Evaluation of a safe infusion device on reducing occupational exposure of nurses to antineoplastic drugs: a comparative prospective study. Contamoins-1.

PURPOSE: Despite the decreasing of environmental contamination throughout the anticancer drug circuit, the administration of chemotherapies remains at risk of occupational exposure for nurses. Many medical devices aim at securing administration, but none have been scientifically evaluated to verify the actual improvement. METHODS: A monocentric comparative before/after study was carried out in an oncology day hospital to evaluate the efficacy of Safe Infusion Devices in reducing drug exposure compared to usual infusion practices. The rate of nurses' gloves contamination was estimated. To avoid false negatives and to ensure sampling reproducibility, each sample of gloves was contaminated with a drop of topotecan. Association between contamination and other variables was investigated using a multivariate logistic regression analysis. RESULTS: The usual practice led to a rate of 58.3% of contaminated samples while Safe Infusion Devices to a rate of 15%: Safe Infusion Devices reduced the risk of gloves contamination by 85% in multivariate analysis (Odds ratio = 0.15; 95% confidence interval = 0.05-0.46; p < 0.001). Topotecan was identified in 100% of the samples. Only one case of cross-contamination has occurred. CONCLUSION: Despite the current practice of using neutral solvent-purged infusers, the occupational exposure remains high for nurses and Safe Infusion Devices significantly reduced this risk of exposure. However, glove contamination is only a surrogate endpoint. The results confirmed that the disconnection of empty bags resulted in occupational exposure. Except a contamination due to the leakage of a bag, no cross-contamination was detected. Safe Infusion Devices were highly effective but did not completely eliminate exposure.

How human activity impacted manufacturing non-compliances: A multivariate analysis in a centralized cytotoxic preparation unit.

INTRODUCTION: The aim of the study was to identify risk factors related to human errors in the preparation of anticancer drugs in order to improve the pharmaceutical process by setting corrective actions. METHOD: Risk factors which could increase the probability of error were identified: daily workload, workload on the previous day and subcontractors' workload, time slot of the preparation, understaffing, incidents which could affect workflow, individual experience of technicians and cleanrooms layout. Drug reconstitution or complex fabrications were also considered as risk factors. We used univariate and multivariate logistic regression analyses to screen for correlation between risks and errors. RESULT: Among 11 278 preparations analyzed, 115 were non-compliant. Univariate analysis shows significant variables: individual experience of technicians, technicians working in the same cleanrooms and technicians' rotations. 2 technicians are significantly associated with a higher risk of error and 5 with a lower risk. The multivariate analysis confirmed the conclusions of the univariate. DISCUSSION: As expected, time slot of the manufacture, cleanrooms layout and some technicians increase the risk of error. Surprisingly, technicians' experience led to increase the risk. This study is a first approach to evaluate the human error aspect in non-compliant preparations, in order to optimize security of antineoplastic drugs preparations.