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Following is a question by the Dr Hon Joseph Lee and a written reply by the Secretary for Food and Health, Dr York Chow, in the Legislative Council today (March 18):
Question:
In reply to my question on February 2, 2005, the Government said that the Hospital Authority (HA), through professional judgement and selection, considered that some medical instruments/consumables (MICs) which were labelled by their manufacturers for single use could be reused, after sterilisation, safely in a limited manner. Moreover, it is learnt that to ensure the safety of patients, some countries have enacted legislation to regulate the procedure for the reuse of MICs for single use. In this connection, will the Government inform this Council whether it knows:
(a) in respect of each year since 2005, the types of MICs reused in public hospitals and the respective times of reuse by their clinical departments (including the Anaesthesia, Medicine and Geriatrics, Neurosurgery, Oncology and Surgery departments);
(b) the criteria adopted at present by HA for selecting, among the various types of MICs labelled for single use by their manufacturers, the types of MICs which can be reused; and whether HA had updated the criteria since 2005; and
(c) how HA ensures that the guidelines and procedure for the reuse of MICs labelled for single use can safeguard the safety of patients?
Reply:
President,
There is no hard and fast rule on the single-use of medical device. According to the international practice, whether the medical device labelled by the manufacturers for single-use are only suitable for clinical use for once should be determined on the basis of risk assessment. As a matter of fact, every hospital under the Hospital Authority (HA) has a dedicated department for decontaminating, cleansing and sterilising medical devices. HA has also put in place procedures, guidelines and standards to provide guidance to staff on the proper way of cleansing and sterilising medical devices for protection of patient safety. In addition, staff responsible for the sterilisation of medical devices and healthcare staff at the operating theatres will carry out inspection of medical devices (including those single-use devices (SUDs) that could be reused) before and after they are used. Devices detected to have problems will be discarded and will not be reused. My replies to various parts of the question are as follows:
(a) SUDs are commonly used in operating theatres, endoscopy procedure rooms and X-ray examination rooms, etc. HA does not have statistics on the number of reuse of such devices.
(b) Based on the guidelines of the Food and Drug Administration of the United States and the international Spaulding Classification for medical devices, HA has classified the risks of reusing SUDs into five levels, i.e. high risk, moderate-high risk, moderate risk, low risk and very low risk. HA also issued internal guidelines in 2006 to ban the reuse of high-risk SUDs. It is also planning to gradually avoid the reuse of moderate-high risk SUDs.
(c) Every hospital cluster under HA has a dedicated team to monitor cluster's compliance with the guidelines on the cleansing and sterilisation of medical device, and to ensure that its healthcare staff will not reuse high-risk SUDs. The teams will also conduct internal audits on a regular basis and report to the HA Head Office on risk assessment involving SUDs. In the light of these risk assessment, the HA Head Office and hospitals will instruct the healthcare staff to avoid reusing certain devices.
Ends/Wednesday, March 18, 2009
Issued at HKT 12:25
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