Permeation measurement of 27 chemotherapy drugs after simulated dynamic testing on 15 surgical and examination gloves: A knowledge update.

PURPOSE: Exposure to anticancer drugs is one of the known risks for people working in specialist oncology units. Wearing gloves is a vital form of personal protection. The aim of this study was to assess, in close to real use dynamic conditions, the permeability of 15 surgical and examination gloves made from different materials when exposed to 27 anticancer drugs included in the list from international Guides and Recommendations. METHODS: Gloves were tested by using controlled dynamic conditions replicating flexion and extension movements that mimic typical clinical applications. Tests were performed at 37°C or at 43°C for 30 min and anticancer drugs were tested at the highest concentration used in clinical practice. To determine the permeation rate, the quantification of anticancer drugs was performed with selective and sensitive analytical methods such as inductively coupled plasma-mass spectroscopy and liquid chromatography-mass spectrometry. RESULTS: All the gloves met the EN 16523-1 European standard (1000 ng/(min.cm2)). The penetration rate of busulfan, carmustine and thiotepa exceeded the ASTM D-6978-05 American standard (10 ng/(min.cm2)) with several surgical and/or examination gloves. This standard was met in all of cases when double gloving was used. Breakage of several nitrile gloves was observed in relation with the excipient used by drugs suppliers. CONCLUSIONS: Permeation is a complex multifactorial phenomenon. However, we have suggested that the thickness of the glove and three physicochemical parameters (molecular weight, topological polar surface area and hydrogen bond donor) of the drug were the main parameters affecting permeation.

Permeability of 13 different gloves to 13 cytotoxic agents under controlled dynamic conditions.

PURPOSE: The permeability of 13 different gloves to 13 cytotoxic agents under controlled dynamic conditions is described. METHODS: Thirteen cytotoxic agents were prepared at the highest concentrations normally encountered by pharmacy personnel. Four glove types--neoprene, natural rubber latex, nitrile, and vinyl--were exposed to the cytotoxic agents for 15, 30, and 60 minutes. Tests were conducted using the middle finger of each glove. Linearity, reproducibility, and sensitivity were evaluated for each drug tested. Assays were run using liquid chromatographic tandem mass spectrometry (LC/MS/MS) and high-performance liquid chromatography with ultraviolet light (HPLC-UV). Permeability testing was conducted using an original system designed to evaluate dynamic constraints, such as rubbing, stretching, and tension. RESULTS: Linearity by LC/MS/MS and HPLC-UV was confirmed at concentrations up to 1000 ng/mL for all drugs. Most glove materials were permeable at rates below ASTM recommendations over the one-hour testing period. Vinyl was the most permeable material. Carmustine permeated the widest variety of materials. Due to the high sensitivity of the analytic methods, all materials displayed low but significant permeability for at least one drug after one hour. Higher resistance to permeation was recorded for all neoprene, some natural rubber latex, and one nitrile glove. CONCLUSION: Neoprene, natural rubber latex, and nitrile gloves displayed the highest resistance to permeation of the 13 cytotoxic agents studied. Additional factors, such as duration of exposure, glove thickness, and drug liposolubility and molecular weight, also affected permeability.

Influence of material properties on gloves' bacterial barrier efficacy in the presence of microperforation.

BACKGROUND: Medical examination gloves and surgical gloves protect the wearer directly and the patient indirectly from the risk of contamination. Because of concerns related to latex allergy, an increasing trend toward the use of synthetic gloves made of materials other than latex is observable. However, currently it is unknown if the physical properties of different materials may influence bacterial passage in case of a glove puncture. METHODS: We examined 9 different medical examination gloves from various manufacturers made of nitrile (n = 4), latex (n = 3), or neoprene (n = 2). Additionally, 1 latex surgical glove each with and without antibacterial chlorhexidine gluconate coating and 1 synthetic surgical glove made of thermoplastic elastomer were included in the experiments. The studied materials were perforated following a standardized procedure, and direct bacterial passage was measured under dynamic conditions. Glove elasticity at 1 cm up to 2.5 cm elongation was measured following EN 455-2. RESULTS: Nitrile gloves demonstrated higher material stiffness compared with latex gloves. Medical examination gloves made of nitrile and neoprene showed a 10-fold higher bacterial passage through a standardized puncture compared with latex gloves. All surgical gloves showed a lower bacterial passage compared with the tested examination gloves. CONCLUSION: Bacterial passage through punctures is correlated with the stiffness or elasticity of the glove material. Therefore, gloves made of latex may have an increased protective effect in case of a glove breach. Whenever gloves are purchased and selected, a risk-benefit assessment should be conducted, balancing the risk of allergy against the degree of required protection in case of a glove puncture.