| Risks in the application of medical devices: human factors in the medical environment. | |
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MedLine Citation:
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PMID: 20924251 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: The more complex a medical device is, the more difficult it is to control the hazards associated with its use. A substantial percentage of harm or injuries to patients resulting from treatment can be attributed to errors. No one knows exactly how many victims have been claimed by medical errors. Studies from the United States and other countries show that 3% to 4% of all hospital patients suffer harm or injuries. This text is intended to provide a practice-oriented approach to the discussion of targeted improvement opportunities in connection with a superficial consideration of the sociotechnical system comprising the manufacturers, the medical devices, and the users in the health facilities. METHOD: Analysis of the risk reports received by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) in connection with undesirable events involving the use of medical devices. Supplementary consideration of additional data from previous human factors research in the field of medicine. The evaluation period for the primary data focuses on the years 2005 to 2008. A differentiation is made between the error causal factors, man, and device. RESULTS: A substantial percentage of the incidents that occurred can be attributed to human blunders. Within the scope of an evaluation of more than 16 000 risk reports in connection with medical devices, 5000 risk reports could not be directly attributed to the failure of a medical device. The lack of an error culture seems to be a considerable problem. CONCLUSION: The safe and reliable development and use of medical devices requires efficient and consistent risk management. Until now, human factors are not sufficiently considered when identifying sources of errors in sociotechnical systems. The useful data required for an extensive risk assessment are missing. An interface-overlapping method of solution is required which permits system-analytical and unbiased error handling and integrates all stakeholders. |
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Authors:
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Uwe Wagner |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Quality management in health care Volume: 19 ISSN: 1550-5154 ISO Abbreviation: Qual Manag Health Care Publication Date: 2010 Oct-Dec |
Date Detail:
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Created Date: 2010-10-06 Completed Date: 2011-01-21 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9306156 Medline TA: Qual Manag Health Care Country: United States |
Other Details:
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Languages: eng Pagination: 304-11 Citation Subset: H |
Affiliation:
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Department for Human and Economic Sciences, University for Health Sciences, Medical Informatics and Technology, Eduard Wallnoefer Center I, Hall in Tirol, Austria. uwe.wagner@umit.at |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Equipment Safety Equipment and Supplies* Humans Medical Errors / prevention & control* Organizational Culture Quality of Health Care / organization & administration Risk Assessment Risk Factors Risk Management / organization & administration* |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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