Source: Hong Kong Government special administrative region
DH follows up on medical incident reported by Tuen Mun Hospital
On May 13, the DH received a notification from the Hospital Authority (HA) indicating that air bubbles had been detected in the coronary artery of a 75-year-old male patient during a Percutaneous Coronary Intervention (PCI) performed earlier at TMH. According to the preliminary information provided by the HA, it is suspected that the incident is related to the pressure monitoring set used during the procedure.
As the pressure monitoring set in question is listed under the DH’s Medical Device Administrative Control System (MDACS), upon receiving the notification, the DH immediately took the following follow-up actions:
DH’s investigation is ongoing. The DH will continue to maintain close communication with the LRP, closely monitor the situation and take follow-up actions based on the investigation report.
The DH introduced the voluntary Medical Device Administrative Control System (MDACS) in 2004, under which a listing system for medical devices and traders as well as a post-market monitoring system for the products are put in place. All listed medical devices meet the safety, quality and performance requirements. Currently, over 9 000 medical devices are listed under the MDACS. Over the past three years, the DH has not received any safety alerts or adverse event reports involving the pressure monitoring set concerned. In response to the latest international regulatory trends, the Government is formulating the statutory regulatory requirements and will consult various stakeholders as appropriate within this year before submitting the legislative proposal to the Legislative Council. The implementation of a statutory registration system for medical devices aligns with the policy directions set out by the Chief Executive in the 2023, 2024 and 2025 Policy Addresses to accelerate the implementation of reforms to the evaluation, approval and registration mechanism for medical products. The HKSAR Government plans to introduce a bill in the second half of this year to achieve the goal of establishing the Hong Kong Centre for Medical Products Regulation (CMPR) under the DH by the end of 2026. Upon its establishment, the CMPR will systematically consolidate the regulatory functions for Western and Chinese medicines as well as medical devices. By leveraging existing legislation governing Western and Chinese medicines and the proposed statutory regulatory framework for medical devices, the CMPR will comprehensively enhance the regulatory and approval mechanism for medical products, thereby supporting Hong Kong’s development as an international Health and Medical Innovation Hub.
Issued at HKT 21:25
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