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Ethics, regulation and the medical devices boom

In an era of medical apps, remote-controlled biomedical devices and 3D printing, regulatory and quality-control challenges will enter unprecedented territory, the latest Consumers Health Forum journal explores.

In a special edition of Health Voices on medical devices, the ethical, practical and personal dimensions of this runaway industry’s frenetic expansion comes under the spotlight.

Australia has seen a number of scandals involving implants in recent years, including metal-on-metal hip replacements, breast inserts and, perhaps most famously of late, trans-vaginal mesh, which is the focus of a paper by Health Issues Centre chief Danny Vedasz.

Vedasz highlights a litany of failings uncovered by the “cautionary tale” of mesh stretching back some 20 years, including:-

  • regulatory approval – more than 100 poorly tested devices made it to marked without adequate clinical assessment of efficacy and safety
  • medical device registry – reliance on manufacturer distribution estimates rather than a centralised implant database
  • adverse event reporting – ‘dismal’ underestimation of the true scale of the problem (96 TGA complaints over 5 years)
  • complaints reporting – failed to detect an ‘alarming recurrence’ of mesh-related complaints within and across state and territory borders
  • informed consent – only 34% felt the risks were adequately explained
  • practice standards – relevant associations agree inadequate training and certification an issue yet accept no responsibility
  • conflicts of interest – undiscolsed manufacturer kickbacks for practitioners
  • product recall procedures – simply don’t exist to the requisite national standards in the medical device sector
  • patient-centred care – patients told their pain either imagined or a natural consequence of ageing

“The momentum and evolving nature of biotechnology is such that it is becoming increasingly more challenging for even the experts to keep up,” writes CHF CEO Leanne Wells in her editorial.

“What are the factors behind these episodes of medical devices gone wrong?  What is being done to prevent recurrences and what are the future implications for medical devices given their rapid development and transforming benefits and hazards?”

The TGA last week withdrew transvaginal mesh from the Australian register following a new review of the clinical evidence and latest international studies.

John Skerritt, deputy secretary of the federal department of health and a former national manager of the TGA, details some of the regulatory challenges of the burgeoning device industry.

Though the government was already implementing a number of recommendations from the medicines and medical devices expert review, Skerritt said it was important to note that the TGA had no power to regulate medical practice, and there was currently no mandatory reporting requirement for adverse outcomes from implants by health care professionals, only by suppliers.

Law academics Bruce Baer Arnold and Wendy Bonython argue that the TGA itself needs to be restructured, that a comprehensive national device register needs to be established and maintained, and that conflicts of interests for health professionals and manufacturers must be meaningfully disclosed.

Bioethicist Mary Jane Walker argues that ethical frameworks are essential to the process by which medical devices come to market, requiring judgments about what levels of risk are acceptable, and whether public health and safety or the potential benefits of an innovation reaching patients as quickly as possible hold greater weight.

The problem in the medical device industry, she writes, is that a high level of risk acceptability is currently built into the system due to the rapidly-evolving nature of implants. This is only likely to become more problematic in an era of customisation, where teachnologies such as 3D printing will pose new and unforeseeable challenges to regulators.

Looking specifically at 3D printing technology, Jason Chuen from Austin Health’s 3DMedLab, examines some of the challenges for regulators, including safe and reliable biocompatible material use and who should be allowed to design and print such devices — patients, doctors or specialist biomedical engineers.

It’s worth checking out the edition in full, and we’d be interested in your thoughts on this complex and emerging area of medicine and health.

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