With the launch of the NHS Implant Analysis Service, we have been active participants in the national conversation regarding patient safety and the responsible post-operative treatment of Used Medical Devices. One of the architects of the service, Jason Wilson, was recently asked to contribute to the Clinical Services Journal regarding the changes in the medical device industry over the last twenty years, specifically thinking about the physical analysis of UMD’s. The full article follows:
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 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 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.
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[1]on-metal controversy that engulfed the industry ten years ago.
There is a serious cost implication when a class of device fails. Secondary, more expensive devices may be needed. Additional procedures will also be required and these represent a drain on resources. Each revision costs thousands of pounds. Therefore, a systemic process for understanding cause of failure and preventing further cases, makes financial – as well as ethical – sense.
Speaking of additional cost, one growing concern over the last 20 years has been the environmental impact of medical waste. UMDs thrown into waste end up in landfill, whereas a move towards a systematic analysis process can encourage a more sustainable means of disposal, with organisations, such as NHS Trusts, reducing their carbon footprint by handing the devices over to independent labs for recycling and recovery of precious elements
In the last 20 years, the UK has seen a rise in the number of litigation cases, with no-win-no-fee solicitors diverting huge sums of money away from frontline patient care. Physical analysis of a retained UMD safeguards Trusts from such litigation by providing strong evidence of the cause of failure, which is often not due to surgeon error or manufacturer error. Equally, if there is a fault, it can be pinpointed with the help of a physical analysis report. If a UMD is disposed of into medical waste, it may rob surgeons of the opportunity to understand the reason for failure.
Looking forward
Now, the NHS Implant Analysis Service (NHS IAS) provides the opportunity to have UMDs (primary hips and primary knees) retained, analysed and reported on. This has been presented to the ODEP and Beyond Compliance, as well as manufacturers, the MHRA and members of NJR at the BOA conference 2022. Surgeons and manufacturers alike are looking to see how this service develops.
The NHS Implant Analysis Service (NHS IAS) will begin providing independent analysis of primary hips and knees, with planned expansion into other orthopaedic products and eventually other specialties as well. Every effort has been taken to provide a service, which is fast, independent, accurate and reasonably priced, compared to standard product analysis, and which provides useful information to the surgeon to consider. In addition, the service allows the opportunity for the surgeon to have dialogue with the manufacturers.
The NHS IAS is a way to ensure independent analysis of UMDs is possible with devices shipped “dirty” direct from the operating theatre, decontaminated, analysed and reported upon within a matter of days. It gives a huge step forward in completing all the pieces of the jigsaw on how medical devices have performed and finally gives surgeons access to an option that colleagues in other countries already enjoy.
Summary
As the number of medical devices, procedures and manufacturers increases, the likelihood of more adverse events affecting patient safety is likely to climb. The last 20 years have shown us the consequences of proceeding to fit implants without a systemic means of physically analysing them to learn from the performance of each individual device. With those lessons keenly in mind, the UK should now be in a position where innovation is welcomed but accompanied by a system of checks and balances to guard against complacency.
Explants thrown in the bin end up denying surgeons, manufacturers and regulators the opportunity to learn more about the true performance of medical devices and use the data to drive change and safeguard patients. Lessons can be learned from all devices analysed.
Many other countries have already recognised the need to analyse used medical devices and the need for truly independent testing has been highlighted several times over the last decade since metal-on-metal hips gained notoriety and launched a stream of legal actions worldwide. Furthermore, the various health authorities in the world also acknowledge work in this area is beneficial including the NHS, the FDA and the Australian Department of health.
Physical analysis of UMDs helps to drive best practice, ensures an early warning system for poor performance of implants, provides data to assist in patient /implant profiling, and drives down costs through value for money. It is the next logical step for an industry that has recognised a need for increased learning opportunities and a renewed focus on patient safety, and it closes a gap in the way we handle surgical implants that has been left open for far too long.
About the author
Jason Wilson, from the NHS Implant Analysis Service, is a medical device specialist.
With over 25 years’ commercial experience, Jason has a background in major Blue Chip companies and extensive worldwide knowledge and experience in the medical device sectors (including roles at DePuy, Pfizer, Johnson & Johnson, Get Orthopaedics and more recently with Medical Explants). An accomplished successful start-up director, with invaluable first-hand experience in regulatory, manufacturing and professional medical marketing, Jason offers multidisciplinary consultancy for manufacturers, legal firms and the NHS. With a career working with many of the largest orthopaedic device manufacturers, Jason has a great depth of knowledge of the industry. This expertise is being used to help the NHS develop and implement a new system for the analysis of used medical devices.
References
Australian Department of Health. No date. https://www.health.gov.au/
Beyond Compliance. No date. https://www.beyondcompliance.org.uk/
Chakfé, N.; Heim, F. 2017. What Do We Learn from Explant Analysis Programs? European Journal of Vascular and Endovascular Surgery. 54(2), pp. 133-134.
Food and Drug Administration. No date. https://www.fda.gov/
Gov.uk. No date. Medicines and Healthcare products Regulatory Agency (MHRA) https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Getting it right first time (GIRFT). No date. https://www.gettingitrightfirsttime.co.uk/
Medical Devices regulation (MDR) (Regulation (EU) 2017/745) which replaced the Medical Device Directives (MDD)((3/42/EEC).2022. https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#full-publication-update-history
National Institute for Clinical Excellence (NICE). No date. https://www.nice.org.uk/
National Joint Registry (NJR). No date. https://www.njrcentre.org.uk/
ODEP (Orthopaedic Data Evaluation Panel). No date. https://www.odep.org.uk/
Therapeutic Goods Administration. No date. https://www.tga.gov.au/
