Hong Kong – DH acts on medical event reported by Tuen Mun Hospital

In reaction to Tuen Mun Hospital (TMH)’s statement of a guard occasion, the Department of Health (DH) today (May 15) stated that the DH is examining the occurrence and following up with the regional accountable individual (LRP) of the medical gadget worried.

On May 13, the DH got a notice from the Hospital Authority (HA) suggesting that air bubbles had actually been spotted in the coronary artery of a 75-year-old male client throughout a Percutaneous Coronary Intervention (PCI) carried out earlier at TMH. According to the initial details supplied by the HA, it is presumed that the occurrence is associated with the pressure tracking set utilized throughout the treatment.

As the pressure tracking embeded in concern is noted under the DH’s Medical Device Administrative Control System (MDACS), upon getting the alert, the DH right away took the following follow-up actions:

1. Called the LRP of the medical gadget worried to determine the information and asked for the LRP to carry out an examination and send an examination report;
2. As a preventive procedure, the LRP has actually been advised to right away suspend sales of the impacted batch and to call all users in Hong Kong who are utilizing medical gadgets from the very same batch to encourage them to momentarily stop utilizing the impacted item. To date, the DH has actually not gotten any unfavorable occasion reporting concerning this medical gadget from other users; and
3. Released a Special Alert on the DH’s Medical Device Division site and alerted stakeholders, advising users who have the impacted item to momentarily suspend their usage and call the LRP for follow up.

DH’s examination is continuous. The DH will continue to keep close interaction with the LRP, carefully keep track of the scenario and take follow-up actions based upon the examination report.

The DH presented the voluntary Medical Device Administrative Control System (MDACS) in 2004, under which a listing system for medical gadgets and traders along with a post-market tracking system for the items are put in location. All noted medical gadgets fulfill the security, quality and efficiency requirements. Presently, over 9 000 medical gadgets are noted under the MDACS. Over the previous 3 years, the DH has actually not gotten any security notifies or negative occasion reports including the pressure tracking set worried. In action to the current global regulative patterns, the Government is creating the statutory regulative requirements and will seek advice from numerous stakeholders as suitable within this year before sending the legal proposition to the Legislative Council. The application of a statutory registration system for medical gadgets lines up with the policy instructions set out by the Chief Executive in the 2023, 2024 and 2025 Policy Addresses to speed up the application of reforms to the examination, approval and registration system for medical items. The HKSAR Government prepares to present a costs in the 2nd half of this year to accomplish the objective of developing the Hong Kong Centre for Medical Products Regulation (CMPR) under the DH by the end of 2026. Upon its facility, the CMPR will methodically combine the regulative functions for Western and Chinese medications in addition to medical gadgets. By leveraging existing legislation governing Western and Chinese medications and the proposed statutory regulative structure for medical gadgets, the CMPR will adequately improve the regulative and approval system for medical items, consequently supporting Hong Kong’s advancement as a worldwide Health and Medical Innovation Hub.