Estudio comparativo de contaminación de tres sistemas cerrados para la preparación de fármacos peligrosos mediante simulación con fluoresceína

Objective: The 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. Method: A 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%. Results: Qualitative 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. Conclusions: The 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.