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Determination of di(2-ethylhexyl) phthalate in plastic medical devices

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The presence of DEHP in dialysis and infusion sets for peritoneal dialysis and parenteral nutrition, which are made of PVC and other plastic polymeric materials, were investigated. Phthalate determination was carried out by gas chromatography - mass spectrometry method (GC-MS). The results showed that the peritoneal dialysis set (bag and tubing) made of PVC contains DEHP in significant amount, about 31 - 34%. Solution for peritoneal dialysis which was stored in the investigated PVC bag, contains low amount of DEHP, about 3.72 ?g dm-3. Infusion bottles which are made of LDPE, also contain DEHP but in lower amount than PVC bags. LDPE bottle for packaging physiological saline solution (0.9% NaCl) showed higher amount of DEHP than LDPE bottle for packaging Ringer?s solution. In contrast, solution stored in bottle with lower DEHP level, i.e. Ringer?s solution contained about three times higher concentration of DEHP than physiological saline solution stored in bottle with higher DEHP level. Concentrations of DEHP in Ringer?s solution and physiological saline solution are 17.30 and 5.83 ?g dm-3, respectively. The obtained values are under estimated upper-bound dose of DEHP received by adult patients undergoing procedures of peritoneal dialysis and parenteral nutrition.
Title: Determination of di(2-ethylhexyl) phthalate in plastic medical devices
Description:
The presence of DEHP in dialysis and infusion sets for peritoneal dialysis and parenteral nutrition, which are made of PVC and other plastic polymeric materials, were investigated.
Phthalate determination was carried out by gas chromatography - mass spectrometry method (GC-MS).
The results showed that the peritoneal dialysis set (bag and tubing) made of PVC contains DEHP in significant amount, about 31 - 34%.
Solution for peritoneal dialysis which was stored in the investigated PVC bag, contains low amount of DEHP, about 3.
72 ?g dm-3.
Infusion bottles which are made of LDPE, also contain DEHP but in lower amount than PVC bags.
LDPE bottle for packaging physiological saline solution (0.
9% NaCl) showed higher amount of DEHP than LDPE bottle for packaging Ringer?s solution.
In contrast, solution stored in bottle with lower DEHP level, i.
e.
Ringer?s solution contained about three times higher concentration of DEHP than physiological saline solution stored in bottle with higher DEHP level.
Concentrations of DEHP in Ringer?s solution and physiological saline solution are 17.
30 and 5.
83 ?g dm-3, respectively.
The obtained values are under estimated upper-bound dose of DEHP received by adult patients undergoing procedures of peritoneal dialysis and parenteral nutrition.

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