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Following is a question by Dr the Hon Joseph Lee and a written reply by the Secretary for Food and Health, Dr Ko Wing-man, in the Legislative Council today (December 19):
Question:
I have received complaints that the authorities have not adopted uniform specifications for acquiring automated external defibrillators (AEDs), and the electrical energy output from some AED models is too high, which may endanger the health and safety of patients suffering from heart attack. Regarding the safety of AEDs, will the Government inform this Council:
(a) whether any mechanism is in place at present to regulate the specifications of AEDs provided in public places, in order to ensure that such devices are safe to use; if so, of the details; if not, the reasons for that;
(b) of the specifications adopted by the authorities for acquiring AEDs; whether they have made reference to the specifications adopted by overseas countries and consulted professionals, so as to ensure that the electrical energy output of AEDs will not cause cardiac injuries or skin burns to the patients; if they have, of the details; if not, the reasons for that;
(c) whether the authorities require that any person using an AED must have received relevant training; if not, whether they will consider promoting such training to teach more members of the public how to use AEDs properly, and requiring that any person using such devices must have received relevant training; and
(d) whether it has assessed if it is suitable to use AEDs on young patients; if it has, of the details; if not, the reasons for that?
Reply:
President,
Automatic external defibrillators (AEDs) are medical devices used to perform cardiac resuscitation on patients. Medical and first-aid researches have shown that with the simultaneous use of an AED in the course of performing cardiopulmonary resuscitation (CPR) on a patient suffering from heart attack, the survival rate of the patient could be increased. At present, all ambulances of the Fire Services Department (FSD) and the Auxiliary Medical Service (AMS), all public hospitals and general out patient clinics under the Hospital Authority (HA), a number of clinics under the Department of Health (DH), as well as aquatic venues (such as public swimming pools and beaches, etc) under the Leisure and Cultural Services Department (LCSD) are equipped with AEDs for first aid treatment. AEDs will also be installed at some government office buildings and LCSD's land-based leisure venues with active facilities or high utilisation rates (including sports centres and major parks, etc.) in 2013. In addition, AEDs have also been installed at a number of places in the territory, including office buildings, theme parks, schools, large shopping malls, private housing estates, private clubhouses, commercial buildings and nursing homes. However, before using AEDs on patients, consideration must be given to the patients' prevailing circumstances and attention must be paid to the operation procedures. In this connection, anyone using AEDs should first receive training on first aid and operation of the device, and should send the patients to hospitals for further medical treatment as quickly as possible.
My reply to the four parts of the question raised by Dr Hon Joseph Lee is as follows:
(a) AEDs are medical devices used to perform cardiac resuscitation on patients. Currently, there is no specific legislation to regulate the manufacture, import/export, sale or use of medical devices in Hong Kong. To raise public awareness of the importance of medical device safety and pave the way for implementing the long-term statutory control, a voluntary Medical Device Administrative Control System was established by DH in 2004. Under this administrative control system, medical devices that conform to requirements on safety, effectiveness and quality will be listed. Manufacturers and traders must comply with the relevant listing conditions and observe the regulatory measures. Since 2005, DH has kept in view the safety warnings and recall notices issued overseas about medical devices and disseminated the information to all parties concerned. As at November 30, 2012, a total of 13 models of AEDs were included in the list under this Administrative Control System.
The Government intends to put in place a statutory regulatory framework for medical devices. The proposed legislation will be based on the existing Medical Device Administrative Control System with an aim to exercise regulation over medical devices as to their safety, effectiveness and quality through the implementation of pre-market and post-market control. Currently, we are undertaking a Business Impact Assessment on the proposed regulatory framework and will consult the Panel on Health Services of the Legislative Council on the legislative proposal in due course.
(b) At present, all ambulances of FSD and AMS, all public hospitals and general out patient clinics under HA, a number of clinics under DH, as well as aquatic venues under LCSD are equipped with AEDs for first aid treatment. Specifications of the AEDs procured by government departments are all set out by taking reference from international standards (such as the professional standards set by the International Electrotechnical Commission, the U.S. Food and Drug Administration approval, or Euro Certificate of Conformity). Generally speaking, government departments will also seek advice from the Electrical and Mechanical Services Department.
(c) The Government has all along promoted the public's awareness of first aid treatment for heart attack through various means. DH organises Basic Life Support Provider Courses covering the proper use of AEDs for its healthcare personnel through its Professional Development and Quality Assurance service. From January 2012 to the present, DH has organised 88 such courses for 488 healthcare personnel. HA's Accident and Emergency Training Centre also provides training courses for healthcare personnel and members of the public on the correct way to use AEDs. Since January 2012, the Centre has organised 281 such courses, and a total of 4 914 healthcare personnel and members of the public have received training. FSD also provides CPR and automated defibrillation training to the public. In 2011, about 2 000 people completed the automated defibrillation training provided by FSD and they included staff of property management companies, airport security personnel, staff of residential care homes for the elderly, government staff, staff in the hotel industry, MTR staff and staff of theme parks.
In addition, training on the use of AEDs is also included in the CPR training provided by organisations such as St. John Ambulance, AMS and the Hong Kong Red Cross, etc. In 2011, the Hong Kong St. John Ambulance organised 814 training courses on the use of AEDs for about 11 090 people, while the Hong Kong Red Cross also offered 139 such courses in which a total of 845 people participated. The Government will continue promoting the public's awareness of first aid treatment for heart attack through various means.
(d) According to the guidelines of the American Heart Association, AEDs are suitable for use on patients of all ages except new-born babies as indicated by clinical experiences. For patients aged eight or above, they should receive the standard dose of energy delivered by AEDs. For patients aged from one to eight, it is more preferable for them to receive the dose of energy applicable to children delivered by AEDs through pediatric attenuated pads/cables. As for children aged below one, the use of manual external defibrillators on them is more preferable.
Ends/Wednesday, December 19, 2012
Issued at HKT 15:52
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