Impact of Augmented Reality-Assisted In-Process Quality Control (FlexOprep^®) on the Safety and Traceability of Chemotherapy Preparations

Background
Medication errors can occur at any stage of the medication-use process and represent a major threat to patient safety, particularly in oncology, where anticancer drugs have a narrow therapeutic index and high toxicity. Current quality control methods have important limitations. Augmented reality smart glasses may offer a novel solution by enabling real-time assistance and improving safety and traceability during chemotherapy compounding.

Objectives
This study aimed to evaluate the contribution of in-process quality control using augmented reality glasses to enhance safety and traceability of chemotherapy preparations. Secondary objectives included assessing ease of use, preparation time, and user experience.

Method
A prospective pre–post study using Failure Mode and Effects Analysis (FMEA) assessed the impact of augmented reality smart glasses on chemotherapy compounding safety by comparing risk priority numbers before and after implementation. Preparation times for selected cytotoxic drugs were measured, and usability and user experience were evaluated using the French System Usability Scale (F-SUS) and the User Experience Questionnaire (UEQ).

Results
FMEA identified 24 potential failure modes, of which 50% showed reduced criticality after implementation, resulting in a 40% reduction in overall risk priority and a 67% decrease for directly impacted modes. All high-risk failures were downgraded and most moderate risks were reduced to low-risk level, although new technology-related risks emerged. Preparation time increased significantly (p = 0.008), with a median increase of 86 seconds per preparation (+34%), ranging from 19.2% to 54.7% depending on the drug. Usability was high, with a mean F-SUS score of 86.7/100 and positive UEQ results across all dimensions.

Conclusion
The implementation of augmented reality smart glasses for in-process quality control in chemotherapy compounding significantly improved safety by reducing risk levels and enhancing error detection and traceability. Despite increased preparation time and the emergence of new technology-related risks, the system was well accepted and showed strong potential to improve practice. Further studies are needed to confirm these findings in larger and long-term settings.

Keywords : Medication Errors, Drug Compounding, Risk Management