A Medical Device Daily

A series of moves to ensure better training for doctors, better information for patients and a tougher regulatory structure for private cosmetic surgery was unveiled by the UK Department of Health last month.

In a response to the Healthcare Commission's “Provision of Cosmetic Surgery in England“ report and the “Expert Group Report on the Regulation of Cosmetic Surgery,“ Chief Medical Officer Sir Liam Donaldson said, “Standards in the cosmetic treatment field must be as high as other areas of healthcare. We must ensure [that] we properly protect patients' safety by improving the training, regulation and information provided.“

He said that in order to ensure better training, the Department of Health “will be asking the relevant professional bodies to develop specialist training programs as a matter of urgency for surgeons undertaking cosmetic surgery.“

Citing the rapid growth of cosmetic procedures in private healthcare, Donaldson said that “many people spend their hard-earned money on these services, [but] some are disappointed with the outcome [and] a minority can suffer serious harm or disfigurement.“

As part of the push, he said that “detailed, accredited advice and education materials will be made available for patients and the public by the summer and we will also be working with the Healthcare Commission to bring additional cosmetic procedures such as aesthetic fillers and Botox facitlities within their regulatory [overview] by the end of the year.“

The Healthcare Commission is the UK's main health regulator.

Noting that the Expert Group has found that, “while there is no firm evidence of harm to patients under the current arrangements for regulation of cosmetic surgery,“ Donaldson said: “This is a growing area, with more people wanting to have procedures and new and different procedures being developed all the time, which demands a more robust regulatory structure.“

He added: “People have to be confident that their treatment will be safe, that the medical practitioners who treat them are qualified and competent, and that they have the information they need to make informed decisions.“

Commenting on the reports and Donaldson's call to action, Andrew Vallence-Owen, medical director for the BUPA Group, said, “We must establish proper training and accreditation in cosmetic surgery, so I urge the profession to urgently address the recommendations in this report.“ He added: “Procedures, for instance those using Botox, must be better-regulated and we have to get tough with the cowboy operators. Low standards, although only practiced by a few, damage patients and give everyone working in this area a bad name.“

The moves outlined by Donaldson include:

  • Ensuring that the facilities where botulinum toxins are injected be licensed with the Healthcare Commission and therefore subject to its regulations.
  • Ensuring that all cosmetic surgeons and nurses provide to potential and actual patients details of their qualifications, registration, membership of professional organizations, and other medical training and education.
  • Ensuring more consistent enforcement of current legislation and regulation governing the use of lasers — that every facility defined in the legislation should be registered with the Healthcare Commission and that laser procedures are overseen by a doctor and conducted by appropriately trained and qualified practitioners.
  • Ensuring that the General Medical Council improves the recording and classification of data about complaints so that comparisons can be made between different medical specialties and procedures.
  • Reviewing the need and scope for additional regulation of aesthetic fillers, in particular any that contain human tissue.

Norwood EyeCare expands in Europe

Norwood Abbey (Melbourne, Australia) subsidiary Norwood EyeCare (Duluth, Georgia), an ophthalmic devices firm, said that as part of the global expansion of its ophthalmic product line it has appointed distributors in Spain, Austria, the Czech Republic, Slovakia and Taiwan for its Epikeratome system for Epi-LASIK.

These new distributors join existing distributors in Italy, Belgium, the Netherlands, Luxembourg, Ireland, the UK, Mexico, Korea and Turkey.

The newly named European distributors are responsible for territories within Europe that account for in excess of 200,000 LASIK procedures annually. Norwood EyeCare said Spain is the largest market in Europe with an average of 180,000 vision correction procedures annually.

In addition, Norwood Abbey named Julian Robert Maughan as business manager for European sales and marketing of Norwood EyeCare. Maughan has more than 20 years of experience in marketing ophthalmic laser systems and other surgical technologies.

Michael Crocetta Jr., president of Norwood EyeCare, said Maughan's “extensive track record in introducing innovative ophthalmic technologies and his experience with global distribution will be instrumental as we continue to expand throughout Europe.“

LASIK vision correction surgery has two stages. The first stage of preparing the eye for the laser procedure currently relies on a cutting device called a microkeratome to create a stromal “flap“ on the surface of the eye, which is then peeled back. The second stage is the laser treatment to correct the patient's vision, then the stromal flap is replaced.

Industry statistics indicate that complications occur in a percentage of patients as a result of cutting the eye.

Norwood EyeCare's next-generation approach, the Epi-LASIK treatment, uses the Epi-keratome system and a disposable separator, removing the need to cut the eye and thus eliminating associated complications, the company said. The device gently separates a thin layer of living cells — the epithelium — on the outside of the eye, along a natural cleavage plane. The clinician then moves the epithelial sheet to one side, the laser corrects the vision and the epithelial sheet is then moved back into place with minimal surgical manipulation.

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