IV infusion of crystalloid fluids and drugsBased on the results of the safety assessment, CDRH concludes that there is little to no risk posed by patient exposure to the amount of DEHP released from PVC IV bags following infusion of crystalloid fluids (e.g., normal saline, D5W, Ringers Lactate). Further, there is little risk posed by exposure to the amount of DEHP released from PVC bags used to store and administer drugs that require a pharmaceutical vehicle for solubilization, when label instructions are followed. Total Parenteral Nutrition (TPN)The dose of DEHP received by adult patients receiving TPN admixtures is estimated to be less than the TI, suggesting that there is little concern for DEHP-mediated effects in these patients. In addition, non-PVC bags and tubing are typically used to administer TPN, further lessening the concern about DEHP-mediated effects.The dose of DEHP received by neonates undergoing TPN supplementation is uncertain. The results of one study suggest that neonates can receive a very high dose of DEHP, whereas another suggests that neonates receive doses of DEHP from TPN that are equivalent to the TI. Therefore, depending on the data used to derive the TI/dose ratio, neonates receiving TPN admixtures with lipid may be at increased risk of DEHP-mediated adverse effects. Blood transfusionRelatively high doses of DEHP can be received by patients who are transfused with large volumes of blood and blood products over a short period (e.g., trauma or surgical patients receiving massive transfusions). However, the TI/dose ratio for this procedure is likely to overestimate the actual risk to these patients, since the TI is intended to be protective for longterm exposures, compared to relatively short-term exposure in acute transfusions. In contrast, a patient undergoing a routine, elective surgical procedure typically receives about two units of packed red blood cells. Transfusion of this volume of blood will result in a DEHP dose equivalent to the TI value, approximately 0.5 mg/kg/day. Long-term transfusion of blood to patients with anemia results in a DEHP dose about an order of magnitude lower. Similarly, infants who receive replacement transfusions in the NICU receive relatively small DEHP doses from the transfusions. Apheresis donors are exposed to relatively little DEHP when the dose is time-averaged over an extended period. Consequently, there is little concern about DEHP-associated adverse effects developing in persons donating platelets or plasma.Two subpopulations of patients that may be at increased risk from exposure to DEHP following transfusions are infants undergoing exchange transfusion and adults undergoing ECMO. However, neither of these procedures is done very often, so the patient population exposed to relatively large doses of DEHP via exchange transfusion or replacement transfusion of adults on ECMO is expected to be small. Cardiopulmonary bypass and ECMOThe aggregate dose of DEHP received by adults undergoing cardiopulmonary bypass procedures may equal or exceed the TI in...

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