Since the late 1960s research has shown that a plastic additive in polyvinyl chloride (PVC), leaches from medical devices and is toxic to multiple organs, especially for premature infants.
Despite more than two decades of evidence, advocacy and education around the issue, PVC products containing this harmful phthalate chemical still dominate the neonatal intensive care unit (NICU) environment.
Feeding tubes, fluid bags, syringes, respiratory support tubes, intravenous lines, nasal cannulas, catheters, incubators — this is only a short list of the PVC medical supplies that assist in everything from eating, to breathing, to sleeping for premature infants in NICU.
The majority of these devices contain DEHP, or Di-2-ethylhexyl phthalate, a class of chemicals called phthalates, which are used to make plastic softer and more flexible.
Phthalates mimic the body’s hormones and can disrupt important processes during an infant’s rapid development.
Scientists have linked phthalate exposure for newborn infants, also known as neonates, with several toxic endpoints including damage to the developing brain, liver, heart, lungs, male reproductive tract and more.
While training as a clinical neonatology fellow and pursuing a masters of public health in the early 2000s, Dr. Annemarie Stroustrup Smith, the vice president and director of neonatal services at Northwell Health in New York, started to draw connections between the emerging research on prenatal phthalate exposure and the health outcomes observed among premature infants.
“We tend to chalk up health challenges that children born preterm have as due to prematurity, but that’s not really a mechanism,” Stroustrup Smith told Environmental Health News, “So my question was, are some of those [health challenges] due to phthalate exposure? And if it is, that’s something we can fix because we totally control the NICU environment.”
Stroustrup Smith’s research adds to a growing body of studies seeking to understand levels of neonatal exposure to DEHP, health effects and the benefits and drawbacks of alternatives.
And the science is making a difference — there is positive movement in the marketplace with phthalate-free devices becoming increasingly available.
However, cost remains an issue and the contaminated medical devices continue to fall through the regulatory cracks.
Lack of medical device regulation
Some DEHP-free medical supplies, such as feeding tubes, are readily available on the market. However, it is impossible to have a completely phthalate-free NICU in the U.S. due to unavailability and the high cost of alternative options.
While the U.S. Food and Drug Administration (FDA) released a guidance document for the pharmaceutical industry on avoiding DEHP in 2012, they have yet to ban or restrict its use in medical supplies, like the European Union has done.
This is despite ongoing research, advocacy and a direct ask from members of Congress who wrote a letter to the FDA last year….