Source: Australian Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) is undertaking a post-market review of all face masks included in the Australian Register of Therapeutic Goods (ARTG) to ensure the quality and effectiveness of face masks, including that they meet the legislative requirements for medical devices, and perform as intended.
For information about the review, including guidance for suppliers and users of face masks, see Post-market review of face masks: Overview.
Our review has identified some face masks are not meeting all the necessary regulatory requirements (e.g. non-conformance with the Essential Principles including labelling, failed TGA laboratory testing) and/or not performing as intended, i.e. as claimed by the manufacturer. These masks may pose an unacceptable risk to public health and safety when used in healthcare settings or industrial / commercial settings where protection from fluids and airborne particulates is required.
Where we have identified issues, masks are being cancelled from the ARTG and/or sponsors are undertaking market actions including communicating information to their customers about the issues identified to minimise risks associated with their use.
Some sponsors may be required to undertake either, a “Product Defect Alert” or a “Product Notification”. These actions are defined in the Uniform Recall Procedure for Therapeutic Goods (URPTG).
Not all face masks that have been cancelled from the ARTG are subject to a market action, for example, where there is no product remaining in the Australian market.
Masks subject to a “Product Defect Alert” or “Product Notification” are not being physically recalled (or removed from the market). Our intention is to advise customers and users of the issues we have identified with the masks and to clarify where it may be appropriate (or not appropriate) for their continued use.
For face masks listed in the table below that are subject to Product Defect Alerts, customers should take a precautionary approach if these masks are being used in a medical / healthcare / surgical / aged care or other workplace setting to reliably protect the wearer against splashes of potentially contaminated liquids or droplets; or against inadequate particulate filtration. Customers should consider:
- quarantining the product;
- using them in another setting; and/or
- if they do not have alternatives, ensuring that a face shield is used in high risk settings.
The TGA is not recalling the masks from the market as they may be used (or redeployed for use) in non-high risk settings.