Posted: | February 16, 2024 11:35 AM |
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From: | Senator Lisa M. Boscola |
To: | All Senate members |
Subject: | Phasing Out Toxic Additives in IV Bags and Medical Equipment |
Soon I will introduce legislation requiring licensed medical facilities in Pennsylvania that utilize IV bags and other medical devices with Diethylhexyl Phthalate (DEHP) to formally notify patients of their use and the documented risks posed by this toxic additive. My proposal would also require a phase out of DEPH IV-bags and medical devices over time, starting with high-risk patients (NICUs, pediatrics, and cancer patients). DEHP belongs to a family of chemicals called phthalates which are added to certain plastic products to increase their flexibility and reduce brittleness. Some medical products such as IV bags and tubing can contain up to 40 percent DEHP by weight.[1] Those additives leach to varying degrees, proving problematic, as extensive research suggests exposures during critical periods of development can interfere with testosterone production and disrupt normal male reproductive development. Studies have also found that DEHP may contribute to increased drug resistance, in the treatment of breast cancer patients, interfering with breast cancer treatment and increasing the likelihood of relapse.[2] 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. Moreover, multiple health systems in our state have already incorporated DEHP-free medical devices into their treatment models. This legislation joins the call made by Congressional members, earlier in 2021, asking the FDA to prioritize reviewing and updating the agency’s 2002 guidelines on the use of phthalates and other endocrine-disrupting chemicals (EDCs) in IV containers and other medical devices.[3] Pennsylvania has an opportunity to become the national leader in reducing the use of toxic additives in medical devices. I encourage my colleagues to join me by cosponsoring this legislation. |
Introduced as SB1301