Regulatory

It’s taken the illegal actions of a rogue implant manufacturer to catalyse what looks increasingly like a radical reform of the cosmetic “surgery” industry in the UK. Lots of sensible recommendations from the aesthetic surgical fraternity, but weren’t these obvious deficiencies?

Gimme a P, Gimme an M, Gimme an A. What do you get? Well, not quite a PMA, but the end result might look mighty like it by the time it hits the streets. Not a bad thing though, and there’s lots of really sensible and even pragmatic stuff in the new device regs, especially the re-hash of notified body rules.

Today is indeed the day on which we welcome the adoption of a new set of medical device regulations, to become law from 2015. It’s about time too in our view because the credibility of the current EU set-up has been damaged by public dissection following a number of high profile product problems.

Taken at face value some new data and reporting suggests that a U.S. style PMA might deliver little benefit in terms of patient safety, yet delay innovations from reaching the market by 43 months. We argue it’s more subtle than that.

The week’s medical device news in one piece of editorial. Quite a challenge, so we don’t even try to capture it all. Highlights and opinions in one bite-size package.

Given Imaging Ltd. developer of the Pillcam Colon 2 swallowable camera system for visualisation of the colorectal lining, has submitted compelling trial data to the Japanese authorities showing that 94% of polyps identified using standard colonoscopy were also spotted by its device.

The National Institute for Health and Clinical Excellence has published final guidance on a new medical technology device designed to be used during surgery. The guidance advises that the use of the Mega Soft Patient Return Electrode could help reduce the risk of localised burns during monopolar electrosurgery

While the toxicology work continues, it seems implant data is still saying the same thing, that PIP implants rupture more frequently than other implants, that in most cases there is no reaction, and when there is a reaction it’s obvious. Most significantly data confirms no resultant cancer.

U.S Regulatory Agency the FDA is issuing guidelines under which it will give medical device makers feedback before they submit a product- or research-specific application.

The US FDA is proposing to establish a system which would require the label of most medical devices and device packages to include a unique device identifier in an endeavour to identify potential problems earlier and better isolate affected populations.

Consumers Union is a powerful patient rights advocacy group in USA, and as such it’s perhaps not surprising to see it welcoming the Unique Device Identifier proposals from FDA… and asking why it’s taken so long.

It’s industry body Eucomed’s job to be the cheerleader for Europe’s medical device industry members. And when Eucomed speaks, we listen. However, in what we’re hoping is a healthy contribution to the debate, we’re taking issue with some aspects of regulatory director John Brennan’s latest blog in which he is arch defender of the status quo.

We thought when we saw the approval for Edwards’ Sapien valve to be extended to include a further patient cohort, that it was a great case study into the difference between EU and US regulatory processes, given the five year approval gap between the continents. Seems we were not alone.

Sir Bruce Keogh, Medical Director of the UK’s NHS, has released his report on the PIP scandal, which reassuringly suggests the content of the implants, while being suitable for mattresses, is also non-toxic to humans. His advice to patients remains the same; If they’re troublesome, take them out.

There’s no doubt that much of what is proposed in the European Parliamentary measures to improve patient safety represent sensible and overdue measures. But the European “PMA” is sounding like a hammer to crack a nut. Eucomed isn’t sounding convinced either.

Parliamentary select committee on medical device regulation saw witnesses from industry and regulatory stakeholders today. It’s all looking very harmonious, but has anyone thought about the cost of the brave new world that is being sold to us?