Massachusetts Enacts Legislation to Phase Out DEHP in Medical Devices by 2030

Pennsylvania is considering legislation to eliminate DEHP from medical devices by 2035, joining a movement among states to restrict harmful chemicals in medical plastics.

Key Highlights

  • Massachusetts' law prohibits manufacturing, sale, or distribution of DEHP-containing IV containers starting in 2030, with tubing restrictions following in 2035.
  • The legislation exempts certain blood collection and cell-therapy products, allowing trace amounts of DEHP up to 0.1% by weight.
  • States are coordinating efforts to identify affected products, work with manufacturers, and ensure a smooth transition to DEHP-free medical devices.

Massachusetts has joined California and North Carolina in enacting legislation to phase out DEHP, a plasticizer used to make medical plastics soft and flexible, from IV solution containers and tubing. Pennsylvania is considering similar legislation.

Massachusetts Gov. Maura Healey signed Senate Bill 3106, the Toxic-Free Medical Devices Act. The law prohibits the manufacture, sale, or distribution of IV solution containers containing intentionally added DEHP beginning Jan. 1, 2030. The prohibition will extend to IV tubing on Jan. 1, 2035.

Manufacturers also may not replace DEHP with other ortho-phthalates. The law exempts human blood collection and storage bags and certain apheresis and cell-therapy products. Unintentional trace amounts of DEHP are permitted at concentrations no greater than 0.1% by weight.

DEHP can leach from plastic medical products and has been associated with hormone disruption and increased risks of breast, liver, lung, and testicular cancers. Supporters of the legislation say safer alternatives are already available and that the phased timeline gives hospitals, suppliers, and manufacturers time to transition.

California’s Toxic-Free Medical Devices Act prohibits intentionally added DEHP and 11 replacement ortho-phthalates in IV solution containers beginning Jan. 1, 2030, and IV tubing beginning July 1, 2032. North Carolina’s law similarly phases out DEHP in IV solution bags by 2030 and tubing by 2035.

Pennsylvania’s pending Senate Bill 804 would phase out DEHP in medical devices by 2035. The measure passed the state Senate 48-1 in March and remains under consideration in the House.

The expanding state-level restrictions will require healthcare supply chain teams to identify affected products, coordinate with manufacturers and distributors, and prepare purchasing and inventory strategies for DEHP-free alternatives.

About the Author

Daniel Beaird

Editor-in-Chief

Daniel Beaird is Head of Content for Healthcare Purchasing News.

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