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. 1. Introduction Most clinical applications of medical devices are safe and effective, but occasionally adverse events do occur [1–7]. Typically the adverse events involving medical devices have several causes, with human fallibility (to err is human [8]) combining with technological imperfections (design, usability, or reliability) and limitations in the supporting infrastructure (maintenance, utility supplies, and procurement processes) to cause incidents. A full understanding of the often complex causes requires a systems approach [1, 9]. Furthermore, adverse events are investigated not simply to retrospectively analyse what went wrong, but to learn lessons to prevent repetitions [10]. Learning lessons requires a comprehensive understanding of the causes. A holistic systems approach to investigations can help ensure that the underlying causes are understood, in turn supporting the development of safety nets and barriers (redesign, alarms, monitoring, procedures, and user interventions) that can help prevent recurrences [9]. Despite the well-recognised multifactorial causes of medical device-related adverse events many investigations focus on a “device” or “user”
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