title: Learning from adverse incidents involving medical devices.
abstract: While an adverse event involving a medical device is often ascribed to either user error or device failure, the causes are typically multifactorial. A number of incidents involving medical devices are explored using this approach to investigate the various causes of the incident and the protective barriers that minimised or prevented adverse consequences. User factors, including mistakes, omissions and lack of training, conspired with background factors--device controls and device design, storage conditions, hidden device damage and physical layout of equipment when in use--to cause the adverse events. Protective barriers that prevented or minimised the consequences included staff vigilance, operating procedures and alarms.
authors.affiliation: Department of Medical Physics, Royal Infirmary of Edinburgh, Edinburgh. John.Amoore@ed.ac.uk
authors.forename: John
authors.initials: J
authors.lastname: Amoore
authors.forename: Paula
authors.initials: P
authors.lastname: Ingram
mesh_terms: D002983:Clinical Competence / Q000592:standards; D004562:Electrocardiography; D004864:Equipment and Supplies / Q000009:adverse effects*; D006801:Humans; D007858:Learning; D019300:Medical Errors / Q000517:prevention & control*; D010138:Pacemaker, Artificial / Q000009:adverse effects; D012308:Risk Management; D013222:State Medicine / Q000592:standards; D017749:Total Quality Management / Q000592:standards; D006113:United Kingdom