The National Institute for Occupational Safety and Health (NIOSH) is seeking input to develop procedures for decontamination of reusable elastomeric respirators, which could be an important and sustainable resource in times of high PPE demand.

Reusable elastomeric respirators with N95 cartridges were used to protect healthcare workers during the SARS outbreak of 2003 and the flu pandemic in 2009. However, there is a need for a standardized protocol to clean and disinfect the elastomeric respirators.

“NIOSH is interested in improving understanding of the best practices for disinfecting and cleaning reusable respirators, appropriate applications for use, and how best to educate and train healthcare workers on proper use of elastomeric respirators,” an agency representative wrote in an email to Hospital Employee Health. “Elastomeric half-face respirators are not commonly used today, but we are aware of the point-of-use challenges and we are seeking expert input on the matter. NIOSH is seeking to sponsor one or more workshops in the coming months to discuss these issues with our partners, stakeholders, and experts in the field.”

There is a pressing need for more PPE options, as the supply chain has little capacity for surge production, resulting in challenges to meeting large, unexpected increases in demand that might occur during a public health emergency, the CDC reports in a new study.1 Additionally, much of the PPE is produced offshore and might not be available to the U.S. market during an emergency.

“The availability of respiratory protective devices remains a major gap in pandemic influenza preparedness,” says Anita Patel, PharmD, MS, the lead author of the paper and a senior advisor on pandemic medical care at the CDC. “Elastomeric respirators are a reusable option that needs to be explored further for feasibility and acceptability for use by select healthcare workers. These possible product options could dramatically decrease the demand on traditional disposable respirators during a pandemic influenza response.”

The 2009 H1N1 influenza pandemic and the 2014 Ebola virus epidemic revealed that adequate stores of PPE are a critical component of the response.

“During the 2009 H1N1 pandemic, as an important component of infection control strategy, CDC recommended respiratory protective devices for healthcare workers, including first responders, when ‘caring for persons with known, probable, or suspected 2009 H1N1 [infection] or influenza-like illness,’’’ Patel and colleagues noted. “Upon release of these recommendations, it became apparent that limited supplies could make the recommendations difficult to implement. Although the release of N95 respirators and facemasks from the federal Strategic National Stockpile increased facility inventory levels, products received were not necessarily the items on which hospital staff were trained and fit tested, posing additional challenges.”

Both the disposable N95 and the reusable N95 elastomeric respirator have a NIOSH assigned protection factor of 10, meaning with proper use as part of a respiratory protection program they will, at minimum, reduce the aerosol concentration to which the wearer is exposed to one-tenth room air levels.

The issue of the potential benefit and current underuse of elastomeric respirators was recently raised in a blog post by Michael Bach, PhD, RN, an American Association of Colleges of Nursing fellow with NIOSH.

“Most healthcare workers are aware of the N95 respirator but may not be aware that the reformable, reusable elastomeric respirators are a viable option for respiratory protection,” Bach wrote.2 “The facepiece is made of synthetic or rubber materials that form a seal against the user’s face, with properties that allow the original shape to be repeatedly re-established if it is temporarily deformed. As the facepiece of the elastomeric respirator should form a tight seal against the user’s face, just like the disposable [N95s], fit testing is still required.”

The best way to disinfect the respirators is with a water-diluted bleach mixture, Bach notes, but adds “the use of bleach and water is not practical between patients. Therefore, alcohol may be used for disinfection by wiping the exterior surface. … Unfortunately, procedures for disinfection and decontamination within healthcare environments are not routine and must be established for the environment where elastomerics may be used.”

One facility developed a cleaning protocol3 with a diluted bleach solution, showing that elastomeric respirators could be reused in a pandemic situation. However, the standard operating procedure (SOP) was not designed for routine use and cleaning the masks between patients. Thus, the issue of transmission via a contaminated respirator serving as a fomite would remain in routine practice. The assumption was that during a pandemic, healthcare workers would be treating cohorts of infected patients, thereby allowing them to clean their masks at the end of their shifts, leaving them to dry in a designated area until they report back to work.

“Frankly, if we had a pandemic, elective cases would stop being done and the hospital becomes a place to care for the pandemic respiratory illness,” says Mary T. Bessesen, MD, lead author of the study and a clinician at Denver Veteran’s Administration Medical Center. “A healthcare worker would likely have all of their patients with the pandemic illness. It wouldn’t be like it is today, where a nurse would have five patients and put on a mask for only one of them. So, she disposes of that disposable mask at the end of caring for that patient. Here, we are thinking of a disaster scenario.”

In the study, healthcare workers were provided with manufacturers’ cleaning and disinfection instructions and all necessary supplies. They were observed and filmed. SOPs were developed based on the observations, and tested on new group of healthcare workers.

“When using respirator manufacturers’ cleaning and disinfection instructions without specific training or supervision, all subjects made multiple errors,” Bessesen and colleagues reported. “When using the SOPs developed in the study, without specific training or guidance, naïve healthcare workers disinfected respirators with zero errors. Reusable facial protective equipment may be disinfected by healthcare workers with minimal training using SOPs.”

The elastomeric respirators were generally comfortable to wear and easier to breathe through than an N95, she says. On the downside, the respirators the hospital tested are somewhat imposing-looking and may frighten patients, with twin filters on either side of the face giving them a more industrial or military look. Presumably, this would become normalized during a pandemic, she says. Can someone adapt the cleaning SOP for routine use?

“There is a drying time issue, so if you were going to do it, you would have to use hospital air [to blow them dry], but I think it’s feasible,” Bessesen says. “The issue would probably be space — you would have to do this on the nursing unit.”

To have other employees cleaning the respirators for reuse in a designated area would be more of a “central service approach,” she says. “We early on judged that to be less feasible in a pandemic situation, and it would be more practical for each healthcare worker to be responsible for his or her equipment.”

NIOSH Q&A

HEH requested further comment from NIOSH on this issue and received the following answers via email from Bach and three colleagues: Lewis Radonovich, MD, senior physician scientist at the National Personal Protective Technology Laboratory (NPPTL) at NIOSH; Ron Shaffer, PhD, chief of NPPTL’s Research Branch, and Debbie Novak, PhD, RN, senior service fellow with NPPTL.

HEH: Can you comment on why most healthcare workers may not be aware of elastomeric respirators?

NIOSH: There are a variety of respiratory protective devices, configurations, makes, and models used in U.S. healthcare. During periods of high demand, the healthcare workforce needs to be aware of supply chain issues so suitable alternatives may be identified.

Estimates indicate that the N95 filtering facepiece respirator has been, and continues to be, the most common respirator used by U.S. healthcare workers.3 Therefore, elastomeric respirators are not commonly used in healthcare, although some institutions have viewed them as a cost-conscious and sustainable alternative, especially when the demand for disposable respirators is unusually high. The availability of personal protective equipment on the U.S. market is closely linked to consumer demand with limited elasticity to meet unexpected surges.

Among facilities polled in 2014 and 2015, the reported usage of elastomeric respirators amounted to 25-35% of all respirators used in healthcare, and most of the respondents who reported using elastomeric respirators were from the Midwest. Therefore, depending on the geographical area, the healthcare workers may not be aware that reusable N95 elastomeric respirators may be a viable option.

A case study in the “Implementing Hospital Respiratory Protection Programs: Strategies from the Field” publication highlights one U.S. hospital that uses the elastomeric half-face respirator exclusively. This facility chose the reusable respirator because “they feel it provides a more reliable and comfortable fit, offers better respiratory protection, is cost-efficient, and it is less time-consuming for fit testing.”4

HEH: The blog notes that the original shape of the elastomeric facepiece can be reformed. Can you comment a little more on why the elastomeric still needs to be fit tested and how often that should be done?

NIOSH: Fit testing is required for all users of tight-fitting respirators, including filtering facepiece and elastomeric respirators. The fit test ensures that the selected brand and size of respirator fits adequately, when donned properly, to protect the wearer from excessive inward leakage of contaminant around the face seal. The fit test must be repeated annually and whenever the employee reports, or the employer, supervisor, or program administrator makes visual observations of, any changes in the employee’s physical condition, such as weight gain or loss, facial scarring, or dental changes that could alter fit of the facepiece. Since many brands and models of elastomeric respirators exist, fit testing continues to remain necessary for proper fit.

HEH: Can you clarify the concern regarding disinfecting the respirators? Is there a possibility that the healthcare worker would expose a subsequent patient to pathogens on the mask from a previous patient?

NIOSH: The purpose of disinfection is to reduce the chances that the respirator would serve as a fomite. Pathogens on the respirator surface may potentially be transferred from one person to another via contamination of the wearer’s hands. However, when an infectious outbreak occurs, it can be very difficult to trace a specific healthcare-acquired infection to a contaminated object. Accordingly, we are not aware of any clinical studies that have clearly established a link between a contaminated respirator and secondary infection.5

The Occupational Safety and Health Administration (OSHA) and NIOSH offer general procedures for disinfecting and cleaning reusable elastomeric respirators; however, specific standard operating procedures are needed for guidance within healthcare facilities.

HEH: You point to the need for education about the elastomeric respirator, but it seems until the aforementioned problems are addressed, routine use could be limited.

NIOSH: It is important for infection prevention and control and safety professionals to understand options for respiratory protection in healthcare. We aim to discuss this topic at the planned workshop(s). Respirator manufacturers often have specific recommendations for their products. From time to time, NIOSH publishes general recommendations or best practices. For example, the Hospital Respiratory Protection Program Toolkit6 is a resource for program administrators and provides insight for the use of respirators. NIOSH seeks to shepherd additional educational and procedural information to marketplace in the near future.

REFERENCES

  1. Patel A, D’Alessandro MM, Ireland KJ, et al. 2017. Personal protective equipment supply chain: Lessons learned from recent public health emergency responses. Health Secur 2017;15(3):244-252.
  2. Bach M. Understanding respiratory protection options in Healthcare: The Overlooked Elastomeric. July 6, 2017. Available at: http://bit.ly/2etKDkU.
  3. Bessesen MT, Adams JC, Radonovich L, et al. Disinfection of reusable elastomeric respirators by health care workers: A feasibility study and development of standard operating procedures. Am J Infect Control 2015;43:629-634.
  4. The Joint Commission. Implementing Hospital Respiratory Protection Programs: Strategies from the Field. Oakbrook Terrace, IL: Dec. 2014: http://bit.ly/2eBHqMf.
  5. Fisher EM, Shaffer, RE. Considerations for recommending extended use and limited reuse of filtering facepiece respirators in health care settings. J Occup Environ Hyg 2014;11:D115-D128.
  6. NIOSH. Hospital respiratory protection program toolkit resources for respirator program administrators. Available at: http://bit.ly/2gJfMBC.