DH follows up preliminary investigation result from local supplier of surgical lights
A spokesman for the DH said that following the surgical light falling off incident of the Hospital Authority (HA) earlier, the Medical Device Division (MDD) of the DH has immediately contacted the local supplier to obtain details of the incident and has requested the local supplier to inform the affected customers of the incident and conduct follow-up.
The MDD earlier received an adverse event report involving a medical device from the HA. The local supplier replied to the DH yesterday that according to the manufacturer's early stage of investigation, the incident might be related to the problem of the screws fixing the surgical light. Moreover, apart from the concerned surgical light (Volista STANDOP), the manufacturer found that the problem may also affect the following three additional Maquet surgical lights using the same fixing means which were distributed in Hong Kong:
- Hanaulux HLX 3000
- PowerLed / Hled
- Maquet PowerLed II
"Concerning the surgical light safety incident, the DH today again reminded the local supplier of the surgical light in writing that it should inform the affected customers immediately and take follow-up actions. It was requested to submit an investigation report within four weeks," the spokesman said.
Since 2004, the DH has launched the voluntary Medical Device Administrative Control System (MDACS), which includes the listing systems for medical devices and traders as well as post-market monitoring mechanism. Following the risk-based approach, Local Responsible Person (LRP) can apply for listing of Classes II, III and IV general medical devices and Classes B, C and D in vitro diagnostic medical devices (IVDMD) under the MDACS. Medical devices of lower risk, i.e., Class I general medical devices (including surgical lights in general) and Class A IVDMDs are not under the current scope of listing under the MDACS.
In terms of the post-marketing monitoring mechanism, the MDACS includes the monitoring of safety alerts of medical devices issued by overseas regulatory authorities; and handling of safety alerts notified by manufacturers. Under the current mechanism, the MDD of the DH will upload the identified safety alerts to the MDD's website, and will inform medical institutions (including the HA and private hospitals) and relevant medical professional associations as appropriate. Furthermore, taking reference to the recommendations of the Global Harmonization Task Force, the MDACS established a Medical Device Adverse Event Reporting System to collect and conduct analysis on information related to adverse event for early detection of safety signals so as to protect the health of patients and users of medical device.
Under the MDACS, the LRP shall offer or arrange to provide preventive and corrective maintenance of the device to the users when requested. For specific repairs, checking and examinations, maintenance and re-inspection of medical devices, it will be arranged by the user and will not be included in the scope of the MDACS.
Concerning the surgical light falling off incident, the MDD has posted special safety alerts on its website on February 20 and 24. Emails have been sent to relevant stakeholders to remind them of the incident and requested them to contact the supplier if they are using the affected surgical lights. The DH also reminds users to assemble, install, use and regularly maintain the medical devices (including ceiling-mounted surgical lights) in accordance with the recommendations of manufacturer and instructions for use.
Meanwhile, the Health Bureau notified the Hong Kong Private Hospitals Association on February 19 the surgical light safety incident announced by the HA. The Office for Regulation of Private Healthcare Facilities of the DH has also contacted all private hospitals and day procedure centres and requested them to check relevant devices thoroughly as well as to arrange checking by the manufacturer/vendor concerned to ensure the safety.
"The DH will continue to closely monitor the situation and follow up with the manufacturer or local supplier concerned," the spokesman added.
Ends/Saturday, February 25, 2023
Issued at HKT 20:45
Issued at HKT 20:45