Post-market review of face masks: Outcomes and actions
The TGA is undertaking a post-market review of all face masks included in the Australian Register of Therapeutic Goods to ensure the quality and effectiveness of face masks.
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 supplied in Australia, 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 ie. as claimed by the manufacturer. Some masks may pose a risk to public health and safety when used in healthcare settings or industrial / commercial settings where protection from contaminated fluids and airborne particulates is required.
Some masks are being cancelled from the ARTG. Not all face masks that have been cancelled from the ARTG require any further action. For example, there may not be any of those masks remaining in the Australian market.
Depending on the non-conformance identified in our post-market review, some sponsors will be required to recall their face masks or issue a Product Defect Alert or a Product Notification notice that describes the exact nature of the concern / issue so that customers can consider the setting the face mask is being used in, so as to minimise risks associated with its continued use.
Product Defect Alerts or Product Notifications
Face masks subject to a Product Defect Alert or Product Notification are not being physically recalled (or removed from the market). However customers should consider taking a precautionary approach, based on the advice within the defect alert or notification and the setting in which they are being used.
The Product Defect Alerts and Production Notifications provide more detailed information regarding the specific batch/s and ARTG entry for affected face masks.
Some face masks and/or respirators have been identified through testing by our laboratories to present an unreasonable risk of harm to end users due to inconsistencies and/or deficiencies in their Particulate Filtration Efficiency (PFE). PFE measures the efficiency of the respirator to filter fine particles from inhaled air.
Redeployment of these masks away from high-risk healthcare settings and redistribution for use in other high risk, industrial / commercial settings or use to minimise exposure to bushfire smoke / poor air quality may present an unreasonable risk of harm and create a false sense of security for end users in these settings. This is particularly the case for some masks, called respirators that are labelled with claims that cannot be supported (such as providing 95% PFE) and in some instances these masks have a different overall appearance to regular face masks.
As these respirators have no evidence to justify their safe usage where an ‘N95’, ‘P2’ or equivalent respirator is required, the sponsors of these masks will be required to recall (physically remove) these goods permanently from the market.
The TGA will liaise with, among others, the Australian Competition and Consumer Commission and Worksafe Australia about respirators that are not regulated by the TGA to manage any potential risks posed by those respirators in light of the signals from the testing of respirators regulated by the TGA.
For more information about face masks visit Face masks and COVID-19.