Unmasking errors – the TGA’s post-market face mask review

The Therapeutic Goods Administration (TGA) has recently had to make amends after releasing information about surgical face masks sponsored by M House Pty Ltd (M House) without authority under the Therapeutic Goods Act 1989 (Cth) (Act).

The Australian Register of Therapeutic Goods (ARTG) saw a rapid rise of medical device inclusions in the wake of the COVID-19 pandemic as a result of the demand for face masks. The TGA, after receiving complaints in relation to face masks, generally, undertook post-market reviews of all masks on the ARTG. Two batches of surgical face masks (the masks) imported by M House were caught up in this review.[1]

Following the TGA’s post-market review of the masks, it released a statement on 4 August 2022 that:[2]

• one batch was non-compliant with a ‘visual inspection’; and
• the other batch was non-compliant with a visual inspection for ‘fluid resistance’ (referring to the requirement for surgical face masks to provide a barrier to fluid penetration to reduce infection risk in medical environments).

The TGA relied on s 61(5C) of the Act to release this information. M House challenged this authority on the basis that the sampling and testing was not conducted in accordance with Part 5 of the Therapeutic Goods Regulations 1990 (Regulations). Unfortunately for the TGA, it had admitted such acts were not conducted in accordance with that part in writing.[3]

Why did the TGA not follow the procedures in that Part 5?

While other factors may have played a part, it was not immediately obvious that Part 5 applied. Information must be of a kind specified in a relevant legislative instrument for s 61(5C) of the Act to authorise its release. The relevant instrument in this case was the Therapeutic Goods Information (Laboratory Testing) Specification 2017 (Specification), which did not provide sufficient guidance on sampling and testing. On proper construction of the Act, in relation to the Specification, sampling and testing had to be done in accordance with Part 5.[4] As such, the information released was not authorised under s 61(5C).[5]

The TGA was ordered to remove the information from its website and publish a notice as to its error.[6]

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Authored by:

Kelly Griffiths, Partner
Clare Smith, Associate

[1] ARTG 337122: Softmed 3PLY earloop disposable face mask (M House Pty Ltd), batches N/B-BTWT260031 and LX202010.

[2] These tests were undertaken to determine compliance with the essential principles set out in Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) Schedule 1; M House Pty Ltd v Secretary, Department of Health and Aged Care [2023] FCA 768, [31].

[3] M House Pty Ltd v Secretary, Department of Health and Aged Care [2023] FCA 768, [25].

[4] M House Pty Ltd v Secretary, Department of Health and Aged Care [2023] FCA 768, [112].

[5] M House Pty Ltd v Secretary, Department of Health and Aged Care [2023] FCA 768, [125].

[6] M House Pty Ltd v Secretary, Department of Health and Aged Care [2023] FCA 768, [130].