Release date: 2006-10-27

Ensuring the optimal performance of medical equipment is a critical task in hospital operations, especially as the share of medical devices within hospital assets continues to grow. In Zhejiang Province, for example, major hospitals allocate between one-third and half of their fixed assets to medical equipment, with values ranging from tens of millions to hundreds of millions of yuan. Managing this equipment efficiently has become a fundamental challenge in maintaining smooth hospital operations. To meet these demands, medical equipment management departments must adopt scientific, rigorous, and forward-thinking strategies. Traditional transactional approaches are no longer sufficient, and a more systematic, process-driven model based on system theory is essential for continuous improvement and adaptation to evolving needs. In June 2005, a delegation from the Zhejiang Provincial Health Department visited Germany to study its advanced medical equipment management practices. The visit included inspections of several hospitals, where they gained insights into procurement strategies, quality assurance, and risk management systems. German hospitals have developed highly effective models that emphasize proactive maintenance, strict compliance with international standards, and seamless integration between clinical and engineering teams. These practices offer valuable lessons for other countries, including China. In Germany, the Clinical Engineering Department plays a vital role in ensuring the reliable operation of medical equipment. It typically includes project managers, biomedical engineers, and clinical engineers, each responsible for different aspects of equipment lifecycle management. While the structure may resemble that of Chinese hospitals, the German approach stands out due to its higher staffing levels, technical expertise, and systematic workflows. German hospitals often locate clinical engineering departments close to clinical areas, enabling rapid response during emergencies. This contrasts with many Chinese hospitals, where such departments are often isolated or under-resourced. At institutions like Münster University Hospital and St. Lucas Hospital, the maintenance areas are well-equipped with cranes, specialized tools, monitoring devices, and safety analyzers. The layout of workstations is also designed for efficiency, with proper grounding and multiple interface options. One of the key features of German medical equipment management is the emphasis on preventive maintenance (PM). Unlike passive maintenance models, German hospitals implement structured, scheduled PM programs to ensure device safety and functionality. This is driven by legal requirements, including adherence to IEC, ISO, and EU standards. PM involves regular testing, maintenance, and documentation to reduce the risk of equipment failure and extend device lifespan. The PM process includes risk assessment, staff training, equipment testing, and data recording. For high-sensitivity devices, such as ventilators, the process is more rigorous, involving thorough cleaning, functional testing, and certification before reuse. This level of care ensures that even older models can remain in service, reducing costs while maintaining safety. Many German hospitals use digital tools to streamline PM and asset management. For instance, Münster University Hospital employs computerized PM programs, while St. Lucas Hospital uses barcode systems for tracking equipment and maintenance records. These technologies enhance accuracy and efficiency in managing large inventories. Beyond routine tasks, clinical engineering departments in Germany actively participate in hospital planning, financial decisions, and research projects. This involvement highlights the department's strategic importance and ensures alignment with broader institutional goals. As a result, these departments receive strong support in terms of staffing and professional development. In contrast, China's clinical medical engineering departments, though having grown significantly since the 1990s, face challenges due to limited regulations and inconsistent management practices. Many hospitals prioritize equipment procurement over long-term maintenance, leading to a decline in technical capabilities and operational efficiency. Germany’s success in medical equipment management underscores the importance of regulatory frameworks, professional training, and integrated teamwork. By adopting similar principles, other countries can improve the reliability, safety, and cost-effectiveness of their healthcare systems. Shanghai Medical Devices

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