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Article type: Research Article
Authors: Cromheecke, Manon E.; | Mak, Rachel | de Mol, Bas A.J.M.; ;
Affiliations: Department of Cardio‐thoracic Surgery, Academic Medical Center of the University of Amsterdam, Amsterdam, The Netherlands | Safety, Systems Engineering, and Technology Assessment Group, Faculty of Technology, Policy, and Management, Delft University of Technology, Delft, The Netherlands
Note: [] Correspondence to: B.A.J.M. de Mol, MD, PhD, JD, Department of Cardio‐thoracic Surgery, Academic Medical Center of the University of Amsterdam, P.O. Box 22700, 1100 DE Amsterdam, The Netherlands. Tel.: +31 20 566 6088; Fax: +31 20 696 2289; E‐mail: [email protected].
Abstract: Oral anticoagulation requires INR and dosage control. The availability of a portable device, called the CoaguChek® system, allows patient self‐monitoring. In this study, this self‐monitoring system is described. Then a risk analysis by means of Failure Mode & Effect Analysis and Fault Tree Analysis was applied. This systemic risk analysis revealed system weaknesses with respect to education, compliance, and technical reliability. This type of risk analysis used by the prescribing physicians can assist in recognizing increased risks of failure in the individual case as well as in analysing adverse events.
Journal: International Journal of Risk and Safety in Medicine, vol. 12, no. 3-4, pp. 173-179, 1999
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