Problems associated with reprocessing of disposable medical devices such as hemodialysers with resterilization for reuse and changes in material properties with resterilization of polymeric (PVC, polypropylene, polyester, polycarbonate) materials intended for development of disposable devices are reviewed. Reprocessing of hospital supplies, polystyrene microtiter plate and angiographic catheter for reuse is also discussed.
1. Landfield, H. 1977. "Selective Parameters for the Use of Plastics in Medical Devices,"NATEC 1977 SPE, Denver, CO, Nov. 8.
2.
2. Favero, M. S. and N. J. Peterson. 1977. "Microbiological Guidelines for Hemodialysis System's,"Dial and Transplan., 6:34-36.
3.
3. Carson, L. A., N. J. Peterson, M. S. Favero and S. M. Aguero. 1978. "Growth Characteristics of a Typical Mycobacteria in Water and Their Comparative Resistance to Disinfection,"Appl. Environ. Microbiol., 36:839-846.
4.
4. Pollard, T. L., B. M. S. Barnett, J. W. Eschbach and B. H. Scribner. 1967. "A Technique for Storage and Multiple Reuse of the Kill Dialyser and Blood Tubing,"Trans. Am. Soc. Artif. Intern. Organs., 13:24-28.
5.
5. National Institute for Occupational Safety and Health. 1975. Suspected Carcinogen's in Toxic Substances List, Pub. No. 75-188, Cincinnati, OH: NIOSH.
6.
6. Baner, H.1983. "Experience with the Disinfectant Peroxyocetic Acid for Haemodialyser Reuse,"ASAIO Abstracts, 12:41
7.
7. Fassbinder, W. and K. M. Koch. 1983. "A Specific Immuno-Haemolytic Anaemia Induced by Formaldehyde Sterilization of Dialyser's,"Contributions to Nephology, 36:51-67.
8.
8. Alter, M. J., M. S. Favero, L. A. Moyer and L. A. Bland. 1991. "National Surveillance of Dialysis-Associated Diseases in United States, 1989"Trans. Am. Soc. Artif. Intern. Organs, 37:97-109.
9.
9. Rames, A. and D. F. Williams. 1991. "Neutrophil Polarization and Immuno Electrophoresis Assays in the Study of Complement Activation by Biomaterials,"Biomaterials, 12:607-613.
10.
10. Hakim, R. M. and R. G. Lowrie. 1980. "Effect of Dialyser Reuse on Leukopenia Hypoxemia and Total Hemolytic Complement System,"Trans. Am. Soc. Artif. Intern. Organs, 26:159-164.
11.
11. Ing, S., P. T. Ivánovich and J. T. Daugirdas. 1987. "First-Use Syndrome and Hypersensitivity During Hemodialysis; Some Pieces of the Puzzle Are Falling Into Place,"Artif Organs, 11(2):79-81.
12.
12. Craddock, P. R., J. Fehr, A. P. Dalmasso, K. I. Brigham and H. S. Jacob. 1977. "Haemodialysis Leukopenia-Pulmonary Vascular Leukostasis Resulting from Complement Activation by Dialyzer Cellophane Membranes,"J. Clin. Invest., 59:879-888.
13.
13. Pearson, F. C., J. Bohon, W. Lee, X. Bruszer, M. Sagona, R. Dawe, G. Jakubowski, D. Morrison and C. Dinarello. 1984. "Comparison of Chemical Analyses of Hollow-Fiber Dialyser Extracts,"Artif. Organs, 8:291-298.
14.
14. Chenoweth, D. E.1980. "Complement Activation Produced by Biomaterials,"Artif. Organs, 12(6):502-504.
15.
15. Payne, M. S. and T. A. Horbett. 1987. "Complement Activation by Hydroxy Ethyl Methacrylate-Ethyl Methacrylate Copolymers,"J. Biomed. Mat. Res., 21:843-859.
16.
16. Ikeda, Y., S. Koljiya, S. Yamashita, H. Fukumura and S. Yoshikawa. 1988. "Activation of the Complement System in Blood on the Surface of Segmented Polyurethane Urea Having Good Blood Compatibility,"Polymer J., 20(3):273-276.
17.
17. Alter, M. J., M. S. Favero, L. A. Moyer, J. K. Miller and L. A. Bland. 1990. "National Surveillance of Dialysis-Associated Diseases in the United States 1988,"Trans. Am. Soc. Artif. Intern. Organs, 36:107-118.
18.
18. Hakim, R. M., J. Breillatt, M. Lazarus and F. K. Port. 1984. "Complement Activation and Hypersensitivity Reaction to Dialysis Membranes,"N. Engl. J. Med., 311:878-882.
19.
19. Charoenpanich, R., K. V. E. Polla, K. S. Kant, M. D. Robson and M. Cathey. 1987. "Effect of First and Subsequent Use of Hemodialyzers on Patient Well-Being: The Rise and Fall of a Syndrome Associated with New Dialyzer Use,"Artif. Organs, 11(2):123-127.
20.
20. Dumler, F., G. Zasuwa and N. W. Levin. 1987. "Effect of Dialyser Reprocessing Methods on Complement Activation and Hemodialyzer Related Symptoms,"Artif. Organs, 11(2):128-131.
21.
21. Vincent, W. W.1981. "Plastics in Medical Tubing Applications-Manufacturing Considerations,"Biomaterials, 2:194-200.
22.
22. Jayabalan, M., K. Streenivasan, P. D. Nair and B. K. George. 1991. "Effect of Repeated Autoclaving of PVC for Biomedical Use,"Biomedicine, 11(1):7-12.
23.
23. Weiselberg, M. 1984. "New Technology in Medical Plastics,"Proc. of West Coast Medical Plastics Conference, El Segundo, CA: T/C Pub., p. 135.
24.
24. Cohen, S. L.1983. Biocompatible Polymers Metals and Composites, M. Szycher, ed., Lancaster, PA: Technomic Publishing Co., Inc., p. 789.
25.
25. Jayabalan, M., K. Sreenivasan, P. D. Nair and K. N. Jalajamani. 1987. "A Study on the Effect of Gamma Radiation Sterilization of Poly Carbonate (LMW)," accepted for Proceedings of the 24th Annual Rocky Mountain Bioengineering Conference, April 27-28, North Dakota State University, USA, (unpublished results).
26.
26. Golden, J. H. and E. A. Hazell. 1963. J. Polym. Sci., part A1:1671.
27.
27. Golden, J. H.1966. Makromol. Chem., 66:73.
28.
28. Williams, D. F. and R. Roaf. 1973. Implants in Surgery. London: W. B. Saunders, p. 186.
29.
29. Plester, D. W.1979. "The Effects of Sterilizing Processes on Plastics,"Biomed. Eng, 5:443.
30.
30. Jayabalan, M., K. Sreenivasan, P. D. Nair and H. Vijayakumar. 1986. Studies on Radiation Sterilization of Polypropylene: Chain Branching on Aging in Biomedical Engineering V: Recent Development, S. Saha, ed., New York: Pergamon, p. 344.
31.
31. Jayabalan, M., P. D. Nair and K. Sreenivasan. 1989. "Ageing of Radiation-Sterilized Poly Propylene: Changes in Semicrystallinity,"Biomaterials, 10:33-37.
32.
32. Skiens, W. E. and J. C. Williams. 1983. Biocompatible Polymers, Metals and Composites, M. Szycher, ed., Lancaster, PA: Technomic Publishing Co., Inc., p. 1001.
34. Chapiro, A.1962. Radiation Chemistry of Polymer Systems. Interscience Pub.
35.
35. Teszler, O. and H. A. Rutherford. 1956. "The Effect of Nuclear Radiation on Fibrous Materials (I) Dacron Polyester Fiber,"Textile Res. J., 26:796.
36.
36. Potnis, S. P., S. M. Shetty, K. N. Rao and J. A. Prakash. 1969. "Effect of Gamma Irradiation on Synthetic Fibers,"Makromol. Chem., 6:127.
37.
37. Nair, P. D., K. Sreenivasan and M. Jayabalan. 1988. "Multiple Gamma Radiation Sterilization of Polyester Fibers,"Biomaterials, 9:335-338.
38.
38. David, C.1975. Comprehensive Chemical Kinetics-Degradation of Polymers, Vol. 14. C. H. Bamford and C. F. H. Tipper, eds., Amsterdam: Elsevier, p. 175.
39.
39. Achhammer, B. G., M. J. Reiney, L. A. Wall and F. W. Reinhart. 1957. Nat. Bur. Stand. (US) circ., 525:205.
