Medical Devices - Seeking Alternatives to DEHP Plasticizers

In view of its potential hazards, many countries have begun to restrict or plan to gradually ban the use of DEHP in medical devices. The European Union has listed DEHP as a Substance of Very High Concern (SVHC) and announced in 2023 that, no later than July 1, 2030, unauthorized medical devices containing DEHP must be prohibited. Some US states, such as California and North Carolina, have also passed legislation that plans to phase out the sale of DEHP-containing infusion bags and tubing starting in 2030.While neither side of the Taiwan Strait has announced a specific timeline for such a ban, both have been gradually strengthening the regulation and monitoring of plasticizer-related risks.

Faced with regulatory and market pressures, medical device manufacturers are actively seeking alternatives. Currently, common alternative plasticizers include DINCH (diisononyl cyclohexane-1,2-dicarboxylate), TOTM (tri(2-ethylhexyl) trimellitate), ATBC (citrate esters), and DOTP(di(2-ethylhexyl) terephthalate). These substances demonstrate good biocompatibility and stability, and have a lower risk of release. Some manufacturers are also switching to plasticizer-free materials, such as ethylene vinyl acetate (EVA), thermoplastic polyurethane (TPU), and silicone, which can further reduce risks.

In summary, although DEHP has certain technological and economic advantages, its use in medical devices is gradually being phased out due to safety concerns and regulatory pressures. Going forward, "DEHP-free" will become the new standard for medical products.