Evaluation of preventive effect of the management of foreign medical instruments on surgical site infections in orthopedic surgery

目的 研究外来医疗器械在预防某三级甲等医院骨科手术部位感染的效果.方法 采用流行病学类试验的研究方法,开展干预前后比较.2014年1月1日-2015年12月31日,对骨科腰椎手术、关节置换术(膝或髋关节)开展手术部位感染前瞻性、目标性监测,了解手术部位感染发生率;抽检上述两类手术的外来医疗器械,评价清洗质量;2016年1月1-2016年12月31日,采取干预措施(外来医疗器械集中清洗、灭菌)、提高器械清洗合格率,根据干预前后的各项监测指标评价手术部位感染预防效果.结果 2014年1月1日-2016年12月31日共行腰椎手术、关节置换术(膝或髋关节)1 825台;研究期间,1 825例腰椎手术、关节置换术(膝或髋关节)的手术部位感染率为1.8％,通过采取干预措施,SSI从1.8％下降至0.3％,差异有统计学意义(P＜0.05),相对危险度(RR值)及95％置信区间(95％CI)为0.172(0.040～0.736).器械清洗合格率从干预前28.7％上升至85.0％,差异有统计学意义(x2=33.835,P＜0.05).术后患者发热平均时长从干预前(4.11±1.18)d下降至干预后(3.01±0.99)d,差异有统计学意义(t=14.141,P＜0.05);术后3日发热患者比例从干预前52.4％下降至40.7％,差异有统计学意义(x2=64.707,P＜0.05);抗菌药物使用强度从干预前46.66 DDDs/百床日下降至干预后31.22 DDDs/百床日;抗菌药物使用时长从416.67天/千床日下降至272.73天/千床日.结论 通过规范外来医疗器械的管理,提高了手术器械清洗质量,并且通过多项评价指标监测数据的变化,全面、综合评价规范外来医疗器械管理的效果,从而为管理层制定相关规范提供更多的数据支持.OBJECTIVE To investigate the effect of the management of foreign medical instruments on preventing surgical site infections in orthopedic surgery in a 3A-level hospital.METHODS A research comparing the infection rate before and after intervention was developed with epidemiological quasi experiment method from Jan.1,2014 to Dec.31,2015.Prospective and targeted surveillance was used on the surgical site infections in major spinal surgery and joint replacement (knee or hip joint) surgery,in order to understand the infection rate in surgical sites.Foreign medical instruments in the surgeries were randomly selected and their washing qualities were evaluated.From Jan.1,2016 to Dec.31,2016,intervening measures (centralized washing and sterilization of the instruments) were used to increase the qualified rate of instruments washing,and the prevention effects of infection were evaluated according to the surveillance indicators before and after the intervention.RESULTS From Jan.1,2014 to Dec.31,2016,1825 major spinal and joint replacement surgeries were performed in total.During the study period,the incidence rate of surgical site infection(SSI) was 1.8％ out of total 1825 major spinal and joint replacement (knee or hip joint) surgeries.By taking intervening measures,the incidence rate of SSI dropped from 1.8％ to 0.3％ with significant difference [P＜0.05,RR=0.172,95％CI(0.040-0.736)].The qualified rate of instruments washing increased from 28.75％ (before intervention) to 85.00％ with significant difference (x2 =33.835,P＜0.05).The average heating duration of postoperative patients dropped from 4.11±1.18 days (before intervention) to 3.01 ± 0.99 days (after intervention) with significant difference(t=14.141,P＜0.05).The postoperative patients heating rate dropped from 52.44％ (before intervention) to 40.71 ％ with significant difference (x2 =64.707,P＜0.05).The antibiotic use density dropped from 46.66 DDDs/100 patient day to 31.22 DDDs/100 patient day,and the antibiotic use duration dropped from 416.67 days/1000 patient-day to 272.73 days/1000 patient-day.CONCLUSION By regulating the management of foreign medical instruments,the washing quality was improved,and by monitoring the data changes with multiple parameters,the effect of instruments regulation was evaluated thoroughly and comprehensively,providing the management with more data to develop relative standards.北京医院科研科技新星基金资助项目(BJ-2016-04)中美新发和再发传染病合作基金资助项目中国科学引文数据库(CSCD)122849-28522