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Purpose: In a monocentric retrospective study, two tunneled hemodialysis catheters have been compared: a twin cylinder catheter (Dualcath) and a split tip catheter (Hemosplit)., Patients and Methods: Patients who got catheters from January 1st 2007 to December 31st 2008 have been selected. Thrombotic events, as well as infectious events, were recorded in their dialysis file during this period of time., Main Results: The study was carried out on 50 patients. Thirty of them were given Dualcath, 23 were given Hemosplit, and three both of them. A Kaplan-Meier analysis has enabled to draw up the catheter survival curves, and the log-rank test enables to establish a survival of 93.1% at 20 months for Dualcath while 42.2% for Hemosplit. As far as the thrombotic complications with catheter incident are concerned, their incidence is 25.5 and 46.4 out of 1000 catheter-days (P<0,0001). The ones with catheter manipulation have incidences of 6.78 and 9.33 out of 1000 catheter-days, respectively for Dualcath and Hemosplit (NS). Dualcath presents catheter-related infections with a rate of 4.38 out of 1000-catheter days while 5.07 for Hemosplit (NS)., Conclusion: The Dualcath catheter presents a better survival than the Hemosplit catheter as well as weaker incident type thrombotic complications., (Copyright © 2011 Association Société de néphrologie. Published by Elsevier SAS. All rights reserved.)

The use of medical devices containing highly criticized phthalates including di(2-ethylhexyl) phthalate (DEHP) has been challenged by European directive 2007/47/CE, put into effect in March 2010. New plasticizers are now being used to soften PVC in medical devices: trioctyltrimellitate (TOTM), di-isononyl-cyclohexan-1,2-dicarboxilate (DINCH) and di(2-ethylhexyl) terephthalate (DEHT). To quantify DEHP in nine DEHP-free medical devices made of PVC softened by alternative plasticizers, high performance liquid chromatography analysis with ultraviolet detection at 220 nm wavelength was achieved. An NMR spectroscopy was performed to confirm DEHP presence. Only two medical devices out of the nine tested were truly without DEHP. One of them showed traces of DEHP exceeding the threshold contamination of 0.1% in plastic mass set by REACH regulations. TOTM plasticizer is still incriminated when polyvinyl-chloride (PVC) is contaminated with DEHP. Manufacturers must verify the purity of their raw material, not only on PVC, but also on other soft plastics entering into the composition of medical infusion devices. The clinical consequences of exposure to certain levels of DEHP have not been evaluated. A solution could be to use alternative PVC-free materials., (Copyright © 2011 Elsevier B.V. All rights reserved.)

Background: The ability of an infusion set to deliver a specific amount of drug to the patient can be directly related to the presence of an antireflux valve and dead-space volume. In this study we quantified separately the impact of these 2 components on drug delivery., Methods: Various infusion sets were assessed differing in length, in dead-space volume, and with or without an antireflux valve. Noradrenaline was infused with a syringe pump simultaneously with a carrier flow. Effluent drug concentration was measured using ultraviolet spectrophotometry. Flow change efficiency (FCE) was calculated from the ratio of the area under the experimental mass flow rate curve to the area under the theoretical instantaneous mass flow rate curve., Results: The FCE for infusion sets with or without antireflux valves were significantly different 10 to 15 minutes after the start of an infusion at flow rates of 7 mL/h for noradrenaline and 35 mL/h to 70 mL/h for the carrier fluid. They were not different with a carrier flow of 115 mL/h., Discussion: These findings suggest that antireflux valves have a significant impact on FCE when the ratio of drug flow rate to carrier fluid flow rate is high. Infusion sets with very low dead-space volume connectors yield better FCE. There is a nonlinear relationship between dead-space volume and FCE 5 to 10 minutes after the onset of drug infusion., Conclusion: Care providers must consider dead-space volume and the presence of an antireflux valve when choosing their infusion sets.

Purpose/objectives: To assess the PCHIMX-1 (Doran International), a new sterile medical device intended by its manufacturer to improve the quality and safety of cytotoxic drug infusions, as well as its influence on manipulation times required for pharmacy technicians and nurses and its effect on infusion line outflow parameters., Design: PCHIMX-1 assemblies were compared to standard infusion sets., Setting: Pharmacy and oncology units of a French general hospital., Methods: Reference assemblies (an infusion bag connected to an infusion set) were compared to PCHIMX-1 assemblies (PCHIMX-1 connected to two bags and to an infusion set). Two assessments were performed: (a) comparison of the times of manipulation during both preparation and administration of 5-fluorouracil infusion bags (n = 40) and (b) effect of PCHIMX-1 on infusion quality., Main Research Variables: Manipulation times in the pharmacy (TP) and in the ward (TW) were measured, as well as flow rate and infusion efficiency., Findings: The results showed that TW was significantly increased, whereas TP was significantly decreased; total time was unchanged. Results also showed that PCHIMX-1 significantly changed infusion efficiency; flow rate was not affected., Conclusions: PCHIMX-1 obliges pharmacy technicians and nurses to change their handling procedures. The device does not have any influence on infusion flow rate but considerably improves infusion quality by ensuring that the full quantity of medication prescribed is administered., Implications for Nursing: PCHIMX-1 guarantees that the complete prescribed dose of chemotherapy is administered without any change in infusion quality and adheres to the latest recommendations concerning occupational exposure protection.

Background: Multiaccess infusion sets allow multiple simultaneous infusions but may induce interference in drug delivery resulting from large variations in the delivery rate of potent drugs. In this study, we sought to understand the influence of multiaccess infusion device properties (dead space volume and antireflux valve [ARV]) on drug delivery during multi-infusion therapy., Methods: Infusion sets differing in length, dead space volume, and presence of an ARV were assessed. Three drugs were infused simultaneously through different access points, and their concentrations were obtained using UV spectrophotometric analysis of the effluent. Different infusion configurations were compared by assessing (1) the amount of drug delivered to the patient per unit of time, (2) the mean amount of drug delivered to the patient per unit of time during the steady-state infusion (mass flow rate plateau), and (3) flow change efficiency calculated from the ratio of the area under the experimental instant mass flow rate curve to the area corresponding to theoretical instant mass flow rate curve., Results: Infusion sets with lower dead space volumes offered significantly higher flow change efficiency (53.0% +/- 15.4% with a dead space volume equal to 0.046 mL 5 min after the start of infusion) than infusion sets with higher dead space volume (5.6% +/- 8.2% with a dead space volume equal to 6.16 mL), whatever the flow rate changes. Even in case of large dead space volumes, the presence of an ARV significantly increased the mass flow rate plateau (from 92.4% to 99.3% of the theoretical plateau without and with the presence of an ARV, respectively)., Conclusions: Multi-infusion therapy induces perturbation in drug delivery. These perturbations (lag time, backflow, and bolus) could be reduced by using infusion sets including very low dead space volume and an ARV.

Objective: This work consisted of the assessment of humidification parameters and flow resistance for different heat and moisture exchanger filters (HMEF) used in intensive care unit. Four electrostatic HMEF were assessed: Hygrobac S (Tyco); Humidvent compact S (Teleflex); Hygrovent S/HME (Medisize-Dräger); Clear-Therm+HMEF (Intersurgical)., Material and Methods: Humidification parameters (loss of water weight, average absolute moisture [AAM], absolute variation of moisture) have been evaluated on a bench-test in conformity with the ISO 9360: 2000 standard, for 24h with the following ventilatory settings: tidal volume at 500 ml, respiratory rate at 15 c/min, and inspiration/expiration ratio at 1:1. The flow resistance of HMEFs assessed using the pressure drop method was measured before and after 24h of humidification for three increasing air flows of 30, 60, and 90 l/min., Results: All the HMEFs allowed satisfactory level of humidification exceeding 30 mgH(2)O/l. The less powerful remained the Clear-Therm. Concerning HMEFs flow resistance, results showed a pressure drop slightly more important for the Hygrobac S filter as compared with other filters., Conclusion: This test showed differences between the HMEFs for both humidification and resistance parameters. When compared to the new version of the standards, HMEFs demonstrated their reliability. However, evolution of humidification and flow resistance characteristics over 24h showed a structural degradation of HMEFs, limiting their use over a longer period.