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Following is a question by the Hon Tang Siu-tong and a reply by the Secretary for Health and Welfare, Dr E K Yeoh, in the Legislative Council today (November 28):

Question :

At present, there is no legislation in Hong Kong for regulating the use of laser devices by beauty salons, and staff of beauty salons, in operating such devices, may voluntarily comply with the Laser Safety Code of Practice drawn up by the Committee on Science and Technology. In this connection, will the Government inform this Council:

(a) whether the Department of Health has taken the initiative to collect statistics on cases in which patrons of beauty salons sustained injuries as a result of laser beauty treatment; if so, of the number of such cases in the past three years and the channels through which the relevant data are collected, and whether it knows the total number of complaints received by the Consumer Council in respect of similar cases in the same period;

(b) of the measures in place to ensure that staff of beauty salons will follow the safety guidelines set out in the Laser Safety Code of Practice; and

(c) as the Panel on Health Services of this Council was advised in June last year that the authorities were studying the feasibility of introducing a regulatory system on the use of health care equipment, including laser devices, of the progress of work in this respect, and the overseas experience to which reference has been made?

Answer :

Madam President,

The Department of Health (DH) has statutory responsibilities relating to medical services, including regulatory matters concerning medical clinics, pharmacy and poisons to safeguard the health of the community. Services provided by beauty parlours generally fall outside the ambit of this system of control. Nevertheless, owners and employees of beauty parlours have a responsibility to ensure the safety of their clients. Consumers who are injured as a result of laser beauty treatment at beauty parlours may seek redress through civil proceedings. In addition, whether the conduct complained of amounts to breaches of the criminal law would depend upon the individual facts and circumstances of the case.

(a) As far as injuries as a result of laser beauty treatment at beauty salons are concerned, aggrieved customers may lodge their complaints with the Consumer Council. The Consumer Council has received a total of 21 complaints in the past three years. These complaints have been settled between the parties concerned with the mediation of the Consumer Council, except for a few cases for which discussions are continuing.

(b) A Laser Safety Code of Practice was prepared by the Committee on Science and Technology, and distributed to the trade and users of laser equipment for their voluntary compliance. The Code of Practice contains guidelines on laser safety in industry, manufacturing, entertainment and display, as well as beauty therapy and biostimulation. Laser equipment is classified according to international standard into Classes 1, 2, 3a, 3b and 4 on the basis of the accessible emission limits of the equipment. Electrical and Mechanical Services Department (EMSD) has been offering advice and education on the safety aspects of lasers to users and owners, including operators of beauty parlours.

Under the Occupational Safety and Health Ordinance, employers are held responsible for ensuring, so far as reasonably practicable, the safety and health at work of their employees. Employers of beauty salons where laser equipment is used are, therefore, required to provide and maintain laser equipment in safe condition and to ensure the safety and health at work of their employees through providing information, instruction, training and supervision as necessary.

In the past three years, the Labour Department inspected about 40 beauty salons, of which twelve were found to use Class 3B and 4 laser equipment. Two improvement notices, three warning letters and seven advisory letters in relation to the display of laser warning labels/signs and the provision of information, instruction and training to the employees were issued to the concerned beauty salons. Subsequent follow-up inspections found that the irregularities had been rectified.

(c) DH has carried out Phase I of the study on the regulation of medical devices. It has studied the experience of overseas countries and also participated in the Global Harmonisation Task Force meetings on the regulation of medical devices and established dialogue with regulatory authorities in Australia, Canada, Singapore, the United Kingdom and the United States of America. The degree of control of medical devices varies in these countries, ranging from self-regulation to legislation. Regulatory controls over medical devices are intended to safeguard the health and safety of patients, users and other persons. Such controls should be proportional to the level of risk associated with a medical device. While the level of regulatory control should increase with increasing degree of risk, taking account of the benefits offered by the use of the device, the imposition of controls should not place an unnecessary burden on regulators or manufacturers.

In view of the rapid advances in medical technology, we have proposed in the Consultation Document on Health Care Reform to carry out a comprehensive review of the present statutory regulations in relation to, among other things, the use of medical facilities/equipment. DH is now working with EMSD, in consultation with interested parties, with a view to proposing a regulatory framework for medical devices.

End/Wednesday, November 28, 2001

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