Recent media reports have exposed the worrying incidence of faulty medical devices around the world and in Australia. When things go wrong, the impact on a person’s ability to work and enjoy a fulfilling life can be profound and game changing. What these reports did not highlight is the disturbing prospect that the regulation of these products is a rapidly growing and increasingly complex challenge for society.

The range of adverse and unexpected glitches and catastrophes that can bedevil medical technology continues to expand along with the phenomenal variety of new devices streaming into health care.  Already drawing deep attention from top medical experts – and investment houses – are developments many consumers may never have heard of, let alone understand.

These include innovations such as 3D printing which can enable the creation of fresh tissue and even body organs, “Google brain”, a dramatic advance in artificial intelligence that is expected to offer huge advances in diagnostics, genomics utilizing genetic knowledge in healthcare, and nanomedicine which uses microscopic particles circulated in the body for diagnosis and treatment.

Imagine for a moment the effort, organisation and expertise that a regulatory system will need to keep on top of these breakthroughs in the face of the clamor from the health sector and patients for the life-saving and life-enhancing benefits these innovations can offer.

The challenge of regulating future technology was a theme of the Consumers Health Forum journal, Health Voices, which last year devoted an edition to medical technology.

The suffering experienced by thousands of Australian women as a result of harms wrought by vaginal mesh and the complications in rectifying the treatment was a trigger for the Health Voices edition.

Several expert authors made the point that regulating medical devices is becoming ever harder, not just because of the explosion in new technology but also because of the elusive nature of the exponential development and modification of existing technology.  While original products may have undergone regulatory scrutiny, the fierce commercial contest to offer new features can transform the original product, opening new risks.

All of this poses a challenge for society, as public policy seeks to balance the community’s access to the many benefits of medical progress with its protection from risk and harm.

There is a tendency to sheet much blame on to the regulator, which in Australia is the Therapeutic Goods Administration, for failing to act to prevent the use of questionable products.

But the speed and complexity of the introduction of medical technology, demands fresh levels of scrutiny from manufacturers, researchers, clinicians and, not least us, the consumers.

The recent media report said that almost 83,000 people have died around the world, 170 of them in Australia in the past decade, due to potentially dangerous medical devices.  And despite Australia’s relatively effective regulatory arrangements, many thousands more in Australia alone suffer unexpected ill-effects of medical devices.

The ABC reported in its series, The Implant Files, cases of hazardous devices, including certain types of textured breast implants which had been linked to a form of lymphoma, a rare blood cancer, but that only 29 of 72 cases of this type of cancer linked to the implant had been included in the TGA data base.  Despite the rise in cases of the new type of lymphoma between 2012 and 2015, the TGA was reported to have said that “the totality of the evidence presently available” indicated the implants were “safe and effective”.

The TGA website list of its alerts involving medical devices indicates 14 items, ranging from thermometers to ventilators, have been the subject of alerts to clinicians and consumers this year. Alerts can be reported to the TGA via the following links –

Users Medical Device Incident Report

or Reporting problems

The TGA has a risk-based approach to regulation. As it says, it would be inefficient to regulate a tongue depressor with the same rigour as a pacemaker. The TGA states that the extent of regulation depends on:

* The intended purpose of the device

*  The degree of risk the device poses to the patient

*   The degree of risk the device poses to the user and those in the vicinity

*    Whether the device is used internally or externally to the patient

*     The duration of use.

Earlier this century in Australia, many hundreds of people suffered chronic pain and disability as a result of the “metal on metal” hip replacement prostheses that surgeons continued to implant despite rising evidence of the product’s problems.  The unsettling aspect of that episode was that the suspect products remained on the market and in use for some years despite the rising rate of adverse outcomes recorded in a national register that tracks the rate of “revisions” or repeat replacements of joint prostheses. The upside is that the national joint replacement register has been associated with an overall fall in the rate of revisions over the years as a result of its data identifying better, and poorer, performing prostheses.

On the wider scene of medical device regulation, the Consumers Health Forum proposes a range of measures, including:

*  The mandatory reporting by medical practitioners of adverse events and side effects of medical devices. It does the medical profession no credit that, in the face of the pervasive influence on their own profession and on patients to use medical devices, that measures to compel doctors to report problems with devices are not mandatory

*  The need for more education and support for consumers to report problematic devices

*   Support for the introduction of consumer device information already being introduced including timely and well targeted patient information to identify potential risks before devices are implanted (with patient information being updated following adverse event reporting)

*   A registry of all implanted devices, including information on patient, surgeon, and device identification to enable follow-up with consumers who have implanted devices in the event of safety and efficacy issues

*   A more effective and practical way to administer a financial penalty system for manufacturers of faulty devices and requirements on manufacturers to replace faulty devices at their own cost to protect consumers

The impressive advances in medical technology offer great benefits to millions of people and that trend seems likely to accelerate the revolution in healthcare. In fact, as citizens in a developed country such as Australia, consumers have every right to expect access to be best health technology medical science can offer.    

It is clear that to safeguard Australian consumers and mitigate the risks of any downsides of this new and rapidly evolving era of technologically-aided healthcare, we need vigilant public policy that keeps well ahead of the development pipeline and more rigorous measures, including more resources for the TGA to enforce them.