Prohibited Chemicals in Medical Devices – Pennsylvania Bill Overview

“Prohibited Chemicals in Medical Devices – Pennsylvania Bill Overview

Objective: The General Assembly of Pennsylvania introduced a bill to amend Title 35 of the Pennsylvania Consolidated Statutes, regulating the use of prohibited chemicals, such as DEHP, in medical devices, particularly intravenous (IV) solution containers and tubing.

Key Provisions:

1. DEHP Usage in Medical Devices:

• DEHP (Di(2-ethylhexyl) phthalate) is a chemical primarily used to add flexibility to plastics like Polyvinyl Chloride (PVC).
• It is commonly found in medical devices such as IV solution containers and tubing.
• Over time, DEHP can leach from plastic containers into their contents.

1. Health Concerns:

• DEHP is classified as an endocrine-disrupting compound and a probable human carcinogen by the United States Environmental Protection Agency (EPA).
• Exposure to DEHP has been linked to adverse effects on reproductive health, development, and metabolism.
• DEHP has also been associated with certain cancers, including breast, liver, lung, and testicular cancer.

1. Prohibitions and Deadlines:

• Starting January 1, 2026, the manufacture, sale, or distribution of intravenous solution containers and tubing with intentionally added DEHP will be prohibited.
• A complete ban on such tubing will take effect by January 1, 2031.
• The legislation also prohibits replacing DEHP with any other ortho-phthalate in newly manufactured or revised medical devices.

1. Patient Notification Requirement:

• Healthcare practitioners must notify patients before using IV solution containers or tubing containing DEHP or other ortho-phthalates.
• The notification must include information about the associated risks and the patient’s right to request DEHP-free alternatives.

1. Effective Date:

• The act is set to take effect 90 days after its introduction.”

Source:https://legiscan.com/PA/text/SB1301/2023##~https://legiscan.com/PA/text/SB1301/id/3018085/Pennsylvania-2023-SB1301-Introduced.pdf

Region: USA