Factors that influence the recognition, reporting and resolution of incidents related to medical devices and other healthcare technologies: a systematic review.

Julie Polisena,Michelle Fiander,Tammy Clifford,Anna Gagliardi,David Urbach

doi:10.1186/s13643-015-0028-0

Abstract

BackgroundMedical 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.MethodsWe 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.ResultsThirty 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.ConclusionsThe 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-015-0028-0) contains supplementary material, which is available to authorized users.

Highlights

Medical devices have improved the treatment of many medical conditions
Lawton et al developed a ‘contributory factors framework’ from the published literature on factors associated with patient safety incidents in a hospital context
The authors found that two main contributory factors related to patient safety incidents were active failures and individual factors [3]

Summary

Introduction

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 have improved care delivery and associated outcomes for many conditions. Despite their benefit, an audit of the UK National Patient Safety Agency over 7 months found that 1,021 of 12,084 patient safety incidents were due to devices. Pfeiffer et al proposed a framework on barriers and motivators for incident reporting They concluded that individual, organizational and incident reporting systems factors impacted reporting behaviour [4]. While not specific to devices, a systematic review identified 1,676 factors contributing to patient safety incidents in 83 eligible studies and categorized factors into 20 domains including active failure in performance or behaviour, clinician, team, institution, system, culture, training, accountability and patient factors [5]

Methods

Results

Discussion

Conclusion