Gants : critères de choix
Gloves offer the first line of protection against contamination for persons handling cytotoxics. The objectives of this work were to validate chromatographic methods able to quantify low cytotoxic concentrations and to develop a dynamic test of permeation assessing the protective efficacy of these gloves.
Permeation levels of 13 cytotoxic drugs through 13 different gloves types involving 4 materials (natural rubber latex or NRL, nitrile, neoprene, vinyl) were studied. The in-house built permeation apparatus tested simultaneously 20 samples at 25°C and during 15-60 min, by regular and standardized constraints involving rubbing, stretching and tension. Cut glove fingers were placed between two tubes : outer surface exposed to the cytotoxic solution and inner surface to the collecting solution. Samples were collected at 0, 15, 30 and 60 min to determine the drug concentration after potential permeation.
Analytical performances were characterized by coefficient of variation <20%, limit of detection ranging from 0.97-63 ng/mL or 0.001-0.07 ng/cm².min according to the drug and the method. As expected, vinyl was the most permeable material, resulting to permeation rate above the limit of the recent International Standard ASTM D 6978-05 for most drugs. Carmustine has been shown to rapidly permeate a variety of materials. Among the other drugs studied, etoposide, 5-fluorouracil, cisplatin, thiotepa, ifosfamide and cyclophosphamide displayed lower but significant permeation (>10 ng/cm².min at least for one glove). Drugs displaying the lowest permeation are methotrexate, vinorelbine and docetaxel. Thickness of the glove, physicochemical properties of the drug, duration of exposure but also manufacturing processes appeared to influence the permeation rate.
Seven gloves offered excellent protection (4 latex, 2 neoprene, 1 nitrile). The worst performances have been observed mainly with vinyl but also with thin nitrile or latex gloves. During the reconstitution phase, gloves should be changed at least every 30 min.