Reforming the regulation of orthopaedic devices in the UKBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7374 (Published 01 November 2012) Cite this as: BMJ 2012;345:e7374
- Matthew Costa, orthopaedic surgeon
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 to reassure the public?
High quality surveillance is certainly achievable. The National Joint Registry for England and Wales was set up for this purpose, and most surgeons and hospitals now take part.5 The problem with this registry, and indeed with most registries around the world, was that it used “revision”—that is, failure of the implant, requiring further surgery—as its endpoint. Revision is an attractive endpoint because it is a clearly defined outcome, so data are relatively easy to collect across a wide range of institutions. However, this endpoint has two drawbacks.
Firstly, an implant could function poorly but not be revised; both surgeons and patients are reluctant to have further surgery unless the implant is broken or demonstrably loose. Secondly, because revision can occur for reasons other than implant wear (such as infection or trauma), it may be years before a trend towards implant related failure is detected. The National Joint Registry has therefore started to incorporate patient reported functional outcomes, which may help to detect underperforming implants more rapidly and, under the Beyond Compliance project, new types of implant will be subject to closer scrutiny. This should facilitate earlier alarms and decisions about patients’ safety.
What about the safe introduction of innovations? Beyond Compliance advocates the use of test centres—with appropriate expertise and governance—where new devices would be introduced. Previously, manufacturers approached individual surgeons or hospitals to try new devices, mostly on the basis of the enthusiasm of the surgeon or centre to do something new. More tightly regulated testing centres with rules about reporting problems as soon as they are identified would certainly facilitate early decisions about safety and improve transparency for patients. Furthermore, the implant industry, which has had to defend its record in introducing new devices,6 would probably welcome the opportunity to work with such approved centres.
Finally, the issue of the initial approval of a new implant remains. The limitations of the CE marking process, where private “notified bodies” enter into confidential contracts with manufacturers—have been clearly identified.7 Beyond Compliance suggest that “good quality advice” is needed to improve this process, but is advice enough? Surely, the current system of initial approval for new implants needs to be replaced with something altogether more robust and transparent? This would probably require legislation, but at least Beyond Compliance is bringing this to the attention of the European Commission and Food and Drug Administration.
Some would argue that new devices should be subject to the same stringent regulations as new drugs. Against a background of patients undergoing revision hip surgery for complications associated with metal-on-metal hip replacements it seems hard to argue against this. However, there are problems with treating devices just like drugs. New bearing surfaces such as metal-on-metal were introduced in an attempt to reduce wear, and hence loosening, seen in the more traditional metal-on-plastic hip replacements. In younger more active patients, about 50% of traditional hip replacements fail at 25 years,8 mostly because of wear to the plastic. How would a drug-type approval process cope with a new drug that took 25 years to show an advantage over an existing product? To make matters even more complicated, patients may actively choose to accept a slightly higher risk of short term failure for the benefits of long term durability.
Beyond Compliance is a step forward in the way that new devices are introduced into patient care. The surgeons and regulators who drove this process should be congratulated for taking positive steps to protect patients from potential harm and, just as importantly, to reassure them that there is a system in place for detecting problems when they occur. This last point is important because devices such as hip replacements, unlike drugs, inevitably fail if they are used for long enough. The key is to pick out which devices are failing early and to make sure that they are removed from clinical care as quickly as possible.
Cite this as: BMJ 2012;345:e7374
Competing interests: The author has completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declares: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Provenance and peer review: Commissioned; not externally peer reviewed.