Simulated neonatal exposure to DEHP and MEHP from PVC enteral nutrition products
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Published on: June 2, 2023
Satoshi Takatori1, You Okamoto, Yoko Kitagawa
1Division of Food Chemistry, Osaka Prefectural Institute of Public Health, 1-3-69 Nakamichi, Higashinari-ku, Osaka 537-0025, Japan. sts-tkt@iph.pref.osaka.jp
Insights
Di(2-ethylhexyl)phthalate (DEHP) leaches from polyvinyl-chloride (PVC) medical devices into neonatal enteral nutrition (EN). Using DEHP-free products significantly reduces infant exposure to DEHP and its metabolite MEHP.
Area of Science:
- Neonatal medicine
- Environmental health
- Materials science
Background:
- Neonatal patients often receive enteral nutrition (EN) via medical devices.
- Polyvinyl-chloride (PVC) medical products frequently contain di(2-ethylhexyl)phthalate (DEHP) as a plasticizer.
- Concerns exist regarding the leaching of DEHP and its metabolite mono(2-ethylhexyl)phthalate (MEHP) into EN.
Purpose of the Study:
- To quantify DEHP and MEHP leaching from PVC medical products into EN under simulated neonatal conditions.
- To assess the potential daily exposure of neonatal patients to DEHP and MEHP.
- To evaluate the effectiveness of DEHP-free medical products in reducing exposure.
Main Methods:
- A simulated study mimicking EN administration to a 3 kg neonatal patient at 25°C.
- Analysis of DEHP and MEHP levels leaching from PVC irrigators and catheters (9.1-31.8% DEHP w/w) into EN.
- Calculation of worst-case daily exposure estimates for DEHP and MEHP.
Main Results:
- Estimated worst-case daily exposures to DEHP and MEHP were 148 and 3.72 µg/(kg day), respectively.
- Leaching significantly increased DEHP and MEHP levels in EN compared to preparation levels.
- The use of DEHP-free medical products reduced exposure to baseline levels present in the EN itself.
Conclusions:
- Medical products containing DEHP can leach significant amounts of DEHP and MEHP into neonatal enteral nutrition.
- Transitioning to DEHP-free medical products is an effective strategy to minimize neonatal exposure to these compounds via EN.
- Reducing DEHP exposure in neonatal care is crucial for patient safety.
Abstract:
The leaching of di(2-ethylhexyl)phthalate (DEHP) and mono(2-ethylhexyl)phthalate (MEHP) from medical products made of polyvinyl-chloride (PVC) to enteral nutrition (EN) for neonatal patients was determined in a simulated study. The study simulated a typical case of EN administration to a neonatal patient (body weight, 3 kg) in a neonatal care unit (temperature, 25 degrees C); the medical products used were an irrigator and catheter containing DEHP (9.1-31.8%, w/w) as a plasticizer. The worst-case daily exposures of the neonatal patient to DEHP and MEHP by the administration of EN were estimated to be 148 and 3.72 microg/(kg day), respectively, as assessed from the levels of these compounds leaching from the medical products to the EN. The use of DEHP-free medical products reduced the exposure of DEHP and MEHP to the minimum levels contained in the EN at preparation. A transition to DEHP-free medical products for neonatal patients would be effective in reducing the exposure of neonatal patients to DEHP via EN administration.
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