September 30, 2024
California’s Toxic-Free Medical Devices Act prohibits the use of intentionally added DEHP in IV solution containers and tubing products beginning January 1, 2030.
California recently passed the Toxic-Free Medical Devices Act (AB 2300), prohibiting the use of di-(2-ethylhexyl) phthalate (DEHP) in almost all intravenous (IV) solution containers and tubing. The bill also prohibits replacing DEHP with eleven other specified ortho-phthalates, including benzyl-butyl phthalate (BBP), di-isononyl phthalate (DINP), and di-n-octyl phthalate (DNOP). The ban on intentionally added ortho-phthalates for IV containers starts on January 1, 2030, six months ahead of similar European Union (EU) restrictions; the ban on IV tubing starts on January 1, 2035. Unintentionally added DEHP, i.e., DEHP in an IV solution container or IV tubing product that is not used for functional or technical effect on the product, may be present at a quantity at or above 0.1 percent weight per weight (w/w).
List of Banned Ortho-phthalates (Including DEHP):
Exemptions to the Ortho-phthalates Ban Include:
Timeline of the Ortho-phthalates Ban:
Choosing the Right Alternatives
Do you need help selecting potential alternatives to satisfy California and EU requirements? Gradient’s experts specialize in alternative assessments comparing the hazards, performance, and regulatory trend of alternatives to prevent regrettable substitutions. When choosing the right alternative, it is also important to consider degradation products under clinical and harsh extraction solvent conditions to minimize safety concerns.
Our colleagues at Cambridge Polymer Group offer holistic thinking on material selection. For example, downstream sterilization techniques dictate upstream material selection, but this is often overlooked until the very end. Choice of starting material must be driven by the anticipated end-use, and often this is influenced by forces out of the designer’s control, such as the regulatory bans being discussed here.
“Selecting the right alternatives goes beyond engineering and performance. It requires holistic evaluations of biological safety and material regulatory trends, all tailored to your device and manufacturing processes.”
Medical Device Approval
A DEHP-free reformulation will require pre-approval from US FDA and/or updates to the product’s design history file. Gradient’s team of medical device experts can help with the biological evaluation and toxicological risk assessment from the material change. In addition, Cambridge Polymer Group can offer material selection consulting support, as well as testing, including chemical characterization.
Gradient Contacts:
Jiaru Zhang, M.P.H., DABT
Principal Scientist
Jiaru.Zhang@gradientcorp.com
Joel M. Cohen, Sc.D., DABT
Principal
Joel.Cohen@gradientcorp.com
Lindsey Borton, M.P.H.
Principal
Lindsey.Borton@gradientcorp.com
Cambridge Polymer Group Contact: