Safe delivery of cold light to the endoscope during elective laparoscopic cholecystectomy: assessment of human factors.

BACKGROUND

Human factors are an important concern in the use-related hazards of medical devices, yet little research has been conducted on factors affecting performance of surgeons using the laparoscopic technology. Elements of a Xenon light chain, commonly used in laparoscopic surgery, may generate extremely high temperatures, capable of causing patient burns and fire ignition. To identify errors potentially compromising patients' safety in minimally invasive surgery, we conducted a proactive error analysis of the process for delivering light from a xenon generator to the tip of the endoscope during laparoscopic cholecystectomy.

METHODS

The process under study was decomposed and re-mapped by means of hierarchical task analysis (HTA), combining complementary methods from the surgeons' and scrub nurses' perspectives. Systematic human error reduction and prediction analysis (SHERPA) was applied to HTA results. Problems and barriers to the performance of tasks, as factors contributing to errors, were examined with work system analysis based on direct procedural observations and face-to-face interviews with personnel.

RESULTS

SHERPA showed 98 credible errors, two of which bearing potentially severe consequences for the patient. Remedy analysis recommended equipment modification, process redesign, standardization, checklists and training. Distracting noise was identified in the work systems analysis to be a commonly perceived problem during surgeries.

CONCLUSIONS

Relying solely on predictive error analysis may miss critical contextual triggers for failure. Pairing SHERPA with qualitative work system observations may offer a richer picture of safety hazards in the operating theatre, identifying how context increases the probability of surgical errors. This hybrid methodology enables a shift from reactive training toward the design of inherently resilient surgical systems. Institutional Review Board (IRB) protocol n. 5234/17; Trial registration: Researchregistry3668 APPLICATION: To the best of our knowledge, this is the first study to describe a multi-methodological, quantitative and qualitative human factors approach to identifying threats to patient safety in a surgical process. The process design is analysed to identify latent task errors that may imply safety hazards; because organizational factors may influence surgical outcomes, the impact of workplace context factors is also assessed on the process design. The remedy analysis offers actionable solutions to task error solutions. The approach described in this study may provide detail-rich data and useful targets for designing effective safety or quality improvement initiatives.