Safety Assessment of DEHP Released from PVC Medical Devices

Patients undergoing medical procedures such as IV therapy, enteral and parenteral nutrition support, blood transfusion, hemodialysis and peritoneal dialysis, cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO) can be exposed to di-(2-ethylhexyl)phthalate (DEHP), a compound used as a plasticizer for polyvinyl chloride (PVC) medical devices. DEHP has been shown to produce a wide range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy. Although the toxic and carcinogenic effects of DEHP have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial. As a result, the ability of DEHP and other phthalate esters to produce adverse effects in humans has been a topic of active discussion and debate in the scientific and regulatory communities. Since patients undergoing medical procedures can be exposed to DEHP, a safety assessment has been conducted by the FDA Center for Devices and Radiological Health (CDRH) to provide risk managers with information necessary for informed regulatory decision making regarding the safety of DEHP released from PVC medical devices. This safety assessment should be viewed as a first step in this process.