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香港醫學會對於規管醫療儀器的立場聲明

適當使用醫療儀器可以造福病人，但是醫療儀器均具潛在風險，對病人可以構成嚴重傷害，因此，醫療儀器必須安全而有效。任何安全而有效的聲稱必須經得起實證的考驗。醫療儀器的規管與註冊、事故報告以及故障儀器的回收等政策措施，實屬必要。

醫療儀器正常用於醫療用途。如有特殊情況容許醫療儀器用於非醫療用途時，對該等用途及其使用者必須嚴格規管，以保障市民免受誤用儀器或來自儀器本身潛在風險的傷害。

本會得悉政府選定20種可用作非醫療用途的醫療儀器。

本會建議該20種醫療儀器的風險水平，由慣常使用該等儀器或醫治因該等儀器導致之併發症的專科醫生釐定。

儀器的名單理應按時更新，對於醫療儀器的風險評估，醫學界責無旁貸。

二零一七年一月廿六日

編輯備忘：

香港醫學會成立於一九二零年，旨在聯繫政府、各公立醫療機構、大學及私人執業的醫務工作者，交流意見，團結一心。醫學會致力將最新的醫療資訊及醫務發展傳遞與會員，提倡會員遵行專業操守，進而服務社會，維護民康。

PRESS RELEASE

26 January 2017

The Hong Kong Medical Association Position Statement

on the Regulation of Medical Devices

Devices used on the human body for medical purposes can be beneficial to patients.  At the same time, such devices may cause serious harm.  Any such device has to be proven safe and efficacious.  Claims on safety and efficacy must be substantiated by research.  Policies have to be in place for the regulation and registration of medical devices, reporting of incidents related to such devices, and recall of faulty medical devices.

Medical devices are used for medical purposes.  If under exceptional circumstances allowance is granted for a medical device to be used for non-medical purposes, such use including the personnel allowed to use such a device have be strictly regulated.  This is to safeguard the public from harm inflicted by such a device, whether by misuse or in relation to the intrinsic risk of the device.

We take note that the Government has proposed a schedule, in which 20 medical devices are listed for non-medical use.  

We are of the opinion that the risk levels of the 20 equipment should be reviewed by Specialists of the relevant Medical Specialty, who normally use such devices for medical purposes, or treat complications relating to such devices.

The list should be updated from time to time.  The Medical profession is here to help evaluate the risks related to any existing or new medical devices.

Notes to editors:

The Hong Kong Medical Association, founded in 1920, aims to bring together Hong Kong's government, institutional, university and private medical practitioners for an effective exchange of views and co-ordination of efforts.  The foremost objective of the Association is to safeguard and promote public health.  The Association speaks collectively for its members and aims to keep its members abreast of medical ethics, issues and advances around the world.  In fulfilling these goals, the association hopes to better serve the people of Hong Kong.