Medical equipment provides a material foundation for health care and a supporting platform for new medical technology in modern hospitals. Medical equipment plays an important role in the diagnosis and treatment, as well as prevention of diseases. While previous it was only an auxiliary tool, it has gradually become a major means of clinical diagnosis and treatment on which clinicians are increasingly dependent. The latest international health care services are based on a patientcentered and outcomes focused medical philosophy for providing best possible treatment, rehabilitation and disease prevention, with the view of providing measurable valuebased wholeprocess medical services of the best quality and outcomes and improving the health of the whole population. The hospital must recognize the safety risks in the use when introducing various advanced medical equipment. The management of safety risks involved in medical equipment is an important part of the hospitals medical quality management system and an important management tool for the hospital to maintain the sustainable promotion of medical services of high quality.
There have been more and more safety incidents and disputes arising from such adverse events. Medical equipment has become one of the major sources of hazards threatening the safe hospital services. Problems in the safety risk management of medical equipment have attracted attention from all stakeholders. The 11337 document adopted by the Executive Committee of the WHO at its 113th session in 2003 put forward a new definition of the safety risk management in the use of medical equipment, including the medical equipment use process management in the scope of the medical technology management. In 2010, the Supervision and Management Department of the Ministry of Health issued Administrative Regulations on Safe Clinical Use of Medical Devices Trial with the view of strengthening the safety management of clinical use of medical devices, reducing risks involved in clinical use of medical devices, improving the quality of medical care and protecting the legitimate rights and interests of both doctors and patients. The Hospital Accreditation Standards Edition 2011 explicitly requires hospital to implement safety control and risk management of clinical use of medical equipment, establish monitoring and reporting systems for clinical use of medical equipment, regularly evaluate the safety use of medical equipment and formulate and implement sustainable inspection and evaluation methods with the view of enhancing the safety management and realizing sustainable improvement of the clinical use of medical equipment. The Regulations for the Supervision and Administration of Medical Devices repeated revised by the State Council from 2014 to 2017 Decree 650, 2014 and Decree 680, 2017 of the State Council, the Measures for the Supervision and Management of Medical Device Operation Decree 18, 2015 by China Food and Drug Administration and the Measures for Management of Clinical Use of Medical Devices by the National Health Commission in 2019 all define the responsibilities for the safety management of the use of medical devices from legal perspectives, with the view of ensuring the safe and effective clinical use of medical devices.
In the Circular on Further Enhancement of Patient Safety Management Guoweibanyifa 2018No.5, the National Health Commission requires hospitals to implement wholeprocess management of the clinical use of medical devices and enhance the efforts for targeted management of safe use of medical devices. However, in spite of those administrative efforts, the safety risks involved in the use of medical devices are not given due attention, especially in primary hospitals. Hospitals also lack experience and technical skills to implement safety risk management. Clinical users of medical devices and clinical engineering personnel need a systematical understanding of safety risks involved in the clinical use of medical equipment as well as theories and modes in safety risk management, methods and practices, and ITbased smart management approaches.
To meet those urgent needs, we have compiled Application Safety and Risk Management for Medical Equipment with reference to the latest advances in relevant technologies, with the hope of providing assistance to clinical users of medical devices and clinical engineering personnel, promoting safe medical treatment and the overall quality of medical services.
We are grateful for the information and support provided by Prof.Tobey Clark, Prof. Yadin David and Prof.Binseng Wang, as well as Fluke Biomdical Co.Ltd., Beijing Health Engine Co.Ltd., Philips Medical Systems Co.Ltd. and the Medical Device Research Institute of Sinopharm and Beijing Aquiferre Technology Co.Ltd..
Editorial Board of Application Safety and Risk Management for Medical Equipment
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