Migration von Additiven (DEHP & TOTM) aus Ph.i.s.i.o.®-beschichteten PVC-Materialien in Medizinprodukten

Klapproth A, Schärli M, Göen T, Eckert E, Schäffer TE, Cesnjevar R, Münch F (2017)

Publication Type: Journal article

Publication year: 2017

Journal

Book Volume: 26

Pages Range: 3-11

Journal Issue: 1

Abstract

Diethylhexylphthalat (DEHP) belongs chemically to the phthalates and is considered a plasticizer. These substances are needed to make polyvinyl chloride (PVC) moldable. The EU classifies DEHP within its guidelines 2003/36/EG and 76/769/EWG as category 2 “toxic to reproduction”. Alternative plasti-cizers are supposed to minimize health risk during exposure. Surface coatings shall additionally ensure that phthalates will not get ac-cess to blood circulation. Three groups were tested in-vitro within six test series. The EKZ-Sets differ in PVC including DEHP (group X), PVC including TOTM (group Y) as well as tubes made of polyolefin (group Z). All systems were re-fined with Ph.i.s.i.o.-surface coating (Liva-Nova, Munich). Washout of plasticizers is evaluated by different analyses. A tubing segment of 1 m length taken out of each set is weighed by analytical scale before and after a 24 hour test phase (Sartorius, Göt-tingen). The surfaces were examined by atomic force microscopy. Blood tests were run additionally in order to analyze the quantitative amount of plasticizers (DEHP & TOTM) and their degradation products (MEHP, MEHTM & TEHTM) at different times. All groups showed loss of weight of the examined tubing segments. Significant differences were measured within group X vs. group Y (p < 0.001). Group Z with 1.55 ± 3.36 mg showed the lowest loss of weight. After 24 h of perfusion, a different surface structure could be seen in all groups. The laboratory analysis of groups X vs. Y showed a significantly higher washout of DEHP vs. TOTM (p < 0.05). Migration within the TOTM-group was approxi-mately 0.46 % of the DEHP-group. Based on a 5 kg infant arise with 95.10 mg/l/d DEHP the 380 times allowable TDI of DEHP. For TOTM with 0.45 mg/l/d it means 0.09 times the TDI of TOTM. The Ph.i.s.i.o.-surface coating cannot prevent the migration of DEHP and TOTM. The main feature of the surface coating is not preventing the migration of plasticizers but improving PVC biocompatibility. The Ph.i.s.i.o.-surface coating cannot prevent migration of phthalates from the PVC matrix. Alternative plasticizers should be used for example TOTM in order to minimize the noxious effects of DEHP.

Authors with CRIS profile

Involved external institutions

Eberhard Karls Universität Tübingen Germany (DE)

How to cite

APA:

Klapproth, A., Schärli, M., Göen, T., Eckert, E., Schäffer, T.E., Cesnjevar, R., & Münch, F. (2017). Migration von Additiven (DEHP & TOTM) aus Ph.i.s.i.o.®-beschichteten PVC-Materialien in Medizinprodukten. Kardiotechnik, 26(1), 3-11.

MLA:

Klapproth, A., et al. "Migration von Additiven (DEHP & TOTM) aus Ph.i.s.i.o.®-beschichteten PVC-Materialien in Medizinprodukten." Kardiotechnik 26.1 (2017): 3-11.

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