An Act relative to toxic-free medical devices

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

Mass. bans intentional DEHP in IV solution containers by 2030 and in IV tubing by 2035, with a 0.1% weight/weight cap on unintentional DEHP to cut patient exposure.

Reported, referred to the committee on Joint Rules, reported, rules suspended and referred to the committee on Public Health

Summary: House Bill HD 4615 — An Act relative to toxic-free medical devices

Overview
HD 4615 seeks to reduce exposure to di(2-ethylhexyl) phthalate (DEHP) and other ortho-phthalates in certain intravenous medical devices in Massachusetts. The measure targets intravenous solution containers (e.g., bags) and intravenous tubing, with phased prohibitions on intentionally added DEHP and a limit on unintentional DEHP, while preserving specific exemptions and offering potential extensions for certain products pending FDA actions.

Key Provisions
- Definitions (Section 245):
- DEHP, ortho-phthalates list (including BBP, DBP, DIDP, DINP, DNOP, etc.), and terms for “intentionally added DEHP” and “unintentionally added DEHP.”
- Defines intravenous solution container and intravenous tubing, and health care practitioner.
- Prohibitions and timelines:
- Beginning Jan 1, 2030: May not manufacture, sell, or place into commerce intravenous solution containers with intentionally added DEHP.
- Beginning Jan 1, 2035: May not manufacture, sell, or distribute intravenous tubing with intentionally added DEHP.
- Prohibits replacing DEHP with another ortho-phthalate in new or revised medical devices.
- Unintentional DEHP limit: IV containers/tubing must not contain unintentional DEHP at ≥0.1% weight/weight.
- Exemptions (consistent with 21 CFR):
- Human blood collection and storage bags.
- Aspheresis and cell therapy blood kits and bags, including integral tubing.
- Extension mechanism:
- If FDA approval for a DEHP-free IV container is pending or manufacturer lacks adequate equipment, a conditional extension to Jan 1, 2032 is allowed, provided:
- By Oct 1, 2025 the entity notifies MA customers that DEHP-free development has commenced.
- By Jan 1, 2028 the entity posts/ notices that it will not meet the original deadline.

Affected Parties
- Manufacturers, distributors, and suppliers of intravenous solution containers and intravenous tubing.
- Health care facilities and providers utilizing these devices.
- Patients indirectly affected via potential changes in device materials and exposure to DEHP.

Procedural and Timeline Aspects
- Effective enforcement deadlines: 2030 (solutions containers) and 2035 (tubing).
- Unintentional DEHP threshold set at 0.1% w/w.
- Exemptions align with select blood-related products under federal exemptions.
- Extensions available only under FDA-related development scenarios with specific notice requirements.
- Legislative history notes: Introduced May 5, 2025; referred to House Rules, later moved to Public Health (as of May 15, 2025 actions).

Rationale and Impact (informational)
- Purpose: Reduce patient exposure to DEHP and related ortho-phthalates in critical medical devices.
- Potential impacts: Required product reformulations, supply chain adjustments, and potential cost implications for manufacturers and health care facilities; exemptions and extension provisions provide targeted flexibility for ongoing FDA processes and manufacturing readiness.

Status
- Status updates include committee referrals and actions in 2025; introduced and filed in 2025, with subsequent committee considerations noted.