Bill > H4298

This bill establishes regulations for reducing the use of Di(2-ethylhexyl) phthalate (DEHP), a potentially harmful chemical, in medical devices, specifically intravenous solution containers and tubing. Starting January 1, 2030, manufacturers will be prohibited from selling intravenous solution containers with intentionally added DEHP, and by January 1, 2035, the same restriction will apply to intravenous tubing. The bill defines various types of ortho-phthalate chemicals and sets a limit of 0.1 percent weight per weight for unintentionally added DEHP in these medical devices. Manufacturers are also barred from replacing DEHP with other ortho-phthalate chemicals. The legislation provides some flexibility for manufacturers, allowing them to delay compliance until January 1, 2032, if they have notified customers about developing DEHP-free products and meet certain notification requirements. Certain medical devices, such as human blood collection and storage bags, are exempt from these provisions. The bill aims to reduce potential health risks associated with DEHP exposure in medical settings by gradually phasing out its intentional use in critical medical equipment.

Health and Social Services

https://malegislature.gov/Bills/194/H4298