title: Factors that influence the recognition, reporting and resolution of incidents related to medical devices and other healthcare technologies: a systematic review.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Canadian Agency for Drugs and Technologies in Health, 600-865 Carling Avenue, Ottawa, ON, K1S 5S8, Canada. Juliep@cadth.ca.|Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON, K1H 8 M5, Canada. Juliep@cadth.ca.
authors: Julie
authors: J
authors: Polisena
authors: Toronto General Research Institute, University Health Network, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada. agagliar@uhnresearch.ca.
authors: Anna
authors: A
authors: Gagliardi
authors: Toronto General Research Institute, University Health Network, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada. david.urbach@uhn.on.ca.|Department of Surgery and Institute of Health Policy, Management and Evaluation, University of Toronto, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada. david.urbach@uhn.on.ca.
authors: David
authors: D
authors: Urbach
authors: Canadian Agency for Drugs and Technologies in Health, 600-865 Carling Avenue, Ottawa, ON, K1S 5S8, Canada. tammyc@cadth.ca.|Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON, K1H 8 M5, Canada. tammyc@cadth.ca.
authors: Tammy
authors: T
authors: Clifford
authors: Cochrane Effective Practise & Organisation of Care (EPOC) Group, Centre for Practice Changing Research, Ottawa Hospital Research Institute, 501 Smyth Road, Box 711, Ottawa, ON, K1H 8 L6, Canada. mfiander@ohri.ca.
authors: Michelle
authors: M
authors: Fiander
mesh_terms: D020811:Biomedical Technology; D004864:Equipment and Supplies / Q000009:adverse effects*; D006801:Humans; D019300:Medical Errors; D011358:Product Surveillance, Postmarketing / Q000379:methods*