The BMJ Today: Medical device regulation – still out of joint

The introduction of new orthopaedic implants has for some time been a major focus of attention within scientific and policy circles since concerns about certain devices used in total hip replacements were brought into the spotlight. One of the conclusions of a BMJ feature by Deb Cohen in 2012 was that “After a series of failures, device regulation is in need of radical change.”

Professor Nick Freemantle commented at the time that the existing European regulatory framework—CE marking— “might be sufficient for electric toasters and kettles,” but is far from adequate for interventions that can affect a patient’s quality of life and can actually cause their death. So have things improved since then? It would seem not.

The authors of a systematic review published today, of five widely used orthopaedic devices, indicate that new technologies continue to be introduced to the commercial market without sufficient high quality evidence for improved benefit over existing proven and safe alternatives. Once again authors call for improved regulation and professional society oversight to tackle this.

In a linked editorial, Kesselheim and colleagues discuss some of the difficulties in regulating evolving technologies that introduce potentially beneficial changes. They suggest that surgeons need better ways of communicating risk with their patients to address the “overestimation of benefits and underestimation of harms” that patients might otherwise expect when learning of “new and improved” models.

Despite many years of reporting on flaws in the system, it would seem that there is still much improvement that could be made to existing European regulatory and approval processes for medical devices before we can be confident that any new devices coming on to the market have been approved and tested sufficiently, to ensure that there are benefits to patients over existing ones, while still allowing a competition and innovation in the market.

Finally we look back at a personal view by surgeon Professor Stephen Westaby, who says that publishing surgeon specific mortality data are unhelpful, not only for the profession but also for patients. Join our readers’ poll this week to have your say.

Rapid responses can be submitted for every article in The BMJ; some are published as formal letters to the editor.

Cath McDermott is head of education, The BMJ.