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

PRIOR PRINTER'S NO. 902 PRINTER'S NO. 1282
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No. 804
Session of
2025
INTRODUCED BY BOSCOLA, COLEMAN, FONTANA, DUSH, COSTA, KEARNEY,
FLYNN, MILLER AND BROWN, JUNE 4, 2025
SENATOR FARRY, INSTITUTIONAL SUSTAINABILITY AND INNOVATION, AS
AMENDED, OCTOBER 28, 2025
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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58A11. Scope of subchapter.
58A12. Legislative findings and declarations.
58A13. Definitions.
58A14. Prohibitions.
58A15. Notice.
§ 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).
"Health care practitioner." An individual who is authorized
to practice some component of the healing arts by a license,
permit, certificate or registration issued by a Commonwealth
licensing agency or board.
"Intentionally added DEHP." Either of the following:
(1) DEHP that a manufacturer has intentionally added to
a product and that has a functional or technical effect on
the product.
(2) DEHP that is an intentional breakdown product of an
added chemical.
"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
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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
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).
"Patient." An individual who is under the medical care of a
health care practitioner, in addition to the following, as
applicable:
(1) The parent or legal guardian of the individual if
the individual is under 18 years of age.
(2) The health care agent, as defined in 20 Pa.C.S. §
5422 (relating to definitions), of the individual.
(3) The health care representative, as defined in 20
Pa.C.S. § 5422, of the individual.
(4) The guardian of the individual if the individual is
deemed an incapacitated person in accordance with 20 Pa.C.S.
Ch. 55 (relating to incapacitated persons).
"UNINTENTIONALLY ADDED DEHP." DEHP IN AN INTRAVENOUS
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SOLUTION CONTAINER OR INTRAVENOUS TUBING PRODUCT THAT IS NOT
USED FOR FUNCTIONAL OR TECHNICAL EFFECT ON THE PRODUCT.
§ 58A14. Prohibitions.
(a) Intravenous solution containers.-- Beginning January 1,
2027 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.--
(1) Beginning January 1, 2027, a person may not
manufacture, sell or distribute intravenous tubing made with
intentionally added DEHP for use in neonatal intensive care
units or for the purpose of nutrition infusions or oncology
treatment infusions.
(2) Beginning January 1, 2032, 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.
§ 58A15. Notice.
(a) Requirement.--A health care practitioner shall notify a
patient prior to use of an intravenous solution container or
intravenous tubing that contains DEHP or other ortho-phthalate
in the course of treatment.
(b) Contents.--Notice under subsection (a) shall include, at
a minimum, information relating to:
(1) The risks associated with exposure to DEHP and other
ortho-phthalates.
(2) The patient's right to request an intravenous
solution container or intravenous tubing that is free from
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DEHP and other ortho-phthalates.
(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.
(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, 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
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NOT MEET THE DEADLINE IMPOSED UNDER SUBSECTION (A).
Section 2. This act shall take effect in 90 days.
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