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Health Department Investigates Angiography Device Incident at Queen Elizabeth Hospital

HK

Health Department Investigates Angiography Device Incident at Queen Elizabeth Hospital
HK

HK

Health Department Investigates Angiography Device Incident at Queen Elizabeth Hospital

2024-09-12 20:30 Last Updated At:09-13 08:41

DH follows up on adverse event reported by Hospital Authority

The Department of Health (DH) is following up on an adverse event reported by the Hospital Authority (HA) yesterday (September 11) relating to an incident involving an angiography system used on a 66-year-old man during a medical procedure at Queen Elizabeth hospital (QEH) on September 9.

A spokesman for the DH said that its Medical Device Division (MDD) immediately contacted the HA and the local responsible person (LRP) of the device to obtain details of the incident and conducted a follow up.

The medical device concerned, namely the Artis Zee Biplane, used for X-ray imaging in medical procedures, is a Class III general medical device listed under the Medical Device Administrative Control System (MDACS). The manufacturer is Siemens Healthcare GmbH.

The medical device concerned has been installed in QEH since April 2011 and is under regular maintenance by the manufacturer. The last maintenance check was conducted on July 24, 2024, and no abnormalities were found. After the incident, the LRP conducted an on-site investigation on September 10, obtained the event log from the system, and sent it to overseas manufacturer for further investigations into the underlying cause of the incident.

Preliminary information from the LRP revealed that the medical device concerned has been distributed to two public hospitals and one private hospital. Apart from maintaining liaison with the HA, the DH will inform stakeholders (including all private hospitals and relevant medical professional associations) to remind them of the incident and request them to contact the LRP as soon as possible if they are using the angiography system concerned. A special safety alert will be also posted on the MDD's website.

Since 2004, the DH has launched the voluntary MDACS, which includes listing systems for medical devices and traders as well as a post-market monitoring mechanism. Following a risk-based approach, LRPs can apply for listing of Classes II, III and IV general medical devices and Classes B, C and D in vitro diagnostic medical devices under the MDACS.

In terms of the post-marketing monitoring system, the MDACS includes monitoring of safety alerts of medical devices issued by other regulatory jurisdictions, and handling of safety alerts notified by manufacturers. Furthermore, taking reference to the recommendations of the Global Harmonization Task Force, the MDACS has established a Medical Device Adverse Event Reporting System to collect and conduct analyses on information related to adverse events for early detection of safety signals to protect the health of patients and users of the medical device.

"The DH will continue to closely monitor the situation and maintain ongoing communication with the LRP," the spokesman added.

Source: AI-generated images

Source: AI-generated images

Labour Department highly concerned about fatal work accident that happened in Jardine's Lookout today

​The Labour Department (LD) is highly concerned about a fatal work accident that happened at a detached house in Jardine's Lookout this morning (January 20), in which a man fell from a wooden folding ladder while installing an air-conditioner. He was certified dead later in hospital. The LD is saddened by his death and expresses its deepest sympathy to his family.

The LD's spokesman said, "We commenced an immediate on-site investigation as soon as we were notified of the accident and have issued suspension notices to the contractors concerned, suspending the air-conditioning works at the detached house concerned. The contractors cannot resume the work process until the LD is satisfied that suitable measures to abate the relevant risks have been taken."

The spokesman added, "We will complete the investigation as soon as possible to identify the cause of the accident, ascertain the liability of the duty holders and recommend improvement measures. We will take actions pursuant to the law if there is any violation of the work safety legislation."

To protect workers' safety, the LD reminds contractors that ladders are usually used for ascending and descending only. Using ladders for work-above-ground is unsafe. Contractors shall provide and ensure that workers use appropriate working platforms or other safe means of support, including step platforms or hop-up platforms in conformity with international or national standards, instead of ladders.

The general duty provisions of the Occupational Safety and Health Ordinance require employers to provide safe working environments, plant and systems of work for their employees. Those who contravene the relevant provisions are liable to a maximum fine of $10 million and imprisonment for two years.

In regard to today's accident, the LD will issue a Work Safety Alert through its mobile application "OSH 2.0", website and email, giving a brief account of the accident concerned to duty holders, workers' unions, professional bodies of safety practitioners and others, and reminding the industry of the importance of following safety precautionary measures to prevent a recurrence of similar accidents.

The LD will also remind the employer concerned of the liability for employees' compensation under the Employees' Compensation Ordinance, assist family members of the deceased to claim employees' compensation and closely follow up on the case. For those with financial difficulties, the LD will assist them to apply for appropriate emergency funds. Subject to the needs and wishes of family members of the deceased, the LD will also liaise with the Social Welfare Department for financial or other assistance.

For the sake of securing the safety and health of employees at work, the LD appeals to employers to provide plant and systems of work that are safe and without risks to health. Employees should co-operate with their employers, adopt all safety measures and use personal protective equipment provided properly to avoid endangering their own work safety and that of other workers.

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