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Product defect alert for some Softmed branded surgical masks

14 November 2020

A Product Defect Alert notice for some Softmed branded surgical masks manufactured by Wuhan Topmed has been issued following the Therapeutic Goods Administration’s (TGA) post market review on face masks. These face masks have been supplied under the Australian Register of Therapeutic Goods (ARTG) entry 333133 by the sponsor M House.

Issue

The Product Defect Alert follows the comprehensive review and laboratory testing carried out by the TGA, which raised concerns with quality control measures, an absence of batch numbers that prevents easy identification of specific batches, and inconsistent testing results, specifically for fluid resistance protection.

This alert was issued, utilising an abundance of caution, as some product did not meet the fluid resistance claims, as labelled, in post-market testing undertaken by the TGA. Given the lack of batch numbers for some batches, affected batches cannot be targeted with this alert.

TGA testing showed the masks did not perform, in relation to fluid resistance claims, as labelled. When tested by the TGA Laboratories, some batches of the masks did not perform at Level 3, but passed at Level 2. Others did not perform at Levels 2 and 3, but passed at Level 1.

Not all Softmed masks are subject to the Product Defect Alert. There are other Softmed branded masks and respirators supplied under other ARTG entries that are not part of the defect alert notice.

The surgical face masks related to the Product Defect Alert may be presented as below:

picture of Softmed face masks packagingpicture of Softmed face masks packaging

What does this mean?

Whilst the face masks are not being physically recalled (ie: removed) from the market, due to the issues found, and the inability to trace batch numbers for some batches, the sponsor has taken the necessary action - by issuing a Product Defect Alert which indicates that a precautionary approach should be taken when using these products.

While many of the masks tested as part of the post-market review passed at Level 2, the TGA has taken this highly precautionary action because of the variability in fluid resistance performance. The TGA is advising to take appropriate safeguards if these masks are being used in high risk settings.

For medical healthcare/surgical/aged care setting, if there are no alternatives, a face shield should be used in addition to a mask in high risk settings. The joint National Health and Medical Research Council and the Australian Commission on Safety and Quality in Health Care Guidelines for the Prevention and Control of Infection in Health Care indicate that Level 1 masks are intended for general purpose medical procedures where the user is not at risk of blood or body fluid splash, or to protect staff and/or the patient from droplet exposure to microorganism. Level 3 masks are for all surgical procedures, major trauma first aid or in any area where the health care worker is at risk of bloody body fluid splash.

NSW Clinical Excellence Commission notes that each mask barrier level (Levels 1, 2 and 3) will provide protection against droplet organisms from a patient with COVID-19. For masks that are used in a non-medical, non-healthcare setting by the general public, there are no formal requirements on the performance of the masks, and these products are not regulated by the TGA.

Next steps

The TGA is awaiting further information from the sponsor regarding some of the Softmed masks and will consider if further regulatory action will be required.

The masks have not been imported into Australia by the sponsor since July 2020, and there are no plans to supply them in the foreseeable future.

Post market review

All face masks that are medical devices are subject to the post market review.

As part of the post-market review, the TGA Laboratories are examining the following key attributes of face masks and respirators:

  • Visual Inspection - a visual and physical examination of labelling, design and construction quality;
  • Fluid Resistance - testing of the ability to provide a barrier against penetration by blood and/or other body fluids;
  • Particle Filtration - testing of the ability to filter out small, aerosolised particles; and
  • Sterility - where a face product claims to be provided in a sterile state, this will be tested.