Developing standards
The public consultation on TC403 ended on 22 May. CEN’s Alina Iatan explained to Prime that the document now goes into committee, which looks at all comments and will produce a first draft proposal. This goes for a final vote, which could be as little as 8 months away. But CEN has earmarked a calendar slot of July–September 2013.
Under the weighted voting system, the proposal needs 71% to pass, after which the final draft would be proposed as a European standard. ‘It is progressing to plan. It will be a breakthrough for Europe. But the difficult part is the first draft.’
The ‘breakthrough’ element is in the fact that many member states have not put in place adequate regulations or standards on how to provide surgery in
a safe environment. Patients are not always made fully aware of the risks associated with aesthetic surgery. The standard should change that, and improve common basic levels of safety.
CEN sees the initiative as a prime example of how standards can be used as an alternative instrument for detailed legislation. ‘CEN’s European standards sit below law — ‘but ignore them at your peril’.’ So says consultant plastic surgeon and former BAAPS president Nigel Mercer, who sits on the UK TC403 delegation.
He adds: ‘A pan-European document will have significant effect. It should mean equal standards across Europe.’ The document received 600 comments.
‘It has been a useful experience. It has also shown up some divisions — deep ones — among certain delegates,’ said Dr Mercer, evoking images of angry surgeons around the table.
For him, this has illustrated the difference between the regulated approach (as adopted in the UK, for instance) and other more liberal approaches. The exercise is extensive. The CEN panel has three delegates per EU/EEA country present plus Turkey, and there are observers too.
Putting patient safety first
The panel started up 2 years ago; before the PIP scandal broke in full. The fact that the process has been running alongside EU and national reviews is pure coincidence. ‘But it has highlighted the need for better regulation,’ says Dr Mercer. ‘Deregulation has gone too far. The prime need is to protect the public’s health.’
The next TC403 meeting is set for late August 2012. The task for the panellists now is to go through the detailed documents with a fine-toothed comb, line by line. ‘We hope it feeds into the EU medical devices review. We have been calling for such an initiative for years — ever since the implants register was closed down. Last month the EP approved ENVI’s call for registers for implants.
‘It’s a mentally-complex situation in this country [the UK], where crisis management often holds sway. It seems to require a disaster before anything is done about it.’
CEN Chair of the UK delegation is Mike Regan, who has a lot of experience in standards. He tells PRIME: ‘My role is to ensure the plastic surgeons, nurses, dentists etc., are all represented in the debate.’
He explains that the interim consultation generated 200 pages of comments in the UK alone. ‘The whole area is massive, as the scope is both non‑invasive and cosmetic surgery — i.e. including highly-invasive liposuction, facelifts and botulinum toxin, simple surface treatments, and hair removal.’
He stresses that the CEN standard is not about products, but services. ‘The interesting element is that there is no Directive for the standard to be harmonised with, and neither is there any sign of movement towards an EU Directive. We have, in one sense, a blank sheet.’
He continues: ‘I am incredibly impressed by the energy of the delegates. A lot of progress has been made. But there is a lot of variation in national laws and regulations.’ The standard covers what some might term ‘soft skills’ — who can do what and the competencies needed.
