key: cord-0768073-s79gl168
authors: Holdsworth, Jill; Preston, Aaron; Gentile, Paul; Rider, Patricia; Yallew, Winta; Juno, Zach
title: Process for disinfection of N95 respirators during COVID-19 utilizing sterile processing department: A single center acute care hospital
date: 2020-12-13
journal: Am J Infect Control
DOI: 10.1016/j.ajic.2020.12.004
sha: 4a8251dceb56c7c95ffcf2fe185d7e1c4769a7b8
doc_id: 768073
cord_uid: s79gl168

During the COVID-19 crisis, disposable N-95 filtering face piece respirators became a critical supply in many health care institutions. Infection preventionists nationwide struggled with ensuring their facilities had personal protective equipment available while utilizing crisis capacity strategies. Many facilities began using US Centers for Disease Control and Prevention and US Food and Drug Administration guidance to disinfect and reprocess N95 respirators for extended use. N95 respirators are collected for all clinical units on a scheduled basis by the sterile processing department (SPD) in individually labeled bins. Bins are checked into SPD and logged into electronic system to track mask volumes by unit. Masks are inspected by SPD team members, packaged in sterile peel packs on the decontamination side and sent to the clean side of the department. Masks are then reprocessed in the appropriate equipment based on the US Food and Drug Administration Emergency Use Authorization guidelines. The facility was able to provide a consistent method of N95 reprocessing throughout the facility. Utilizing an interdisciplinary team to include the operating room, infection preventionist, SPD, and nursing leadership to troubleshoot and identify barriers on a routine basis was key to making the program a success for the many months of the COVID-19 pandemic.

With the beginning of the coronavirus crisis in China at the end of 2019, now known as COVID-19, health care facilities across the world began analyzing stock and supply of personal protective equipment (PPE). Disposable N95 filtering facepiece respirators (FFR), referred to as N95 respirators, are critical pieces of PPE recommended for the care of COVID-19 patients. 1 With the onset of crisis capacity in early March health care facilities began utilizing crisis capacity strategies for PPE conservation or risk depletion of PPE. A national survey of 1,140 infection preventionists (IPs) in March 2020 by the Association for Professionals in Infection Control and Epidemiology found that 233 (20.46 %) reported their facilities have no respirators; an additional 317 (27.83%) say they are almost out of these critical devices used to protect health care workers caring for patients with COVID-19 and other infectious diseases. 2 While disposable N95 filtering face piece respirators are not approved for routine decontamination as conventional standards of care, FFR decontamination, and reuse may be needed during times of critical shortage to ensure continued availability. 3 Lack of necessary supplies can lead to exposures, illness and staff and patient harm. Following US Centers for Disease Control and Prevention (CDC) guidance for limited reuse of N95 respirators and manufacturer guidance for respirator decontamination the decision was made to implement a process for safe reprocessing of N95 respirators. 1 Consideration for decontamination of N95 respirators involve inactivation of the SARS-CoV-2 virus and maintenance of both the fit and filtration efficiency of the N95 respirator while minimizing the risk of crosscontamination for users during donning and doffing. 4

CDC released guidance for facilities to optimize their supply of N95 respirators. Interventions included engineering controls, administrative controls, and respiratory protection based on the level of shortage (Conventional, Contingency, Crisis, and None). Under "Crisis Strategies (during known shortages)", CDC released guidance on potential methods for decontamination. It is important for any health care entity wishing to pursue this part of the CDC guidance for optimizing N95 respirators to know: Latest emergency use authorization (EUA) information from the US Food and Drug Administration (FDA), manufacturer's recommendation for decontamination (if it exists), limitations of decontamination on the respirator, and potential for breakdown of the FFR material if done in the absence of guidance. 4 The FDA on March 2, 2020 released its first EUA regarding disposable FFRs. This same EUA was reissued on March 27 to include language to be decontaminated via an FDA approved decontamination system. 5 The FDA issued its first EUA for decontamination systems for personal protective equipment on March 29, 2020. Since then, there are 9 total decontamination systems with a EUA. 6 This EUA remains in effect during the public health emergency. The EUA gives directions on approved decontamination of the respirators based on criteria set out in the EUA. Facilities are advised to check the respirator manufacturer guidance, the decontamination system being used, and the claims they are stating in using the combination. Mismatches between any of these categories can result in inability of the respirator to provide the perceived protection after decontamination, or overstating results with false sense of security of the wearer. 4 

The N95 respirators are collected on a scheduled basis from the hospital units. Infection Prevention collaborates with the unit leadership to make a decision on where the plastic bins are placed for collection. Each unit is given 2 plastic bins. This enables one bin to be on the unit at all times once SPD picks up the other. Lids secure the respirators in the container, and prevent outside contamination. Prior to placement in the covered plastic bin, the health care workers are instructed to visually assess the mask for visible soil or breakdown in integrity. Upon completion of the visual assessment, the health care worker will label their N95 by writing name on the lower front portion of the mask with a permanent marker. The health care worker will then insert the labeled N95 into a paper bag. The paper bag with the labeled N95 is placed into the plastic bin.

On a scheduled basis, the team member from the sterile processing department (SPD) will make rounds on the units to check if there are any N95s that need to undergo reprocessing. The team member will then collect the labeled N95s in the covered plastic bin and transport to the decontamination area in SPD. All masks must remain in the paper bag that they were stored in while on the unit. If masks need to be transported on nonscheduled pickup days, the unit teams bring the bins down to a designated rack just inside the decontamination area back door.

The masks arrive to the decontamination area of the SPD, where the team members are dressed in appropriate PPE, which consists of hospital laundered scrubs, surgical masks, eye shield, additional fluid-resistant gown, hair cover, shoe covers, and gloves. Masks are first inspected for visible soil, defects, and proper labeling of the employee name. If these parameters are not met, the masks are discarded and a note is sent back in the container to the unit/department to let them know how many masks were processed versus sent and why those that were not returned had to be discarded. Masks are packaged individually in peel packs with the outer surface of the mask facing the clear side of the peel pack so the user can view their name written on the outside of the mask when it is returned. A "tick" mark is placed on each mask before being packaged to demonstrate the amount of times it has been processed, as well as an alphabetical code designation for the type of cycle/equipment it was processed in. Once packaged, the peel packs are sent through the pass-through window, where they are received by a sterile processing technician who prepares them for the appropriate cycle. All masks are logged into the instrument tracking software system by individual unit, to account for total numbers of supplies, and processed mask volume. Each peel pack label for the individual mask contains the unit/department that the mask will be returned to for ease of identification.

The hospital began reprocessing N95 respirators by using the lowtemperature plasma vaporized hydrogen peroxide option first using the before-mentioned process for collection, delivery and preparation in the decontamination area. This method was the first to be approved by an FDA EUA, and thus the first method our facility was able to begin using for reprocessing. Previous studies have demonstrated that N95 respirators still met performance requirements even after decontamination with hydrogen peroxide vapor in the laboratory setting for over 50 times. 7 For our hospital, the barrier for this method was that it only allowed for the mask to be reprocess 2 times along with the 55-minute process time. This machine capacity would only allow for 10 masks to be processed at a time, due to the size of the chamber, which resulted in extended turnaround time and hindered the workflow of the department. Also, masks must be aerated after the process was completed for 1 hour, increasing the total turnaround time. 8 

The facility began the new method of low-temperature vaporized hydrogen peroxide reprocessing, in addition to the before-mentioned plasma H 2 O 2 method, when the additional FDA EUA was approved. This assisted with workflow, as the 2nd method utilized a newer machine with a shorter cycle time of 28 minutes, as well as allowing 10 cycles before the mask must be discarded and no requirement for aeration. All masks that began with the first method were completed with that process and could not be combined with the second method. Advantages included shorter overall turnaround time for the process and more reprocessing cycles per each mask. This method also allowed for approximately 10 masks per cycle due to chamber size.

The FDA has granted an additional EUA in June 2020 to temporarily provide an option to effectively decontaminate certain NIOSH approved respirators up to 10 times using certain steam sterilizers. This opened up a new workflow and capacity for the facility for N95 reprocessing in that each cycle could hold up to 180 masks at one time. The steam decontamination cycle parameters are lower than ARTICLE IN PRESS the normal operating temperature for a steam sterilizer and are achieved once the temperature, pressure, and time parameters of 145.4-163.4 F are reached. The team altered the current workflow to accommodate for increasing Operating Room volumes due to hospital recovery and chose to prepare/package masks during 3rd shift/ overnight, and begin prepping the sterilize for the decontamination cycle early in the morning. The masks would be placed in peel packs on the sterilizer rack overnight for efficient workflow in the morning when the sterilizer was ready. This improved overall workflow turnaround time and allowed for one cycle run per each day with all masks included in the cycle. 9

Once the N95s are reprocessed, a designated health care worker from the unit will pick up the reprocessed N95s from an assigned location at SPD in a newly cleaned plastic bin. Upon receipt, health care workers are advised to make sure there's a chemical indicator inside of the peel pack which ensures that the sterilization process was completed satisfactory. For quality control purposes, the chemical indicator is added to ensure the sterilant achieved good penetration for the N95s being decontaminated. Reprocessed N95 remains in the peel pack until use.

The hospital worked diligently to reduce the burn rate of PPE in the face of this pandemic. This process gave confidence to the front line level staff that were inundated with patients both with a positive COVID-19 screening and those under investigation. We optimized the sterilization process through the use of our electronic tracking software, helped contribute to the department's productivity. Our SPD's productivity is based on items processed whereas trays count singularly and 10 peel packs are counted as one tray. This process could be further optimized with some sort of metric tied back to the specific unit that the masks came from. Creating a link for logging employee masks that updated to a single repository spreadsheet would be a great way to track compliance for the process by unit.

Ensuring the process was maintained when the operating room (OR) began increasing their caseload was a challenge that required frequent communication between the OR, IP, and SPD teams. Changes to the workflow, collection, and processing schedules as well as pickup and drop-up protocols occurred throughout the process to ensure there was adequate coverage in SPD and also availability of the program to continue.

An interdisciplinary team of facility leaders met on a routine basis to review data and process steps on the program to ensure the process was running as expected and to identify barriers. Members of the IP and Administration team joined the SPD team members during pick-up rounds to identify barriers and assist with providing solution to workflow. Daily PPE calls with clinical leaders were utilized to discuss opportunities related to clean mask pickup and unit readiness for the SPD team to arrive on the unit for soiled mask rounds. An electronic method for submitting soiled mask pickup needs was developed to assist the SPD team workflow, which was submitted for the daily PPE calls with leaders. An interdisciplinary team created a "huddle" call on Fridays with OR, IP, SPD, and Administration to review the week's progress, barriers and successes, which was followed by a Friday recap to all clinical leaders.

Team members throughout the hospital felt comfort and security with receiving their mask back decontaminated and processed in a peel pack. With PPE shortages and reuse of PPE during the COVID-19 pandemic, ensuring that team members felt safe in their PPE was a priority. This process allowed the hospital to work together in ways it had not previously and has set the stage for collaboration with future challenges; a true team effort.

Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings

Protecting Healthcare Workers During the COVID-19 Pandemic: A Survey of Infection Preventionists. Association for Professionals in Infection Control

Optimizing Personal Protective Equipment (PPE) Supplies

A Scientific Consortium for Data-Driven Study of N95 Filtering Facepiece Respirator Decontamination

Implementing Filtering Facepiece Respirator (FFR) Reuse, Including Reuse After Decontamination, When There Are Known Shortages of N95 Respirators

emergency-use-authorizations-medical-devices/decontamination-systems-personal-protective-equipment-euas

Decontamination and Reuse of N95 Respirators with Hydrogen Peroxide Vapor to Address Worldwide Personal Protective Equipment Shortages During the SARS-CoV-2 (COVID-19) Pandemic

Instructions For Use for Reprocessing N95 Masks in STERRAD Sterilization Systems During the COVID-19 Public Health Emergency