Defibrillator malfunction fears flagged in SA
A piece of lifesaving equipment used by SA ambulances is under the microscope of the national medicine watchdog.
The Therapeutic Goods Administration has suspended orders of a defibrillator from reaching any more Australian ambulances for three months after reports of “unexpected shut down and rebooting during use”.
The Corpus 3 and 3T devices are manufactured in Germany and used to resuscitate and monitor hearts in patients. They are currently installed in 400 South Australian ambulances, but the state’s ambulance service said they do not need to be removed.
“The suspension applies to the supply of new devices and does not require devices currently in use by SA Ambulance Service to be withdrawn,” SA Ambulance Service said in a statement today.
“Patient safety remains our highest priority. SAAS continues to use the devices in accordance with established clinical guidelines and procedures and will respond to any further advice from the TGA as required.”
The defibrillators – ranging in cost from $7000 to $29,000 – are fitted in thousands of ambulances across South Australia, Western Australia and New South Wales.
InDaily understands this specialist model of defibrillator is used in ambulances, but not in South Australian hospitals.
You might like
But the Ambulance Employees Association of South Australia wants clarity, saying members had raised “a number of concerns” regarding whether these devices were suitable for the “demanding pre-hospital environment”.
The union’s general secretary Paul Ekkelboom said he was aware of paramedics struggling with inaccuracies in monitoring patient breathing and blood pressure, and “connection and charging issues associated with the monitor’s modular design, and increased troubleshooting and training requirements”.
“There were also issues identified during the initial rollout, including incompatibility with existing electrode stock, which resulted in inaccurate ECG readings until the problem was addressed.
“While some concerns may have improved over time, members have continued to raise questions about the monitor’s reliability. Paramedics work in an environment where clinical decisions are often time-critical and dependent on accurate patient monitoring.
“Frontline clinicians need equipment that is reliable, robust and fit for purpose, and they must have absolute confidence that the clinical information being provided is accurate.
“In the pre-hospital environment, where clinical decisions are often made under significant pressure and in time-critical situations, the accuracy and reliability of monitoring and defibrillation equipment are paramount.
Stay informed, daily
“Patients and clinicians alike deserve confidence that the equipment being used will perform as intended every time.”
Health Minister Blair Boyer said today that the Therapeutic Goods Administration (TGA) had not issued a recall, reassured the public about safety and confirmed the Corpuls defibrillators “continue to be safe to use”.
“I have sought advice from SAAS who advise me they will work with the TGA to ensure patient safety,” Boyer said.
The TGA released a statement on Wednesday saying that it was aware of media reports about defibrillator safety, and that its suspension of allowing new Corpuls devices from entering the country “does not represent a finding that the devices are unsafe”.
“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,” the statement said.
Shadow Health Minister Jack Batty has called for more transparency from the government about whether these devices were putting South Australians at risk.
“South Australians need to have absolute confidence that lifesaving equipment will work when it is needed most,” Batty said.
“The minister should immediately disclose whether there have been any faults involving these devices in South Australia.
“Our paramedics need to know they can rely on their equipment in an emergency.”
New South Wales paramedics also reportedly were seeing frequent failures with the Corpus devices.
Want to see more stories from InDaily SA in your Google search results?
- Click here to set InDaily SA as a preferred source.
- Tick the box next to "InDaily SA". That's it.
