Background: Medical devices have improved the treatment of many medical conditions. Despite their benefit, the use\nof devices can lead to unintended incidents, potentially resulting in unnecessary harm, injury or complications to the\npatient, a complaint, loss or damage. Devices are used in hospitals on a routine basis. Research to date, however, has\nbeen primarily limited to describing incidents rates, so the optimal design of a hospital-based surveillance system\nremains unclear. Our research objectives were twofold: i) to explore factors that influence device-related incident\nrecognition, reporting and resolution and ii) to investigate interventions or strategies to improve the recognition,\nreporting and resolution of medical device-related incidents.\nMethods: We searched the bibliographic databases: MEDLINE, Embase, the Cochrane Central Register of Controlled\nTrials and PsycINFO database. Grey literature (literature that is not commercially available) was searched for studies on\nfactors that influence incident recognition, reporting and resolution published and interventions or strategies for their\nimprovement from 2003 to 2014. Although we focused on medical devices, other health technologies were eligible for\ninclusion.\nResults: Thirty studies were included in our systematic review, but most studies were concentrated on other health\ntechnologies. The study findings indicate that fear of punishment, uncertainty of what should be reported and how\nincident reports will be used and time constraints to incident reporting are common barriers to incident recognition\nand reporting. Relevant studies on the resolution of medical errors were not found. Strategies to improve error\nreporting include the use of an electronic error reporting system, increased training and feedback to frontline clinicians\nabout the reported error.\nConclusions: The available evidence on factors influencing medical device-related incident recognition, reporting\nand resolution by healthcare professionals can inform data collection and analysis in future studies. Since evidence\ngaps on medical device-related incidents exist, telephone interviews with frontline clinicians will be conducted to\nsolicit information about their experiences with medical devices and suggested strategies for device surveillance\nimprovement in a hospital context. Further research also should investigate the impact of human, system,\norganizational and education factors on the development and implementation of local medical device surveillance\nsystems.
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