[Determination of Plasticizer DEHP Released from Medical Hungary

  • [Determination of Plasticizer DEHP Released from Medical Hungary
  • [Determination of Plasticizer DEHP Released from Medical Hungary
  • [Determination of Plasticizer DEHP Released from Medical Hungary
  • What is DEHP?
  • DEHP, or diethylhexylphthalate, was the most commonly used plasticizer for softening PVC medical devices until 2010. It was favored for its good efficiency/cost ratio. However, in flexible plasticized PVC, phthalates like DEHP are not chemically bound to PVC and they are released into the environment, potentially coming into contact with patients.
  • How much DEHP can be used in PVC medical devices?
  • The use of DEHP in PVC medical devices is now limited to 0.1% by mass of plasticised material by the European Regulation N o 2017/245 on medical devices .
  • Can plasticizers be released from a medical device?
  • As plasticizers are not chemically bound to PVC, they can be released from the medical device during contact with blood, enteral or total parenteral nutrition admixtures, or lipophilic drugs, which might lead to unwanted patient exposure , , .
  • What plasticizer alternatives are present in medical devices?
  • Analytical methods for the determination of plasticizer alternatives to DEHP in medical devices: a review. Until 2010, diethylhexylphthalate (DEHP) was the most commonly used plasticizer in medical devices due to its good efficiency/cost ratio. However, the passage does not provide information about the specific alternatives.
  • Are DEHP and glucuronide conjugates a biomarker of plasticizer exposure in human urine?
  • Our study aimed to develop a novel sensitive and selective method to simultaneously identify and quantify DEHP and 17 other plasticizer metabolites (free or glucuronide conjugates), which are specific biomarkers of DEHTP, TOTM, DINP, DINCH and DEHA exposure in human urine.
  • Can NMR detect traces of DEHP in PVC medical devices?
  • Genay et al. used NMR to identify traces of DEHP in PVC medical devices presented as DEHP-free, i.e., with an amount lower than 0.1% . However, Lutyten et al. identified several drawbacks, including low sensitivity, while working on the quantification of different plasticizers present in PVC tubes.

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