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S 3106

An Act relative to toxic-free medical devices

194th Legislature (2025-2026) Introduced by Joan Lovely and 1 co-sponsor

Massachusetts bans intentionally added DEHP in IV solution containers by 2030 and in IV tubing by 2035 to reduce patient exposure to phthalates.

Passed to be engrossed -139 YEAS to 0 NAYS (See YEA and NAY No. 221 )
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Bill Summary · S 3106

Purpose and intent

  • The bill, titled An Act relative to toxic-free medical devices, aims to reduce or eliminate the use of certain toxic chemicals—specifically di(2-ethylhexyl)phthalate (DEHP) and other ortho-phthalates—in intravenous (IV) medical devices.
  • It prohibits the manufacture, sale, or offering for sale of intravenous solution containers and intravenous tubing products in Massachusetts that contain intentionally added DEHP, with phased-in compliance timelines. The goal is to minimize patient exposure to potentially harmful phthalates in medical settings.

Key provisions and changes

  • Definitions (Section 250(a)):
    • DEHP: Di(2-ethylhexyl)phthalate.
    • Intentionally added DEHP: DEHP intentionally added to an IV solution container or IV tubing product to provide a functional or technical effect.
    • Intravenous solution container: Containers holding medicines, fluids, or nutrition delivered intravenously (with certain exclusions such as human blood collection/storage bags and specific blood kit/bag components).
    • Intravenous tubing product: Tubing used to administer fluids, medications, or nutrients intravenously.
    • Ortho-phthalate: A broader class of phthalates that includes DEHP and several listed compounds.
  • Prohibitions on intentionally added DEHP (Section 250(b) and 250(c)):
    • Intravenous solution containers: It shall be unlawful to manufacture, sell, or offer for commerce in Massachusetts if they contain intentionally added DEHP. Trace amounts of DEHP are allowed only if the DEHP is not used for any functional/technical purpose and is not more than 0.1% weight/weight.
    • Intravenous tubing products: It shall be unlawful to manufacture, sell, or offer for commerce in Massachusetts if they contain intentionally added DEHP. Trace amounts are allowed only if not used for a functional/technical purpose and are not more than 0.1% weight/weight.
    • In both cases, replacing DEHP with another ortho-phthalate in new or revised IV containers or tubing products is not allowed.
  • Effective dates (timelines):
    • Section 2: The prohibition or restrictions related to DEHP in IV containers take effect on January 1, 2030.
    • Section 3: The prohibition or restrictions related to DEHP in IV tubing products take effect on January 1, 2035.

Who/what would be affected

  • Manufacturers, distributors, and retailers of intravenous solution containers and intravenous tubing products in Massachusetts.
  • Health care facilities, hospitals, outpatient facilities, and other health care providers that use IV solutions and IV tubing, as they would need to ensure their products comply with the new standards.
  • The bill would not apply to certain devices or bags used for blood collection/storage or specific apheresis/cell therapy kits as defined in the statute’s definitions, focusing specifically on IV solution containers and IV tubing products.

Procedural and timeline aspects

  • Legislative history (as filed): Introduced in the Senate as Senate Bill 3106, substituting for an earlier draft (Senate No. 2579) with amendments.
  • Status: Reported out of the Senate Committee on Ways and Means with a recommendation to pass the bill with an amendment creating a new draft (Senate No. 3106). Ordered to a third reading as of June 1, 2026.
  • Sponsors: Co-sponsors include Jim O’Day and Joan Lovely.
  • Enactment timeline: New prohibitions apply starting January 1, 2030 (IV solution containers) and January 1, 2035 (IV tubing products), allowing time for industry transition and compliance planning.

Potential impact and considerations

  • Public health and safety: Aims to reduce patient exposure to DEHP and related ortho-phthalates in IV devices, potentially reducing associated health risks.
  • Industry impact: Requires reformulation or replacement of DEHP-containing IV containers and tubing with alternatives; may drive demand for phthalate-free materials and encourage innovation in safer polymers.
  • Regulatory alignment: Establishes clear, long lead times for compliance to facilitate adoption and reduce supply disruptions in health care settings.
  • Exemptions and scope: Focused on devices with intentional DEHP use and allows trace amounts under strict conditions; excludes certain blood collection and apheresis/cell therapy products per definitions.

Compiled from official sources — confirm details with the bill’s official record.

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