The Department of Health has advised that Softmed surgical masks have been impacted by a defect alert that can be found on the Therapeutic Goods Administration (TGA) website.
This alert affects level 2 and 3 Softmed surgical masks. These masks have been supplied under the Australian Register of Therapeutic Goods entry 333133 by the sponsor M House.
North West Melbourne Primary Health Network (NWMPHN) has distributed these masks from the National Medical Stockpile to general practices. NWMPHN has not distributed these masks to pharmacy or allied health services.
The Department has advised that when tested by 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.
All of the Softmed masks dispatched from the National Medical Stockpile and tested by the Therapeutic Goods Administration (TGA) passed at Level 2. Level 2 masks are deemed suitable for a wide range of uses, such as in aged care or emergency departments.
This is a sufficiently high level to support their use in moderate to high-risk environments – noting public health advice in some jurisdictions also recommend the use of an additional barrier (face shield) to mitigate the risk of fluid penetration.
NWMPHN will no longer distribute the Softmed surgical masks. At this stage this advice is not affecting Softmed P2 masks.