************************************************************************************************* CASE STUDY 3-1 Reprocessing single-Use Devices (Canada) 案例研究 3-1 一次性使用的器械的重用 (加拿大) Sandra Callery, RN, MHSc, CIC Introduction 引言 The finance department at Sunnybrook Health Sciences Centre (SHSC) asked for cost-saving measures throughout the hospital. The operations director for the operating room (OR) and outpatient procedures requested that the Reprocessing Steering Committee (the Committee) consider approving the reuse of some high-cost single-use devices (SUDs) that are used in the cardiac catheterization unit and OR. Currently the hospital’s policy on reuses state that it would not consider reprocessing any critical or semicritical SUD within the institution. However, if area or user chooses to have an SUD reprocessed by a third party, the third must provide documentation to the Committee that it follows the methodology and validation processes as outlined by an establish regulatory body, such as the US Food and Drug Administration (US FDA). 森尼布鲁克健康科学中心(SHSC)财政部要求在整个医院开展节约成本措施。手术室和门诊手术室手术主任请求器械重用指导委员会(简称委员会)考虑批准一些高成本的一次性使用的器械在心导管术单元和手术室重用。目前医院的政策再次规定在机构内不考虑高度危险或中度危险的一次性使用的器械的重用。然而,如果区域或使用者应第三方的要求选择一次性使用的器械的重用,第三方必须向委员会提供遵循监管机构如美国食品药品管理局的方案和制度文件。 Methods 方法 The Committee reviewed government regulation regarding reprocessing SDUs, including liability. The Committee established the hospital’s weighted criteria at the time of submission of request for purchase (RFP). The responses to the RFPs were assessed by the Committee. Reference checks were conducted. Prior to selection, a site tour of the licensed reprocessor’s facility was conducted by the Committee to review practices and procedures and to ensure that it had been certified by a regulatory authority or an accredited quality system auditor to ensure the cleanliness, sterility, safety, and functionality of the reprocessed equipment/devices. In addition, the Committee verified its ability to 委员会收到政府关于一次性使用的器械重用的法规,包括责任。该委员会确认了医院在请求购物时提交的加权标准。回答请求购物需委员会评估。证明已经进行了检查。在此之前的选择,一个由委员会领导对授权重用设施限期检查的机构对设施进行检查处理的做法得到了管理机构的肯定,能重用的设备/设施被可信任的质检员认为是清洁、无菌、安全,在功能上是可用的。另一方面,委员会证明它们能: a) track and label equipement/devices; a)追踪和标记设备/设施; b) recall improperly reprocessed medical equipement/devices; b)召回不宜再使用的医疗设备/设施; c) test for pyrogens; c)检查致热源; d) report adverse events; d)报告不良事件; e) provide good manufacturing procedures; e)提供好的修理工序; f) establish the maximum number of reuses specific for each device. f)确保每个设施能重用的最大次数。 The Committee collaborated with the prospective third party reprocessors to determine eligible instruments and to perform a cost-benefit analysis. 委员会与潜在的第三方合作修理确定合格的器械并做成本效益分析。 Staff and departments involved included representation from senior leadership and the following teams and departments: IPC, OR, ambulatory care, central reprocessing, and materials management. The Committee has a reporting structure to the IPC Committee and the Medical Advisory Committee of the hospital. 涉及的员工和部门包括上层领导的代表和下列团队与部门:感染预防控制、手术室、门诊、器械修理中心和材料管理部门。委员会有条理地向医院感染预防控制委员会和医学顾问委员会报告。 Results 结果 Canadian regulations do not recommend the reprocessing of SUDs by health care institutions unless the reprocessing is done by a licensed reprocessor. Submissions were reviewed by a hospital committee, site tours were conducted, and SHSC selected a licensed repocessor to reprocess 100 different critical SUD items, with annual saving of more than $300,000. 加拿大法规不同意一次性医疗服务器械的重用,除非得到许可修理后的重用产品。意见书经医院一个委员会评审,限期机构分析,SHSC选择重用100种不同危险等级的一次性使用的器械品种的重用,每年节约30万美元。 Lessons Learned 经验教训 Careful consideration and execution must be used when entering into reprocessing of SUDs, including the following tips: 必须实行一次性使用的器械重用时,应仔细考虑以下几点: ●Provide adequate time for discussion with the Committee members and to the reporting committees. ●提供充足的时间给委员会成员讨论,并报告委员会。 ●Ensure adequate representation of affected hospital services/programs during preliminary discussions. ●在初步讨论时,确保影响医院服务/程序的成员广泛参与。 ●Do homework by reviewing hospital policies regarding hospital liability. ●为修订医院关于医院职责的政策作准备工作。 ●Develop exclusion and inclusion criteria. ●制订排除和入选标准。 ●Keep physicians and surgeons informed of the decisions throughout the process. ●在讨论的整个过程,尊重内科医生和外科医生的意见。 ●Ensure that hospital policies and procedures give clear direction on the hospital’s position and ongoing monitoring of compliance with the reprocessing protocols. ●确保医院政策和规程在医院工作和持续改进方面符合重用协议。 ************************************************************************************************* |