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H 4298

An Act relative to toxic-free medical devices

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

Bill H 4298 bans DEHP in intravenous solution containers by 2030 and tubing by 2035, enhancing patient safety and protecting against harmful chemicals in healthcare.

Referred to the committee on House Ways and Means with the amendment pending
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Bill Summary · H 4298

Summary of Bill H 4298: An Act Relative to Toxic-Free Medical Devices

Purpose and Intent

Bill H 4298 aims to regulate the manufacture and sale of intravenous solution containers and tubing that contain di(2-ethylhexyl) phthalate (DEHP), a chemical associated with potential health risks. The legislation seeks to eliminate the intentional use of DEHP in these medical devices, thereby promoting safer healthcare practices and protecting patients from harmful substances.

Key Provisions

The bill introduces several important provisions regarding the use of DEHP in medical devices:

  1. Definitions:

    • DEHP: A chemical used in various medical products.
    • Intravenous Solution Container: A container for delivering medicine or nutrients intravenously.
    • Intravenous Tubing: Tubing for administering fluids or medications directly to patients.

  2. Prohibitions:

    • Manufacturing and Sale:
      • Starting January 1, 2030, the manufacture and sale of intravenous solution containers with intentionally added DEHP will be prohibited.
      • Starting January 1, 2035, the same prohibition will apply to intravenous tubing.

  3. Replacement Restrictions:

    • Manufacturers cannot replace DEHP with other ortho-phthalates in new or revised medical devices.

  4. Unintentional DEHP:

    • Any intravenous solution container or tubing must not contain unintentional DEHP at levels of 0.1% weight per weight (w/w) or higher.

  5. Exemptions:

    • Certain items, such as human blood collection bags and specific blood therapy kits, are exempt from these regulations.

  6. Extension for Compliance:

    • Manufacturers may have until January 1, 2032, to comply with the prohibition on DEHP if they notify customers of their development of DEHP-free products by October 1, 2025, and provide updates on their progress by January 1, 2028.

Affected Parties

This legislation will primarily affect:
- Manufacturers of medical devices, particularly those producing intravenous solution containers and tubing.
- Healthcare providers who utilize these medical devices in patient care.
- Patients who receive intravenous treatments, as the bill aims to enhance their safety by reducing exposure to toxic substances.

Procedural Timeline

  • Introduced: May 5, 2025
  • Reported Favorably: November 13, 2025
  • Referred to Committee: Health Care Financing
  • Hearing Scheduled: September 10, 2025

Conclusion

Bill H 4298 represents a significant step towards ensuring the safety of medical devices used in healthcare settings by addressing the risks associated with DEHP. By setting clear timelines for compliance and prohibiting the use of harmful chemicals, the bill aims to protect both healthcare practitioners and patients in the Commonwealth of Massachusetts.

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

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