20 YEARS OF MEDICAL DEVICE S
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
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