Category: Professional Posters
Purpose: Select chemotherapeutic agent labeling recommends the use of polyethylene(PE)-lined infusion tubing to reduce leaching and sorption. Leaching may result in compounds from tubing plastic entering the fluid pathway. For example, PE-lined tubing is recommended for Paclitaxel that includes the vehicle Kolliphor EL which leaches Di(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) tubing. Sorption may result in a reduced dose of medication delivered to the patient. The data supporting these labeling recommendations may not be fully available for assessment of clinical significance. This study compares leaching and sorption of PE-lined tubing versus non-PE-lined tubing when exposed to a panel of chemotherapeutic agents.
Methods: This study was conducted in a laboratory setting. Three types of infusion tubing were evaluated: PVC tubing with a propriety non-DEHP plasticizer (non-DEHP PVC tubing), polyurethane tubing, and PE-lined PVC tubing with a proprietary non-DEHP plasticizer (PE-lined PVC tubing). Each tubing set was exposed to 0.9% sodium chloride and chemotherapy placebos representing: Docetaxel, Valrubicin, Paclitaxel, Temsirolimus, and Teniposide. Simulated intravenous fluid administration sets were constructed and evaluated in static and dynamic dwell conditions. In static dwell, the sets were primed and stored at room temperature. In dynamic dwell, the sets were primed and set in an infusion pump circular loop. At completion, the dwelled fluid and administration sets were collected for analysis.
Leachable assessment of the fluids was completed for semi-volatile and non-volatile leachable compounds using chromatograpgic and spectroscopic techniques. Sorption was assessed by a before and after dwell administration set weight comparison. The primary study outcome was an assay for the presence of toxic leachable compounds for the non-DEHP PVC tubing. Secondary study outcomes were an assay of leachables below the toxic threshold and a comparison of leachables and sorption by tubing material.
Results: Data from the leachable study was analyzed for toxicity under normal conditions of use and worst-case total daily intake (TDI). Based on the toxicologic analysis, the leachables for non-DEHP PVC tubing are considered non-toxic with negligible risk to patients. These non-toxic results are considered equivalent to that of the PE-lined PVC tubing and the polyurethane tubing. PE-lined PVC tubing (industry standard) and polyurethane tubing (USP class VI) have established safety profiles for use with chemotherapeutic drugs.
Sorption study data showed that non-DEHP PVC tubing has similar sorption characteristics to PE-lined PVC tubing and polyurethane tubing. For all tubing materials, sorption was below 0.2 ml over 24 hours dwell in all simulated testing conditions. It should be noted that tubing material is one of many materials that are used for the construction of IV sets and these materials and components, such as cassettes and connectors, can influence sorption.
Conclusion: This study evaluates the impact of a proprietary non-DEHP PVC tubing material on leaching and sorption with a panel of placebo chemotherapeutic agents. The results suggest that leaching and sorption with the non-DEHP PVC tubing is equivalent to polyurethane and PE-lined PVC tubing and may have equivalent clinical performance in applications analogous to these testing scenarios. These results in the laboratory setting enhance the information available to clinicians to evaluate infusion therapy material options. Further study is required to confirm and evaluate the implications of these results.