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The laxity of rules governing medical devices in Australia is ‘shocking’ · The Morning Edition

0:04
S1: There are nearly 1.5 million registered medical devices on the
0:09
S1: market in Australia. Now, you would think that these life
0:12
S1: saving devices, pacemakers, defibrillators and pain pumps among them would
0:17
S1: be subject to the same sorts of clinical trials that
0:20
S1: drugs here are. Right. I'm Samantha Selinger Morris, and you're
0:25
S1: listening to Morning Edition from The Age and the Sydney
0:28
S1: Morning Herald. Today, investigative reporter Liam Mannix, on which devices
0:34
S1: Australians have made complaints about the most, and the medical
0:37
S1: device under investigation by a coroner after a tragic case
0:41
S1: in a regional town in Victoria. It's July the 20th. Welcome, Liam,
0:52
S1: back to the podcast.
0:53
S2: Thanks for having me, Sam.
0:55
S1: Okay, let's start off with the basics. What are medical devices.
0:59
S3: Medical devices are devices technology that we use in all
1:04
S3: sorts of healthcare applications. So that ranges right from really
1:08
S3: simple things like surgical masks or tongue depressors up to
1:12
S3: much more advanced stuff like implantable pacemakers, glucose monitors, insulin pumps.
1:19
S3: So a really, really broad range of technology. And I
1:22
S3: think it's important to emphasize the breadth of that technology.
1:27
S3: There are about 1.4 million registered medical devices in Australia,
1:32
S3: which to me just seems like a bit of a
1:34
S3: crazy number really.
1:35
S1: And you have identified a problem with medical devices. So
1:39
S1: just tell us what that problem is broadly. And how
1:42
S1: did you actually come across it?
1:44
S3: Sam. For me, this story starts in 2018. I was
1:49
S3: reading an American report about spinal cord stimulators. These are
1:53
S3: implantable devices that go into the spine that promise to
1:58
S3: treat chronic pain. In America, they have one of the
2:03
S3: highest rates of reports of adverse events to the regulator.
2:08
S3: And I thought, isn't that interesting? I wonder if that's
2:10
S3: true in Australia. Once I started looking into it, I
2:14
S3: quickly discovered that it's almost impossible to discover that in Australia.
2:18
S3: So we have a public database of adverse event reports
2:22
S3: linked to medical devices. You can query an individual medical device,
2:27
S3: but due to the design of this database, it is
2:30
S3: impossible to get out aggregate statistics. Now aggregate statistics is
2:35
S3: the stuff that we really want to know. How do
2:37
S3: medical devices compare which medical devices are producing the most
2:42
S3: adverse event reports?
2:45
S1: And just to let listeners know, I'll just jump in
2:47
S1: and say you're speaking about the Therapeutic Goods Administration, otherwise
2:51
S1: known as the TGA, its database, isn't it?
2:54
S3: Yeah that's correct. The TGA database known as the Database
2:57
S3: of Adverse Event Notifications. What we ended up having to do, Sam,
3:01
S3: was put in a Freedom of information application to get
3:04
S3: back the data on spinal cord stimulators. This is supposed
3:07
S3: to be public data, but this database essentially makes it
3:10
S3: almost inaccessible. I had long looked at that story and gone, well,
3:15
S3: the TGA had this data. They just weren't taking action
3:18
S3: on it until I started writing about it. What else
3:21
S3: might be on this database? We cracked open this database
3:25
S3: and downloaded about 81,000 adverse event reports. And then we
3:30
S3: started wading through them, working out which devices were associated
3:34
S3: with the most reports and which devices had interesting patterns
3:38
S3: of reports that we could try and drill down into.
3:41
S3: At the same time, we interviewed about 70 people inside
3:45
S3: and outside the TGA doctors, scientists, patients to really build
3:49
S3: a picture of how the regulations governing medical devices work
3:54
S3: and how effective the regulator is at keeping unsafe medical
3:58
S3: devices out of Australia.
4:00
S1: And it's really quite an incredible story here. Even the
4:02
S1: back story is incredible because before recording, you told me that,
4:06
S1: as you just mentioned, this database is meant to be public,
4:09
S1: but it's inaccessible. It's ultimately you can't get the information
4:12
S1: from it because of the way it's designed. So you
4:14
S1: actually had to use AI to create code, which would
4:18
S1: enable you to scrape this database to get the aggregate
4:22
S1: information that you wanted. So just tell us, like, what
4:25
S1: did you actually discover? What devices were causing the most problems?
4:30
S3: So we were able to build a series of web
4:32
S3: scrapers through a bit of my coding and a bit
4:33
S3: of AI coding that was able to go into this database.
4:36
S3: And over the course of several months individually, get out
4:40
S3: all of these adverse event reports from each registered medical
4:44
S3: device in Australia. One of the most striking findings was
4:48
S3: the devices that seemed to be causing the most adverse
4:51
S3: event reports at the moment and their diabetes devices. So
4:55
S3: that's continuous glucose monitors and automated insulin pumps. And that
5:00
S3: really surprised me. We know a lot of people use
5:03
S3: these devices, but when you speak to scientists and doctors,
5:06
S3: they say they're terrifically safe. They're highly effective. So then
5:10
S3: it became a real question what's going on here? What
5:13
S3: might be driving these high numbers of adverse event reports?
5:16
S1: And I do want to ask just just straight off,
5:18
S1: I mean, how many Australians have diabetes? Because as a layperson,
5:21
S1: I think this is a common condition. So a lot
5:24
S1: of people could be potentially at risk here if the
5:27
S1: devices are faulty. Right.
5:28
S3: You're absolutely right, Sam. About 1.3 million Australians live with diabetes.
5:33
S3: In recent years, the federal government has started to subsidise
5:36
S3: a lot of these devices, particularly continuous glucose monitors for
5:41
S3: some people with diabetes. So they've been rolled out really widely.
5:45
S3: But along with that rollout, we're also starting to see
5:49
S3: a significant uptick in problems in people saying, I've had
5:53
S3: a significant problem with this device.
5:55
S1: Okay, so tell us, what are the major issues with
5:58
S1: the diabetes management devices?
6:01
S3: We spoke to a range of patients who said to us,
6:05
S3: we are having accuracy issues with these devices. Continuous glucose
6:10
S3: monitors are meant to be able to give you an
6:12
S3: estimate of what your blood glucose is, so you can
6:15
S3: make treatment decisions, injecting insulin or not. But we spoke
6:19
S3: to a range of patients who said, I got a
6:21
S3: reading from my continuous glucose monitor, and then I double
6:25
S3: checked it with a finger prick test, and my reading
6:28
S3: was way off. And when that happens, that really worries
6:32
S3: people with diabetes because getting the treatment decisions wrong can
6:36
S3: lead to really, really nasty outcomes. And that seems to
6:40
S3: be backed up by the adverse event data that we
6:43
S3: have where there are so, so many complaints about inaccuracy
6:47
S3: and in some cases, people who have been injured by
6:50
S3: making treatment decisions based on those inaccurate readings. And when
6:54
S3: we looked further into this sector, we noted that there
6:57
S3: have been a number of recalls and product alerts and
7:00
S3: regulatory concerns about the accuracy of these devices. And I
7:05
S3: want to call out one really interesting specific issue, Sam,
7:09
S3: which is the case of William Swail. So the coroner's
7:13
S3: court at the moment is investigating multiple fatalities linked to
7:17
S3: a car accident in Daylesford.
7:21
S4: It's a lazy afternoon in a busy beer garden, families
7:25
S4: enjoying themselves, oblivious to the horror that's about to strike.
7:31
S5: Breaking news in Victoria, where five people have been confirmed
7:34
S5: dead after a car crash into a beer garden just
7:37
S5: after 6 p.m. in Daylesford, at the foothills of the
7:40
S5: Great Dividing Range.
7:41
S6: Witnesses say a BMW launched itself towards the pub's courtyard.
7:45
S6: It's a grassy area with a few picnic tables, nothing
7:48
S6: dividing patrons and the road.
7:50
S7: It's one of the most confronting scenes I've been told
7:53
S7: that experienced officers have been to.
7:57
S3: And the court has heard evidence that the driver at
8:00
S3: the time, William Swale, who was a type one diabetic,
8:04
S3: was driving while his continuous glucose monitor was connected to
8:09
S3: his smartphone, which in turn was connected via Bluetooth to
8:12
S3: his car. These continuous glucose monitors are meant to give
8:16
S3: you audible alerts when your blood glucose is getting low,
8:20
S3: but Swale said his did not, apparently because once the
8:25
S3: phone was connected to the car Bluetooth, it automatically muted
8:29
S3: the alarms. In 2025, US medical regulators warned that connecting
8:35
S3: a phone linked to a continuous glucose monitor to a
8:38
S3: car Bluetooth system can mute blood sugar alarms. But our
8:42
S3: investigation discovered that the TGA never passed on that warning
8:48
S3: despite receiving a number of adverse event reports about people
8:53
S3: who had issues with Bluetooth connections and continuous glucose monitors,
8:58
S3: the TGA told us it publishes device specific or general
9:02
S3: safety information about medical devices on its website, where appropriate.
9:07
S3: This is informed by safety signals and any trends, including
9:11
S3: numbers of adverse event reports received from both overseas and
9:15
S3: the Australian market.
9:16
S1: And Liam, just to play devil's advocate for a moment
9:19
S1: when it comes to the glucose monitors, you know, you
9:21
S1: said you've spoken to some scientists who say there's really
9:24
S1: robust clinical evidence these devices are safe. So could it
9:28
S1: be that the amount of complaints that you're seeing about these,
9:32
S1: or that the TGA is receiving, that it's just part
9:35
S1: of this margin of error for any device or for any,
9:39
S1: you know, mechanised item on the market that it is
9:42
S1: generally safe and Sometimes, in rare cases, these things aren't safe.
9:48
S3: That seems plausible. Sam. And it's important to emphasize that
9:53
S3: a range of scientists we spoke to, and doctors said
9:57
S3: that these devices were robust, reliable and accurate. And there
10:02
S3: is high quality clinical evidence showing that. But I don't
10:07
S3: think we should dismiss the patient experience. It wasn't hard
10:11
S3: for us to find many, many people who said they
10:14
S3: had serious and in their description, life threatening issues with
10:19
S3: these devices.
10:24
S1: After the break.
10:26
S3: At the moment, I think it's left to patients to
10:29
S3: try and work out the safety and efficacy of their
10:32
S3: medical devices, and I don't think that's good enough.
10:40
S1: And you have found problems with the system more broadly, though, right.
10:43
S1: Aside from this very tragic incident of this man with
10:47
S1: type one diabetes.
10:48
S3: That's exactly right, Sam. Listeners will remember the pelvic mesh
10:52
S3: scandal from several years ago, where a number of Australian
10:54
S3: women were injured, ended up with chronic pain due to
10:58
S3: a medical device. And we wanted to ask, have the
11:01
S3: regulatory loopholes that were identified in that case been fixed?
11:06
S3: And we don't think they have. The Therapeutic Goods Administration
11:10
S3: states that all medical devices approved in Australia need clinical
11:15
S3: evidence showing that they are safe and perform as expected.
11:21
S3: But that clinical evidence doesn't look like what you and
11:24
S3: I might think of. Many medical devices are approved without
11:30
S3: randomised controlled clinical trials, the type that you'd expect to
11:33
S3: see for drugs. Some are approved on the basis of equivalence,
11:38
S3: which is this idea that your medical device looks similar
11:42
S3: to another company's medical device, and therefore you can rely
11:46
S3: on their clinical data to show that your device is safe.
11:51
S3: And in Australia, about 85% of our medical devices are
11:55
S3: approved based on European certification, which introduces an additional problem.
12:02
S3: Unlike Australia in Europe, medical devices can be approved by
12:07
S3: notified bodies, which are private, for profit corporations typically paid
12:12
S3: by the manufacturer of the medical device to audit and
12:16
S3: approve the device, and that, many experts tell us, introduces
12:22
S3: an almost unmanageable conflict of interest right at the heart
12:26
S3: of the safety of medical devices.
12:31
S1: Okay, that seems wild to me, though, that a device
12:34
S1: either might be implanted in your body, or perhaps one
12:37
S1: that you rely on to prevent serious medical issues was
12:40
S1: not subject to a big clinical trial. I mean, you
12:43
S1: mentioned just there that you would expect them to be
12:45
S1: like clinical trials are of course used before drugs are approved.
12:49
S1: And you mentioned, of course, the lawsuits with the mesh.
12:52
S1: And those were transvaginal mesh that was implanted in women,
12:56
S1: I believe, to treat urinary incontinence and other issues. Isn't
12:59
S1: it a bit shocking that those aren't subjected to a
13:01
S1: clinical trial?
13:03
S3: I find it absolutely shocking, Sam, and I suspect many
13:06
S3: of your listeners would as well. Spinal cord stimulators had
13:10
S3: this very problem because there were no high quality clinical trials.
13:15
S3: We ended up with a raft of devices approved and
13:18
S3: being widely used without. Experts told me, high quality evidence
13:24
S3: showing that they were effective and safe. As part of
13:27
S3: our series, we've picked up another device that's often used
13:31
S3: for chronic back pain, a pain pump, and once again,
13:35
S3: this device was approved many years ago based on European
13:40
S3: certification and despite being approved for years and in use
13:44
S3: in many patients, we still lack high quality evidence showing
13:48
S3: it's safe and works. The problem, Sam, is once a
13:53
S3: company has a device approved, they in fact have a
13:57
S3: disincentive to run a high quality clinical trial because it
14:00
S3: might show the device doesn't work terribly well. It's almost
14:04
S3: better not to know.
14:06
S1: So tell us, though, what have these companies and the TGA,
14:09
S1: what have they said in response?
14:10
S3: Well, the TGA says that all medical devices supplied in
14:14
S3: Australia must and do have clinical evidence sufficient to demonstrate
14:18
S3: an appropriate level of safety and performance when used for
14:22
S3: their intended purpose. Medtronic, the manufacturer of the Synchromed two
14:27
S3: pain pump we spoke about, said the system was registered
14:31
S3: in line with legal requirements, and the device has more
14:33
S3: than two decades of established clinical evidence and is used
14:38
S3: by physicians globally. The manufacturers of continuous glucose monitors told
14:42
S3: us that it was likely that their devices had high
14:45
S3: numbers of adverse events because they were very widely used.
14:49
S3: They said that there was high quality clinical evidence showing
14:52
S3: the devices were safe and effective, reduced complications, and improved
14:57
S3: blood glucose control.
14:59
S1: So what then needs to change? Like what are the
15:01
S1: first things that need to happen.
15:03
S3: To my mind? Sam. The low hanging fruit here is
15:06
S3: allowing external researchers to participate in the surveillance process. There
15:12
S3: are lots of researchers around who are highly skilled at
15:15
S3: looking at medical data and spotting problems. I think the
15:19
S3: TGA could do more to pair with them, open up
15:22
S3: its data and say, here's what we're hearing. Can you
15:25
S3: help us spot the problems as they emerge?
15:29
S1: But is there not a problem even earlier on in
15:32
S1: the process, in terms of things that are being approved
15:35
S1: here without having a clinical trial. That seems to be
15:38
S1: a problem. No.
15:39
S3: Yeah. I couldn't agree more, Sam. I think the standards
15:42
S3: that we set for medical devices could be much higher.
15:46
S3: We could demand high quality clinical trials before devices are
15:50
S3: approved and licensed for use. We could demand that devices
15:54
S3: actually be formally tested by the TGA. We could say
15:58
S3: that it's not good enough for many devices to be
16:00
S3: approved without any auditing or testing at all. At the moment,
16:05
S3: I think it's left to patients to try and work
16:08
S3: out the safety and efficacy of their medical devices, and
16:11
S3: I don't think that's good enough.
16:12
S1: And then, Liam, just to wrap up, I imagine a
16:14
S1: lot of listeners would be hearing this and thinking what
16:17
S1: I'm thinking, which is that if they're about to be
16:20
S1: fitted for a medical device, or if they've got a
16:22
S1: loved one who perhaps is about to be. What questions
16:24
S1: can they ask their medical health providers that might help
16:28
S1: them ensure, as best that they can, that the device
16:31
S1: that they're being recommended to use is actually safe, and
16:34
S1: it hasn't been safe flagged as having problems in another country.
16:38
S3: I think you should always be willing to ask your doctor,
16:41
S3: what are the risks and what are the benefits of
16:43
S3: this device and what's the quality of the evidence. Like
16:46
S3: how do we really know that the benefits of this device,
16:49
S3: for me outweigh the risks?
16:52
S1: But does someone's general practitioner. Are they likely to be across?
16:56
S1: What sort of complaints have been flagged about devices overseas? Like,
16:59
S1: is that something we can reasonably expect of our GPS
17:02
S1: or other health providers?
17:04
S3: I think any health professional who recommends a medical device
17:09
S3: should be able to explain to you the benefits and
17:13
S3: the risks, but you hit an important point, Sam. Many
17:16
S3: doctors simply trust that the TGA wouldn't approve a device
17:21
S3: without high quality evidence showing it works, but unfortunately, that
17:25
S3: is simply not always the case.
17:28
S1: So, Liam, obviously the listeners don't have the benefit of
17:31
S1: your skills at their fingertips in their own private households.
17:34
S1: But what will you be doing in future? You know
17:36
S1: what databases or what sort of private research will you
17:39
S1: be doing to ensure something is safe? Do you have
17:41
S1: any tips for the listeners?
17:43
S3: While people should always be guided by their health professionals,
17:46
S3: I think it is reasonable to hop on the internet
17:49
S3: and sort of look for any potential red flags related
17:52
S3: to their device recalls, safety alerts, adverse events because the
17:58
S3: TGA does make this data public, and you can check
18:01
S3: it and then bring it to your doctor and say, look,
18:03
S3: you know, I've read about this. What does it mean?
18:06
S3: And how worried about it should I be?
18:10
S1: That is very helpful. Thank you so much, Liam, as always,
18:14
S1: for your time.
18:15
S3: Thanks, Sam. Thanks for having me.
18:19
S1: And just a note on a couple of things raised
18:21
S1: in this episode. Firstly, in the case of the Daylesford crash,
18:25
S1: the driver, William Swail, was initially charged over the deaths.
18:29
S1: A magistrate struck out those charges in 2024, saying a
18:33
S1: reasonable jury could not convict Swale of the criminal offences.
18:37
S1: And secondly, in response to this series, the TGA said
18:41
S1: all medical devices included in the Australian Register of Therapeutic
18:45
S1: Goods must meet regulatory requirements for safety and performance. This
18:51
S1: is demonstrated through appropriate evidence, regardless of pathway. No device
18:55
S1: is approved for supply in Australia unless it meets these requirements.
19:07
S1: Today's episode was produced by Josh towers. Our executive producer
19:11
S1: is Tammy Mills, and our podcasts are overseen by Lisa
19:15
S1: Muxworthy and Tom McKendrick. If you like our show, follow
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S1: the Morning Edition and leave a review for us on
19:21
S1: Apple or Spotify. Thanks for listening.