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 and, 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.
Note
If you are reprocessing medical devices for reuse, 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.
Note
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.
