Six Congresswomen seek removal of toxic additives in IV bags, neonatal equipment
Douglas Fischer for the Environmental Health News
The
U.S. has made "minimal progress" in reducing harmful exposures in the
United States over the past 20 years—even as alternatives become available and
other jurisdictions, notably Europe and California, take steps to reduce
patient risk, say Reps. Katie Porter, Jackie Speier, Anna Eshoo, Lucille
Roybal-Allard (all D-Calif.), Susan Wild (D-Pa.) and Jan Schakowsky (D-Ill.).
"Patients
should not be exposed to phthalates and EDCs [endocrine-disrupting chemicals]
when they seek medical treatment," the representatives wrote in a letter
to acting Food and Drug Administration chief Dr. Janet Woodcock. "It's
also not something parents should worry about when their infant is receiving
critical treatment in the neonatal intensive care unit."
The
Congresswomen called on the FDA to create a "senior level" working
group to do three things:
- Review and update FDA guidelines on the use of phthalates and other hormone-hijacking chemicals in IV bags and other medical equipment;
- Identify and recommend rules needed to protect patients from toxics exposure in medical products; and
- Establish an education program to build "clinician awareness" of the risks of using medical devices with toxic additives like DEHP.
"The
time for action on this health risk is long overdue," the lawmakers said.
Evidence of DEHP harm to reproduction, fertility
Manufacturers
add phthalates like DEHP to plastic products to increase flexibility and reduce
brittleness. Some medical products such as IV bags and tubing can contain up to
40 percent DEHP by weight, according to an analysis by
Health Care Without Harm.
Those
additives leach to varying degrees from medical devices. DEHP is particularly
problematic, as extensive research suggests exposures during critical periods
of development can interfere with testosterone production and disrupt normal
male reproductive development.
The
European Union considers DEHP a reproductive toxicant and an endocrine
disruptor; rules developed in 2017 require risk-benefit analysis before
phthalates like DEHP can be used in medical devices.
California
has declared DEHP a reproductive and developmental toxicant and a carcinogen
and advises patients to request DEHP-free devices when seeking medical care.
Meanwhile the FDA hasn't updated its rules since 2002, when it recommended health care providers "consider" alternatives to DEHP when treating high-risk patients.
That
needs to change, the lawmakers say.
"Despite
these findings and the growing body of evidence that has confirmed earlier
research and identified additional risks of adverse health effects on
vulnerable patients, there has been minimal progress in the U.S. over the last
20 years in reducing the use of DEHP in medical devices," the lawmakers
said.
"It
is time for a reckoning in the healthcare community to address our role in
exposing patients to potentially harmful chemicals."
Download
a copy of the letter here:
Letter to FDA about DEHP IV Bags.pdf
Related: The danger of hormone-mimicking chemicals in medical devices and meds