DH follows up Field Safety Corrective Action notice by Olympus Hong Kong and China Limited

     The Department of Health (DH) today (November 5) announced that it has received a Field Safety Corrective Action (FSCA) notice from the Olympus Hong Kong and China Limited (Olympus) regarding one of their products, namely the Olympus High Flow Insufflation Unit (Model number: UHI-4). Olympus has become aware of patients experiencing complications due to excessive insufflation during use and the DH is closely monitoring the situation. To date, the DH has not received any reports of adverse events related to this issue.

     The device is mainly used by doctors to inflate the abdomen or colon with carbon dioxide gas during laparoscopic or endoscopic surgeries. Over insufflation may lead to complications including air embolism, arrhythmias, pneumothorax, and potentially death. The concerned device in this incident would not be used or operated by general public, and it is not listed under the Medical Device Administrative Control System set up by the DH.

     A spokesman for the DH stated that its Medical Device Division (MDD) has always been closely monitoring safety alerts of medical device issued by relevant local and overseas regulatory authorities as well as the World Health Organization, under the established mechanism, and will take action according to actual circumstances as appropriate, including maintaining contacts with local suppliers and notify relevant stakeholders, such as the Hospital Authority, private hospitals, and medical professional associations, as well as publishing safety alert summary and special alerts on its website etc.

     The DH noticed that a medical device recall was issued by the United States (US) Food and Drug Administration (FDA) on October 31, requesting Olympus America to notify users in the US to cease using the affected device until a root cause investigation is completed. The DH has taken a proactive approach with a view to ensuring safety and addressing the issue effectively. The MDD of the DH has swiftly reached out to Olympus to obtain information regarding the incident, and requested them to notify affected customers and ensure appropriate follow-up actions are carried out. Also, the MDD has posted a Special Alert on its website to provide the latest development of the incident and updated information. In addition, the DH also promptly informed relevant stakeholders about the latest situation and urged them to contact the supplier as soon as possible if they are utilising the concerned device.

     According to information provided by Olympus, approximately 200 units of the concerned device have been distributed to public hospitals, private hospitals and a day procedure centre locally. Olympus has informed users through an FSCA notice, highlighting cases of patients experiencing complications due to over insufflation during use and includes an amendment to the instructions for use, aimed at reducing the risk of such complications. The DH understands that the process of notifying the affected institutes has been completed yesterday (November 4).

     "The DH will continue to closely monitor the situation and maintain ongoing communication with the relevant local supplier and stakeholders." the spokesman added.




Police Hong Kong Island Regional Headquarters conducts inter-departmental exercise in response to large-scale power outage (with photos)

     Police Hong Kong Island Regional Headquarters, together with the Hospital Authority, the Fire Services Department, the Transport Department, the Electrical and Mechanical Services Department, the Lands Department and the Hong Kong Electric, conducted an inter-departmental major incident exercise codenamed "PHOENIXSPIN" at the Tung Wah Eastern Hospital in Happy Valley this morning (November 5). The exercise simulated a large-scale power outage in the area to enhance the collaboration, prevention, and emergency response capabilities of Police and stakeholders.

     The first part began with a tabletop exercise, which simulated a major power outage with authentic situations in Wan Chai district during peak hours and a series of subsequent events triggered as a result. Various unexpected incidents were also included in the exercise, requiring immediate deployment to test the response capabilities and response plans of respective departments as well as their collaboration with stakeholders.

     The second part of the exercise involved a practical simulation, simulating the impact of the incident on the Tung Wah Eastern Hospital, where the backup generators also failed, resulting in the need to urgently transfer some patients to other hospitals. This aimed to test and strengthen the personnel's ability to plan and execute large-scale inter-departmental rescue operations.

     The exercise utilised for the first time the Geospatial Analytics, Information and Applications (GAIA) system developed by the Innovation and Solution Lab, Information Systems Wing of Police. The system can provide the spatial information of a specific location by presenting various terrains and buildings in a three-dimensional format. As a result, participating units will be able to quickly understand the relevant terrains and situation in the event of an accident, as well as formulate and execute the optimal action plan based on different situations, thereby enhancing rescue efficiency.

     Police will continue to maintain close contact with stakeholders, conduct regular inter-department exercises, and review contingency plans for major incidents to strengthen co—ordination between different departments and organisations.

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Secretary for Health to lead delegation to visit Beijing

     The Secretary for Health, Professor Lo Chung-mau, today (November 5) will lead a delegation for a three-day visit in Beijing to meet relevant Mainland authorities and introduce to Mainland officials the latest development of various healthcare policies in Hong Kong, with a view to pursuing deeper exchanges and further co-operation with the Mainland in the healthcare aspect.
      
     The Permanent Secretary for Health, Mr Thomas Chan; the Director of Health, Dr Ronald Lam; the Chairman of the Hospital Authority (HA), Mr Henry Fan; and the Chief Executive of the HA, Dr Tony Ko, are among the delegation. Professor Lo will return to Hong Kong on November 8. During his absence, the Under Secretary for Health, Dr Libby Lee, is the Acting Secretary for Health.




Hong Kong Customs detects drug-trafficking case by sea worth about $140 million (with photo)

     Hong Kong Customs on October 25 detected a large-scale seaborne drug-trafficking case, and seized about 484 kilograms of assorted drugs with an estimated market value of about $140 million at the Tsing Yi Customs Cargo Examination Compound. A 23-year-old man suspected to be connected with the case was arrested.

     Through risk assessment and intelligence analysis, Customs inspected a 40-foot seaborne container, declared as carrying 15 air compressors, arriving in Hong Kong from Northern America at the Tsing Yi Customs Cargo Examination Compound on October 25. Upon examination, Customs officers found about 484kg of assorted drugs, including about 311kg of suspected cannabis buds, 88kg of suspected methamphetamine, 82kg of suspected 3,4-methylenedioxymethamphetamine (MDMA) and 3.2kg of suspected fentanyl, concealed inside 15 air compressors. The estimated market value amounted to about $140 million.

     A follow-up investigation led to the arrest of a 23-year-old man, suspected to be connected with the case, in Tuen Mun on November 3.

     Customs believes the operation has successfully intercepted the inflow of the batch of drugs to local markets. An investigation is ongoing. The likelihood of further arrests is not ruled out.

     Under the Dangerous Drugs Ordinance, trafficking in a dangerous drug is a serious offence. The maximum penalty upon conviction is a fine of $5 million and life imprisonment.

     Members of the public may report any suspected drug trafficking activities to Customs' 24-hour hotline 2545 6182 or its dedicated crime-reporting email account (crimereport@customs.gov.hk) or online form (eform.cefs.gov.hk/form/ced002/).

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Transcript of remarks by SHYA at media session

     Following is the transcript of remarks by the Secretary for Home and Youth Affairs, Miss Alice Mak, at a media session after attending a radio programme today (November 5):
 
Reporter: Miss Mak, can you recap in English how is Care Teams' (District Services and Community Care Teams) function affected as some of its members are going to join the District Council election?
 
Secretary for Home and Youth Affairs: So far around 460 Care Team members declared that they will involve in the election-related activities, either they are candidates running in the election, or they are the election agents of those candidates. And they have already acted according to our guidelines and declaration mechanism, so they have already declared to the District Officers. Their services will suspend for a period of time during this election.
 
     This reflected that we have a very effective declaration mechanism to ensure that all Care Team members observed our mechanism, so that the election can be carried out in a fair and proper manner. During this period, we still have more than 4 000 Care Team members providing services in our districts. Our Care Team services will not be affected by the temporary suspension of certain members, that is less than 10 per cent of total number of our Care Team members.
 
     And also the mobilisation ability of Care Teams is the main concern. When organisations applied for being a Care Team, they need to show their capabilities in local and cross district mobilisation. This is reflected during the rainstorm in September. We can see that the Care Team in Shek O could not discharge their duties because of the temporary suspension of the land transport. So Care Teams from other districts went to help them. This is the proof of the mobilisation capability of the Care Teams, ensuring that the service of the Cares Teams will not be affected just because of the temporary suspension of certain members.

(Please also refer to the Chinese portion of the transcript.)