OSHA Issues Guidance For N95 Mask Sterilization
Based on strong demand from hospitals and other healthcare organizations, the Occupational Safety and Hazard Administration (OSHA) issued guidance for the reuse of N95 respirators. As many hospitals are facing an extreme shortage of personal protective equipment (PPE) due to the Covid-19 pandemic, this gives additional credibility to the idea of reusing sterilized N95 masks to address the lack of PPE.
OSHA, citing evidence from the National Institute for Occupational Safety and Health (NIOSH), has provided interim guidance for filtering facepiece respirators (FFRs), such as N95 masks, to give hospitals instructions on what is and is not permissible when it comes to FFR sterilization. The interim guidance from OSHA explains that:
“If respiratory protection must be used, and acceptable alternatives are not available for use in accordance with OSHA’s previous COVID-19 enforcement memoranda, NIOSH has identified limited available research that suggests the following methods offer the most promise for decontaminating FFRs:
- Vaporous hydrogen peroxide;
- Ultraviolet germicidal irradiation; and/or
- Moist heat (e.g., using water heated in an oven).
If such methods are not available, the above-referenced NIOSH-evaluated research showed the following methods could also be suitable decontamination options:
- Microwave-generated steam; and/or
- Liquid hydrogen peroxide.
Based on the above-referenced NIOSH-evaluated research, employers should not use the following methods unless objective data that sufficiently demonstrate the safety and effectiveness of such methods become available:
- Dry heat;
- Isopropyl alcohol;
- Dry microwave irradiation;
- Chlorine bleach; and/or
- Disinfectant wipes, regardless of impregnation (i.e., chemical saturation); and/or
- Ethylene oxide (EtO).
The NIOSH-evaluated research provides justification for each method evaluated.
Note that, according to NIOSH, only respirator manufacturers can reliably provide guidance on how to decontaminate their specific models of FFRs. In the absence of manufacturers’ recommendations, third parties (e.g., respiratory protection or other industrial hygiene consultants) may also provide guidance or procedures on how to decontaminate respirators without impacting respirator performance.
Further, the effectiveness of using any of the methods mentioned in this guidance should be explored with specific filtering facepiece respirator models and with manufacturer, and, if needed, third party expert, input and support to better understand the impact on respirator performance, including filtration and fit, and structural integrity (including integrity of head straps and other parts). Employers should be able to demonstrate effectiveness of any decontamination method(s) used against the likely contaminant(s) (i.e., pathogens) of concern. Employers should also ensure that any decontamination method(s) used do not produce additional safety hazards (e.g., electrical arcs resulting from placing FFRs with metal parts into microwaves), or that workers are adequately protected from those hazards through appropriate engineering and administrative controls, safe work practices, and personal protective equipment.
OSHA will continue to consider methods for decontamination of FFRs on a case-by-case basis as objective data demonstrating the safety and effectiveness of such methods become available, and the agency will provide updated guidance, as appropriate.
The following specific enforcement guidance is provided for CSHOs inspecting workplaces where workers are using decontaminated FFRs.
All employers should:
Make a good-faith effort to provide and ensure workers use the most appropriate respiratory protection available for the hazards against which workers need to be protected. Efforts should be consistent with flexibilities outlined in OSHA’s previous COVID-19 enforcement memoranda.
When respirators must be decontaminated to facilitate their reuse in ways consistent with OSHA’s previous COVID-19 enforcement memoranda and the U.S. Centers for Disease Control and Prevention (CDC) Strategies for Optimizing the Supply of N95 Respirators, ensure that decontamination is accomplished according to the methods described above and detailed in CDC’s Decontamination and Reuse of Filtering Facepiece Respirators using Contingency and Crisis Capacity Strategies.
Ensure users perform a user seal check each time they don a respirator. Employers should not permit use of a respirator on which the user cannot perform a successful user seal check. See 29 CFR § 1910.134, Appendix B-1, User Seal Check Procedures.
Train employees to follow appropriate precautionary measures prior to using a decontaminated filtering facepiece respirator (FFR). See cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html.
Train employees using decontaminated respirators to understand that if the structural and functional integrity of any part of the respirator is compromised, it should not be used by that individual as respiratory protection. The inability to achieve a successful user seal check could be an indicator that the integrity of the respirator is compromised.
Visually inspect, or ensure that workers visually inspect, the FFRs to determine if the structural and functional integrity of the respirator has been compromised. Over time or as a result of the decontamination process, components such as the straps, nose bridge, and nose foam material may degrade, which can affect the quality of the fit and seal.
Train employees on the procedures for the sequence of donning/doffing to prevent self-contamination. See cdc.gov/niosh/npptl/pdfs/PPE-Sequence-508.pdf.
If no manufacturer or third-party guidance or procedures are available to support the specific decontamination method(s) employed, avoid the use of decontaminated FFRs when healthcare personnel perform surgical procedures on patients infected with, or potentially infected with, SARS-CoV-2 or perform or are present for procedures expected to generate aerosols or procedures where respiratory secretions are likely to be poorly controlled (e.g., cardiopulmonary resuscitation, intubation, extubation, bronchoscopy, nebulizer therapy, sputum induction). If decontamination methods degrade FFR performance, including filtration and fit, or otherwise affect structural integrity, the decontaminated FFR may not provide the level of protection needed or expected during aerosol-generating procedures.”
In order to effectively track sterilized N95 masks and other personal protective equipment (PPE) and adhere to published guidelines, hospitals and health systems must have the proper protocols and tracking mechanisms in place. Mobile Aspects has developed a unique software tracking system to address this specific challenge. The system works by tracking the number of uses of each piece of PPE using RFID technology to track usage counts at the item level. Whenever an item reaches its usage limit, users will immediately be notified to discard the item. If anyone tries to use PPE past its usage limits, alerts will go out so that the user can be notified. And if anyone is in possession of multiple pieces of in-demand PPE, administrators will be notified so they can instruct the employee to return their excess PPE. With this system in place, hospitals and healthcare systems can be assured that sterilized PPE is being used only as recommended, no more and no less.
If your facility is exploring ways to track sterilized PPE, contact Mobile Aspects to find out more about its innovative new software.