Pelvic mesh and 3D printing – you could hardly think of two more diverse subjects. Yet it is a telling mark of the impact and complexity of medical devices and the issues they raise that this edition of Health Voices ranges from the deeply painful implications of pelvic mesh to the remarkable feats and future promise of 3D printing.
Questions concerning the quality and safety of medical devices highlighted by the pelvic mesh issue were what initially triggered the decision to make medical devices the focus of this edition.
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 momentum and evolving nature of biotechnology is such that it is becoming increasingly more challenging for even the experts to keep up.
With the pelvic mesh tragedy and earlier harmful episodes such as with metal on metal hip prostheses, a key feature was that change built upon change in the use and development of products to an extent where what had seemed safe developments to start with, turned into insidiously mounting risks.
And now the 3D venture, which is offering such huge scope for benefit, can also be seen not only to transform and benefit care, but because of continuing re-adaption and customisation, to have the potential of drifting away from rigorous evidence-based use in circumstances that are difficult for regulators to monitor.
This presents an expanding challenge for consumer advocates like the Consumers Health Forum in keeping track of systemic issues of quality and safety in health care.
As Danny Vadasz writes in the opening article, “The calibre of a quality and safety system is not how it operates in a business-as-usual environment but how well it prevents catastrophic consequences.” Danny took a leadership role with the Health Issues Centre and other state consumer organisations in initiating a social media conversation that provided a link to a national survey of de-identified respondents’ tragic experience with transvaginal mesh. The response was overwhelming. Within six weeks the campaign had reached over 160,000 women of whom 2,400 participated in the survey.
This national survey of suffering raises profound questions including: How did over 100 variants of a poorly -tested device get into the market without adequate clinical testing for safety and efficacy? How was it that we could not say how many of these devices have been implanted over 20 years other than to rely on inventory estimates that between 100,00 – 150,000 products that have been distributed? How could the mandatory adverse event reporting so dismally understate the extent of the problem — 96 cases recorded by the TGA over five years and how could state and federal complaints mechanisms fail to detect and signal the alarm about the recurrent failure and pain?
Danny concludes that the ultimate tragedy of mesh is that it demonstrates that our world class health system is not accountable to the people it was built to serve. “We need to make it so.”
Dr John Skerritt, who heads the Therapeutic Goods Administration, acknowledges that medical device regulation is “a challenging and changing area”. Reforms are underway including allowing designated commercial bodies in Australia to undertake medical device assessments; and options for a proposed register for higher-risk implantable devices. New approaches for gathering safety “signals” for devices are possible through analysis of large sets of de-identified patient data from hospital admissions and discharges, Medical Benefits Schedule item claims, and increasingly, electronic health record data. And while reporting of adverse device outcomes is mandatory for suppliers, in Australia there is not a corresponding requirement for such reporting from clinicians, so TGA is more actively encouraging voluntary reporting. And given the speed of medical and technical innovation device regulatory systems need to evolve to accommodate these developments in technologies, Dr Skerritt says.
A clinician at the centre of this evolving world is Dr Jason Chuen, a 3D printing pioneer who says it’s now possible to design replacement body parts — jaws, hips, knees, and spinal implants — custom-made to guide surgery and fit individual patients perfectly. Regulators need to ensure that medical designs and 3D printers are used safely. This signals a paradigm shift in the responsibility for products that do not perform to specification, or what the specifications should be in the first place. “Ethical issues arise in whether patients, doctors or specialised “bio-medical engineers” should be allowed to design and make medical parts,” writes Dr Chuen.
It’s important to recognise the value to patients that could come from customised implanted treatment to address structural impairments, while ensuring safety and long-time stability write two leading authorities who bring a mix of biomedical and bioethics philosophy to the subject, Professor Susan Dodds and Professor Gordon Wallace. Developments such as knee cartilage repair, printing ear structures for patients with ear deformities and even 3D printed neuronal networks to explore neurological disorders like epilepsy and schizophrenia makes vital checks and balances to ensure safety, regulatory and policy issues are being developed and to ask whether there might be unexpected ethical concerns arising from this rapidly expanding research, they say.
The challenge is “the past keeps happening”, as Associate Professor Wendy Bonython and Assistant Professor Bruce Arnold say. When it comes to medical devices, as the pelvic mesh saga has shown, we need to emphasis anticipation rather than reacting to biotechnical fiascos after the event. They say these problems are not unfixable but require a restructuring of the TGA, making it report directly to the Parliament, funded on a needs rather than a costs recovery basis to ensure expertise in areas such as the “emerging Internet of Things” rather than merely existing devices. TGA needs to maintain a comprehensive national register of all devices and ensure timely information sharing about device failures.
Henry Ko writes that the recently announced TGA actions to: (1) increase the evidence requirements of surgical mesh devices to that of a Class 3 medical device, (2) improve the product information given to consumers, and (3) have patient implant cards, are sensible actions to improve accountability in this device type, but it may be too little too late to patients affected by the devices. We need to now ask what other devices out in the market have “flown under the radar”, in terms of proper clinical evidence, providing adequate consumer information, and having adequate product tracking and accountability?
While much of the heat has been directed to the medical device regulatory approval process, Dr Sally Wortley and Dr Samara Lewis make the point that a clinician-led, consumer-focused approach has the potential to reduce harm and engage those who are most affected by these technologies. That approach could follow the example of the Choosing Wisely campaign which currently tends to focus on discouraging unnecessary medical tests in reporting adverse events, establishing patient registries and better-informed doctors and patients. With the use of high-risk medical devices, Choosing Wisely precepts would support conversation between clinician and patient to ensure full consent and awareness of risks, benefits and uncertainties.
As Ian Burgess says, the life cycle of medical devices is much shorter than that of medicines, and the technology moves at a faster pace. Therefore, running large clinical trials over many years is not sustainable for medical devices. Instead significant evidence can be generated from the use of the device outside the clinical trial setting. The current regulatory system does recognise the data challenges unique to devices and therefore mandates that adverse event data be reported every six months for the first three years following the marketing approval of a device.
Dr Wendy Lipworth and Assistant Professor Tamra Lysaght write that the issue of enabling faster consumer access to health technologies raises two fundamental questions for consumer advocates: first, what do consumers really know and want when it comes to access to health technologies? And what responsibilities do consumer advocates have to balance (valid) calls for access to health technologies against (equally valid) demands for thorough regulatory oversight?
Even prosaic items of health care like dentures are being transformed by technological advance, with potentially big benefits for the consumer. Scott Davis says 3D printing and the advent of exciting new materials will mean that dental and orthodontic products like dentures could be made locally and this should allow for faster manufacture at a lower price.
As Lorraine Chiroiu states, the stark reality is that if it were not for commerce, medical device research would most likely remain a journal article or an award, not reaching consumers or being of practical use.
Our concluding article importantly raises the prospect of these huge changes requiring watershed changes to regulations. Rapidly emerging technologies may offer considerable advances but are challenging the regulatory system in profound ways that prompt the question of whether we need to consider radical alternative approaches, says Dr Mary Jean Walker. She cites the difficulties of regulating the constantly changing and updating functionality of computerised devices like pacemakers and insulin pumps, and customisation of devices, through developments like 3D printing and computer-aided design to tailor the device to individual patient physiology. This complicates collecting evidence on safety and effectiveness which hitherto relied on assessment of a population-wide use of standardised devices. “Whatever the result of these considerations, my point is that there is value in questioning all features of the system and the assumptions built into them, even radically, if we are to arrive at an approach based on reasoned assessment, and defensible ethical decisions.”