基于手供一体化的手术植入物追溯系统的研发与应用

Development and application of surgical implant traceability system based on integrated surgery-supply design

目的:开发并应用基于手供一体化设计的手术植入物全程追溯系统,实现对患者使用的每块钢板及螺钉进行全程追溯,确保追溯信息完整准确。方法:2018年烟台毓璜顶医院在医院消毒供应中心(CSSD)追溯系统中基于手供一体化研发完善了植入物追溯管理模块,对植入物实施全程闭环式追溯管理。收集植入物追溯系统应用前后3个月的相关记录,将2018年5—7月处置使用的植入物设为对照组,共处理2246件,处置使用过程手工记录与交接;将2018年8—10月处置使用的植入物设为试验组,共处理2570件。比较两组植入物交接质量;抽检追溯系统应用前后各1个月的骨科钢板60个,比较应用前后追溯所用时长及追溯信息完整率。结果:试验组植入物交接名称规范、数量及灭菌标签信息的清晰度、完整性均全部合格,对照组分别有78、107、260、285件不合格,差异均有统计学意义(χ2值分别为90.721、125.217、314.485、346.626;P<0.01)。试验组植入物交接中发生型号错误88件,灭菌标签错误27件,对照组分别为113、48件,差异均有统计学意义(χ2值分别为7.740、9.230;P<0.01)。试验组植入物追溯信息完整率为100%(60/60),追溯时长为(1.1±0.2)min,对照组分别为90%(54/60)、(74.2±7.9)min,两组比较差异有统计学意义(P<0.05)。结论:我院自主研发的植入物追溯系统,实现了手术室、CSSD以及物资采购供应处等多部门联动追溯管理,能够对患者使用的每块钢板及螺钉进行有效监管与可追溯,提高了CSSD的工作质量。

Objective To develop and apply a full-course traceability system for surgical implants,realize full traceability of each steel plate and screw used for patients,and ensure complete and accurate traceability information.Methods In 2018,an implant traceability management module was developed and improved in the Central Sterile Supply Department(CSSD)traceability system of Yantai Yuhuangding Hospital,and the entire closed-loop traceability management of the implants was carried out.The relevant records of the 3 months before and after the implementation of the implant traceability system were collected.Totally 2246 implants used between May and July 2018 were included into the control group,and the disposal and use process was recorded and handed over manually,while 2570 implants used between August and October 2018 were included into the experimental group.The quality of handover of implants was compared between the two groups;a total of 60 orthopedic steel plates 1 month before and after the implementation of the system was sampled,and the insertion time and completeness rate of traceability information were compared before and after the implementation.Results The specification of implant transfer name,quantity,and the clarity and completeness of the sterilization label information in the experimental group were qualified,while the control group had 78,107,260,285 unqualified cases,and the differences were statistically significant(χ2=90.721,125.217,314.485,346.626;P<0.01).There were 88 cases of model errors in implant transfer and 27 cases of sterilization label errors in the experimental group,whereas the numbers in the control group were 113 and 48,and the differences were statistically significant(χ2=7.740,9.230;P<0.01).The completeness rate of implant traceability information in the experimental group was 100%(60/60),and the traceability time was(1.1±0.2)min,while those in the control group was 90%(54/60)and(74.2±7.9)min,and the differences were statistically significant(P<0.01).Conclusions The implant traceability system independently developed by our hospital realizes the linked traceability management of the operating room,CSSD and material procurement and supply department,which can effectively supervise and trace each steel plate and screw used for the patient,and improve the quality of work in CSSD.