Reevaluation of ethylene oxide hemolysis and irritation potential

Journal of Biomedical Materials Research - Part A

Volumn 64, Issue 4, 2003, Pages 648-654

  Anand, V P ^a,g   Cogdill, C P ^a   Klausner, K A ^b   Lister, L ^b   Barbolt, T ^c   Page, B F J ^d   Urbanski, P ^e   Woss, Casimir J ^c   Boyce, John ^f  

^a BOSTON SCIENTIFIC CORPORATION   (United States)

^b Toxikon Corporation   (United States)

^c ETHICON INC   (United States)

^d Medtronic Inc ^*

^e MEDTRONIC INC   (United States)

^f CHARLES RIVER LABORATORIES   (United States)

^g Idenix Pharmaceuticals Inc   (United States)

Author keywords

Biocompatibility; Ethylene oxide; Hemolysis; Medical devices; Mucosal irritation

Indexed keywords

BIOCOMPATIBILITY; ETHYLENE; EXTRACTION;

HEMOLYSIS;

BIOMATERIALS;

ETHYLENE OXIDE;

ANALYTIC METHOD; AQUEOUS SOLUTION; ARTICLE; BIOCOMPATIBILITY; CHEEK MUCOSA; DEVICE; HEMOLYSIS; HISTOCOMPATIBILITY; MUCOSA INFLAMMATION; MUTAGENICITY; TOXICITY TESTING;

EID: 0344306334     PISSN: 00219304     EISSN: None     Source Type: Journal    
DOI: 10.1002/jbm.a.10422     Document Type: Article

References (20)

1. Health assessment document for ethylene oxide. EPA Working Group. TA: Environmental Protection Agency PG: YR: 1985 IP: VI:EPA-600/8-84-009F.
2. ANSI/AAMI/ISO 10993-7: 1995, Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals. Association for the Advancement of Medical Instrumentation, Arlington, VA.
3. Amendment I to AAMI Technical Information Report No. 19-1998, Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices. Part 7. Ethylene oxide sterilizatio residuals: 1999. Association for the Advancement of Medical Instrumentation, Arlington, VA.
4. Ministry of Health and Welfare Japan, Evaluation and Licensing Division, Pharmaceutical and Medical Safety Bureau. Draft guidance to control ethylene oxide residue in medical devices (Notice 1998.3.31).
5. Autian J. Authorized toxicity testing protocols. Vol. I. (ATTP-I) Memphis: Materials Science Toxicology Laboratories, University of Tennessee Center for the Health Sciences; April 1977.
6. Piliero SJ, Carson S, LiCalzi M, Pentel L, Piliero JA, Kaufman EG, Schulman A, Willigan DA. Biocompatibility evaluation of casting alloys in hamsters. J Prosthet Dent 1979;Feb;41:220-223.
7. Roy M, Wishe HI. Establishment of an improved implantation technique for hamster mucous membrane irritation testing. J Dent Res 1986; Nov 65:1365-1370.
8. National Institutes of Health: Revised guide for the care and use of laboratory animals. Vol. 25, No. 28, August 16, 1996.
9. Matsumoto T, Hardaway RM, Pani KC, Sater CM, Bartak DE, Margetis PM. Safe standard of aeration for ethylene oxide sterilized supplies. Arch Surg 1968;96;464-470.
10. Gunther DA. Safety of ethylene oxide gas residuals. Part I. Am J Hosp Pharm 1974;31:558-561.
11. Gunther DA. Safety of ethylene oxide gas residuals. Part II. Am J Hosp Pharm 1974;31:684-686.
12. Jones AB. in vitro evaluation of hemolytic and cell culture toxicity potential of residual ethylene oxide in selected medical materials. J Biomed Mater Res 1979;13:207-216.
13. Tanaka S, Nakura S, Kawashima K, Kasuya Y, Omori Y. Studies on the hemolytic activity and the dermal irritability of ethylene oxide and its reaction products. Ikakikai Gaku 1982;52:21-28.
14. Ohba T. Safety of residual ethylene oxide and ethylene oxide concentrations in the working environment of sterilization facilities. In: Gaughren E, Morrissey R, You-sen W, editors. Sterilization of medical products. Vol. IV. Montreal, Canada: Polyscience Publications, Inc., 1986; p 172-177.
15. Hirose T, Goldstein R, Bailey CP. Hemolysis of blood due to exposure to different types of plastic tubing and the influence of ethylene oxide sterilization. J Thorac Cardiovasc Surg 1963;45:245-251.
16. O'Leary RK, Guess WL. Toxicological studies on certain medical grade plastics sterilized by ethylene oxide. J Pharm Sci 1968;57:12-17.
17. United States Pharmacopoeia 24, National Formulary 19, 2000.
18. OECD (Organization for Economic Cooperation and Development) Guidelines for Testing of Chemicals. Acute Dermal Toxicity; 402, adopted 24 February 1987.
19. Shupack JL, Andersen SR, Romano SJ. Human skin reactions to ethylene oxide. J Lab Clin Med 1981;98:723-729.
20. Federal Register: July 12, 1999 (Vol. 64, No. 132).