PRESS RELEASE: An urgent warning to all Australians
LifeVac Australia
Media Contact – Simon Gould
1300 890 345
[email protected]
FOR IMMEDIATE RELEASE
A WARNING TO ALL AUSTRALIANS
LifeVac Australia is an Australian-owned company and is the sole authorised, ARTG registered, legal importer and distributor of the genuine LifeVac® Airway Clearance Device, a device that has already saved over 3000 lives after first aid has failed, all without any harm or failure. The genuine LifeVac® device is listed on the Australian Register of Therapeutic Goods (ARTG #285082) as a Class 1 medical device as required under law, is compliant with all the TGA requirements for safety and evidence and has been subjected to a 2-year post-market review, including evidence and clinical risk review processes and is only sold by LifeVac Australia www.lifevac.net.au and its authorised agents listed on the website.
Since October 2022, LifeVac Australia has been reporting to the regulator, (the Therapeutic Goods Administration (TGA)), the growing number of illegal, dangerous, counterfeit (LifeVac copycat) devices being sold on e-commerce and social media sites in Australia. So far more than 10,000 sales of these dangerous fake devices have been reported to the TGA. These same dangerous counterfeit devices were recently subject to an urgent public alert in the UK by their regulator due to the high risk to public safety if these fakes were trusted in an emergency i.e. can result in serious injury or death. The MHRA (the UK equivalent to the TGA) has worked with LifeVac in the UK to identify and stop the sale of these dangerous medical devices that are being manufactured in China (a country where LifeVac has never been manufactured or sold). Despite the volume of formal safety reports, the TGA has repeatedly refused to treat this issue as a safety concern for Australians and even returned (unopened) defective, unsafe, counterfeit devices sent for their inspection.
Despite these medical devices being illegal to advertise and sell in Australia and illegal to import, (and are likely to cause serious injury or death in a choking emergency) the TGA has decided that unlisted Class 1 medical devices are not subject to investigation, or any regulatory or compliance enforcement and has stated that “until an Australian dies or suffers serious harm we will not even consider any regulatory action or warn the public of the danger”(source TGA Legal Department). Despite having conducted no inspection or testing, reviewing any evidence, and having no compliance with the TGA “Essential Principles”, (required by law), anyone is free to breach the law and to advertise and sell defective and dangerous, unlisted medical devices that have no proof of safety or reliability to unsuspecting Australians.
As the TGA has already and emphatically advised the Health Minister (in writing) and without any investigation, inspection, or testing and without any corroboration from the manufacturer or the MHRA; (all in reach by a simple phone call) that any dangerous counterfeit LifeVac device that looks “a bit the same as a genuine device” are “genuine” and therefore the TGA believes they are not subject to the Therapeutic Goods Act nor have to be listed on the ARTG, or undertake any compliance with safety, quality, surveillance, risk management or reliability standards. This position is inconsistent with the requirements of the Therapeutic Goods Act.
Australians need to be aware, that our regulator of medical devices, the Therapeutic Goods Administration (TGA), is completely ineffective and uninterested in protecting Australians from dangerous, counterfeit medical devices (including but not limited to the LifeVac®) despite this being part of their primary role under the THERAPEUTIC GOODS ACT 1989, Chapter 5. Part 5.1 and 5.2. Australians should therefore have no faith that the Australian Regulator (the TGA) is acting to protect their safety and that there is any compliance enforcement being carried out in relation to counterfeit medical devices. Australians should therefore exercise extreme caution in shopping for medical devices as there is currently no effective regulation, safety evaluation, or enforcement in Australia of counterfeit Class 1 medical devices. Further, the regulator’s strategy to protect the public is that it requires someone to die or suffer serious harm before regulation under the Therapeutic Goods Act is even considered.
