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October 16-20, 2010 San Diego, CA Home Abstract Archive Search Abstracts 2010 Session Grid 2010 Meeting Website Policy Statements ASA Website Feedback 
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A767
October 19, 2008 2:00 PM - 4:00 PM Room Hall E2-Area N, |
| Development of a Standard for Reducing Use Errors with Medical Devices |
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Carl Wallroth, Ph.D., Peter Carstensen, B.S.M.E., Dave Osborn, M.E., Gerald Panitz, M.S., Dwayne Westenskow, Ph.D. Dräger Medical AG&Co.KG, Lübeck, Germany |
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Introduction: Approximately 2/3 of the accidents which occur with medical devices are associated with human errors. Medical device regulatory agencies look carefully at accident reports to assess the severity of injury associated with medical device use, and to ascertain whether the risks associated with device use are acceptable when weighed against the benefits to the patient. Methods: The standard (IEC 62366) was developed to help manufacturers improve the usability and safety of medical devices. The standard recognizes that the use of all medical devices has associated risks. It provides an engineering process for identifying, assessing, and mitigating those risks. Results: IEC 62366 describes a process that addresses medical device use errors and divides those errors into categories to guide their analysis. This process can be used to assess and mitigate risks caused by the usability problems associated with the normal and abnormal use of a medical device. As shown in the figure below, use errors can be first separated by whether there were intended or unintended user actions or inactions. All unintended actions, as well as intended actions that are categorized as either mistakes or correct use, are considered normal (and thus foreseeable) use. The manufacturer can only be responsible for normal use. Abnormal use errors are outside the scope of manufacturer responsibility; they need to be controlled by the hospital.[figure1]"Copyright 2007 by IEC. Used by permission." Conclusion: If the usability engineering process detailed in this standard has been complied with then the residual risk associated with usability of the medical device is presumed to be acceptable. Patient safety will improve as future medical devices are designed to comply with this standard. Reference: IEC 62366:2007, Medical devices – Application of usability engineering to medical devices. Approved 7 Sep 2007, pending publication. Anesthesiology 2008; 109 A767 |
Figure 1
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