A comparative study of contamination in three closed systems for the preparation of hazardous drugs through simulations with fluorescein

Abstract

ObjectiveThe objective of this study was to compare the environmental contamination generated during the preparation of cytostatic agents using three different methods through simulations using fluorescein, and the time required for preparation of each method. MethodA comparative study of the processing of fluorescein mixtures using three types of closed systems was conducted at the centralized unit for hazardous drugs of the Pharmacy Department of a General Teaching Hospital. Environmental contamination was detected in critical points of connection, and in splashes produced at any other points. The main variable was qualitative detection of contamination through ultraviolet light when three methods were compared (method A: ChemoClave®, method B: SmartSite® valve and Texium® connector, method C: PhaSealTM with BD luer extension). A final number of 60 mixtures were prepared to detect differences of at least 5%. ResultsQualitative contamination at the critical points during preparation, was seen in groups A and B for every mixture that was processed. No contamination at all in critical points was seen in any of the mixtures prepared using PhaSealTM. Statistically significant differences were found between arms A and C (p < 0.001) and arms B and C (p < 0.001); no differences were found between arms A and B. ConclusionsThe combination of PhaSealTM system in conjunction with the BD luer extension for administering hazardous drugs from a tree modality system has been shown to be the system with the lowest level of contamination during processing without increasing the time required for preparation of the mixture.