An Overview of Pandemic Guidance 
BY MARK TARTAGLIA, SCOTT C. SHINN, AND PAUL E. ALLEN
Decontamination and Reuse of PPE in Healthcare

The impact of COVID-19 on the healthcare industry has been seen far and wide—specifically, in healthcare settings during the early months of the pandemic when stresses on the personal protective equipment supply chain created situations where reuse strategies were being considered. As industrial hygienists, we recognize that reusing disposable PPE is a last resort and should only be considered when all other options have been eliminated.  Given the current environment, it is important to understand PPE reuse and extended-use guidance that has been shared by OSHA, CDC, and other United States governmental entities. OEHS professionals in the healthcare industry must also know how to efficiently and effectively evaluate the best PPE options for each healthcare setting. Research, testing, and guidance for the use and reuse options are changing rapidly and will need to be monitored on an ongoing basis.
REUSE OF RESPIRATORY PROTECTION
One of the more common types of respiratory protection used in the healthcare industry is the N95 filtering facepiece respirator (FFR), including a surgical or healthcare N95 respirator. OSHA defines FFR as “a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium.” As it had for other PPE, the COVID-19 pandemic resulted in incredibly high demand for FFRs, and despite significant increases in production capabilities by respirator manufacturers, FFRs continue to be in short  supply. This shortfall has led some healthcare facilities to explore methods of extended use or reuse of FFRs, find alternative types of respiratory protection, or both. CDC has issued guidance on reuse and disinfection of FFRs, recommending contingency and crisis strategies, including the use of FFRs past their shelf life, extended use of FFRs, use of other types of respirators, use of respirators from other countries, reuse of respirators, and decontamination of respirators. Decontamination of FFRs should only be considered after all other options have been eliminated.
Extended Use or Reuse Options
Extended use and limited reuse of FFRs are two contingency and crisis capacity strategies suggested by CDC.
Extended
use refers to the practice of wearing the same N95 respirator for repeated close contact encounters with several patients without removing the respirator between patient encounters. Reuse refers to the practice of using the same N95 respirator for multiple encounters with patients but removing it after each encounter. The respirator is stored in between encounters to be put on again prior to the next encounter with a patient. Implementing these strategies should be given careful consideration. All decisions regarding extended use and reuse should be made jointly with the facility’s respiratory protection program manager and industrial hygiene/occupational health and infection control staff. Extended use or reuse of an FFR does not come without risk. A portion of pathogens that accumulate on the outer surface of the respirator may be transferred to the respirator wearer’s hands during handling, which could create risk of infection if hand hygiene is not properly practiced. 
Decontamination and Reuse
Decontamination and reuse of FFRs should be considered only as a last resort. If it is determined that this is the only option available, there are at least four key aspects of successful decontamination of respirators that should be considered. The decontamination method must: 
  • inactivate the target organism, such as the virus that causes COVID-19
  • not damage the respirator’s filtration
  • not affect the respirator’s fit
  • be safe for the person wearing the respirator
FFRs are tight-fitting respirators and rely on a good seal in addition to effective filter media to provide the specified level of protection. If the respirator filtration is damaged or the respirator fit compromised as a result of the decontamination process, it will not help reduce exposure to airborne particles at the level indicated, such as N95, N100, and so on. CDC recommends a wait-and-reuse approach, based on surface survivability research, before considering other decontamination approaches. Key points from the CDC guidance are:
  • The healthcare staff member can wear one N95 FFR each day and store it in a breathable paper bag at the end of each shift with a minimum of five days between each N95 FFR use, rotating the use each day between N95 FFRs.
  • As a caution, healthcare personnel should treat reused FFRs as though they are contaminated.
  • If supplies are even more constrained, and five respirators are not available for each worker who needs them, N95 FFR limited reuse with FFR decontamination may be necessary.

It is important to also remember that according to OSHA, decontaminating FFRs voids the respirators’ NIOSH approval. However, OSHA has published an enforcement memorandum indicating that during the COVID-19 pandemic, U.S. healthcare employers may consider using certain decontaminating methods in their procedures for reusing N95s. This dispensation stands only if employers have eliminated many other options, such as the strategies recommended by CDC, including engineering and administrative controls to reduce the need for respiratory protection or managing the use of respirators to try to ensure adequate supply. OSHA emphasizes that employers should look to respirator manufacturers for guidance regarding which decontamination methods are compatible with specific respirator models. Several companies that manufacture decontamination equipment are assessing decontamination processes for FFRs, and the Food and Drug Administration is evaluating and granting Emergency Use Authorizations (EUAs) for such decontamination systems during the COVID-19 outbreak. All issued EUAs for PPE with regard to COVID-19 are available on the FDA website. Currently, CDC is suggesting that the methods listed below have shown the most promise for FFR decontamination:
  • vaporous hydrogen peroxide
  • ultraviolet germicidal irradiation
  • moist heat (for example, using water heated in an oven)

Research, testing, and guidance on FFR decontamination are rapidly changing; thus, it is imperative that healthcare facilities review the most current information published by CDC and consult the respirator manufacturer prior to any decisions about decontamination and reuse.
Use of Other Types of Respiratory Protection
Another strategy suggested by CDC when FFRs are in short supply is use of another type of respirator. This may include half and full elastomeric facepiece respirators and powered air-purifying respirators (PAPRs) with a tight-fitting half or full facepiece or a loose-fitting head cover. Unlike FFRs, which are designed to be discarded at the end of their useful life instead of cleaned or decontaminated, elastomeric respirators and PAPRs are designed and intended to be cleaned and reused.  Respirator manufacturers will provide instructions for cleaning and disinfecting respirator facepieces and exterior surfaces for PAPR components. It is generally not recommended that filter media be cleaned and disinfected; filters and cartridges should be discarded and replaced at the end of service life. Some filters, however, are covered by a hard protective case, and it may be acceptable to wipe clean and disinfect the external surfaces of these items. 
Possible disinfection methods include:
  • sodium hypochlorite solution (at a free chlorine concentration of 5,000 ppm) with one-minute contact time
  • 70 percent isopropanol solution with one-minute contact time

EPA maintains a list of registered disinfectants and their effectiveness against common pathogens. Healthcare facilities should review this information thoroughly prior to selecting a disinfecting product for their equipment and specific application, and follow established hygiene and infection control practices for the targeted organisms, including coronaviruses. Respiratory protection program administrators should be aware that certain cleaning and disinfectant solutions may damage respirator components, and protocols must include rigorous inspection and maintenance elements. Always consult with respirator manufacturers, including the user instructions as well as applicable government guidance, prior to selecting a disinfectant.
REUSE OF PROTECTIVE GARMENTS
The COVID-19 pandemic has resulted in comparable high demand for and shortages of protective garments despite the significant increases in production capabilities by garment manufacturers. The shortfall has led healthcare facilities to explore methods of extended use or reuse of isolation gowns, the most common protective garment in use, and find alternative types of acceptable protective clothing. In this article, the term “isolation gowns” is used to refer to the variety of gown types worn in healthcare settings. As with FFRs, CDC has issued guidance on reuse of isolation gowns used for the protection of healthcare workers as part of the agency's strategies for optimizing PPE supplies. The CDC guidance provides contingency and crisis strategies, including the use of gowns past their shelf life, extended use of gowns, use of gowns from other countries, use of other types of protective garments, and reuse of gowns. CDC offers other strategies prior to the reuse of gowns, such as prioritizing gown use for high exposure risk activities or cancelling non-urgent and elective procedures that would otherwise consume supplies. While CDC is not advocating the decontamination and reuse of gowns, FDA has issued an EUA granting consent for the decontamination and reuse of a limited selection of gowns and other apparel. Decontamination and reuse of gowns should only be considered after all other options have been eliminated.
Unlike for FFRs, there is a lack of official guidance on decontamination and reuse for gowns.
Extended Use or Reuse Options
Extended use and limited reuse of isolation gowns are two contingency and crisis capacity strategies suggested by CDC.
Extended
 use refers to the practice of wearing the same gown for repeated close contact encounters with several patients, without removing the gown between patient encounters; while reuse refers to the practice of using the same gown for multiple encounters with patients but removing it after each encounter. The gown is stored in between encounters to be put on again prior to the next encounter with a patient.  The use of disposable versus reusable gowns is an additional consideration to factor into the reuse decision. Cloth gowns are believed to be more amenable to reuse without laundering due to their lower susceptibility to damage to ties or fasteners during the doffing process. Extended use or reuse of an isolation gown comes with risk. In addition to potential damage to disposable gown components during doffing, contamination of the outer gown surface may be transferred to the wearer, which could create risk of infection if proper doffing, subsequent handling, and hand hygiene are not practiced. In all cases, any gown that becomes visibly soiled during patient care should be disposed of or decontaminated for reuse. Implementation of these strategies should be given careful consideration. All decisions regarding extended use and reuse should be made jointly with the facility’s industrial hygiene/occupational health and infection control staff.
Use of Other Types of Protective Garments
Another strategy suggested by CDC when gowns are in short supply is the use of another type of protective garment. This may include coveralls that provide 360-degree protection since they cover the whole body, including the back and lower legs. In some cases, they also may cover the head and feet. Comparisons between coveralls and gowns can be found in CDC’s guidance on the considerations for selection of protective clothing in healthcare. Both have been used effectively by healthcare workers for patient care in clinical settings. Healthcare workers are generally more familiar with the use of gowns compared to coveralls, and the former are easier to don and doff. While coveralls provide more body protection than gowns, they may also be associated with heat buildup inside the coverall.  According to FDA guidance, if no gowns are available, healthcare facilities should refer to the guidance in CDC’s “Considerations for Selecting Protective Clothing Used in Healthcare for Protection Against Microorganisms in Blood and Body Fluids” to identify acceptable alternatives.
Decontamination and Reuse
Unlike for FFRs, there is a lack of official guidance on decontamination and reuse for gowns. Other than an EUA from the FDA, there is no other official guidance from CDC or OSHA regarding the decontamination and reuse of isolation gowns or other protective garments for healthcare. The scope of the FDA EUA for decontamination and reuse of gowns is limited to certain approved products for use in low- or minimal-risk-level care to COVID-19 patients as classified by CDC. Gowns exempt from premarket review are included in the EUA; however, gowns subject to premarket review and ones intended to provide Level 3 or Level 4 liquid barrier protection under the FDA- recognized ANSI/AAMI PB70 standard are not included in the scope of the EUA. Level 3 and 4 gowns are ones with demonstrated liquid barrier performance against microorganisms, including viruses. The reuse of gowns under the FDA EUA is limited to those covered gowns that have been decontaminated by an authorized decontamination system. FDA issues individual EUAs authorizing acceptable decontamination systems. Some organizations, such as EPA and ASTM International, are attempting to address the lack of official guidance for gowns and are developing guidelines and standards.  Decontamination and reuse of gowns or other protective garments should be considered only as a last resort. If it is determined that this is the only option available, at least four key aspects of successful PPE decontamination should be considered. In the case of protective garments, the decontamination method must: 
  • be harmless to the user
  • ensure the original performance properties of the garment
  • remove the viral threat—in this case, the SARS-CoV-2 virus
  • not compromise the integrity of both the garment fabric and components (thread, elastic, zippers, ties, and so on)
Methods of decontamination that may have effectiveness for protective garments include:
  • ultraviolet (UV) irradiation
  • ethylene oxide
  • vapor-phase hydrogen peroxide
  • moist or dry heat
  • washing (if compatible with the fabric material)
As research, testing, and review of applicable government guidance for the use and reuse of PPE continue to evolve, facilities should monitor governmental guidance to inform their practices in their ongoing operations. As the overall strain on the PPE supply chain is lowered, the need to reuse PPE for multiple patient interactions should be reduced. Simultaneously, it is preferred to resume standard practices as PPE availability increases. If the need develops to consider the reuse and extended use strategies in the future, each facility will need to evaluate the best options for their operation after consulting with their safety professionals, industrial hygienists, and members of the infection control team.
MARK TARTAGLIA, MSPH, CIH, is president and principal consultant, EHS Impact Solutions LLC.
SCOTT C. SHINN, CIH, is advanced technical service specialist, 3M Personal Safety Division.
PAUL E. ALLEN, CIH, CSP, ARM, AOEE, is risk control consulting director, Industrial Hygiene, CNA. Send feedback to The Synergist
Disclaimer:
This material is intended to present a general overview for illustrative purposes. The information, examples, and suggestions presented in this material have been developed from sources believed to be reliable, but they should not be construed as legal or other professional advice. CNA accepts no responsibility for the accuracy or completeness of this material and recommends the consultation with competent legal counsel and/or other professional advisors before applying this material in any particular factual situations.