Is It OK To Adopt A New Technique Without Some Form Of Regulatory Approval?

In short

I don’t know if you’ve seen the extensive press coverage today about a U.S. Orthopedic Surgeon who has adopted a new approach to hip replacement and is seemingly getting good results. We ask what’s so different between a new technique and a new device such that one is tightly regulated and the other is adopted in clinical practice with no such control.

Background

It’s all about evidence isn’t it? When company X launches a new device it usually does so having proven to itself or its regulatory body that the device works. Getting to that point can be an enormously expensive exercise and one that is not going to get any easier… ever. I mean, take a look at metal-on-metal hips and tell me that the next time someone with the power to rubber stamp an approval is faced with the dossier he or she won’t be poring over every nuance the “evidence” turns up. That’s assuming it gets to the point where a product ever gets to be ripe for approval. It could be that an increasing regulatory burden cuts a lot of new technologies off at the fertilisation point, let alone reaching delivery. And maybe that would be a good thing if it means that companies can no longer gain approval to market pretty much anything based on a bunch of historical predicate data, a few selectively selected pre-clinical slides and a quick clinical “study” which is hidden from public view. Nonetheless there exists a process, like it or hate it, both sides of the pond, for approving everything from a scalpel blade to a heart assist device.

So the extensively circulated news that a U.S. surgeon has found a new way of implanting a hip prosthesis provides food for thought, mainly because of the contrast between adoption of a new technique and introduction of a new technology.

It’s a right old conundrum really because who’s going to say to a surgeon “you must do it this way or that” when the surgeon has the patients life in their hands and is usually by definition the responsible and best qualified person to make that call? So do we accept the fact that the surgeon can go off piste whenever he has a new idea, or do we do something about restricting the way things are done, ending up with a sort of recipe, replacing that bearnaise sauce with a cleanly executed hernia repair?

Well the reality of course is that clinicians don’t usually get away with being cavalier for long. Results are increasingly scrutinised and the good guys, many of whom are of the pioneering type, like to show their workings off. So we’re not criticising surgeons for doing it their own way, and we’re certainly not questioning the skill or judgement of the chap in the article featured here. But what we are doing is posing the question, where’s the evidence and what’s the process and indeed motivation for gaining some?

In fact we’re probably also asking whether it’s always possible or desirable to seek it! Take the UK orthopaedic surgeon who used to employ a British Rail soup spoon to ream out the acetabulum because it was just the right shape. Those days are gone, but who’s going to say he was wrong or that he should have presented evidence to his clinical team leader before he embarked on the practice? But progress is about taking the performance of an operation and reducing it to its component parts, derisking and optimising those parts in order to improve the outcome. Surely then the regulation of the operator is as important as the regulation of the thing he’s operating with. We hear plenty about revalidation of clinicians to ensure they are educated an up to date, but that doesn’t stop them doing exactly what they judge to be the best thing to do in the operating room. While for most medical professionals, most of the time their education and training is enough to ensure they do the right thing, but there are enough incidences in history of things going wrong that one wonders whether its enough to hope that audit, that ultimate clinical form of post-marketing surveillance, is enough.

Source: Medical News Today