OSHA guidance allows use of decontaminated masks under certain conditions
by A.J. Plunkett (aplunkett@decisionhealth.com)
If you are authorizing the decontamination and reuse of N95 or other protective face masks for healthcare personnel in the face of supply shortages, ensure you are updating your respiratory protections policies, training your personnel, and documenting the evidence-based criteria you are using to reuse the masks.
Just as it did with fit-testing requirements for filtering facepiece respirators (FFR), OSHA is telling it inspectors to review “good-faith efforts” made by employers in decontaminating and reusing the masks when supplies are short.
In absence of those efforts, however, employers could receive citations under the “serious violation” category. Depending on the gravity of the hazard, a citation means civil penalties between $964 and $13,494 per violation.
The April 24 memo for administrators of federal and state OSHA regulations outlines acceptable methods of decontaminating the FFRs and what inspectors should take into consideration when investigating violations of the federal Respiratory Protection standard.
The interim guidance, “Enforcement Guidance on Decontamination of Filtering Facepiece Respirators in Healthcare During the Coronavirus Disease 2019 (COVID-19) Pandemic,” says that overall OSHA will continue to hold employers accountable for protecting workers from respiratory hazards. It encourages employers to reassess other ways of protecting workers, such as providing barriers or other engineering controls, changing work practices, or issuing administrative controls to decrease the need for respirators,
However, OSHA says it recognizes ongoing supply limitations, and that it will also recognize the use of decontaminated FFRs.
Reprocessing N95 and other masks to protect healthcare workers from aerosolized COVID-19 particles has become a focus in healthcare in the face of a worldwide supply shortage of the masks and other personal protective equipment (PPE).
Effectiveness must be evidence-based
The chosen methods of decontamination must be based on evidence of effectiveness. According to the memo:
“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.”
The memo also outlined unacceptable methods:
“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:
- Autoclaving;
- Dry heat;
- Isopropyl alcohol;
- Soap;
- Dry microwave irradiation;
- Chlorine bleach; and/or
- Disinfectant wipes, regardless of impregnation (i.e., chemical saturation); and/or
- Ethylene oxide (EtO).”
It notes that the latter, EtO, is a known carcinogen.
Employers should still manage their respiratory protection programs in accordance with the OSHA requirements, including identifying and evaluating ongoing hazards, and updating and implementing worksite-specific procedures to maintain protection. Written programs should be updated to reflect changes.
Good faith efforts outlined
The memo also outlines what inspectors should look for when investigating respiratory protection problems, including if the employer made a good-faith effort to protect workers.
Here are the efforts inspectors are being told to look for “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.[11]
- Train employees to follow appropriate precautionary measures prior to using a decontaminated filtering facepiece respirator (FFR). See www.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 www.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.”
What OSHA inspectors will be looking for
In considering whether to issue a citation, inspectors are told:
“OSHA will, on a case-by-case basis, exercise enforcement discretion related to the reuse of FFRs that have been decontaminated using the methods recommended above when considering issuing citations under 29 CFR § 1910.134(d) and/or the equivalent respiratory protection provisions of other health standards in cases where:
- Other feasible measures, such as using partitions, restricting access, cohorting patients, or using other engineering controls, work practices, or administrative controls that reduce the need for respiratory protection, were implemented to protect employees;
- The employer has made a good faith effort to obtain other alternative FFRs, reusable elastomeric respirators, or PAPRs, including NIOSH-certified equipment or equipment that was previously NIOSH-certified but that has surpassed its manufacturer's recommended shelf life (in accordance with OSHA's April 3, 2020 memo), that is appropriate to protect workers;
- The employer has monitored its supply of FFRs, prioritized their use according to CDC guidance (www.cdc.gov/coronavirus/2019-ncov/release-stockpiled-N95.html; www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html), and controlled the number of times a respirator is decontaminated before issuing a new one given supply level and burn rate considerations; and
- Surgical masks and eye protection (e.g., face shields, goggles) were provided as an interim measure to protect against splashes and large droplets (note: surgical masks are not respirators and do not provide protection during aerosol-generating procedures).
“Where the above efforts are absent and respiratory protection use is required, or voluntary use is permitted, and an employer fails to comply with fit testing, maintenance, care, and training requirements, cite the applicable provision(s) of 29 CFR § 1910.134 as serious violations.”
Here is a list of the temporary guidance OSHA has issued related to the COVID-19 public health emergency, as of April 24:
- 04/24/2020 — Enforcement Guidance on Decontamination of Filtering Facepiece Respirators in Healthcare During the Coronavirus Disease 2019 (COVID-19) Pandemic
- 04/16/2020 — Discretion in Enforcement when Considering an Employer's Good Faith Efforts During the Coronavirus Disease 2019 (COVID-19) Pandemic
- 04/13/2020 — Interim Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19)
- 04/10/2020 — Enforcement Guidance for Recording Cases of Coronavirus Disease 2019 (COVID-19)
- 04/08/2020 — Expanded Temporary Enforcement Guidance on Respiratory Protection Fit-Testing for N95 Filtering Facepieces in All Industries During the Coronavirus Disease 2019 (COVID-19) Pandemic
- 04/03/2020 — Enforcement Guidance for Use of Respiratory Protection Equipment Certified under Standards of Other Countries or Jurisdictions During the Coronavirus Disease 2019 (COVID-19) Pandemic
- 04/03/2020 — Enforcement Guidance for Respiratory Protection and the N95 Shortage Due to the Coronavirus Disease 2019 (COVID-19) Pandemic — [1910.134 App B-1]
- 03/14/2020 — Temporary Enforcement Guidance — Healthcare Respiratory Protection Annual Fit-Testing for N95 Filtering Facepieces During the COVID-19 Outbreak
A.J. Plunkett is editor of Inside Accreditation and Quality.
No ebook available.