Anaheim, Calif. — Eastman Chemical Co. conducted a clinical trial to evaluate a non-phthalate plasticizer for medical applications and the results indicate it could become a “lead alternative” to using DEHP to soften PVC blood bags.
DEHP, or di-2-ethyyllhexyl phthalate, has provided the medical industry with a stable ortho-plasticizer for many years and has even been found to extend the length of time blood can be stored to 42 days.
However, DEHP migrates at low levels into the blood product. And exposure to DEHP has been shown to have adverse effects on the development of reproductive systems in male laboratory animals.
The European Commission has classified DEHP and three other phthalates as substances of very high concern and banned their use in electrical equipment by July 2019. A similar restriction for medical devices about to hit the market is expected to be enforced in July 2021. In the meantime, some companies and scientists have been trying to come up with a viable Plan B for blood bags.
“If the Europeans do put a law in place saying by 2020 you won't be able to use a whole host of materials, one of which is DEHP, that will drive change in the industry,” Mark Brucks, Eastman's market development manager for plasticizers, said at the Medical Device & Manufacturing trade show, held Feb. 7-9 in Anaheim.
“The year 2020 seems far away,” he added, “but in the medical world that's tomorrow.”
Eastman partnered with the BloodCenter of Wisconsin to test Eastman 168 SG, which is a sensitive-grade di-2-ethylhexyl terephthalate (DEHT). Although structurally and functionally similar to DEHP, DEHT is different from a metabolic and toxicological standpoint. It is not an ortho-phthalate, carcinogen, mutagen or reproductive toxicant.
In the clinical trial, overall, the DEHT bags showed comparable performance to the DEHP bags, which “suggests it should be considered a lead alternative plasticizer for PVC blood bags,” the study concluded.
Dr. Kathleen Puca, medical director of BloodCenter, oversaw the evaluation at the facility, which is part of Verti, a Milwaukee-based non-profit organization that specializes in blood services including diagnostic testing, donation and research.
“Our work with Eastman has provided valuable results that will benefit the blood banking industry,” Puca said in a news release. “The DEHT trial results offer new light about a well-established plasticizer that has now been proven to have an even broader application within health care: providing safer blood products.”