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.
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