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Reprocessing N95 Masks: Q & A with Brandon VanHee

04.24.2020 • Industry News

The global COVID-19 pandemic is putting a huge strain on healthcare systems across the globe. Shortages of critical personal protective equipment (PPE), including N95 respirators, is forcing facilities to ask an impossible question: How do we protect frontline staff without access to needed resources? The simple solution of buying more PPE is often not an option. Many health systems have reported usage increases of 17 times more than average for N95 respirators since treating their first COVID-19 patients. Even with significant production capacity increases from the largest N95 respirator manufacturers like 3M, the supply cannot keep up with demand. To combat this continued supply shortage, facilities have chosen to combine increasing inventory of critical PPE supplies with reprocessing forms of PPE such as N95 respirators. As more facilities take on the challenge of reprocessing items that were designed to be single-use, we have received many questions on the topic.  Brandon VanHee, CRCST, CIS, CER, CHL, AGTS, Clinical Education Manager at Key Surgical, answers the most common questions about N95 reprocessing.

Q: What methods are validated for decontaminating N95 respirators?
A: At the time of this publication, 3M, the largest global manufacturer of N95 respirators, has collaborated with multiple sterilization companies to evaluate validated methods for decontaminating N95 respirators, and many other methods are currently being investigated. The methods that have undergone specific validation/testing for decontamination are vaporized hydrogen peroxide sterilizers and environmental decontamination systems, ultraviolet light environmental decontamination systems, and low temperature moist heat. The US FDA has also recently issued Emergency Use Authorizations (EUA) to sterilization equipment manufacturers including Steris, Advanced Sterilization Products (ASP), and Battelle for emergency use of their products in decontaminating compatible N95 respirators. The table below summarizes the decontamination methods that have been evaluated by 3M at the time of publication.


Q: How can N95 respirators be sterilized if they aren’t being cleaned?
A: This is a great question for a number of reasons, but in order to address it we will have to break it into two separate parts:
  • Are we really sterilizing N95 respirators?
The simple answer is NO! At this point any mention of sterilization of N95 respirators should be considered inaccurate and be more accurately described as decontamination. The term sterilization has very specific requirements and I have not found any documentation of N95 reprocessing research that suggests these requirements are being met. On the other hand, there is abundant data that suggests the decontamination methods that have been evaluated to date are effective against the target organism SARS-CoV-2 which is the causative agent of COVID-19.
  • Do N95 respirators need to be cleaned prior to further reprocessing?
I know, it’s every sterile processing professional’s worst nightmare! The very idea of not cleaning something before putting it into a sterilizer goes against the DNA of sterile processing. The truth of the matter is that there is no identified method of cleaning soil from N95 respirators that will not affect the fit, compromise the filtration integrity, or otherwise damage the respirator. To mitigate the risk of soil interfering with the decontamination process, all N95 respirators MUST be inspected for prior to reprocessing and any respirator that is visibly soiled (e.g. blood, dried sputum, makeup, bodily fluids) cannot be reprocessed and should be discarded.

Q: Why do N95s need to be tracked at the respirator level instead of just by sterilizer load?
A: There are several reasons that it is important for any facility that is reprocessing N95 respirators to track the process at the respirator level. First, OSHA requires that fit tests must be performed before employer-mandated use of N95 respirators and in order for an N95 respirator to be effective, they must create a tight seal between the respirator and the user’s face. For this reason, it is important that any reprocessed N95 respirator be returned to its original user to reduce the risk of fitment and sealing issues.

Another reason that N95s must be tracked at the respirator level, is to ensure the maximum number of reprocessing cycles is not exceeded. Depending on the decontamination method and equipment used, there are varying maximum reprocessing cycles that have been validated to effectively decontaminate N95 respirators without compromising the fit or filtration integrity.

Q: How do I find manufacturer specific protocols and other documentation for decontaminating N95 respirators?
A: Manufacturer specific documentation has become more readily available over the last 2 weeks as the FDA issued EUAs for multiple decontamination methods. As part of the EUA, decontamination system manufacturers are required to provide Instructions for Healthcare Facilities, Instructions for Healthcare Personnel, and Fact Sheets for Healthcare Personnel that outline that provide important information for any facility implementing an N95 respirator decontamination program. Current documentation (at the time of publication) for the manufacturers that have been issued EUAs for decontaminating N95 respirators can be found here:

 
Steris V-Pro Emergency Use Authorization
  Healthcare Facility Instructions
  Healthcare Personnel Instructions
  Healthcare Personnel Fact Sheet
ASP Sterrad Emergency Use Authorization
  Healthcare Facility Instructions
  Healthcare Personnel Instructions
  Healthcare Personnel Fact Sheet
Battelle CCDS Emergency Use Authorization
  Healthcare Facility Instructions
  Healthcare Personnel Instructions
  Healthcare Personnel Fact Sheet
Sterilucent HC80TT Emergency Use Authorization
  Healthcare Facility Instructions
  Healthcare Personnel Instructions
  Healthcare Personnel Fact Sheet
Stryker STERIZONE VP4 Emergency Use Authorization
  Healthcare Facility Instructions
  Healthcare Personnel Instructions
  Healthcare Personnel Fact Sheet























Q: Why can’t N95 respirators containing cellulose be decontaminated? And how do I tell if my respirator contains cellulose?
A: N95 respirators may be able to be decontaminated by certain methods; however, the three decontamination methods that have been issued EUAs from the US FDA utilize vaporized hydrogen peroxide (VHP) to achieve inactivation of the target organism. Cellulose is incompatible with vaporized hydrogen peroxide decontamination systems and any materials containing cellulose cannot be used.

Some of the most common N95 respirators such as 3M’s 1804, 1804S, 1805, 1805S, 1860, 1860S, and 8210 do not contain cellulose and can be decontaminated utilizing some VHP systems. If you’re not sure whether the N95 respirators at your facility contain cellulose, contact the respirator manufacturer before performing decontamination using a VHP system.

Q: Do I need to wear additional PPE when reprocessing N95 respirators?
A: When handling contaminated materials (including N95 respirators) in the decontamination area, normal PPE worn for decontamination including gloves, gown, face shield, and mask, should be sufficient. Additional controls should be implemented to reduce the risk of exposure when transferring potentially contaminated sterilization packaging (i.e. peel pouches) to the decontamination equipment and loading for decontamination. Some examples of additional controls are loading peel pouch sterilization racks in the decontamination area to limit exposure to contaminated material, and the use of closed transportation containers/carts for transfer of contaminated packages that are disinfected after each use.

All personnel handling potentially contaminated items MUST wear gloves and should perform hand hygiene immediately after doffing PPE. Although there currently isn’t data to support the benefit of wearing N95 respirators while handling items that are potentially contaminated with SARS-CoV-2, if they are available, their use should be considered.

Q: Should I be concerned about residual hydrogen peroxide and off-gassing when reprocessing N95 respirators?
A: The safety of frontline healthcare staff is of the utmost importance and many have questioned whether reprocessing N95 respirators is creating more risk than reward. According to toxicological studies performed as part of the N95 decontamination process validation, the N95 respirators decontaminated using processes and equipment that have been issued FDA EUAs are safe for use. With that being said, I am a firm believer in using an abundance of caution regarding the health and safety of healthcare professionals and recommend the use of chemical exposure monitoring systems as an additional safety measure to ensure reprocessing staff are not exposed to harmful levels of hydrogen peroxide vapor during increased utilization of chemical decontamination methods.

There is a high likelihood that reprocessing N95 respirators will become “the new normal” for many facilities during the global COVID-19 pandemic, but it is important to note that whenever possible, N95 respirators should be considered single-use to prevent potential complications associated with reprocessing single-use devices. The decision to reprocess N95 respirators, choosing the most appropriate decontamination modality, and developing standardized processes for collection, reprocessing, and distribution, should happen at the facility level to ensure a safe, effective, and efficient N95 reprocessing program is adopted. Furthermore, new research is constantly being conducted to explore novel N95 respirator decontamination methods and improve on existing methods. It is incredibly important to stay abreast with new developments and continue to provide the highest standards of care for patients and healthcare professionals alike.

Additional helpful links:

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-devices-and-covid-19-coronavirus-pandemic#PPE
https://multimedia.3m.com/mws/media/1824869O/decontamination-methods-for-3m-n95-respirators-technical-bulletin.pdf
https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/index.html
https://www.n95decon.org/






 
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