Failure Modes and Effects Analysis of bilateral same-day cataract surgery.
Failure Modes and Effects Analysis of bilateral same-day cataract surgery.
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双侧当日白内障手术的失败模式和效果分析。
DOI：
10.1016/j.jcrs.2016.12.025
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发表时间：
2017
影响因子：
2.8
通讯作者：
Herrinton,LisaJ
中科院分区：
文献类型：
--
作者：
Shorstein,NealH;Lucido,Carol;Carolan,James;Liu,Liyan;Slean,Geraldine;Herrinton,LisaJ
目的系统分析双侧当日白内障手术过程中可能出现的失误，以提高患者的安全性。地点：美国北加州Kaiser Permanente手术中心21家。设计回顾性队列研究。方法质量专家进行了失效模式和影响分析（FMEA），包括无菌处理、药物、围手术期临床和手术中心就诊以及生物测定的评估。确定了人为因素和沟通（模式）方面的潜在故障。本研究评估了2010年至2014年双侧同日手术的眼内炎、中毒性前段综合征（TASS）和意外人工晶状体（IOL）植入的发生率。结果该研究包括4754只眼睛。分析确定了15种重要的潜在失效模式。其中包括器械处理失误和眼内抗生素的复合错误，可能导致眼内炎或TASS，以及外科医生对人工晶状体选择的模糊记录，这可能导致意外的人工晶状体植入。在研究样本中，1只眼发生眼内炎，1只眼发生意外人工晶状体植入术（发生率为2 / 10000；95%置信区间[CI]， 0.1-12.0 / 10000），无眼发生塔斯综合征（95%置信区间上限，8 / 10000）。建议包括改进对清洁和消毒操作的监督，为每只眼睛分离大量复方药物，以及加强人工晶状体的验证程序。结论采用FMEA确定双侧当日白内障手术的潜在失效模式和推荐措施。根据目前的证据和标准，这些发现可能有助于提高当日双侧白内障手术的可靠性和安全性。
PurposeTo systematically analyze potential process failures related to bilateral same-day cataract surgery toward the goal of improving patient safety.SettingTwenty-one Kaiser Permanente surgery centers, Northern California, USA.DesignRetrospective cohort study.MethodsQuality experts performed a Failure Modes and Effects Analysis (FMEA) that included an evaluation of sterile processing, pharmaceuticals, perioperative clinic and surgical center visits, and biometry. Potential failures in human factors and communication (modes) were identified. Rates of endophthalmitis, toxic anterior segment syndrome (TASS), and unintended intraocular lens (IOL) implantation were assessed in eyes having bilateral same-day surgery from 2010 through 2014.ResultsThe study comprised 4754 eyes. The analysis identified 15 significant potential failure modes. These included lapses in instrument processing and compounding errors of intracameral antibiotics that could lead to endophthalmitis or TASS, and ambiguous documentation of IOL selection by surgeons, which could lead to unintended IOL implantation. Of the study sample, 1 eye developed endophthalmitis, 1 eye had unintended IOL implantation (rates, 2 per 10 000; 95% confidence interval [CI], 0.1-12.0 per 10 000), and no eyes developed TASS (upper 95% CI, 8 per 10 000). Recommendations included improving oversight of cleaning and sterilization practices, separating lots of compounded drugs for each eye, and enhancing IOL verification procedures.ConclusionsPotential failure modes and recommended actions in bilateral same-day cataract surgery were determined using an FMEA. These findings might help improve the reliability and safety of bilateral same-day cataract surgery based on current evidence and standards.
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影响因子：
2.8
作者：
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通讯作者：
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作者：
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作者：
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影响因子：
8.1
作者：
S. Neel
通讯作者：
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影响因子：
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作者：
Neel, Sean T.
通讯作者：
Neel, Sean T.