The EMSD is currently responsible for the maintenance of over 40 000 pieces of medical equipment in the public hospitals in Hong Kong. In late 2019, the EMSD conducted a comprehensive review on the maintenance management system for medical devices. Focusing on the safety and performance of medical devices, we put forth further improvements on the aspects of risk management, contractor monitoring, traceability of procedural documents and records, the medical incident reporting mechanism, etc. In addition, with enhanced analysis of maintenance data (e.g. causes of faults, their trends, etc.), the EMSD had a more solid grasp of the operation of the devices and the ways to conduct targeted maintenance correspondingly, thereby enhancing their reliability and maintainability.
The enhanced quality management system was launched in August 2020 and successfully obtained the certification of ISO 13485 Medical Devices - Quality Management System early this year. Among the third-party maintenance service providers of multi-brand medical devices in Hong Kong, the EMSD is one of the few having such certification. The certification not only testifies that our quality services reach internationally recognised standards, but also acknowledges the EMSD’s commitment to our clients on continuous improvement and provision of safer and more reliable medical engineering services.