| REGULATORY STANDARDS | ANALYSIS
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. 'ItÕs 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. Decisions need to be made by
consensus, however. 'This is the main issue; it can be difficult at EU level ® it is not an easy task.' If there is conflict, a deviation can be raised ® stricter than a European standard ® for implementation in national law only. In his role, managing the debate and
pursuing best practice, Mr Regan has seen the vast differences, variations and approaches across Europe. He adds, however, that the Austrian secretariat is 'doing a good job' in what is the biggest move towards EU standardisation in this area. The CEN standards could even become an ISO standard ® a worldwide standard.
Mr ReganÕs task at hand is to bring
experts together, achieve an understanding of standards and regulations, and agree on a statement of best practice. 'In my opinion, the initiative is a good thing. It puts patient safety at the forefront, where it should be.'
Conclusions CEN European standards are voluntary, but their impact is significant, says CEN communications manager Celine Oeyen. 'They help consumers make intelligent choices and create a level playing field for service providers, and fill gaps in existing legislation.' Ultimately, with an agreed CEN
standard, enhanced powers for the authorities to police manufacturers, and generally better awareness of the serious nature of cosmetic surgery (and implantables in particular), a repeat of the PIP scandal should be avoided.
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prime-journal.com | July/August 2012 ❚
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