20 YEARS OF MEDICAL DEVICE S
A changing landscape: explant analysis
The last 20 years has been a time of great innovation and technological advancement for medical devices, with an ever-increasing number of new products. Unfortunately, not all theoretical innovations have performed as well as anticipated in the human body, as the last 20 years have shown. Jason Wilson provides an overview of the past two decades and discusses some of the key issues.
Over the last 20 years, there have been occasions of less-than-optimal product outcomes, which has seen patient safety compromised (such as some metal-on-metal hips and pip breast implants). This has led to improved safeguards, a demand for new regulations and now a closing of the loop through the introduction of widespread physical analysis.
The UK has an enviable regulatory system. Some of these initiatives include: GIRFT (Getting it right first time); Beyond Compliance; ODEP (Orthopaedic Data Evaluation Panel); National Institute for Clinical Excellence (NICE) and the National Joint Registry (NJR). The focus of these organisations is very much around data collection and the conclusions which can be deduced from this data, building up a national picture – which has often been missing is the physical analysis and reporting of used medical devices (UMDs). Data collection is good standard practice and allows for audit and evaluation, but one could argue that without the physical analysis it is still an incomplete picture. In the UK, physical analysis of a UMD is not mandated and approximately less than 1% of all revised primary hips and primary knees are physically analysed. Those that are usually involve clinical research, which is invaluable for validating the overall performance of medical devices, but which takes many years to be published in the medical journals. Manufacturers also offer analysis in case of a complaints process, but this is not routinely actioned. For surgeons, neither option is routine within their clinical practice. The end result is the endemic process of sending UMDs to landfill with no physical analysis. This all takes place
NOVEMBER 2022
devices are performing well, data which can sit alongside assessment criteria from the NJR, ODEP and Beyond Compliance as well as the other tools the surgeon has available (x-rays, blood tests etc.). If all UMDs are analysed we can see not just what has failed and why, but also what has survived far longer than expected, and what has therefore been a major success. This is post-market surveillance, and it is a benefit for manufacturers, surgeons and patients.
against the backdrop of an industry still recovering from the metal-on-metal recall of 10 years ago.
The UK has lagged behind in introducing a more systemic approach to physical analysis. In Australia for instance, they report that around 70% of all orthopaedic devices are analysed upon revision and, in the US, the FDA has taken steps to focus on more in-depth reviews of UMDs, including the need for physical analysis. In the UK, the MHRA has stated that UMDs should be retained and not destroyed, though this is only in relation to adverse incident reporting. This is a missed opportunity, as these other countries have recognised.
Physical analysis of UMDs as standard helps to develop a complete picture of which
Regulatory changes Regulations around medical devices are changing with the introduction of the Medical Devices regulation (MDR) (Regulation (EU) 2017/745) which places a greater emphasis on post market surveillance (which is a collection of processes and activities used to monitor the performance of medical devices). These activities are designed to quickly identify device design and/or device usage problems, as well as demonstrate the real-world device behaviour and clinical outcomes in general settings, away from specialist research centres. Obviously, the analysis of UMDs would be a suitable means to assist with this post-market surveillance and through utilising a centralised system of device retention, the UMD can still be made available to manufacturers once it has been independently analysed.
The physical analysis of UMDs has other advantages directly to patient safety, as it can serve as an early warning system of potential product issues. It can also assist with the assessment of general trends of product failure, versus smaller sporadic events. Robust physical analysis of failed products would have averted the metal- on-metal controversy that engulfed the
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