Reforming the regulation of orthopaedic devices in the UK

Serious and continuing concerns have been raised about the safety of metal-on-metal total hip replacements.1 2 These concerns have also prompted wider debate about the introduction and regulation of new devices in general.3 So what have the surgeons who introduce new devices to patients been doing to deal with these concerns?

The British Orthopaedic Association and the Medicines and Healthcare Products Regulatory Agency have developed a joint initiative called “Beyond Compliance,”4 which is designed to provide a framework for the safe introduction of new implants. It has three key objectives. The first is: “to improve the rigor of processes around CE marking before an implant is sold, by offering good quality advice.” The second is: “to provide guidance and support for the safe and agreed introduction of innovations.” And the last is: “to provide high quality surveillance and a decision making process to identify failures at the earliest point and suggest appropriate actions.” This all sounds sensible, but can these objectives be delivered, and will they help …