Polisena Julie, Gagliardi Anna, Urbach David, Clifford Tammy, Fiander Michelle
Canadian Agency for Drugs and Technologies in Health, 600-865 Carling Avenue, Ottawa, ON, K1S 5S8, Canada.
Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON, K1H 8 M5, Canada.
Syst Rev. 2015 Mar 29;4:37. doi: 10.1186/s13643-015-0028-0.
Medical devices have improved the treatment of many medical conditions. Despite their benefit, the use of devices can lead to unintended incidents, potentially resulting in unnecessary harm, injury or complications to the patient, a complaint, loss or damage. Devices are used in hospitals on a routine basis. Research to date, however, has been primarily limited to describing incidents rates, so the optimal design of a hospital-based surveillance system remains unclear. Our research objectives were twofold: i) to explore factors that influence device-related incident recognition, reporting and resolution and ii) to investigate interventions or strategies to improve the recognition, reporting and resolution of medical device-related incidents.
We searched the bibliographic databases: MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and PsycINFO database. Grey literature (literature that is not commercially available) was searched for studies on factors that influence incident recognition, reporting and resolution published and interventions or strategies for their improvement from 2003 to 2014. Although we focused on medical devices, other health technologies were eligible for inclusion.
Thirty studies were included in our systematic review, but most studies were concentrated on other health technologies. The study findings indicate that fear of punishment, uncertainty of what should be reported and how incident reports will be used and time constraints to incident reporting are common barriers to incident recognition and reporting. Relevant studies on the resolution of medical errors were not found. Strategies to improve error reporting include the use of an electronic error reporting system, increased training and feedback to frontline clinicians about the reported error.
The available evidence on factors influencing medical device-related incident recognition, reporting and resolution by healthcare professionals can inform data collection and analysis in future studies. Since evidence gaps on medical device-related incidents exist, telephone interviews with frontline clinicians will be conducted to solicit information about their experiences with medical devices and suggested strategies for device surveillance improvement in a hospital context. Further research also should investigate the impact of human, system, organizational and education factors on the development and implementation of local medical device surveillance systems.
医疗设备改善了许多医疗状况的治疗效果。尽管它们有益，但设备的使用可能导致意外事件，可能给患者带来不必要的伤害、损伤或并发症、投诉、损失或损害。医院日常使用设备。然而，迄今为止的研究主要限于描述事件发生率，因此基于医院的监测系统的最佳设计仍不明确。我们的研究目标有两个：i）探讨影响与设备相关事件识别、报告和解决的因素，ii）调查改善医疗设备相关事件识别、报告和解决的干预措施或策略。
我们检索了文献数据库：MEDLINE、Embase、Cochrane对照试验中心注册库和PsycINFO数据库。检索了灰色文献（非商业可得文献），以查找2003年至2014年发表的关于影响事件识别、报告和解决的因素以及改善这些方面的干预措施或策略的研究。尽管我们专注于医疗设备，但其他卫生技术也符合纳入标准。
我们的系统评价纳入了30项研究，但大多数研究集中在其他卫生技术上。研究结果表明，对惩罚的恐惧、应报告内容及事件报告用途的不确定性以及事件报告的时间限制是事件识别和报告的常见障碍。未找到关于医疗差错解决的相关研究。改善差错报告的策略包括使用电子差错报告系统、增加培训以及向一线临床医生反馈所报告的差错。
关于医疗保健专业人员影响医疗设备相关事件识别、报告和解决的因素的现有证据可为未来研究中的数据收集和分析提供参考。由于存在医疗设备相关事件的证据空白，将对一线临床医生进行电话访谈，以征求他们关于医疗设备使用经验以及医院环境下改善设备监测的建议策略的信息。进一步的研究还应调查人员、系统、组织和教育因素对当地医疗设备监测系统开发和实施的影响。
