Top Gun: or is it?
Don’t tool around with the TGA
Image courtesy of Ajay Suresh
by Liz Sharkey
In Australia, the Therapeutic Goods Administration (TGA) is responsible for regulating therapeutic goods to ensure their safety, quality, and effectiveness. This includes devices that make therapeutic claims, potentially capturing those commonly used in a massage therapy clinical setting such as percussion tools, dry needles, and Gua Sha and cupping instruments. Even some kinds of tape are classified as therapeutic devices due to the claims made about them.
Here are a few reasons why devices used in a massage therapy clinic should be registered with the TGA:
- Safety: The TGA ensures that medical devices are safe for use by healthcare professionals and patients. By registering devices used in a massage clinic, the TGA can assess the safety of these devices and ensure that they meet relevant safety standards.
- Quality: The TGA sets quality standards for medical devices, which helps to ensure that they are manufactured and designed to a high standard. By registering devices used in a massage clinic, the TGA can assess the quality of these devices and ensure that they meet relevant quality standards.
- Effectiveness: The TGA assesses the effectiveness of medical devices and ensures that they are designed and manufactured to perform their intended function. By registering devices used in a massage clinic, the TGA can assess the effectiveness of these devices and ensure that they meet relevant effectiveness standards.
- Accountability: The TGA can ensure that the manufacturer is accountable for the safety, quality, and effectiveness of the device. This means that if there are any issues or concerns with the device, the manufacturer can be held accountable and required to take appropriate action.
Do I need to check the registration status of my equipment?
Other than your hands, any equipment that you use in your clinic that claims to carry therapeutic benefits may be considered a therapeutic device. Percussion gun? Yep! Dry Needles? Big yep! Vacuum cups? Indubitably! TENS machine? Shockingly, yes!
So, how do you know if the equipment in your clinic is safe to use? There are a few ways to verify:
- Check the product specifications or packaging. If it is registered with the TGA it will have an ARTG number. This can be presented as an ARTG number or an AUST number. (For example, Red Coral single use needles used for Dry Needling are ARTG 308294).
- Ask the supplier. If the supplier has been through the correct processes for their product, they will be more than happy to supply you with information. If the supplier is evasive, consider purchasing from a company that will provide information about the registration status of their products.
- Search the ARTG. (Australian Register of Therapeutic Goods). The ARTG is a searchable database for all therapeutic goods that have undergone the process of safety, quality and effectiveness testing. Doing a search for your equipment can be a bit hit and miss because products are often imported under a different name than the brand name, so you might have to do a fair bit of digging.
Does my insurance cover the use of therapeutic devices that are not on the ARTG register?
Advice from Fenton Green, AMT’s preferred insurer, is that you must be able to show you have undertaken due diligence when selecting the equipment you use in your clinic. Research reputable health and medical equipment providers rather than hunting down the cheapest option. If you have just raced off to purchase the cheapest device you can find on Amazon or eBay, then your insurance may be void if something goes wrong. Also, exercise caution around equipment that is sold by training providers as part of professional development courses – make sure you ask the training provider whether the equipment is registered (and approved for use in humans!).
When in doubt, check with your insurance underwriter before you make the purchase.
Using devices that are TGA registered helps to ensure that the devices are safe, high quality, effective, and that the manufacturer is accountable for their performance.
About the Author
Liz Sharkey is passionate about compliance and supporting massage therapists to practice safely. The only thing she loves more than a fact sheet is a checklist but it’s a close run.