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The Therapeutic Goods Administration (TGA) is aware of media reports about the safety of defibrillator devices used in some ambulance services and healthcare facilities.
The TGA recognises that these media reports may cause concern to the Australian public and healthcare professionals, who rely on medical devices for critical healthcare. This statement is being released to reassure the public about the safety of medical devices, including the defibrillators used in ambulances.
Defibrillators in Australian ambulances and healthcare facilities continue to be safe to use. The TGA has not issued a recall of these devices. They should be used in line with manufacturer’s instructions for use and any clinical safeguards put in place by healthcare facilities or authorities.
All medical devices are subject to the TGA’s regulatory controls. These include pre-market assessment, post-market monitoring, compliance activities, inspections, recalls, and other market actions. Regulatory action may occur for a number of reasons, including safety, quality or performance concerns. Regulatory action does not always mean that a product needs to be removed from the market, or that a product is not safe.
When there are issues or concerns, the TGA has compliance and enforcement powers such as imposing conditions on the supply of products and suspending or removing products from supply. For defibrillator devices, the TGA has taken a precautionary approach to suspend further supply of the Corpuls 3 and 3T devices and has issued information to healthcare facilities and authorities about the suspension. A suspension does not represent a finding that the devices are unsafe.
Whilst the suspension is in place, existing devices already in ambulances and healthcare facilities can continue to be used and serviced, but no new devices can be supplied. This suspension allows time for the manufacturer to address the identified concerns.
The TGA publishes information as soon as practicable, to support transparency of its regulatory activities. This enables affected users, healthcare facilities and other stakeholders to assess their own situation and put in place risk mitigations or alternative arrangements where necessary and/or prepare for any forthcoming regulatory action. In some instances, the legislation under which the TGA operates limits the detail that the TGA can release publicly about regulatory action, without the agreement of the sponsor.
Device Technologies Australia Pty Ltd (DTA), the sponsor of the relevant products, and the manufacturer of Corpuls has agreed to provide additional information to assure the public about the safety of Corpuls 3 and 3T devices.
These products were suspended whilst investigations continue into reports of unexpected device shut down and rebooting during use. Actions to reduce the risks associated with these issues have been communicated to users by the sponsor, and are published on the TGA website. The TGA has requested documentary evidence to further demonstrate the effectiveness of those actions, including software related reboot issues, as well as the adequacy of the systems and processes it uses to identify, investigate and respond to future device-related issues and non-conformances in a timely manner.
The TGA has already been undertaking work to further increase transparency around its regulatory decisions. A public consultation on the issue will be released on the TGA website in coming days.
At all times the TGA considers the risk of a device being available against the risk of no access to essential devices. This includes what measures can be put in place by health services to reduce and manage these risks. The TGA has been working closely with all relevant state and territory health departments, including ambulance services and other affected users of the devices, to consider any operational impacts arising from the suspension. All consumers, healthcare professionals or hospitals who find a problem with a medical device or experience an adverse event are encouraged to report it directly to the TGA.