Use of a human factors classification framework to identify causal factors for medication and medical device-related adverse clinical incidents

This study examined non-fatal adverse clinical incidents involving patient loss of function or requiring increased levels of care of a patient relating to medication and medical devices to determine if incident causal factors can be identified using the Human Factors Classification Framework (HFCF) for patient safety. A random sample of 200 medication- and 200 medical device-related clinical incidents in Australia were reviewed using the HFCF for patient safety. The framework identified key precursor events (PE) and contributing factors (CF) of these events. Descriptive statistics and correspondence analysis were used to examine the characteristics of the events. Medication and communication or documentation issues were the most common types of PE identified for medication incidents, while for medical devices the most common PEs were medical device breakage/failure or lack of medical equipment. Correspondence analysis for medication incidents showed that rule-based errors were strongly related to omitted dose or wrong drug. Factors relating to the organisation (86.5% and 25.0%) or the patient (7.7% and 17.9%) were the most commonly identified CFs for both medication and medical device-related incidents, respectively. The HFCF for patient safety identified the role of human factors, particularly human error, in non-fatal clinical incidents involving medication and medical devices, highlighting the need for targeted approaches to inform risk management strategies in the healthcare sector based on an understanding of how and why these incidents occur.