Transmissible spongiform encephalopathies: Decontamination considerations for manufacturing environments

American Pharmaceutical Review

Volumn 9, Issue 2, 2006, Pages

  Scott, Dorothy E ^a   Asher, David M ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AUTOCLAVE; COLUMN CHROMATOGRAPHY; DISEASE TRANSMISSION; DISINFECTION; DRUG CONTAMINATION; GOOD MANUFACTURING PRACTICE; HUMAN; NONHUMAN; PRION DISEASE; REVIEW; RISK REDUCTION;

EID: 55749110769     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (45)

1. Will, RG, Ironside, JW, Zeidler, M, Cousens, SN, Estibeiro, K, Alperovich, A, Poser, S, Pocchiari, M, Hofman, A, and Smith, PG. A new variant of Creutzfeldt-Jakob disease in the UK. Lancet 347:921-5, 1996.
2. CJD Statistics in the United Kingdom, at http://www.cjd.ed.ac.uk/figures. htm (accessed 1/2006).
3. Peden, AH, Head, MW, Ritchie, DL, Ball, JE, Ironside, JW. Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 364: 527-9, 2004.
4. Llewelyn, CA, Hewitt, PE, Knight, RS, Amar, K, Cousens, S, Mackenzie, J, Will, RG. Possible transmission of variant Creutzfeldt- Jakob disease by blood transfusion. Lancet 363:417-421, 2004.
5. Prusiner, SB. Shattuck lecture - Neurodegenerative diseases and prions. NEJM 344: 1516-26, 2001.
6. Hilton, DA, E Fathers, P Edwards, JW Ironside, J Zajicek (1998). Prion immunoreactivity in appendix before clinical onset of variant Creutzfeldt-Jakob disease. Lancet 352(9129): 703-704.
7. Hilton, DA, AC Ghani, L Conyers, P Edwards, L McCardle, M Penney, D Ritchie, JW Ironside (2002). Accumulation of prion protein in tonsil and appendix: Review of tissue samples. BMJ 325(7365): 633-634.
8. Hilton, DA, AC Ghani, L Conyers, P Edwards, L McCardle, D Ritchie, M Penney, D Hegazy, JW Ironside (2004a). Prevalence of lymphoreticular prion protein accumulation in UK tissue samples. J Pathol 203(3): 733-739.
9. Hilton, DA, J Sutak, ME Smith, M Penney, L Conyers, P Edwards, L McCardle, D Ritchie, MW Head, CA Wiley, JW Ironside (2004b). Specificity of lymphoreticular accumulation of prion protein for variant Creutzfeldt-Jakob disease. J Clin Pathol 57(3): 300-302.
10. FDA Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products, at http://www.fda.gov/cber/gdlns/cjdvcjd0602. htm (accessed 1/2006).
11. Foster, PR, Welch, AG, McLean, C, Griffin, BD, Hardy, JC, Bartley, A, MacDonald, S, and Bailey, AC. Studies on the removal of abnormal prion by processes used in the manufacture of human plasma products. Vox Sang 78:86-95, 2000.
12. TSE Advisory Committee Meeting, February 20, 2003, at http://www.fda.gov/ohrms/dockets/ac/cber03.html#TransmissibleSpo ngiform (accessed 1/2006); and http://www.fda.gov/ohrms/dockets/ac/cber04. html#TransmissibleSpo ngiform (accessed 1/2006).
13. Gibbs, CJ, Asher, DM, Kobrine A, Amyx, HL, Sulima, MP, and Gadjusek, DC. Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes contaminated during neurosurgery. J Neurol Neurosurg Psych 67:757-8, 1994.
14. Asher DM, KL Pomeroy , L Murphy, RG Rohwer, CJ Gibbs Jr, DC Gajdusek DC (1986). Practical inactivation of scrapie agent on surfaces. IXth International Congress of Infectious and Parasitic Diseases, Munich, Germany, Futuramed Verlag.
15. Asher, DM, KL Pomeroy, L Murphy L, CJGibbs, Jr, DC Gajdusek (1987). Attempts to disinfect surfaces contaminated with etiologic agents of the spongiform encephalopathies. VIIth International Congress of Virology, Edmonton, Alberta, Canada 1987.
16. Weissmann, C, Enari, M, Klohn, P-C, Rossi, D, and Flechsig, E. Transmission of prions. PNAS 99: 16378-83, 2002.
17. Flechsig, E, Hegyi, I, Enari, M, Schwarz, P, Collinge, J, and Weissmann, C. Transmission of scrapie by steel-surface-bound prions. Mol Med 7:679-84, 2001.
18. Taylor, DM. Inactivation of transmissible degenerative encephalopathy agents: a review. Vet J 159:10-17, 2000.
19. Somerville, RA, Oberthur, RC, Havekost, U, MacDonald, F, Taylor, DM, and Dickinson AG. Characterization of thermodynamic diversity between transmissible spongiform encephalopathy agent strains and its theoretical implications. J Biol Chem 277:11084-9, 2002.
20. Rutula, WA and Weber, DJ. Creutzfeldt-Jakob Disease: recommendations for disinfection and sterilization. Clin Inf Dis 32: 1348- 56, 2001.
21. Taylor, DM, and McConnell, I. Autoclaving does not decontaminated formol-fixed scrapie tissues. Lancet Jun 25 1(8600): 1463-4, 1988. and McConnell, Lancet 1988.
22. Taylor, DM, Fraser, H, McConnell, I, Brown, DA, Brown, KL, Lamza, KA, and Smith, GR. Decontamination studies with the agents of bovine spongiform encephalopathy and scrapie. Arch Virol 139: 313-26, 1994.
23. World Health Organization (1999). General considerations for effective TSE agent decontamination in healthcare settings. WHO Publ. WHO/CDS/CSR/APH/ 2000.3 (accessed 24 Jan 2006 at).
24. Rohwer, RG (1984a). Scrapie infectious agent is virus-like in size and susceptibility to inactivation. Nature (London) 308: 658-662.
25. Rohwer, RG (1984b). Virus-like sensitivity of scrapie agent to heat inactivation. Science 223: 600-602.
26. Brown, P, Rau, EH, Lemieux, P, Johnson BK, Bacote AE, Gadjusek DC. Infectivity studies of both ash and air emissions from simulated incineration of scrapie-contaminated tissues. Environ Sci Technol 15: 6155-60, 2004. 2000.
27. Brown, P, Rau, EH, Johnson, BK, Bacote, AE, Gibbs, CJ Jr, Gadjusek DC. New studies on the heat resistance of hamster-adapted scrapie agent: threshold survival after ashing at 600 degrees C suggests an inorganic template of replication. Proc Natl Acad Sci USA 28: 3418-21, 2000.
28. Ernst, DR, and Race, RE. Comparative analysis of scrapie agent inactivation methods. J Virol Meth 41: 193-202, 1993.
29. Manuelidis, L. Decontamination of Creutzfeldt-Jakob disease and other transmissible agents. J. Neurovirol 3:62-5, 1997.
30. Peretz, D, Suachai, S, Giles, K, Vergara, J, Freyman, Y, Lessard, P, Safar, JG, Glidden, DV, McCulloch, C, Nguyen, H-O B, Scott, M, DeArmond, SJ, and Prusiner, SB. Inactivation of prions by acidic sodium dodecyl sulfate. J Virol 80: 322-31, 2006.
31. Kasermann, F, and Kempf, C. Sodium hydroxide renders the prion protein PrPSc sensitive to proteinase K. J Gen Virol 84: 3173- 6, 2003.
32. Fichet, G, Comoy, E, Duval, C, Antloga, K, Dehen, C, Charbonnier, A, McDonnell, G, Brown, P, Lasmezas, CI, Deslys, J-P. Novel methods for disinfection of prion-contaminated medical devices. Lancet 364: 521-6, 2004.
33. Groner, A, and Boose, JA. Evaluation of a cleaning procedure for its capacity to remove prions from equipment used in the production of plasma derivatives. 47th Ann Meet Soc Thromb Haem Res, 2003 (abstract).
34. Brown, P, RG Rohwer, DC Gajdusek (1986). Newer data on the inactivation of scrapie virus or Creutzfeldt-Jakob disease virus in brain tissue. Journal of Infectious Diseases 153(6): 1145-1148.
35. Jackson, GS, McKintosh, E, Flechsig, E, Prodromidou, K, Hirsch, P, Linehan, J, Brandner, S, Clarke, AR, Weissmann, C, and Collinge, J. An enzyme-detergent method for effective prion decontamination of surgical steel. J Gen Virol 86:869-78, 2005.
36. Langeveld JPM, Wang, J-J, Van de Wiel, DFM, Shih, GC, Garssen, J, Bossers, A, and Shih, JCH. Enzymatic degradation of prion protein in brain stem from infected cattle and sheep. JID 188: 1782-89, 2003.
37. Sehulster, LM. Prion inactivation and medical instrument reprocessing: challenges facing healthcare facilities. Inf Cont Hosp Epi 25: 280-3, 2004. 4.
38. Foster, PR, Griffin, BD, Bieneck, C, McIntosh, RV, MacGregor, IR, Somerville, RA, Steele, PJ, and Reichl, HE. Distribution of a bovine spongiform encephalopathy-derived agent over ion-exchange chromatography used in the preparation of concentrates of fibrinogen and factor VIII. Vox Sang 86: 92-99, 2004.
39. Reviewed in reference (10).
40. Evatt B, Austin, H, Barnhart, E, Schonberger, L, Sharer, L, Jones, R, DeArmond, S. Surveillance for Creutzfeldt-Jakob disease among persons with hemophilia. Transfusion 38: 817-20, 1998.
41. TSEAC June 2001, at http://www.fda.gov/ohrms/dockets/ac/cber01. htm#Transmissible Spongiform, (accessed 1/2006).
42. Lee, DC, Stenland, CJ, Miller, JLC, Cai, K, Ford, E, Gilligan, KJ, Hartwell, RC, Terry, JC, Rubenstein R, Fournel, M, Petteway SR. A direct relationship between partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins. Transfusion 41:449-55, 2001.
43. Trejo, SR, Hotta, JA, Lebin, W, Stenland, C, Storms, RE, Lee, DC, Li, H, Petteway, S, Remington, KM. Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process. Vox Sang 84:176-87, 2003.
44. Brown, P, Cervenakova, L, McShane, IM, Barber, P, Rubenstein, R, Drohan, WN. Further studies of blood infectivity in an experimental model of transmissible spongiform encephalopathy, with an explanation of why blood components do not transmit Creutzfeld-Jakob disease in humans. Transfusion 39: 1169-78, 1999.
45. TSEAC transcripts 2005, topic II, http://www.fda.gov/ohrms/dockets/ac/ cber05.html#TransmissibleSpongiform (accessed 1/2006).