Navigating non-DEHP legislation while protecting cryopreserved cord blood inventories during regulatory transitions

Cord blood banking relies on extensive inventories of cryopreserved units whose safety is determined not only by the biological quality of the cells but also by the materials used to store them. Legislators in both the European Union (EU) and the US are increasing pressure to remove di-2-ethylhexyl phthalate (DEHP) from medical devices, including polyvinyl chloride (PVC) freezing bags routinely used for cellular therapies, due to mounting evidence of its toxicological risks. This commentary examines how emerging US proposals could affect public cord blood banks as it raises concern that many cryopreserved units stored in DEHP-containing containers could be barred from public use under new regulations, wasting valuable donor contributions. We discuss supply-chain vulnerabilities and the US healthcare system’s heavy reliance on imported medical devices, arguing that the country’s distinctive market dynamics warrant a pragmatic, risk-based regulatory approach.

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