U.K. Establishes Implant Analysis Service

In the United Kingdom, used medical devices (UMDs) rarely undergo a physical analysis despite repeated calls from surgeons and regulatory bodies for such evaluations to become routine. Most devices are discarded in the operating room without gathering an understanding of their performance beyond a cursory look at the end of surgery. In fact, less than 1% of all revised primary hips and primary knees are physically routinely analysed, according to the NHS. Discarded explants deny orthopedic surgeons, manufacturers, and regulators the opportunity to learn about a device’s true performance.
 
There has been controversy in the past 20 years over metal-on-metal hips, orthopedic polyethylene, breast implants and, more recently, vaginal mesh. So wide and strong are the implications of failed devices that Baroness Julia Frances Cumberlege, a British Conservative Party politician, was asked to chair a committee to report on used medical devices, published in 2020. It is against this backdrop of metal- on-metal hips and the Baroness’ report, as well as the recognized need by various interested parties/organizations that the NHS has created an Implant Analysis Service (IAS). 
 
The NHS Implant Analysis Service aims to address the need for used device evaluations and drive solutions, distinguishing genuine product issues from sporadic events. Delivered by the NHS, it will not only confirm recognized best practices by providing a quick efficient service for the independent analysis and reporting of UMDs but also establish robust, solid evidence. The service will directly improve outcomes for all healthcare organisations as well as post-market surveillance for manufacturers, and assist longer-term research by ensuring more devices are physically available.  

The NHS Implant Analysis Service is an independent, fast, efficient and cost-effective service, which conducts physical analysis and issues reports on UMDs to the benefit of the NHS, patients and manufacturers. The service is intended to be used as an adjunct to the other data and information surgeons currently have at their disposal to provide a more comprehensive picture of how a UMD has performed.

“In BC (Beyond Compliance) we have always thought that explant analysis of all retrieved implants, particularly if they are novel, should be undertaken,” said Keith Tucker, chair of ODEP and the Beyond Compliance Advisory Group. “To date this has hardly happened and BC and ODEP are delighted that the NHS Implant Analysis Service is going to facilitate this essential part of implant monitoring.”
 
Not only will the NHS Implant Analysis Service act as an early warning system for poor performance of UMDs, it will also provide validation of well performing devices. It provides physical evidence to assist in patient/implant profiling and drives down costs and risks to patients receiving possible underperforming devices whilst also reducing medical waste and providing a more sustainable route for disposal. It is the next logical step for the orthopedic industry, which recognizes and supports a need for increased learning opportunities and a renewed focus on patient safety. It closes a gap in the way UMDs are handled in the United Kingdom, the NHS claims.