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Exposure Assessment of Phthalates Released from the Tubing of Certain Fluid Delivery Pumps

IVA medical device firm had developed a "finger pump" designed to introduce moderate quantities of blood or chemotherapy drugs into the human bloodstream. The repetitive flexing of the plastic tubing performed during the pumping process was alleged to increase the leaching of Bis(2-ethylhexyl)phthalate (DEHP) and other phthalates from the tubing. Cardno ChemRisk conducted a study using human blood and various pharmaceutical agents, measured the percentage loss of phthalates from the tubing over time, and provided an overall human risk assessment of the possible health hazard from the device.

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