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Safe Infusion Therapy (ET)



Sellel hüperlingil klõpsates lahkute meie veebilehelt. B. Braun ei ole avatava veebilehe omanik ega halda selle sisu.

[1]European Union Risk Assessment Report. bis(2-ethylhexyl)phthalate (DEHP).

[2] Cadogan DF, Howick CJ (2000)
Plasticizers in Ullmann’s Encyclopedia of Industrial Chemistry,
Wiley-VCH, Weinheim. doi: 10.1002/14356007.a20_439.


[4] Umweltbundesamt, Berlin, Hrsg. (2/2007)
Phthalate – die nützlichen Weichmacher mit den unerwünschten Eigenschaften: 3, 10.

[5] Kroschwitz JI (1998) Kirk-Othmer Encyclopedia of Chemical Technology. Fourth Edition. John Wiley and Sons, New York.


[7]SCENIHR opinion on the safety of medical devices containing dehp plasticized pvc or other plasticizers on neonates and other groups possibly at risk 2008.

[8] Haishima Y, Seshimo F, Higuchi T, Yamazaki H, Hasegawa C, et al. (2005)
Development of a simple  method for predicting the levels of di(2-ethylhexyl) phthalate migrated from PVC medical devices into pharmaceutical solutions.
Int J Pharm 2005; 298:126-42.

[9] Hanawa T, Muramatsu E, Asakawa K, Suzuki M, Tanaka M, et al. (2000)
Investigation of the release behavior of diethylhexyl phthalate from the polyvinyl-chloride tubing for intravenous administration.
Int J Pharm; 210:109-15.

[10] Hanawa T, Endoh N, Kazuno F, Suzuki M, Kobayashi D, et al. (2003)
Investigation of the release behavior of diethylhexyl phthalate from polyvinyl chloride tubing for intravenous administration based on HCO60.
Int J Pharm; 267:141-9.

[11] Loff S, Kabs F, Witt K, Sartoris J, Mandl B, Niessen KH, Waag KL (2000)
Polyvinylchloride infusion lines expose infants to large amounts of toxic plasticizers.
J Pediatr Surg; 35:1775-81.

[12] Loff S, Kabs F, Subotic U, Schaible T, Reinecke F, Langbein M (2002)
Kinetics of diethylhexylphthalate extraction from polyvinylchloride- infusion lines.
JPEN J Parenter Enteral Nutr; 26:305-9.

[13] Loff S, Subotic U, Reinicke F, Wischmann H, Brade J (2004)
Extraction of Di-ethylhexyl-phthalate from Perfusion Lines of Various Material, Length and Brand by Lipid Emulsions.
J Pediatr Gastroenteral Nutr; 39:341-345.

[14] Bourdeaux D, Sautou-Miranda V, Bagel-Boithias S, Boyer A, Chopineau J (2004)
Analysis by liquid chromatography and infrared spectrometry of di(2-ethylhexyl)phthalate released by multilayer infusion tubing.
J Pharm Biomed Anal; 35:57-64.

[15] Demore B, Vigneron J, Perrin A, Hoffman MA, Hoffman M (2002)
Leaching of diethylhexyl phthalate from polyvinyl chloride bags into intravenous etoposide solution.
J Clin Pharm Ther; 27:139-42.

[16]FDA Public Health Notification: PVC Devices Containing the Plasticizer DEHP.

[17] Rubin RJ, Schiffer CA (1976)
Fate in humans of the plasticizer, di-2-ethylhexyl phthalate, arising from transfusion of platelets stored in vinyl plastic bags.
Transfusion 16(4), 330–335.

[18] Jaeger RJ, Rubin RJ (1972)
Migration of a phthalate ester plasticizer from polyvinyl chloride blood bags into stored human blood and its localization in human tissues.
N Engl J Med 287(22), 1114–1118.

[19] Sjöberg P, Bondesson U, Sedin G and Gustafsson J (1985a)
Disposition of di- and mono-2ethylhexyl)phthalate in newborn infants subjected to exchange transfusions.
Eu J Clin. Invest. 15, 430-436.

[20] Easterling RE, Johnson E, Napier EA (1974)
Plasma extraction of plasticizers from “medical grade” polyvinylchloride tubing.
Proc Soc Exp Biol Med 147, 572–574.

[21] Mazur HI, Stennett DJ, Egging PK (1989)
Extraction of diethylhexylphthalate from total nutrient solution-containing polyvinyl chloride bags.
JPEN J Parenter Enteral Nutr; 13:59-62.

[22] Demoré B, Vigneron J, Perrin A, Hoffman MA, Hoffman M (2002)
Leaching of diethylhexyl phtalate from polyvinyl chloride bags into intravenous etoposide solution.
J Clin Pharm Ther;27:139-42.

[23] Fachinformation Taxol (1/2009), Abschnitt 6.2. Brystol-Meyers-Squibb.

[24] Health Canada (2002) An exposure and toxicity assessment. Medical Devices Bureau, Therapeutic Products Directorate, Health Products and Food Branch, Ottawa, Canada.

[25] Pearson SD, Trissel LA (1993)
Leaching of diethylhexyl phthalate from polyvinyl chloride containers by selected drugs and formulation components.
Am J Hosp Pharm; 50:1405-9.

[26] Beitza C, Bertsch T, Hannak D, Schrammel W, Einberger C, Wehling M (8/2005)
Compatibility of plastics with cytotoxic drug solutions—comparison of polyethylene with other container materials.
Int Journ of Pharm; (1)185: 113–121.

[27] Trissel LA, Pearson SD (2/1994)
Storage of lorazepam in three injectable solutions in polyvinyl chloride and polyolefin bags.
Am J Hosp Pharm; 1;51(3):368-72.

[28] Lee MG, Fenton-May V (1981)
Absorption of isosorbide dinitrate by PVC infusion bags and aministration sets.
J Clin Hosp Pharm, Sep;6 (3):209-11.

[29] Treleano A, Wolz G, Brandsch R, Welle F (3/2009)
Investigation into the sorption of nitroglycerin and diazepam into PVC tubes and alternative tube materials during application.
Epub 2008 Nov 5. Int J Pharm; 18;369(1-2):30-7.

[30] Martens HJ, De Goede PN, Van Loenen AC (2/1990)
Sorption of various drugs in polyvinyl chloride, glass, and polyethylene-lined infusion containers.
Am J Hosp Pharm; 1990 Feb;47(2):369-73.

[31] Frenette AJ, MacLean RD, Williamson D, Marsolais P, Donnelly RF (9/2011)
Stability of levothyroxine injection in glass, polyvinyl chloride, and polyolefin containers.
Am J Health Syst Pharm; 15;68(18):1723-8.

[32] Hedley AJ, Wong TW, Hui LL, Malisch R, Nelson EA (2/2006)
Breast milk dioxins in Hong Kong and Pearl River Delta.
Environ Health Perspect; 114(2):202-8.

[33] WHO Factsheet no 225, 2010,
Dioxins and their effect on human health, May 2012


[35] Desdoits-Lethimonier C, Albert O, Le Bizec B, Perdu E, Zalko D, Courant F, Lesné L, Guillé F, Dejucq-Rainsford N, Jégou B (3/2012)
Human testis steroidogenesis is inhibited by phthalates.
Hum Reprod; 2012 Mar 8. [Epub ahead of print]

[36] Dodson RE, Nishioka M, Standley LJ, Perovich LJ, Brody JG, Rudel RA
Endocrine Disruptors and Asthma-Associated Chemicals in Consumer Products
Online 8 March 2012

[37] Hannas BR, Furr J, Lambright CS, Wilson VS, Foster PM, Gray LE (2011)
Dipentyl phthalate dosing during sexual differentiation disrupts fetal testis function and postnatal development of the male Sprague-Dawley rat with greater relative potency than other phthalates.
Toxicol Sci 120(1):184-193.

[38] Colborn T, vomSaal F, Soto A (1993)
Developmental effects of endocrine-disrupting chemicals in wildlife and humans.
Environ Health Perspect 101(5):378-385.

[39] CERHR and Health Care Without Harm, HCWH, FDA, C. f. D. a. R. H. (2002)
Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP).
Released from PVC Medical Devices. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080457.pdf

[40] Rais-BAHRAMI et al.
Environmental Health Perspectives,

[41] Sharpe RM, Skakkebaek NE (2008)
Testicular dysgenesis syndrome: mechanistic insights and potential new downstream effects.
Fertil Steril 2008; 89(2 Suppl):e33-e38.

[42] Rusyn I, Peters JM, Cunningham ML (5/2006)
Effects of DEHP in the Liver: Modes of Action and Species-Specific Differences.
Crit Rev Toxicol; 36(5): 459–479. doi:10.1080/10408440600779065

[43] Latini G (2000)
Potential hazards of exposure to di-(2-ethylhexyl)-phthalate in babies. A review.
Biol Neonate 78:269–276.

[44] Tickner JA, Schettler T, Guidotti T, McCally M, Rossi M (1/2001)
Health risks posed by use of Di-2-ethylhexyl phthalate (DEHP) in PVC medical devices: a critical review.
Am J Ind Med;39(1):100-11.

[45]IARC 2000 Monograph 77 on the evaluation of carcinogenicity to humans.

[46] National toxicology programm, the US department of health and human services (11/2006)
Center for the evaluation of risks to human reproduction: NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di(2-Ethylhexyl) Phthalate (DEHP).
NIH Publication No. 06 – 4476.
[47] Tomatis L.
The IARC monographs program: changing attitudes towards public health.
Int J Occup Environ Health. 2002 Apr-Jun;8(2):144-52.

[48]Fachinformation (Zusammenfassung der Merkmale des Arzneimittels/ SPC) for Torisel (temsirolimus). Wyeth, Januar 2009, Abschnitt 6.2.

[49] Panknin HT.
Particle release from infusion equipment: etiology of acute venous thromboses.
Kinderkrankenschwester. 2007;26:407-8.

[50] Danschutter D, Braet F, Van Gyseghem E, Hachimi-Idrissi S, Van Bruwaene B, Moloney-Harmon P, Huyghens L.
Di-(2-ethylhexyl) phthalate and deep venous thrombosis in children: a clinical and experimental analysis.
Pediatrics. 2007;119:e742-53.

[51] Treleano A, Wolz G, Brandsch R, Welle F (3/2009)
Investigation into the sorption of nitroglycerin and diazepam into PVC tubes and alternative tube materials during application.
Int J harm;18;369(1-2):30-7.

[52] IARC (1997)
Polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans.
IARC Monogr Eval Carcinog Risks Hum 69:1–343.

[53] Steenland K, Bertazzi P, Baccarelli A, Kogevinas M (2004)
Dioxin revisited: developments since the 1997 IARC classification of dioxin as a human carcinogen.
Environ Health Perspect 112:1265–1268.

[54] IARC Working Group on the Evaluation of Carcinogenic Risks to Humans:
Polychlorinated Dibenzo-Para-Dioxins and Polychlorinated Dibenzofurans.
IARC Monogr Eval Carcinog Risks Hum. 1997;69:1-631.

[55] EPA 2012
Reanalysis of key issues related to dioxin toxicity and response to NAS comments

[56] Wargo et al.
Plastics That May Be Harmful to Children and Reproductive Health.
Environment & Human Health, Inc. 2008

[57] European Commission, T. S. C. o. M. P. a. M. D. (2002).
“Opinion on Medical Devices Containing DEHP Plasticised PVC; Neonates and Other Groups Possibly at Risk from DEHP Toxicity.”

[58] Greenpeace International (2003)
PVC-Free Future: A Review of Restrictions and PVC-free Policies Worldwide.

[59]Änderung im Anhang der REACH-Regulation (PDF), Stand 17. Februar 2011

[60]REACH - Registration, Evaluation, Authorisation of Chemicals (2007)

vom 5. September 2007 zur Änderung der Richtlinien 90/385/EWG des Rates zur Angleichung der Rechtsvorschriften der Mitgliedstaaten über aktive implantierbare medizinische Geräte und 93/42/EWG des Rates über Medizinprodukte sowie der Richtlinie 98/8/EG über das Inverkehrbringen von Biozid-Produkten

[62] Emerson C, ALP Australia Bans Phthalates in Toys.

[63]PVC: The Poison Plastic. PVC Governmental Policies around the World.
[64]Referenz-Nr.: 9211/0506 DEHP als Weichmacher in Medizinprodukten aus PVC. Erstellt: 22.05.2006

[65] Health Canada, (2002) DEHP in Medical Devices: an exposure and toxicity assessment. Medical Devices Bureau, Therapeutic Products Directorate, Health Products and Food Branch, Health Canada. Ottawa, Canada.

[66] Health Canada. Consumer Product Safety. (2007) Proposal for legislative action on di(2-ethylhexyl) phthalate under the Hazardous Products Act.


[68] Japanese Makers to Switch from PVC to Eco-Based Containers’, Nikkei, Tokyo, January 14, 1998.

[69]FoodBev.com, 31.01.2012


Health Care Without Harm (2003)
Glanzing Clinic in Vienna is First PVC-Free Pediatric Unit Worldwide.
Press release (June 13, 2003).

[72]Initiative „Schadstofffreies Krankenhaus“ gegen PVC-haltige Medizinprodukte.
Deutsches Ärzteblatt, Ausgabe 15. November 2006;

[73]OSPAR List of Chemicals for Priority Action (Revised 2011), Reference number 2004-12;

[74]Wirnitzer, U (2011) Non-Clinical Testing of the Plasticizer Di-2-ethylhexyl-terephtalate (DEHT) under Clinically relevant Conditions. ITO Symposium 15.-16. Sep 2011.

[75] Wirnitzer U, Rickenbacher U, Katerkamp A, Schachtrupp A.
Systemic toxicity of di-2-ethylhexyl terephthalate (DEHT) in rodents following four weeks of intravenous exposure.
Toxicol Lett. 2011 Aug 10;205(1):8-14.

[76] Unpublished data, Eastman Chemical Company.


[78] Stoffers, N.H., Stoermer, A., Bradley, E.L., Brandsch, R., Cooper, I., Linssen, J.P.H., Franz, R., 2004.
Feasibility study for the development of certified reference materials for specific migration testing: Part 1. Initial migration concentration and specific migration.
Food Addit. Contam. 21, 1203–1216.

[79] Stoffers, N.H., Brandsch, R., Bradley, E.L., Cooper, I., Dekker, M., Stoermer, A., Franz, R., 2005.
Feasibility study for the development of certified reference materials for specific migration testing: Part 2. Estimation of diffusion parameters and comparison of experimental and predicted data.
Food Addit. Contam. 22, 173–184.

[80]European Pharmacopoeia monograph 3.1.4 of the Polyethylene without additives for containers for preparations for parenteral use and for ophthalmic preparations.

[81] Kaiser J., Krämer I.
Physicochemical stability of diluted trastuzumab infusion solutions in polypropylene infusion bags.
Int J Pharm Compounding 2011 15:6 (515-520).

[82] Menard C., Bourguignon C., Schlatter J., Vermerie N., Schlatter J.
Stability of Cyclophosphamide and Mesna Admixtures in Polyethylene Infusion Bags.
Annals of Pharmacotherapy 2003 37:12 (1789-1792).

[83] Arsène M., Favetta P., Favier B., Bureau J., Favetta P.
Comparison of ceftazidime degradation in glass bottles and plastic bags under various conditions.
Journal of Clinical Pharmacy and Therapeutics 2002 27:3 (205-209).

[84] Jenke D, Couch T, Gillum A, Sadain S.
Modeling of the solution interaction properties of plastic materials used in pharmaceutical product container systems.
PDA J Pharm Sci Technol. 2009 Jul-Aug;63(4):294-306.

[85] Römpp Lexikon Chemie, 9. Auflage 1992

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