Packaging and Sterilization of UHMWPE

UHMWPE Biomaterials Handbook

Volumn , Issue , 2009, Pages 21-30

  Kurtz, Steven M ^a  

^a DREXEL UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 79960969444     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-12-374721-1.00003-1     Document Type: Chapter

References (42)

1. Costa L, Bracco P, Brach del Prever EM, Kurtz SM, Gallinaro P Oxidation and oxidation potential in contemporary packaging for polyethylene total joint replacement components. J Biomed Mater Res B Appl Biomater 2006, 78(1):20-26. July.
2. Kurtz SM, Hozack WJ, Purtill JJ, Marcolongo M, Kraay MJ, Goldberg VM, et al. Significance of in vivo degradation for polyethylene in total hip arthroplasty. Clin Orthop Relat Res 2006, 453:47-57.
3. Isaac GH, Dowson D, Wroblewski BM An investigation into the origins of time-dependent variation in penetration rates with Charnley acetabular cups-wear, creep or degradation?. Proc Inst Mech Eng 1996, 210(3):209-216.
4. Kurtz SM, Muratoglu OK, Evans M, Edidin AA Advances in the processing, sterilization, and crosslinking of ultra-high molecular weight polyethylene for total joint arthroplasty. Biomaterials 1999, 20(18):1659-1688.
5. Jahan MS, Wang C Combined chemical and mechanical effects on free radicals in UHMWPE joints during implantation. J Biomed Mater Res 1991, 25:1005-1017.
6. Kurth M, Eyerer P, Ascherl R, Dittel K, Holz U An evaluation of retrieved UHMWPE hip joint cups. J Biomater Appl 1988, 3(1):33-51.
7. Rimnac CM, Klein RW, Betts F, Wright TM Post-irradiation aging of ultra-high molecular weight polyethylene. J Bone Joint Surg 1994, 76A(7):1052-1056.
8. Bostrom MP, Bennett AP, Rimnac CM, Wright TM The natural history of ultra-high molecular weight polyethylene. Clin Orthop 1994, 309(309):20-28.
9. Kurtz SM, Rimnac CM, Bartel DL Degradation rate of ultra-high molecular weight polyethylene. J Orthop Res 1997, 15(1):57-61.
10. Kurtz SM, Bartel DL, Rimnac CM Post-irradiation aging affects the stresses and strains in UHMWPE components for total joint replacement. Clin Orthop 1998, 350:209-220.
11. Edidin AA, Jewett CW, Kwarteng K, Kalinowski A, Kurtz SM Degradation of mechanical behavior in UHMWPE after natural and accelerated aging. Biomaterials 2000, 21(14):1451-1460.
12. Collier JP, Sperling DK, Currier JH, Sutula LC, Saum KA, Mayor MB Impact of gamma sterilization on clinical performance of polyethylene in the knee. J Arthroplasty 1996, 11(4):377-389.
13. Sutula LC, Collier JP, Saum KA, Currier BH, Currier JH, Sanford WM, et al. Impact of gamma sterilization on clinical performance of polyethylene in the hip. Clin Orthop 1995, 319:28-40.
14. Kennedy FE, Currier JH, Plumet S, Duda JL, Gestwick DP, Collier JP, et al. Contact fatigue failure of ultra-high molecular weight polyethylene bearing components of knee prostheses. J Tribol 2000, 122:332-339.
15. McGovern TF, Ammeen DJ, Collier JP, Currier BH, Engh GA Rapid polyethylene failure of unicondylar tibial components sterilized with gamma irradiation in air and implanted after a long shelf life. J Bone Joint Surg Am 2002, 84-A(6):901-906. June.
16. Orthopaedic Products. In: Smith RC, Geier MA, Reno J, Sarasohn-Kahn J, editors. Medical & Healthcare Marketplace Guide. New York: IDD Enterprises, L.P.; 1996. p. 265-72.
17. McKellop HA, Shen F-W, Campbell P, Ota T Effect of molecular weight, calcium stearate, and sterilization methods on the wear of ultra-high molecular weight polyethylene acetabular cups in a hip simulator. J Orthop Res 1999, 17(3):329-339.
18. Wang A, Essner A, Polineni VK, Stark C, Dumbleton JH Lubrication and wear of ultra-high molecular weight polyethylene in total joint replacements. Tribol Int 1998, 31(1-3):17-33.
19. Hopper RH, Young, AM, Orishimo KF, Engh CA Effect of terminal sterilization with gas plasma or gamma radiation on wear of polyethylene liners. J Bone Joint Surg Am 2003, 85-A(3):464-468. March.
20. Sychterz CJ, Orishimo KF, Engh CA Sterilization and polyethylene wear: clinical studies to support laboratory data. J Bone Joint Surg Am 2004, 86-A(5):1017-1022. May.
21. Bruck SD, Mueller EP Radiation sterilization of polymeric implant materials. J Biomed Mater Res 1988, 22(A2 Suppl.):133-144.
22. Ries MD, Weaver K, Beals N Safety and efficacy of ethylene oxide sterilized polyethylene in total knee arthroplasty. Clin Orthop 1996, 331:159-163.
23. Page BFJ, Cyr H A guide to AAMI's TIR for EtO-sterilized medical devices. Med Dev Diag Indust 1998, 20(2):73-78.
24. Goldman M, Lee M, Gronsky R, Pruitt L Oxidation of ultrahigh molecular weight polyethylene characterized by Fourier Transform Infrared Spectrometry. J Biomed Mater Res 1997, 37(1):43-50.
25. Collier JP, Sutula LC, Currier BH, Currier JH, Wooding RE, Williams IR, et al. Overview of polyethylene as a bearing material: comparison of sterilization methods. Clin Orthop 1996, 333(333):76-86.
26. Ries MD, Weaver K, Rose RM, Gunther J, Sauer W, Beals N Fatigue strength of polyethylene after sterilization by gamma irradiation or ethylene oxide. Clin Orthop 1996, 333:87-95.
27. Wang A, Sun DC, Yau S-S, Edwards B, Sokol M, Essner A, et al. Orientation softening in the deformation and wear of ultra-high molecular weight polyethylene. Wear 1997, 203-204:230-241.
28. White SE, Paxson RD, Tanner MG, Whiteside LA Effects of sterilization on wear in total knee arthroplasty. Clin Orthop 1996, 331(331):164-171.
29. Muratoglu OK, Kurtz SM Alternative bearing surfaces in hip replacement. Hip Replacement: current Trends and Controversies 2002, 1-46. Marcel Dekker, New York. R. Sinha (Ed.).
30. Goldman M, Pruitt L Comparison of the effects of gamma radiation and low temperature hydrogen peroxide gas plasma sterilization on the molecular structure, fatigue resistance, and wear behavior of UHMWPE. J Biomed Mater Res 1998, 40(3):378-384. June 5.
31. Feldman LA, Hui HK Compatibility of medical devices and materials with low-temperature hydrogen peroxide gas plasma. Med Dev Diag Indust 1997, 19(12):57-62.
32. Kyi MS, Holton J, Ridgway GL Assessment of the efficacy of a low temperature hydrogen peroxide gas plasma sterilization system. J Hosp Infect 1995, 31(4):275-284.
33. Reeves EA, Barton DC, FitzPatrick DP, Fisher J Comparison of gas plasma and gamma irradiation in air sterilization on the delamination wear of the ultra-high molecular weight polyethylene used in knee replacements. Proceedings of the Institution of Mechanical Engineers 2000, 214(3):249-255.
34. Charlebois SJ, Daniels AU, Lewis G Isothermal microcalorimetry: an analytical technique for assessing the dynamic chemical stability of UHMWPE. Biomaterials 2003, 24(2):291-296. January.
35. McKellop H, Shen FW, Lu B, Campbell P, Salovey R Effect of sterilization method and other modifications on the wear resistance of acetabular cups made of ultra-high molecular weight polyethylene. A hip-simulator study. J Bone Joint Surg Am 2000, 82-A(12):1708-1725. December.
36. Costa L, Luda MP, Trossarelli L, Brach del Prever EM, Crova M, Gallinaro P Oxidation in orthopaedic UHMWPE sterilized by gamma-radiation and ethylene oxide. Biomaterials 1998, 19(7-9):659-668. April-May.
37. Ultra-High Molecular Weight Polyethylene (UHMWPE) components of joint replacement implants. Medical Devices Agency Safety Notice MDA SN 9816; 1998.
38. ASTM F 1980-02. Standard guide for accelerated aging of sterile medical device packages. West Conshohocken, PA: American Society for Testing and Materials; 2002.
39. Edidin AA, Muth J, Spiegelberg S, Schaffner SR. Sterilization of UHMWPE in nitrogen prevents oxidative degradation for more than ten years. Transactions of the 46th Orthopedic Research Society. Orlando, FL; 2000 February 9-13. p. 1.
40. Greer K. A prospective study of the effects of five years shelf aging on the properties of UHMWPE following gamma sterilization in air or in a vacuum foil pouch. Transactions of the 28th Society for Biomaterials; 2003. p. 378.
41. Streicher RM Ionizing irradiation for sterilization and modification of high molecular weight polyethylenes. Plast Rubber Proc Appl 1988, 10(4):221-229.
42. Lu S, Orr JF, Buchanan FJ The influence of inert packaging on the shelf ageing of gamma-irradiation sterilised ultra-high molecular weight polyethylene. Biomaterials 2003, 24(1):139-145. January.