Single-use face masks are used where it is necessary to keep cross contamination between people to a minimum. They form part of the personal protective equipment (PPE) in a health care environment, used to minimise mucous membrane exposure to potentially infectious droplets.
A respirator is a type of respiratory protective equipment that tightly fits the face. It prevents the inhalation of contaminated air, including airborne viruses, with a greater level of protection than face masks.
Due to a rapid increase in demand for the manufacturing, importation and sale of face masks and respirators, there has been an increase in medical device inclusions in the Australian Register of Therapeutic Goods (ARTG), particularly for face masks and other items of PPE.
In response to this increase, and in conjunction with the Post-market Review, the TGA Laboratories has developed a rapid assessment testing plan, in order to provide the Australian community with timely information about the suitability of face masks and respirators available. Laboratory testing is being conducted to assess compliance with the requirements of the relevant standards.
The Laboratories will conduct a rapid assessment of the compliance of face masks and respirators that have recently been included in the ARTG. The masks and respirators in the National Medical Stockpile will be prioritised within our testing plan.
The TGA Laboratories, guided by the relevant Standards, will examine the following attributes of face masks and respirators:
- Particle filtration – testing of the ability to filter out small, aerosolised particles
- Fluid penetration resistance – testing of the mask’s ability to provide a barrier to blood and/or body fluids. Preliminary testing is conducted on the main body (including the melt-stamped logo), and at the front melt-welded seam, demonstrated by TGA Laboratory testing to ISO 22609 (Level 1)
- Sterility – where a face mask claims to be provided in a sterile state, this will be tested.