Biologically active contaminants of intravenous saline in PVC packaging: Australasian, European, and North American samples

Anaesthesia and Intensive Care

Volumn 33, Issue 1, 2005, Pages 78-81

  Story, D A ^a,e   Leeder, J ^b,c   Cullis, P ^c   Bellomo, R ^d  

^a UNIVERSITY OF MELBOURNE   (Australia)

^b Leeder Consulting   (Australia)

^c RMIT UNIVERSITY   (Australia)

^d AUSTIN HEALTH   (Australia)

^e AUSTIN HOSPITAL   (Australia)

Author keywords

Equipment, Infusions: saline, contamination, packaging

Indexed keywords

2 ETHYLHEXANOL; 2 TERT BUTYLCYCLOHEXANONE; CYCLOHEXANONE; ORGANIC COMPOUND; PHTHALIC ACID BIS(2 ETHYLHEXYL) ESTER; POLYVINYLCHLORIDE; SODIUM CHLORIDE;

ARTICLE; AUSTRALIA; CAPILLARY GAS CHROMATOGRAPHY; CONCENTRATION (PARAMETERS); CONTAMINATION; CONTROLLED STUDY; DESORPTION; EUROPE; GEOGRAPHIC DISTRIBUTION; INTRAVENOUS ADMINISTRATION; MASS SPECTROMETRY; NORTH AMERICA; PACKAGING; PACKAGING MATERIAL; PRINTING;

EID: 14244253560     PISSN: 0310057X     EISSN: None     Source Type: Journal    
DOI: 10.1177/0310057x0503300113     Document Type: Article

References (22)

1. Story DA, Thistlethwaite P, Bellomo R. The effect of PVC packaging on the acidity of 0.9% saline. Anaesth Intensive Care 2000; 28:287-292.
2. ASTM subcommittee D 19.06. Standard Practice for Identification of Organic Compounds in Water by Combined Gas Chromatography and Electron Impact Mass Spectrometry. West Conshohocken, Pennsylvania, USA: American Society for Testing and Materials, 1994.
3. Wahl HG, Hoffmann A, Haring HU, Liebich HM. Identification of plasticizers in medical products by a combined direct thermodesorption - cooled injection system and gas chromatography-mass spectrometry. J Chromatogr A 1999; 84:1-7.
4. Pearson SD, Trissel LA. Leaching of diethylhexyl phthalate from polyvinyl chloride containers by selected drugs and formulation components. Am J Hosp Pharm 1993; 50:1405-1409.
5. Arbin A, Jacobsson S, Hanninen K, Hagman A, Ostelius J. Studies on contamination of intravenous solutions from PVC-bags with dynamic headspace GC-MS and LC-diode array techniques. International Journal of Pharmaceutics 1986; 28:211-218.
6. Van Dooren AA. PVC as pharmaceutical packaging material. A literature survey with special emphasis on plasticized PVC bags. Pharm Weekbl Sci 1991; 13:109-118.
7. Tickner JA, Schettler T, Guidotti T, McCally M, Rossi M. Health risks posed by use of Di-2-ethylhexyl phthalate (DEHP) in PVC medical devices: a critical review. Am J Ind Med 2001; 39:100-111.
8. Sharpe RM, Irvine DS. How strong is the evidence of a link between environmental chemicals and adverse effects on human reproductive health? Bmj 2004; 328:447-451.
9. Agency for Toxic Substances and Disease Registry. Toxicolgical profile for di(2-ethylhexyl)phthalate. Atlanta: U.S. Department of Health and Human Services, Public Health Service, 2002.
10. Scientific Committee on Medicinal Products and Medical Devices. Medical devices containing DEHP plasticised PVC; neonates and other groups possibly at risk from DEHP toxicity: European Commission, 2002:1-34.
11. Blount BC, Silva MJ, Caudill SP, Needham LL, Pirkle JL, Sampson EJ, et al. Levels of seven urinary phthalate metabolites in a reference population. Environ Health Persp 2000; 108:979-982.
12. Centre for Devices and Radiological Health. Safety assessment of Di92-ethylhexyl)pthalate (DEHP) released from PVC medical devices. Rockville: U.S. Food and Drug Administration, 2001.
13. Expert Advisory Panel. DEHP in medical devices: Health Canada, 2002.
14. Latini G, De Felice C, Presta G et al. In utero exposure to di-(2-ethylhexyl)phthalate and duration of human pregnancy. Environ Health Perspect 2003; 111:1783-1785.
15. Cobellis L, Latini G, De Felice C et al. High plasma concentrations of di-(2-ethylhexyl)-phthatate in women with endometriosis. Hum Reprod 2003; 18:1512-1515.
16. Loff S, Kabs F, Witt K et al. Polyvinylchloride infusion lines expose infants to large amounts of toxic plasticizers. J Pediatr Surg 2000; 35:1775-1781.
17. Cyclohexanone. IARC Monogr Eval Carcinog Risks Hum. 1999; 71 Pt 3:1359-1364.
18. Pollack GM, Shen DD, Dorr MB. Contribution of metabolites to the route- and time-dependent hepatic effects of di-(2-ethylhexyl) phthalate in the rat. J Pharmacol Exp Ther 1989; 248:176-181.
19. Baxter Healthcare. The Use of DEHP in Medical Devices. Available at http://www.baxter.com/about_baxter/about_baxter/news_room/ positions_policies/index.htm. Accessed October 7, 2004.
20. B.Braun. PVC-free and DEHP free. Available at: http://www.bbraunusa.com/safety/non-pvc.html. Accessed October 7, 2004.
21. Lichtman B. Flexible PVC Faces Stiff Competition. Medical Device Link. Available at http://www.devicelink.com/emdm/archive/00/03/special.html. Accessed October 7, 2004.
22. Health Care Without Harm. PVC and DEHP. Available at: http://www.noharm.org/pvcDehp/issue. Accessed October 7, 2004.