COVID-19 outbreak necessitated an extensive study on the Personal Protective Equipment (PPE) regulations. Depending on the PPEs’ (face masks, gloves and gowns) therapeutic purpose, TGA has designed certain guidelines for manufacturers, consumers and healthcare professionals.
Reliant to the therapeutic use, some PPEs are included in the Australian Register of Therapeutic Goods (ARTG) before the supply. All PPEs serving the therapeutic purpose and clinical setting usage should meet medical device definition and the Regulatory requirements as per the Therapeutic Goods Act 1989, Therapeutic Goods (Medical Devices) Regulations 2002 and Therapeutic Goods Regulations 1990. All Classes of medical devices should meet the conformity assessment procedures prior to manufacturing. Supplying these devices and PPEs during COVID-19 pandemic should meet the following standards:
- the intended purpose of the device
- the environment in which it is to be used
- users of the device
The key PPEs’ guidance focus on criteria of selection, care, use, maintenance, performance, risk-assessments, control methods, penetration and permeation testing (determination of materials resistance used in protective clothing to permeation against chemicals, microbes, liquids & gases) for various medical applications like:
- Respiratory Protection (half & full facepiece masks, respirators)
- Surgical Masks (single-use face masks, utility mask, N95 respirator)
- Surgical Apparels (drapes, theatre gowns, clean air suits, hand towels, wrappers)
- Surgical Gloves (single-use rubber surgical and medical examination gloves)
- Eye and Face Protectors (goggles and visors)
To respond to the COVID-19 pandemic compliantly, the PPE manufacturers should ensure to meet all the relevant standard requirements in Australia. Proactively aligning with the proposed regulations or standards will streamline the market-entry of PPEs in Australia in this needy hour. Walk the right Regulatory pathway. Stay safe. Stay informed. Stay compliant.