清洗消毒机程序漂移的器械风险及全流程管控策略

Risks to Surgical Instruments Caused by Program Drift of Washer‑Disinfectors and Full‑Process Control Strategies

摘要: 目的：复盘本院AMSCO 3052型全自动清洗消毒机无预警程序参数漂移不良事件，分析程序异常对复用手术器械造成的清洁缺陷、器械腐蚀及医院感染风险，建立设备程序溯源管控体系与标准化预防性维护方案，防范同类故障反复发生。方法：采用单案例复盘法，调取标准与故障时段设备运行日志，对比CYCLE8程序全部工艺参数；对故障批次206件、标准对照201件手术器械开展ATP荧光、蛋白残留及外观锈蚀检测；采用鱼骨图从人、机、料、法、环开展根因分析；运用PDCA循环实施软硬件协同整改，连续追踪6个月，对比干预前后器械清洗合格率与程序异常发生率，计数资料采用χ²检验。结果：本次程序漂移核心异常：漂洗由2轮缩减为1轮且时长大幅缩短，热力漂洗自动新增润滑油加注；故障器械ATP阳性率31.1%、蛋白残留阳性率28.2%、油脂残留阳性率18.4%，均显著高于对照组(P < 0.001)，部分器械出现关节锈蚀、活动卡顿。故障根因包括设备主板存储老化、无程序变更预警、科室缺乏参数复核制度、维保未校验程序四大类。落实三级程序核查、操作权限锁定、标准化维保及不良事件闭环管理后，连续6个月未出现程序漂移故障，器械清洗合格率由86.4%提升至99.5%。结论：清洗消毒器隐性程序漂移隐蔽性强，可同时破坏机械冲洗、化学清洗、热力消毒效果，加速器械损耗并提升交叉感染风险。构建程序溯源核查、软硬件约束、分级预防性维护一体化管控体系，能够从源头规避设备程序失控，保障复用器械处置质量与患者安全。

Abstract: Objective: To review an adverse event of unwarned program parameter drift of the AMSCO 3052 automatic washer-disinfector in our hospital, analyze the risks of inadequate cleaning, instrument corrosion and healthcare‑associated infection induced by program abnormalities on reprocessed surgical instruments, and establish a traceability management system for equipment programs as well as a standardized preventive maintenance protocol to prevent recurrence of similar failures. Methods: A single‑case retrospective review was adopted. Equipment operation logs under standard and faulty conditions were retrieved, and all process parameters of the CYCLE8 program were compared. A total of 206 surgical instruments from the faulty batch and 201 instruments from the standard control batch were tested for ATP bioluminescence, protein residue and surface rust. Root‑cause analysis was performed using a fishbone diagram from the dimensions of manpower, machine, material, method and environment. Hardware‑software collaborative rectification was implemented via the PDCA cycle. A 6‑month continuous follow‑up was conducted to compare the qualified rate of instrument cleaning and the incidence of program anomalies before and after intervention. The χ² test was used for enumeration data. Results: Core anomalies of the program drift included reduction of rinsing cycles from 2 to 1 with markedly shortened duration, and automatic unexpected lubricant injection during thermal rinsing. The positive rates of ATP, protein residue and grease residue in faulty instruments were 31.1%, 28.2% and 18.4%, respectively, which were significantly higher than those in the control group (P < 0.001). Partial instruments exhibited joint rusting and activity jamming. Root causes consisted of aging main‑board storage chips, absence of program‑change early‑warning function, lack of routine parameter review protocols in the department, and neglect of program‑parameter verification in maintenance work. After implementation of three‑level program verification, operation‑authority locking, standardized maintenance and closed‑loop adverse‑event management, no program drift occurred within 6-month follow-up. The qualified rate of instrument cleaning increased from 86.4% to 99.5%. Conclusion: Silent program drift of washer‑disinfectors is highly concealed. It impairs mechanical flushing, chemical decontamination and thermal disinfection simultaneously, accelerates instrument deterioration and elevates cross‑infection risks. An integrated management system combining program traceability verification, hardware‑software constraints and hierarchical preventive maintenance can fundamentally avoid out‑of‑control equipment programs and guarantee the quality of reprocessed instruments as well as patient safety.