Table of Contents
Journal of Medical Engineering
Volume 2014 (2014), Article ID 314138, 13 pages
http://dx.doi.org/10.1155/2014/314138
Research Article

A Structured Approach for Investigating the Causes of Medical Device Adverse Events

Department of Medical Physics, Crosshouse Hospital, Kilmarnock KA2 0BE, UK

Received 21 May 2014; Revised 10 October 2014; Accepted 14 October 2014; Published 27 November 2014

Academic Editor: Anthony J. McGoron

Copyright © 2014 John N. Amoore. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Aim. Medical device-related adverse events are often ascribed to “device” or “operator” failure although there are more complex causes. A structured approach, viewing the device in its clinical context, is developed to assist in-depth investigations of the causes. Method. Medical device applications involve devices, clinical teams, patients, and supporting infrastructure. The literature was explored for investigations and approaches to investigations, particularly structured approaches. From this a conceptual framework of causes was developed based primarily on device and clinical team caring for the patient within a supporting infrastructure, each aspect having detailed subdivisions. The approach was applied to incidents from the literature and an anonymous incident database. Results. The approach identified and classified the underlying causes of incidents described in the literature, exploring the details of “device,” “operator,” or “infrastructure” failures. Applied to incident databases it suggested that causes differ between device types and identified the causes of device unavailability. Discussion. The structured approach enables digging deeper to uncover the wider causes rather than ascribing to device or user fault. It can assess global patterns of causes. It can help develop consistent terminology for describing and sharing information on the causes of medical device adverse events.