Calls to regulate sale of cosmetic medical lasers

A consultant dermatologist has described Ireland’s lack of regulation of cosmetic medical lasers as “madness” that is putting people at risk of severe scarring.

Calls to regulate sale of cosmetic medical lasers

Anyone can legally buy, import, and operate a medical-grade laser here for cosmetic services such as tattoo removal or thread vein removal. There are no mandatory training or licensing requirements because EU regulations don’t recognise medical devices used for cosmetic purposes.

Dr Callaghan Condon is a consultant dermatologist in the Blackrock Clinic and a member of the Irish Association of Dermatologists. He is calling on the Health Products Regulatory Authority to seek change at an EU level to protect the safety of people using cosmetic laser services in Ireland.

“It’s absolute madness. It seems to be down to a glitch in the regulations; some of these things are being brought in as medical devices and are being operated by people with no medical training whatsoever,” Dr Conlon said.

“I’ve had to write a number of medical reports for people suffering scarring following cosmetic treatments.

“I’ve seen people suffering all sorts of damage done by cosmetic lasers. Sometimes they’ve visited a clinic and had a successful treatment and then returned, been treated by a different person and suffered damage because the new practitioner doesn’t know what they’re doing.”

Cosmetic lasers can cause scarring, swelling, and pain when operated at a high frequency. Tattoo removal poses a particular set of risks due to the process involved.

“An incredibly high-intensity light beam shatters the pigments under the skin and they splatter through the skin. There’s blood, so aerosolised [airborne] viruses are a real concern, as well as the potential for eye damage. It’s definitely a biohazard,” Dr Conlon said.

“The Irish Association of Dermatologists and the Irish Association of Surgeons are both trying to take action to have the regulatory loophole closed at an EU level because it’s a very dangerous situation.”

Certificate courses in cosmetic laser use are available in beauty therapy schools in Ireland, but there are no requirements for training to operate the machines, as well as no certification or inspection system for the machines themselves.

Salon-grade machines can be purchased online for as little as €1,300. They are not subject to cosmetic regulation but do fall under the General Product Safety Directive.

The Health Products Regulatory Authority (HPRA) is responsible for the regulation of medical devices in Ireland, but not the approval or certification of specific devices.

The authority said in a statement: “Lasers used for removing tattoos and other cosmetic purposes do not qualify as medical devices as they do not have a medical purpose and are not regulated under the medical device legislation in Ireland.

“The HPRA has supported the idea of including such lasers under the medical device legislation during the discussions to revise the European legislation.”

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