ANALYSIS | REGULATORY STANDARDS | for all high-risk (class III) devices ® would
not have prevented the PIP scandal, as the manufacturer was knowingly contravening the rules. Hence the belief among device users
themselves that the best means of regulation for implants and, more widely, devices, in the EU remains the system in place at present, as strengthened by new legal instruments (Regulations rather than Directives) and, as the icing on the cake, a new standard covering cosmetic surgery services, known as CEN/TC403 (Aesthetic Surgery Services Standard), under the European Committee for Standardisation (CEN). The proposal from the Austrian
Standards Institute (ASI) to create a project committee on aesthetic surgery services targets the development of an EU-wide standard for aesthetic surgery services. In the UK, BAAPS (the British Association of Aesthetic Plastic Surgery),
the CQC (Care Quality Commission), the Royal College of Ophthalmologists, and the British Association of Oral and Maxillofacial Surgeons are among those involved in this standard-setting process.
Developing standards The public consultation on TC403 ended on 22 May. CENÕs 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 JulyÐ 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
The proposal from the Austrian
Standards Institute to create a project committee on aesthetic surgery
services targets the development of an EU-wide standard for aesthetic surgery services.
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. 'CENÕs European standards sit below law ® Ô but ignore them at your perilÕ .' 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 between the regulated
difference
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 publicÕs health.' The next TC403 meeting is set for
14 ❚
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
July/August 2012 |
prime-journal.com
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