Years after the deaths of beauty clinic clients and serious injury to others, HK continues to stew over the need for regulations to protect the public and how they might affect business. Cornelia Zou reports.

The quest for that beauty treatment to die did have fatal consequences for three Hong Kong women. The medical miscarriages took place over less than three-and-a-half years. Nothing has changed. The city's beauty industry still is pretty much free to do whatever makes it most profitable.

A 46-year-old woman named Chan walked into a DR beauty center in Hong Kong, back in October 2012, for a beauty treatment that promised younger looking skin. She never learned the answer. She died a week after being admitted to hospital suffering from septic shock.

Three more DR clients went to hospital with septic shock. Their beauty treatments involved a still experimental immunotherapy for cancer patients, DC-CIK (dendritic cell/cytokine-induced killer cells).

The Hong Kong government promised better regulation. Nothing's been done while the government frets and fusses over the usual: studies and preliminary reports and final reports and recommendations and more consultations.

Just about anyone can buy, sell or use most medical devices that are available. There are no regulations effectively. Just about anybody can pick up a medical device and use it. They don't even need to be registered. A woman who walks into a beauty treatment center has no clue if the equipment operator promising to shape her body and make her more beautiful is a fraud, a charlatan, or even competent.

Lee Ka-ying was a 32-year-old dance teacher. She died in June 2014 after going to a hair treatment clinic for liposuction. She fell into a coma, and died almost immediately.

A 59-year-old woman died after being given electric shocks in a traditional Chinese medicine (TCM) treatment to "clear her energy channels". In TCM they are called meridian and collateral channels.

People have complained. The Consumer Council had 1,140 complaints about beauty services in 2014. More than 170 involved plastic surgery, injections and invasive optical instruments.

Beauty clinics don't bother giving clients descriptions of the devices they use. Experts say there is no standard for evaluation. An effective system would need to have even the serial numbers of the devices.

The Consumer Council says it's time the government woke up and started to regulate medical devices used in the beauty industry. The government promised it would four years ago, soon after Chan's untimely death. The Consumer Council says records need to be kept, including any history of adverse, client reactions, intrinsic risk, wavelengths of lasers. And the council wants sale of these devices regulated.

"I did laser hair removal and photofacial a few times at beauty centers," said Sarah Lo, a marketing and communications officer at an international electronics company in Hong Kong. "I saw the diplomas of the practitioners there but never asked about the safety of the equipment."

"I think it's necessary to ask about the safety of the equipment but I just glanced at their brochure. They didn't offer anything about it either," said Lo. "However, their professionalism did offer me relief."

Andros Chan, chairman of the Hong Kong Medical and Healthcare Device Industries Association, told China Daily that the city has highly trained professional medical staff. Then, he added, "Invasive cosmetic treatments should be done by strictly trained professionals."

"In private practice, there is still debate over whether simple medical devices should be used only by qualified Medical Doctors. It's a matter of business and professional ethics," Chan added.

Never-ending studies

ECRI Institute (formerly the Emergency Care Institute) began a study last October on the control and use of selected medical equipment in Hong Kong, examining procedures and risk. ECRI Institute is also charged with coming up with some proposals for regulation medical devices. Preliminary findings are expected within the next few months.

As likely as not, it will add to the already impressive pile of reports and consultation papers on the issue, dating back nearly to two decades.

There was a three-year study that began back in 2000. Four years after that, the Medical Device Control Office was set up "to develop risk-based, cost-effective regulations".

After briefing the Legislative Council Panel on a regulatory framework at the end of 2010, the Department of Health was requested by the Business Facilitation Advisory Committee to conduct another study to further assess the impact of the proposed statutory regulation on the business side which lasted another two years from 2011 to 2013.

"There is currently no overarching legislation that regulates the import, distribution, sales or use of medical devices in Hong Kong," said Alison Wong, a lawyer at Bird & Bird, an international law firm. "Individual laws may apply depending on the nature and characteristics of the medical device."

Devices that give off radiation fall under the Pharmacy and Poisons Ordinance and the Radiation Ordinance, for example.

Even for medium and high risk devices, there's no mandatory registration but a voluntary system. There's also the Medical Device Administrative Control System (MDACS) that requires products to meet certain standards but that affects only the riskiest and most complex devices.

It appears the best the government can do in the interest of public safety is put out pamphlets: What do laser treatments do. Beauty clinics don't bother to inform their clients about their procedures and clients rarely ask.

"I have done some radio frequency treatments at a French beauty chain," said one woman in her 20s who makes routine trips to the beauty salon. "I don't know about the regulation of medical devices in Hong Kong. But I checked online about how the machine works to improve my skin and I did ask about the device. They just told me it was imported It doesn't matter if you ask about the safety of the device or not, they will definitely tell you that it's good. But I wouldn't go for invasive treatments."

Striking a balance

BMI Research predicts that Hong Kong's medical device market could reach $939 million by 2018, at an annual growth rate of more than 10 percent. In 2013, Hong Kong spent around $122.6 per capita on devices, compared to $11.6 on the Chinese mainland. Unlike Hong Kong, the mainland does regulate devices and the market.

"The government is still in the process of developing an appropriate regulatory framework for medical devices in Hong Kong," said Wong from Bird & Bird.

"Assuming that the regulatory framework will mean higher costs on the market, companies may become more selective when deciding what medical devices to sell," added Wong. "The government's task is to develop a framework in line with international practices... The challenge, however, is that this has to be balanced against the interests of the industry by avoiding excessive compliance costs and administrative requirements on the industry."

Hong Kong could develop its own medical device-related industry. "There is potential for Hong Kong to become a hub for testing and certification of medical devices," said Wong. "Although the regulatory framework is still being developed, the government shall consider practices in other jurisdictions to ensure that Hong Kong will be in line with international practices where possible."

Other Asian countries and regions famous for their beauty industries like South Korea and Japan are stricter. Devices have to be tested by an independent laboratory and to meet international standards. Still, there is little regulation over the use of devices for cosmetic purposes.

There is a system of mandatory registration of high risk devices in Japan and South Korea. In South Korea, even acupuncture needles and powered wheel chairs must be approved and tested.

"The Department of Health in Hong Kong set up MDACS based on the International Medical Device Regulators Forum principles and intends to make MDACS a mandatory system at some stage," said Karen Simpkins, a medical device market analyst at BMI Research.

For the time being, the government is wringing its hands over the issue of public safety, worrying about the effects on industries that produce and use medical devices.

"Presumably if new regulations were introduced it would increase the cost of medical devices," said Simpkins. "The main concerns at the moment seem to focus on loss of income of clinics and healthcare practitioners if stricter regulations regarding aesthetic procedures were introduced."

(HK Edition 04/28/2016 page8)