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Reuse of face masks and gowns during the COVID-19 pandemic
21 May 2020: Updated to include new section on Reprocessing of PPE by Healthcare facilities
The Therapeutic Goods Administration (TGA) has received several enquiries from organisations wishing to reuse medical face masks and gowns amid shortages of these products during the COVID-19 pandemic.
In order to make single-use products suitable for reuse, they must be reprocessed. While the TGA understands the critical need to consider all available options to address shortages, it is important to note that reprocessing single-use medical devices to enable their reuse could expose patients and medical staff to unnecessary risks.
Individuals or organisations contemplating reprocessing single-use face masks and gowns for reuse need to check the manufacturer's instructions for use (IFU) and their website. Many products are not suitable for reuse.
The following information aims to ensure organisations clearly understand and minimise the risks of reprocessing single-use medical devices for reuse.
If you are reprocessing a medical device for reuse and then supplying it to another organisation or entity, you will meet the legislative definition of a manufacturer. You will therefore need to meet all the responsibilities of a manufacturer under the therapeutic goods legislation and regulations.
You are also assuming responsibility and liability should the device fail to perform as intended.
What is reprocessing?
Reprocessing is a series of validated processes, carried out in a controlled manner, to render a medical device that has previously been used or contaminated as fit and safe for reuse. Reprocessing steps may include cleaning, disinfection, drying, inspection, testing, packaging, sterilisation, storage and transport.
If you or your organisation are contemplating reprocessing single-use face masks and gowns for reuse, then it is likely that these items will be subject to disinfection processes, rather than a sterilisation process that has been validated to deliver a known sterility assurance level.
It is important that organisations considering reprocessing medical devices intended for single-use understand the following points:
- Disinfection or re-sterilisation alone is not sufficient to render the device fit for reuse.
- Reprocessing (cleaning and disinfection and/or sterilisation) may have a severe deleterious effect on the safety and performance of the masks and gowns that may not be obvious to the end user.
Any individual or entity reprocessing medical devices for reuse meets the legislative definition of a manufacturer under the therapeutic goods legislation and will need to meet all legislative obligations and responsibilities for manufacturers.
These responsibilities include ensuring that reprocessing activities (such as repeated cleaning and disinfection or sterilisation) do not affect the material properties or effectiveness of the device.
Check the original manufacturer's instructions for use or website for information.
Cleaning removes visible soil from a used medical device. Soil includes blood, respiratory secretions, tissue, other biological material, dirt and debris. If not removed properly, soil can interfere with the effectiveness of disinfection and sterilisation processes.
Disinfection kills many microorganisms, including human pathogens, to a level considered suitable for further use or handling of a medical device.
Disinfection, decontamination, bio-decontamination and bioburden reduction usually have the same meaning when referring to reprocessing of a medical device.
Disinfection is not effective against high numbers of bacterial spores.
Sterilisation destroys all microorganisms on a medical device, including high numbers of bacterial spores, rendering it free from contamination of living microorganisms.
Re-sterilisation is exposure of a medical device to more than one sterilisation process.
Regulatory requirements for reprocessed devices
When a single-use medical device is reprocessed for reuse, and then supplied to another organisation or entity, the person or company responsible for carrying out reprocessing activities meets the legal definition of a manufacturer under the Therapeutic Goods Act 1989, as they have:
- changed the intended purpose of the device
- certified the device is suitable for reuse
- assumed legal liability for the quality, safety and performance of the device.
If you are reprocessing single-use medical devices for reuse and on-supply and you meet the definition of a manufacturer, you will need to:
- apply appropriate conformity assessment procedures relevant to the risk classification of the device
- obtain market authorisation by including the device(s) in the Australian Register of Therapeutic Goods (ARTG).
For general information about conformity assessment and including medical devices in the ARTG, please refer to Manufacturing medical devices (including 3D-printed devices) for COVID-19.
Reprocessing of PPE by Healthcare facilities
Some healthcare facilities have taken steps to put strategies in place during the COVID-19 pandemic that will allow for the decontamination and reuse of N95/P2 respirators, if supply levels become critical and there are no alternative PPE available.
The TGA is working closely with a small number of sponsors of Class IIb medical devices, which may be used for the decontamination of other medical devices. Prior to disseminating information about the decontamination system to healthcare facilities, the sponsors of these medical devices will be required to provide detailed documentation to the TGA, which includes the following:
- details of the decontamination system, including critical cycle parameters and their tolerances, validation evidence to show inactivation of microorganisms under worst case conditions, and information on routine monitoring and controls such as chemical and biological indicators
- evidence of material compatibility of respirators with the decontamination system, including the integrity of respirators following decontamination (filtration system, head straps) and the number of cycles each respirator can withstand
- evidence that any residues remaining on the respirator after decontamination are insignificant and unlikely to cause a health hazard or affect the user
- procedures which ensure any visibly soiled or contaminated respirators (e.g. blood, fluid, respiratory secretions) are discarded and do not undergo decontamination
- procedures to ensure that once decontaminated, the respirator is only reused by the original health care worker
- instructions for health care facilities undertaking the reprocessing activities, including the details of the decontamination cycles, protection of personnel performing the tasks and monitoring of their health and wellbeing
- instructions for health care workers, relating to packaging and transport of contaminated respirators, inspection of returned respirators to identify faulty or visibly damaged respirators or that fit poorly, and reporting of adverse events.
Reprocessing within healthcare facilities for reuse by the same organisation is not considered to be manufacturing and supply.
If healthcare facilities choose to decontaminate a used N95/P2 respirator that they have purchased, then returns it to the same healthcare worker for reuse in line with their infection control and prevention procedures, it is considered "off-label" use.
Healthcare facilities that reprocess single-use medical devices to make them suitable for reuse during the COVID-19 pandemic are responsible for all risks and associated liabilities with "off-label" use of medical devices.
Decontamination for reuse of used single-use PPE is only recommended when critically necessary to address supply shortages during the COVID-19 pandemic.
Healthcare facilities are recommended to use decontamination systems that are approved as Class IIb medical devices, and where evidence to support the effective microbial inactivation and required process controls for decontamination of N95/P2 respirators has been reviewed by the TGA.
There are a number of decontamination systems, such as those used for disinfecting or sanitising equipment or the environment, that are regularly used as part of the infection control and prevention strategy in healthcare facilities and other clinical settings. While suitable for use as a hard surface disinfectant, these systems are not approved as medical devices or intended to be used for decontaminating another medical device. If healthcare facilities choose to use these types of systems "off-label", such as for the decontamination of N95/P2 respirators, there are significant risks associated with this practice. Published information on the various decontamination methods may not be appropriate for some types of respirators, and may cause damage to the filtration function or form, or leave harmful residues.
The provisions in place to facilitate the planned decontamination of PPE is limited to N95/P2 respirators. It does not extend to other types of PPE such as gloves, gowns and medical or surgical facemasks unless full comprehensive data supporting the safe and effective decontamination of that type of PPE is provided.
Sponsors of environmental disinfection systems or decontamination units, who provide instructions or other information to healthcare facilities by way of advertising, printed material or other means, about use of their decontamination system in the reprocessing of single-use PPE, without having an appropriate ARTG inclusion, are considered to be supplying an unapproved medical device.
Ensuring your reprocessed device is safe and fit for its intended purpose
Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including IVD medical devices) complies with the Essential Principles. The Essential Principles relate to aspects of the device including its design and construction. Demonstrating compliance with the Essential Principles establishes that the device is safe and fit for its intended purpose.
Factors to consider when reprocessing single-use medical devices for reuse in order to meet the Essential Principles include the following:
- How can procedures and safeguards be implemented to prevent inadvertent environmental contamination with hazardous microorganisms (including from the point of collection environment through to the reprocessing environment)?
- How can procedures and safeguards be implemented to prevent inadvertent exposure of individuals in these environments to hazardous microorganisms?
- How can a chain of custody be established for reprocessed items to enable traceability and tracking during reprocessing and reuse?
- Will reprocessing be effective against living microorganisms on the mask or gown, including SARS-CoV 2, mycobacteria and bacterial spores?
- Is reprocessing intended to disinfect/bio-decontaminate the items or to sterilise the items so they can be supplied with a label claim of sterility?
- If soils cannot be adequately removed from used masks or gowns, how might this interfere with the effectiveness of disinfection or sterilisation processes?
- Are the materials of the masks or gowns compatible with the disinfection/bio-decontamination or sterilisation processes?
- Does reprocessing interfere with the breathing or filtration capability of a mask, or its ability to retain a tight fit for users during reuse?
- Are procedures in place to identify and destroy items pre or post-reprocessing that are visibly damaged or otherwise not fit for purpose?
- Could reprocessing residues in reprocessed items pose a risk to the user during reuse?
- How many times can an item be reprocessed, remain fit for its intended purpose and not present a risk to the user during reuse?
- How will reprocessed devices be appropriately packaged and labelled?
Some face masks, such as N95/P2 respirators, may not be compatible with reprocessing activities, including gamma and ionizing radiation, as these activities damage or impair the device.
Organisations which reprocess single-use medical devices must be able to demonstrate that the device will continue to perform as originally intended following their reprocessing activities, noting that damage to the device may not be apparent during a visual inspection.
Reprocessed face masks and gowns
The regulations for face masks and gowns that have undergone reprocessing activities, including decontamination or disinfection, packaging and labelling, depend on whether or not they are claimed as being supplied sterile.
Face masks that have undergone reprocessing activities and are not supplied in a "sterile" state are regulated as Class I non-sterile, non-measuring medical devices.
Reprocessed surgical masks and gowns intended for a medical purpose that are supplied in a sterile state are regulated as Class I sterile medical devices.
Class I non-sterile, non-measuring
The low risk classification of these items does not negate the manufacturer's responsibilities to ensure the quality, safety and performance of reprocessed devices. If your product meets the definition of a Class I non-sterile, non-measuring device, please review information about manufacturing and supplying Class I non-sterile medical devices.
Class I (sterile) devices
Manufacturers of Class I sterile medical devices supplied in Australia are required to hold Quality Management System (QMS) certification issued by the TGA or another comparable overseas regulator that shows the manufacturer has applied, as a minimum, Production Quality Assurance procedures to that device.
Achieving QMS certification means that:
- the manufacturer must meet the requirements of ISO13485:2016 (excluding clause 7.3)
- for devices supplied in a sterile state, the sterilisation procedures used by the manufacturer (or their contract steriliser) must have been assessed and found to meet the requirements relevant to the method of sterilisation used for those devices.
Reprocessing methods available for the cleaning and disinfection and/or sterilisation of face masks and gowns are not likely to meet the criteria for medical devices that are to be labelled as sterile.
The TGA is actively working to develop further information concerning reprocessing of single-use face masks and gowns in the event of insufficient supplies during the COVID-19 pandemic. This information will be made available as soon as possible.