The Implant Files reveal defibrillators pulled from market still being used in emergencies

Updated

In Australia we've nicknamed them "Packer Whackers" in a nod to the late media mogul Kerry Packer, who helped fund the installation of mobile defibrillators in all New South Wales ambulances after his near-death experience in 1990.

Key points: The defibrillator has been linked to at least one death in Australia

Device manufacturer Philips says 3,000 of these devices were sold in Australia over 14 years

It is still used by ambulances services in at least three states and territories

These devices, which have saved thousands of lives over the years by jump-starting faltering hearts, are now standard issue emergency services equipment.

But a joint investigation by ABC News and the International Consortium of Investigative Journalists has found that a defibrillator with a history of safety problems is still being used in Australia nearly 18 months after it was withdrawn from sale.

The defibrillator in question is the HeartStart MRx. The manufacturer, Dutch multinational Philips, voluntarily pulled the device from the market in July 2017 citing the age of the technology.

Despite the known issues, Philips says the defibrillator is still being used in Western Australia, South Australia, the Australian Capital Territory and the Northern Territory — although the NT operator, St John Ambulance, says the MRx has not been in use for "some time now".

The ACT Government said its units are due to be replaced next year. A spokeswoman added that all ambulances carry a back-up defibrillator.

The devices, which sold for about $40,000 each, were even purchased by the Federal Department of the Environment for use in the Australian Antarctic Division.

The sale and use of devices, like the defibrillator, are overseen by the Therapeutic Goods Administration (TGA).

And according to its complaints database, the MRx model alone has been the subject of more than 100 "adverse events" since 2012.

The complaints show the product has been linked to at least one death, but also include issues such as failing to shock, turning off unexpectedly and trouble pacing heart rhythms.

Using data scraped from the TGA's adverse events database, ABC News can reveal that the defibrillator belongs to a device class that has the third-highest number of complaints in Australia.

It is a similar story in Canada, where official records show that the MRx has been implicated in 22 deaths in 10 years.

This ranks it fourth in a list of devices linked to deaths in that country.

Health Consumers Council WA executive director Pip Brennan said the revelations would raise questions in the minds of families who had lost loved ones.

"All families would, I'm sure, be a bit concerned about whether their family member, their loved one, got the right care at the right time," she said.

"It's one of those things where the assumption the public makes is that patient safety is top of the list."

'Sheer costs' prevent replacement

Associate Professor Wendy Bonython from University of Canberra is both a scientist and lawyer who specialises in medical regulation.

She questioned why it was Philips and not the TGA that withdrew the MRx from sale.

"It raises questions about is the regulator really acting promptly enough to pull some of these devices," she said.

"Are they possibly looking too much towards the interests of the manufacturers, rather than risks being posed to consumers?"

Professor John Skerritt, the TGA's deputy secretary, acknowledged there were issues with the device, but said the regulator had no choice but to work with Philips to phase out the device by 2022.

"[What] we've heard from the state ambulance departments was that if all those products just came straight off the market now, they wouldn't be able to have defibrillators in many ambulances just because of the sheer costs," he said.

He said instructions had been issued to all ambulance crews still using the MRx to double-check the devices before heading out on jobs.

Do you know more about this story? Email backgroundbriefing@abc.net.au or Specialist.Team@abc.net.au



Not breaking the law

St John Ambulance, which operates the ambulance service in Western Australia, has confirmed there are MRx defibrillators in nearly 170 of its vehicles across the state.

St John WA Clinical Services director Dr Paul Bailey said the service had bought a second defibrillator for its ambulances while it clinically trialled and tested possible new units.

"The cost to replace the units is significant, however this hasn't caused any delay in the decision making to purchase new devices. St John is fully funding the replacement of these units," he said.

Professor Skerritt said the Western Australian Government was not breaking the law by having the devices in its ambulances.

Under Australian law it is only an offence to supply a product that is not on the Australian Register of Therapeutic Goods, not to continue having one.

A TGA statement said it was making Philips continue to report any problems and maintain spare parts and servicing until the products had all been replaced.

It pointed out that defibrillators were used in cases of heart failure, a situation where death was a high possibility.

"The reporting of an adverse event associated with the use of a medical device does not mean that the device in question caused the adverse event."

Philips said it had sold 3,000 units in Australia over 14 years and estimated they had been used for monitoring and defibrillation or pacing millions of times during that period.

A spokeswoman for Philips said in a statement that the MRx had a "long and successful history in helping save sudden cardiac arrest victims" worldwide.

She said since it removed the product from the market the company had continued to support hospitals, private clinics and ambulance fleets.

She rejected suggestions the product was pulled to avoid regulatory action.

"The MRx is safe for their intended usage, for both patients and users of the device," she said.

Potential legal ramifications

Defibrillators are regularly defined as a Class IIb devices by the TGA, the second-highest level of risk.

What this means is that the products are subject to less scrutiny than top-level devices such as hip replacements or pacemakers, and new defibrillators are not automatically audited by the regulator.

Associate Professor Bonython said the device had a lower rating because it was not internal, but that this was problematic when it came to defibrillators.

"I would have expected it to be a higher classification given it's essentially putting electric currents through the patient and exposing not just the patient, but the paramedic, to risks," she said.

Background Briefing How safe are medical devices?

At their best, they save lives. At their worst, they cut them short. More than 57,000 medical devices are approved for use in Australia, but are patients aware of the risks? About

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At their best, they save lives. At their worst, they cut them short. More than 57,000 medical devices are approved for use in Australia, but are patients aware of the risks?

She also queried the potential legal ramifications for ambulance services that continued to use the MRx.

"They are going to be liable if the device fails and costs a life or causes injury to either a paramedic or a patient," Associate Professor Bonython said.

The TGA, which is scheduled to review the product categories in 2019, denies it considers the defibrillator to be a lower risk device.

"Certainly, it is one of the highest categories and therefore the clinical evidence and the performance of those products are looked at very closely," the regulator said.

A spokeswoman for the Federal Department of Environment said the devices used by its Antarctic division were being managed to keep them in service.

Explore the International Medical Devices Database, a searchable portal that gathers global recall notices, safety alerts and field safety notices

Topics: doctors-and-medical-professionals, health, medical-procedures, medical-research, australia

First posted