A review of alternatives to di (2-ethylhexyl) phthalate-containing medical devices in the neonatal intensive care unit

Objective: To conduct an extensive literature and toxicological database review on substitute compounds and available alternative medical products to replace polyvinyl chloride (PVC) and/or di(2-ethylhexyl) phthalate (DEHP), and conduct a DEHP-medical inventory analysis at a large metropolitan neonatal intensive care unit (NICU).

Study design: A systematic search for DEHP-free alternative products was performed using online databases. An informal audit of a large metropolitan NICU was undertaken in 2005 and 2006; 21 products were identified that could potentially contain DEHP. Availability of DEHP-free alternatives was determined through company websites and phone interviews.

Result: Two alternative approaches are available for replacing DEHP in NICU medical products: (1) replacement by DEHP-free plasticizers; and (2) replacement of PVC entirely through the use of other Polymers. Both approaches seem to provide less harmful substitutes to DEHP, but support PVC-free Polymers as the preferred alternative. However, significant data gaps exist, particularly for the alternative Polymers. In all, 10 out of 21 (48%) products in the NICU audit were DEHP-free; six consisted of alternative Polymers and four of alternative plasticizers. Of the remaining 11 products, only three were available without DEHP at the time of the audit.

Conclusion: Because of significant data gaps, systematic toxicological testing of DEHP-free alternatives is imperative. Continued development of alternative products is also needed.