title: A proposed framework to improve the safety of medical devices in a Canadian hospital context.
abstract: OBJECTIVE
  Medical devices are used to monitor, replace, or modify anatomy or physiological processes. They are important health care innovations that enable effective treatment using less invasive techniques, and they improve health care delivery and patient outcomes. Devices can also introduce risk of harm to patients. Our objective was to propose a surveillance system framework to improve the safety associated with the use of medical devices in a hospital.
  
  
  METHODS
  The proposed medical device surveillance system incorporates multiple components to accurately document and assess the appropriate actions to reduce the risk of incidents, adverse events, and patient harm. The assumptions on which the framework is based are highlighted. The surveillance system was designed from the perspective of a tertiary teaching hospital that includes dedicated hospital staff whose mandate is to provide safe patient care to inpatients and outpatients and biomedical engineering services.
  
  
  RESULTS
  The main components of the surveillance system would include an adverse medical device events database, a medical device/equipment library, education and training, and an open communication and feedback strategy. Close linkages among these components and with external medical device/equipment networks to the hospital must be established and maintained. A feedback mechanism on medical device-related incidents, as well as implementation and evaluation strategies for the surveillance system are described to ensure a seamless transition and a high satisfactory level among the hospital staff. The direct cost items of the proposed surveillance system for consideration, and its potential benefits are outlined.
  
  
  CONCLUSIONS
  The effectiveness of the proposed medical device surveillance system framework can be measured after it has been implemented in a Canadian hospital facility.
authors.affiliation: Canadian Agency for Drugs and Technologies in Health, Ottawa, ON, Canada ; Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
authors.forename: Julie
authors.initials: J
authors.lastname: Polisena
authors.affiliation: Interdisciplinary School of Health Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, ON, Canada.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Jutai
authors.affiliation: Biomedical Engineering, The Ottawa Hospital, Ottawa, ON, Canada.
authors.forename: Rana
authors.initials: R
authors.lastname: Chreyh
keywords: adverse events; devise failure; maintenance; safety; surveillance system; training