 FFR was required on every call which was simply not sustainable.
This case report highlights LifeLine’s experience with procuring and implementing EHMRs at its Michigan headquarters location. After management discussed the decision to fit test first responders to EHMRs, LifeLine decided to share feedback on how the company managed to maintain its EHMR program after N95 FFR supplies stabilized, and other lessons learned for readers considering reusable respirators at their workplace.
Table of Contents
Identifying EHMRs as an Option for Respiratory Protection
At the onset of the pandemic, LifeLine was contracted to transport patients who tested positive for COVID-19. The organization had to be proactive about protecting its workforce which included having an adequate supply of respiratory protection devices on hand. Fortunately, later in 2020, Lifeline found that NIOSH-Approved EHMRs were available for purchase from local paint stores and in some cases, directly from the manufacturer. An EHMR is a reusable air-purifying respirator with exchangeable cartridge elements that provide various levels of filtration (e.g., N95, P100®).3 The facepieces of EHMRs are composed of synthetic or natural rubber material which allows for cleaning, disinfection, storage and reuse.
LifeLine explored EHMRs as an initial feasibility option with its transport crews. Crews consisted of emergency medical technicians (EMTs), paramedics, and critical care paramedics. Road supervisors were a combination of EMTs and paramedics. Due to some patient transports being over 100 miles, crew comfort and safety were primary concerns among management. The initial exploration of EHMRs included fit testing and the typical education and training about the reusable respirators and their role in preventing exposures to airborne or bloodborne pathogens. LifeLine found that, not only was there a stable supply of EHMRs, but they also provided a comfortable face seal and could contribute to longer-term cost savings for the organization because of reusability.
After the initial order, but before any subsequent orders, an opportunity was posted on a Federal Register Notice,4 indicating that any health or public safety organization could request EHMRs from the Strategic National Stockpile (SNS).LifeLine was one of 24 public safety organizations that requested EHMRs. In 2021, the SNS purchased and distributed three EHMR models, all without exhalation valves or with filtered exhalation valves. A second stroke of luck occurred when the 225 EHMRs that LifeLine received from the SNS were the same make and model series (i.e., 3M 6000) that LifeLine had already been using to develop its program. However, the 3M 6000 models purchased by the SNS also came equipped with an exhalation valve filter to mitigate source control concerns during the pandemic. Consequently, training was provided about EHMRs without an exhalation valve, specifically, regarding protecting both the wearer and patient against exposure to SARS-CoV-2. Updates were also made to LifeLine’s Respiratory Protection Program (RPP) to include the use of EHMRs. All information adhered to the COVID-19 response plan mandated by the State. Three years later, the company is still using them.
Collaborating with NIOSH
After receiving EHMRs from the SNS, LifeLine volunteered to participate in EHMR research led by the National Personal Protective Technology Laboratory (NPPTL), a division within NIOSH. NPPTL’s research sought to better understand experiences and challenges related to the implementation of EHMRs during the COVID-19 pandemic. Although EHMRs alleviated supply shortages associated with N95 FFRs, there were barriers to use that needed to be studied to adequately inform widespread adoption and sustainability.
To this end, LifeLine conducted an informal survey of its transport crews regarding the EHMRs prior to full-scale rollout to preemptively address any concerns. The company found that most crew members were not only receptive to the idea but were also outright relieved for the protection. A few, it would turn out, had already looked into going to the local paint store to purchase their own. The long-range transport crews especially liked the EHMR in comparison to an N95 FFR. The various sizes, soft rubber material, and adjustment straps made for a more comfortable product. Further, in comparison to the standard FFR disposable respirators, transport crews positively commented on the comfortable seal to the face. Perhaps in response to the seal and increased comfort, many crew members had the perception that EHMRs offered superior protection in comparison to disposable FFRs – even though the assigned protection factors are the same as for N95 FFRs, LifeLine found that EHMRs were good for its culture from a psychological standpoint, further encouraging full-scale fit testing of the respirators.
Integrating and Sustaining the Use of EHMRs
Even though overall feedback on EHMRs was positive and the program was advantageous for LifeLine, these respirators still presented some distinctive challenges; some were predictable and some were not. For those who are considering the use of EHMRs in an ambulatory environment, some key experiences and takeaways are provided here to assist with the process.
Fit Testing Experiences
Per OSHA’s fit testing procedures (1910.134), EHMRs, like FFRs, can be fit tested using either qualitative or quantitative methods. At LifeLine, fit testing was conducted in-house using the Moldex® qualitative fit test system (see Photos). The group had five individuals who were already trained and qualified to conduct fit testing. Administering fit testing in-house was a time and cost saver, with crews helping to assemble EHMRs prior to fit testing. The respirators arrived in factory packaging and had to be assembled, which was a perfect task for employees on light duty. It took about two weeks to fit test all 135 LifeLine employees. Fit testing of new-hire employees was integrated into the orientation process.
As a part of maintaining compliance, OSHA also requires medical evaluations and ongoing recordkeeping of the medical evaluations and fit testing of each employee (1910.134(m)). Prior to having these EHMRs, sometimes the FFR models received would vary, which required repeat fit testing from model to model. A major advantage was that these reusable respirators eliminated the need for repetitive fit testing on different N95 FFRs. Although EHMRs can also afford organizations an additional option if employees cannot pass a fit test for an N95 FFR, all LifeLine employees were able to annually fit test to an N95 FFR. Currently, employees are fit tested for an N95 FFR and EHMR to ensure the seal is adequate and the fit is tolerable throughout the shift.
Some organizations have a centralized cleaning and disinfection program so that one piece of respiratory protection can be used by multiple employees. LifeLine opted to assign each employee their own EHMR, noting to each employee fit tested – “It’s the toothbrush theory – once it’s used, it’s yours.” Employees were also given a storage bag to transport the EHMR like that provided for a self-contained breathing apparatus (SCBA) along with an adequate supply of manufacturer-recommended cleaning wipes. The biggest challenge from an individual employee perspective was the accountability that everyone needed to take on to maintain their EHMR. As learned from this example, decontaminating the device is likely an initial challenge most organizations will experience, along with resistance to change among a portion of the workforce. Monitoring employee adherence to these practices is an important part of program maintenance and facilitated by LifeLine’s RPP.
Updating the Respiratory Protection Program
LifeLine, like every other EMS agency in Michigan, had a mandated COVID-19 Preparedness & Response Plan and Respiratory Protection Program (RPP) in place. However, these RPPs did not have EHMRs included. LifeLine found that integrating the EHMRs into the RPPs and other plans was rather straightforward and could be done prior to EHMR distribution. Although there were shipping delays for the EHMRs, this provided more time to develop and update Lifeline’s RPP. Having this plan in place made integration of EHMRs must easier and is advisable to other organizations preparing for a widespread distribution. Specifically, an EMHR policy was created that included training, maintenance, storage, and of course, indications for use. Another tip is that having accredited and trained staff – including those who possess an Instructor/Coordinator state-issued license – allowed the company to apply for continuing education credit for the training.
Maintaining C-Suite Support, Team Engagement, and Communication
A key component on the procurement and deployment side was the full support of LifeLine’s out-of-state corporate directors. Relatedly, the success of this program was made possible due to the team mentality from which it was approached. No one person can sustain a project of this magnitude in a timely or effective manner. LifeLine leaders each assumed a role in addition to their “normal” responsibilities. Also, the trust that LifeLine management and team members had in providers was critical to gaining buy-in of the EHMR program. Team members Derek Thews, CCP, Frank Gilbert, CCP, I/C-P, and Chris Palmer, M.S., A-EMT, cannot be thanked enough!
Obviously, buy-in of the program was key among management, but so was engagement from the frontline transport crews. The company found that participation was better with transparent communication programs that encouraged any reporting of an incident during transports, including those that involved PPE. Although rare, examples of such incidents included physical failure of the EMHR (filter bracket, securing straps) or a crew member not properly using the PPE. A non-punitive near miss reporting system was implemented to better understand and intervene around such incidents.
The combination of supply chain instability and learning to work with COVID-19 as an ongoing risk has changed the mentality of the workforce. Consequently, there is a need for the messaging around potential exposures and protective health practices to evolve. Moving forward, the use of EHMRs is likely to be more situational among employees. Meanwhile, an important question that organizations may ask themselves is, “how can we encourage EHMR use during routine, potential high-risk situations?” In LifeLine’s case, the company changed messaging from being COVID-19-specific to focusing on the utility of EHMRs in preventing the transmission of other types of respiratory illness. Even though there might not always be a medical need for respirator use in all these scenarios, the messaging employed by LifeLine assisted in developing and supporting habits around respirator use in routine and emergency situations as well as complying with existing state guidelines and operational protocols that require the need to always have at least N95 respiratory protection available to employees. Importantly, these guidelines and protocols were in place prior to COVID-19.
Considering EHMR Sustainability Challenges for the Future
Although LifeLine has experienced several advantages to using EHMRs, there are still issues to contend with while trying to sustain this program for all employees. First, resource management and allocation issues continue to be a barrier to implementation and sustainability. Specifically, storage is still an issue as the personal space available to each employee is not large enough to keep the EHMRs in station while off shift. Because of limited storage and the mobile aspect of this workforce, many paramedics resort to taking their EHMRs home. A drawback to this is relying on employees to be personally accountable for their respirators off site. Therefore, organizations should expect that employees will take and leave their EHMRs at home from time to time and a plan should be in place for when this happens. Furthermore, as the pandemic progressed, many hospitals and facilities denied entry to personnel using FFRs with non-filtered exhalation valves. Because LifeLine had an EHMR with the exhalation valve filter, employees did not have this issue. However, this is important to be aware of for planning purposes, particularly when it comes to adhering to protocols in place at other organizations. Of course, regardless of other organization’s protocols, it is still necessary for employees to comply with all occupational safety and health standards and regulations as outlined in OSHA’s general duty clause.
In summary, even though N95 FFRs are readily available, EHMRs continue to be a long-term PPE solution for LifeLine. Their sustained use has supported a reduction in N95 FFR purchasing, saving thousands of dollars to date. The support of federal agencies in this initial procurement and research effort was able to alleviate stress at the onset of the program. It is our hope that sharing this experience will help to inform future programs for and long-term PPE solutions for EMS personnel.
Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. Mention of any company or product does not constitute endorsement by the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.
Attribution: N95 and NIOSH Approved are certification marks of the U.S. Department of Health and Human Services (HHS) registered in the United States and several international jurisdictions. P100 is a certification mark of the U.S. Department of Health and Human Services (HHS) registered in the United States.
1. U.S. Centers for Disease Control and Prevention. Optimizing Supply of PPE and Other Equipment during Shortages. Updated July 16, 2020. Available at: www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/general-optimization-strategies.html. Accessed November 9, 2022.
2. Federal Register. (2020, 03/27/2020). Notice of emergency use authorization declaration, 85 FR 17335, pgs 17335-17336. Document number: 2020-06541. Published March 27, 2020. Available at: www.federalregister.gov/documents/2020/03/27/2020-06541/emergency-use-authorization-declaration.
3. U.S. Centers for Disease Control and Prevention. Elastomeric half mask respirator resources. Updated February 15, 2022. Available at: www.cdc.gov/niosh/npptl/respirators/elastomeric/default.html. Accessed November 9, 2022.
4. Federal Register. (2020, 09/14/2020). A National Elastomeric Half Mask Respirator (EHMR) Strategy for Use in Healthcare Settings During an Infectious Disease Outbreak/Pandemic. 85 FR 56618, Vol. 85, No. 178. www.govinfo.gov/content/pkg/FR-2020-09-14/pdf/2020-20115.pdf.