新监督法规下医疗设备全生命周期管理实践

Practice of Life Cycle Management of Medical Equipment Under New Supervision Regulations

目的按照《医疗器械使用质量监督管理办法》等法律法规的要求,在依法合规的前提下,做好医疗设备的管理。方法以我院医疗设备管理实践为基础,建立新监督法规下的医疗设备全生命周期管理新模式。结果形成了诸如配置决策多学科协作治疗模式、集召集采等切实可行的措施,能为医院医疗设备管理部门提供具体的管理手段。结论新监督法规下医疗设备全生命周期管理,能有效地提升医疗设备管理水平,并降低使用风险。

Objective According to the requirements of laws and regulations,such as measures for quality supervision and management of medical devices,the management of medical equipment shall be carried out on the premise of compliance with laws and regulations.Methods Based on the practice of medical equipment management in our hospital,a new model of medical equipment life-cycle management under the new supervision regulations was established.Results Practical measures such as configuration decision multidisciplinary team and collection and collection were formed,which provided specific management methods for the hospital medical equipment management department.Conclusion The life cycle management of medical equipment under the new supervision and regulation can effectively improve the management level of medical equipment and reduced the risk of use.