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We undertook a post-market review of all face masks included in the ARTG.
Background of the review
The COVID-19 pandemic increased the demand and supply of personal protective equipment (PPE), which included face masks and respirators, gloves, face shields, goggles, and gowns. These items were essential in helping protect individuals from the transmission of disease, illness, and infection.
In response to the urgent need for PPE, the Australian Government introduced the Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption in March 2020. This emergency exemption enabled the rapid procurement of specific medical devices to support the national COVID-19 response.
The exemption played a critical role in facilitating access to medical devices designed to reduce the risk of infection, particularly among patients and healthcare professionals. It remained in effect until 31 January 2021.
As a result of the surge in manufacturing, importation, and sales of face masks during this period, there was an increase in medical device inclusions of these products in the ARTG.
Concerns were raised about the quality and effectiveness of some products. In particular, that face masks:
- Were included in the ARTG but did not meet the legislative requirements for medical devices.
- May not, or did not, perform as intended.
- Were fraudulent or counterfeit.
- National Medical Stockpile and
- State and Territory Health Departments.
As part of our commitment to public safety, a post-market review was initiated.
Outcomes and actions
All face masks included in the ARTG were reviewed to ensure they met all the regulatory requirements and performed as intended.
Our post-market review prioritised masks for the:
Search for all Face mask market actions
Our review identified some face masks that did not meet all necessary regulatory requirements. For example, instances of non-conformance with the Essential Principles including labelling mistakes, failed TGA lab tests, and products not performing as claimed.
Some face masks were subsequently cancelled from the ARTG. In some cases, no further action was necessary, as those products were no longer available in the Australian market.
Search Face mask cancellations
Product defect alerts or product notifications
When used in healthcare or industrial/commercial settings, masks that fail to meet performance standards can pose a risk to public health - especially where protection from contaminated fluids and airborne particulates is required.
Based on the type and severity of non-conformance identified during the post-market review, some sponsors were required to take further action. These actions included:
- Recalling affected face masks, or
- Issuing a Product Defect Alert or a Product Notification.
Face masks subject to a Product Defect Alert or Product Notification weren't physically recalled. Instead, customers were advised to take a precautionary approach, based on the defect alert or notification and the setting in which the product is being used.
The alerts and notifications issued provided detailed information about the affected batches, and ARTG entries.
Product recalls
Through testing, we found that some face masks and/or respirators posed an unreasonable risk of injury to users. These products showed inconsistencies and/or deficiencies in their Particulate Filtration Efficiency (PFE). PFE measures the efficiency of the respirator to filter fine particles from inhaled air.
Respirators that failed to meet PFE requirements were physically removed from the market as they could not be deployed to other settings, such as industrial or commercial environments, due to the potential risk of harm and the false sense of security they might provide to users.
Non-compliance notices and ARTG variations
To keep users informed about the face masks they were using, we published information about masks that required regulatory labelling modifications or ARTG entry changes.
Our review identified several types of non-compliances, including:
- Missing Australian sponsor information on the labelling
- Incomplete or absent manufacturer details
- Product identifying information missing or provided in a language other than English
- Product claims or compliance to standards that were incomplete, inaccurate, or in a language other than English
- Incorrect Global Medical Device Nomenclature (GMDN) code
- An intended purpose that contained incorrect or misleading information