California Bans DEHP in Medical Devices, Excludes Blood Bags

California Governor Gavin Newsom signed legislation last week that will phase out the use of Di(2-ethylhexyl) phthalate (DEHP), a commonly used plasticizer, in medical devices such as IV bags and tubing. The law will take full effect on Jan. 1, 2030, and bans 11 additional substitute phthalates in new or modified medical products.

DEHP is often used in polyvinyl chloride (PVC) to enhance flexibility and durability in medical products. However, studies have shown that when exposed to heat or pressure, DEHP can leach from plastics into the fluids being administered to patients. In the United States, the Agency for Toxic Substances and Disease Registry classified DEHP as “reasonably anticipated to be a human carcinogen.”

Notably, the legislation exempts “human blood collection and storage bags” and “apheresis and cell therapy blood kits and bags, including integral tubing.” The full text of the legislation is available online.