HB2614: Providing for medical devices.

PRIOR PRINTER'S NO. 3566 PRINTER'S NO. 3633 THE GENERAL ASSEMBLY OF PENNSYLVANIA HOUSE BILL No. 2614 Session of 2026 INTRODUCED BY KOSIEROWSKI, ISAACSON, HILL-EVANS, HANBIDGE, BRENNAN, SANCHEZ, RIVERA, BOROWSKI, VENKAT, PROBST, SHUSTERMAN, STEELE, GUENST, DONAHUE, K. HARRIS, MAYES, CEPEDA-FREYTIZ, PASHINSKI, GREEN, GUZMAN, WAXMAN, OTTEN, MADDEN AND KAZEEM, JUNE 8, 2026 AS REPORTED FROM COMMITTEE ON HEALTH, HOUSE OF REPRESENTATIVES, AS AMENDED, JUNE 17, 2026 AN ACT Amending Title 35 (Health and Safety) of the Pennsylvania Consolidated Statutes, providing for medical devices. The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows: Section 1. Title 35 of the Pennsylvania Consolidated Statutes is amended by adding a chapter to read: CHAPTER 58A MEDICAL DEVICES Subchapter A. Preliminary Provisions (Reserved) B. Prohibited Chemicals in Medical Devices SUBCHAPTER A PRELIMINARY PROVISIONS (Reserved) SUBCHAPTER B PROHIBITED CHEMICALS IN MEDICAL DEVICES 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Sec. 58A11. Scope of subchapter. 58A12. Legislative findings and declarations. 58A13. Definitions. 58A14. Prohibitions. § 58A11. Scope of subchapter. This subchapter relates to prohibited chemicals in medical devices. § 58A12. Legislative findings and declarations. The General Assembly finds and declares as follows: (1) DEHP and other ortho-phthalates are toxic chemicals and used primarily to produce flexibility in plastics, mainly polyvinyl chloride. (2) DEHP is the most common plasticizer used in medical devices, including intravenous solution containers, which are also known as IV bags, and intravenous tubing. (3) Over the course of its shelf life, DEHP leaches from plastic containers such as medical devices into a simulant. (4) DEHP is classified as an endocrine-disrupting compound because it can: (i) Interfere with the hormonal system in humans and animals. (ii) Mimic or block the actions of hormones, leading to adverse effects on reproductive health, development and metabolism. (5) Studies have suggested a potential link between DEHP exposure and certain types of cancer, including breast, liver, lung and testicular cancer. (6) The United States Environmental Protection Agency has determined that DEHP is a probable human carcinogen. 20260HB2614PN3633 - 2 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 (7) DEHP exposure: (i) Has been associated with adverse effects on reproductive organs and fertility. (ii) Can disrupt normal reproductive development, reduce sperm quality and affect hormone levels in both males and females. (8) DEHP is metabolized in the liver and can accumulate in the body over time. Prolonged exposure to high levels of DEHP has been shown to cause liver and kidney damage in animal studies. (9) Inhalation or ingestion of DEHP can cause respiratory irritation and allergic reactions in some individuals, particularly those with preexisting respiratory conditions or sensitivities. (10) The leaching of DEHP from medical devices at varying concentrations has been linked to multidrug resistance in breast cancer cells, inhibiting the effectiveness of breast cancer drugs. This phenomenon has been observed at both high and low concentrations of DEHP, highlighting the potential impact of DEHP leaching on cancer treatment outcomes. (11) Exposure to DEHP has been linked to multidrug resistance in triple-negative breast cancer cells, inhibiting the apoptosis mechanism induced by breast cancer drugs, such as tamoxifen, and increasing cell proliferation. (12) DEHP has been suggested to serve as a mitogenic factor for estrogen receptor-positive breast cancer cells, potentially making them multidrug resistant. § 58A13. Definitions. The following words and phrases when used in this subchapter 20260HB2614PN3633 - 3 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 shall have the meanings given to them in this section unless the context clearly indicates otherwise: "DEHP." Di(2-ethylhexyl) phthalate (Chemical Abstracts Service Registry Number 117-81-7). "Intentionally added DEHP." DEHP that a manufacturer has intentionally added to a product and that has a functional or technical effect on the product. "Intravenous solution container." A container used to house medicine, fluid or nutrition therapy that is intravenously delivered to a patient in a hospital, outpatient facility or other health care facility. "Intravenous tubing." Tubing used to administer fluids, medication or nutrients directly to an individual. "Ortho-phthalate." A class of chemicals that are esters of ortho-phthalic acid, including DEHP or any of the following: (1) Benzyl butyl phthalate (BBP) (Chemical Abstracts Service Registry Number 85-68-7). (2) Dibutyl phthalate (DBP) (Chemical Abstracts Service Registry Number 84-74-2). (3) Dicyclohexyl phthalate (DCHP) (Chemical Abstracts Service Registry Number 84-61-7). (4) Diethyl phthalate (DEP) (Chemical Abstracts Service Registry Number 84-66-2). (5) Diisobutyl phthalate (DIBP) (Chemical Abstracts Service Registry Number 84-69-5). (6) Diisodecyl phthalate (DIDP) (Chemical Abstracts Service Registry Number 26761-40-0). (7) Diisononyl phthalate (DINP) (Chemical Abstracts Service Registry Number 28553-12-0). (8) Di-n-hexyl phthalate (DnHP) (Chemical Abstracts 20260HB2614PN3633 - 4 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Service Registry Number 84-75-3). (9) Di-n-octyl phthalate (DNOP) (Chemical Abstracts Service Registry Number 117-84-0). (10) Di-n-pentyl phthalate (DnPP) (Chemical Abstracts Service Registry Number 131-18-0). (11) Diisoheptyl phthalate (DIHP) (Chemical Abstracts Service Registry Number 71888-89-6). "Unintentionally added DEHP." DEHP in an intravenous solution container or intravenous tubing product that is not used for functional or technical effect on the product. § 58A14. Prohibitions. (a) Intravenous solution containers.-- Except as provided under subsection (f), beginning January 1, 2030 , a person may not manufacture, sell or distribute intravenous solution containers made with intentionally added DEHP. (b) Intravenous tubing.--Beginning January 1, 2035, a person may not manufacture, sell or distribute intravenous tubing made with intentionally added DEHP. (c) Replacement.--A person may not replace DEHP with another ortho-phthalate in a new or revised medical device. (d) Unintentionally added DEHP.--An intravenous solution container or intravenous tubing product may not have unintentionally added DEHP present at a quantity at or above 0.1% weight per weight (w/w). (e) Exemptions.--The following items, as described in 21 CFR (relating to food and drugs), are exempt from the provisions of this section: (1) Human blood collection and storage bags. (2) Apheresis and cell therapy blood kits and bags, including integral tubing. 20260HB2614PN3633 - 5 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 (f) Extension.--A person, due to pending United States Food and Drug Administration approval for the DEHP-free intravenous solution container or due to the manufacturer not having adequate equipment to manufacture the DEHP-free intravenous solution container, shall meet the requirement under subsection (a) by January 1, 2032, if all of the following conditions are met: (1) The person notified its customers in this Commonwealth, no later than July 1 DECEMBER 31 , 2026, that the person has commenced development of the DEHP-free intravenous solution container to meet the requirements of this section. (2) The person provides notice to its customers in this Commonwealth and posts to its publicly accessible Internet website, no later than January 1, 2028, that the person will not meet the deadline imposed under subsection (a). Section 2. This act shall take effect in 90 days. 20260HB2614PN3633 - 6 - <-- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17