An Act amending Title 35 (Health and Safety) of the Pennsylvania Consolidated Statutes, 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
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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.
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(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
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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
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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.
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(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.
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