Guidance for Routine Cleaning and Care of Reusable Respirators
Considerations related to Powered Air-Purifying Respirators (PAPRs) and Full Face, Dual-Cartridge Respirators
In healthcare environments where hazardous drugs (HDs) are handled, ensuring proper use and maintenance of Personal Protective Equipment (PPE) is not just about safety—there are OSHA and USP regulatory implications. USP <800> states “An appropriate full-face chemical cartridge-type respirator or powered air-purifying respirator (PAPR) should be worn when there is a risk of respirator exposure to HDs including when:
- Attending to HD spills larger than what can be contained with a spill kit
- Deactivating, decontaminating, and cleaning underneath the work surface of a C-PEC
- There is a known or suspected airborne exposure to powders or vapors
USP <797> requires the use of sporicidal agents at least monthly to all surfaces of the sterile compounding suite. Some sporicidal agents have demonstrated the ability to decontaminate HD residues on surfaces. Sporicidal agents generally produce noxious odors and gases even when vapor-limiting strategies are employed. So, for these reasons, many organizations choose to provide staff with full respiratory protection against particles and noxious vapors during certain activities in both the HD and non-HD sterile compounding environments.
Full Respiratory Protection: Reusable Respirator Types
There are two common types of full respiratory protection employed in the instances described above. The first is a full-facepiece, chemical cartridge-type respirator (multigas cartridge and P100 filter) which must be used in accordance with the OSHA respiratory protection standard (29 CFR 1910.134). The other type of protection is a powered-air purifying respirator (PAPR) which must be used according to the manufacturer’s (e.g., 3M Versaflo PAPR or MaxAir CAPR Cuff or Shroud) instructions. Though fit-testing of these PAPRs is not required, OSHA does require all respirator users to complete a medical evaluation questionnaire and take initial/annual training on the respirators used. Refer to the link above for specific compliance related to OSHA and respirators.
For more detailed information on these common PAPRs:
- 3M issued a Technical Bulletin titled Respiratory Protection Guidance for Hazardous Drug Handling in Healthcare.
- MaxAir’s CAPR system issued a Frequently Asked Questions document.
Proper use of these devices is essential to avoid contamination, reduce exposure risks, and ensure staff safety.
This blog provides general guidance about the general care of full reusable respiratory protection devices commonly used in sterile compounding.
Considerations in Care and Maintenance of Reusable Respirators
1. Storage: It is best to dedicate a closed plastic bin with a removable top for full face respirators and PAPR storage. Since these are devices donned after performing hand hygiene and either just prior to or just after donning of gowns (HD or non-HD covered by HD), most organizations find it most convenient to store these devices inside these bins on the clean side of the LOD in the anteroom. Respirators should only be placed inside these bins after cleaning reusable parts and replacing single-use parts. Therefore, respirators are stored in a ready-to-use condition. Clean and disinfect the inside and outside of storage containers used for respirators at least monthly with a sporicide. It is also recommended that the surfaces are wiped with sterile IPA after use of the sporicide to prevent residues from damaging the storage container.
2. Donning Respirator: Follow the manufacturer’s instructions on assembly and use of each device. Be aware that the CAPR device has different systems available (cuff, shroud and others though the cuff and shroud systems are most often used in sterile compounding locations). Ensure that the application of the respirator does not compromise the protections afforded by the organization’s standard nonhazardous or hazardous sterile compounding garb such as head covering if donning a full-face respirator. Headcovers and/or facemasks may not be required depending on the system used. Alcohol-based hand sanitizer must be applied to all surfaces of hands and wrists after donning respirator and before donning sterile gloves.
3. Cleaning and Decontamination: After use, remove any single-use parts (if applicable based on the device used and type of system selected such as face seals, helmet covers, etc.). Wipe the reusable parts of the respirator headpiece, belt, hose, cartridges, facepiece and motor/battery kit with a low-lint wipe saturated with TB1-3300 or other disinfectant of choice. Any reusable surfaces should additionally be wiped with IPA to remove residues that could damage the reusable materials. If these items are used in an HD environment, they are not likely to come in contact with HD residues so decontamination with PeridoxRTU is not generally necessary unless desired. Allow the respirator parts to dry before continuing. Never immerse/soak any part of the respirator in cleaning solutions.
4. Respirator Assembly: Should new single-use parts be required, install them at this time. Remove the battery for charging if necessary.
5. Return to Storage: Store the respirator in ready-to-use condition in closed storage in its designated location.
6. Documentation: Document respirator use, cleaning and storage as required by organizational SOPs.
7. Standard Operating Procedures: The garbing SOP must clearly identify the sequence of donning and doffing garb in both HD and non-HD applications in situations where full respiratory protection is required. A separate standalone Full Respiratory Protection SOP is recommended that addresses at least the following in detail:
a. Device used along with parts and specifications of filters to be used
b. Step by step assembly, part changes and disassembly
c. Detailed use, cleaning, and troubleshooting
d. Specification about when to change filters and other disposable parts
e. Initial and ongoing training
f. Competency assessment form
Additional Considerations
- Filter Selection: Organic vapor (OG)/Acid gas (AG) absorbing carbon/Particulate cartridges reduce exposure to both HDs as well as sodium hypochlorite and peracetic acid/peroxide-based cleaning agents. Work with your organization’s occupational health officer and device manufacturer to select the correct cartridges/filters/canisters.
- Routine Filter Changes:
- Change the particulate filters on full face respirators when they are damaged, dirty or difficult to breathe through unless the device manufacturer or organizational Standard Operating Procedures (SOPs) specify more frequent intervals.
- Change the OV/AG cartridges as specified in SOPs. In sterile compounding facilities the anticipated exposure to vapors is extremely low and not practically measured. Therefore, change these cartridges after a specified number of hours or number of uses based on your organization’s occupational health and infection control officers’ recommendations.
- Battery Maintenance: For PAPRs/CAPRs, ensure that batteries are maintained and charged appropriately, as a failure in power can compromise protection during use.
- Training and Monitoring: Staff that may be required to use full-face respirator protection differs depending on your organizational protocols but may include: EVS or pharmacy staff that perform monthly cleaning, those who perform HD spill cleanup and those who decontaminate, clean and disinfect then remove residues in C-PECs by opening the BSC or CACI (thereby loosing containment). Ensure all staff who use full respiratory protection receive initial and ongoing training as required by OSHA and organizational SOPs. Fit-testing is required initially and annually for those using full-face, dual-chamber chemical cartridge respirators.
Your organization is making a commitment to worker safety by providing these devices to staff. It is important to ensure that they are used and maintained properly.
Contact Contec Healthcare today to explore our full line of cleaning solutions designed to meet regulatory standards and keep your staff safe.
