The medical devices that may be a ticking time bomb

A range of commonly used medical devices is responsible for 83,000 deaths worldwide.

blood bags

A range of commonly used medical devices has been responsible for 83,000 deaths worldwide and 170 in Australia, according to a global investigation by the ABC and the International Consortium of Investigative Journalists (ICIJ).

The investigation team’s report also revealed that 1.7 million people had been injured in the past decade as a result of the devices, including more than 8500 in Australia.

The ICIJ report divided the ‘devices’ into four groups: low risk, such as slings, bandages and tongue depressors; low-to-medium risk, such as X-ray film and intravenous tubing; medium-to-high risk, such as surgical meshes and blood bags, and high risk, such as pacemakers and cochlear implants.

It explains that more than 57,000 medical devices have been approved for use in Australia and that many improve lives. However, “lax regulations and vested interests” have allowed dangerous devices into the country and many recipients of these devices may not be aware of the risks, it says.

“Risky medical devices undergo a process called ‘conformity assessment’ before being approved in Australia. About 90 per cent of these assessments, for the most serious devices, are carried out in Europe by for-profit private certifiers called ‘notified bodies’,” the report says.

The Therapeutic Goods Administration (TGA) regulates the safety of medical devices in Australia, but only the highest risk devices are automatically audited.

The TGA has defended Australia’s approval system, with deputy secretary Professor John Skerritt telling the investigation it was wrong to say Australia “rubberstamped” approval given to devices made in Europe.

“We call in additional evidence depending on whether we’re not happy with what we see from Europe, or for high-risk devices, we automatically call in the full gamut of evidence,” he said.

“The Australian system isn’t just the same as the European system. It’s very definitely Europe plus.”

Associate Professor Wendy Bonython, from the University of Canberra, said she believed there were flaws in the way medical devices were regulated in Australia.

“There are patients who have suffered catastrophic consequences as a result of device failure,” she told investigators.

“The TGA’s focus is very much on manufacturers and the market. Somewhere along the line it needs to bring its focus back more on consumers and look at some of the consequences of device failure on consumers.”

Have you had an experience with a faulty medical device? Were you warned about any potential problems?

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    COMMENTS

    To make a comment, please register or login
    BrianP
    27th Nov 2018
    11:38am
    Yet another serious case of Government allowing companies to put Profit before people safety. Wake up!
    Anonymous
    27th Nov 2018
    11:58am
    What else can you expect under a Lieberal far-Right government?
    Infinityoz
    27th Nov 2018
    11:40am
    Useless article - it doesn't say WHICH medical devices are causing injury!
    Darts44
    27th Nov 2018
    1:45pm
    correct
    Gypsy
    27th Nov 2018
    2:19pm
    Agree. It could be anything! Hubby had a knee replacement that's gone wrong. 3 extra ops later & he's now crippled. Drs are wondering if he's reacting to the metal in the prothesis!
    Yup I Know
    27th Nov 2018
    12:00pm
    Hundreds of thousands people worldwide know the affects of devices. Thousands upon thousands of women/men (hernia and transvaginal mesh) in Australia know about and suffer from debilitating affects of mesh. An eye opener is Netflix The Bleeding Edge.
    Yup I Know
    27th Nov 2018
    12:00pm
    Hundreds of thousands people worldwide know the affects of devices. Thousands upon thousands of women/men (hernia and transvaginal mesh) in Australia know about and suffer from debilitating affects of mesh. An eye opener is Netflix The Bleeding Edge.
    KB
    27th Nov 2018
    2:59pm
    I have heard of faulty hip replacements that caused people a lot of pain.They have had to go and have replacements
    Tilly
    27th Nov 2018
    3:54pm
    My titanium hip prosthesis broke 6 years after it was implanted. After a big, complicated and painful operation, I am still trying to recover 14 months later. I have just had another operation- a bone graft. The prosthesis manufacturer has never replied to my letter to them. TGA were no help either. I feel I am totally alone in my struggle.
    Ragamuffin
    27th Nov 2018
    7:09pm
    Had two knee replacements over the past five years - on the same knee. I was told, by the surgeon, that the second one would 'fix the problem- it came from America'.!! The surgeon is going by the xrays; which show a perfect fit. But I still cannot bend it more than 90'. Now I have had another one- in the right knee; two weeks ago. I wonder where THAT one comes from. I will ask! Fieldmouse.


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