Skip to main content
×
×
Home

Guideline for Disinfection and Sterilization of Prion-Contaminated Medical Instruments

  • William A. Rutala (a1) (a2) and David J. Weber (a1) (a2)
Copyright
Corresponding author
Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, NC 27599-7030, (brutala@unch.unc.edu)
References
Hide All
1.Centers for Disease Control and Prevention (CDC). Surveillance for Creutzfeldt-Jakob disease—United States. MMWR Morb Mortal Wkly Rep 1996;45:665668.
2.Johnson, RT, Gibbs, CJ Jr.Creutzfeldt-Jakob disease and related transmissible spongiform encephalopathies. N Engl J Med 1998;339:19942004.
3.Collins, SJ, Lawson, VA, Masters, CL. Transmissible spongiform encephalopathies. Lancet 2004;363:5161.
4.Belay, ED, Sejvar, JJ, Shieh, W-J, et, al. Variant Creutzfeldt-Jakob disease death, United States. Emerg Infect Dis 2005;11:13511354.
5.Centers for Disease Control and Prevention (CDC). Probable variant Creutzfeldt-Jakob disease in a U.S. resident—Florida, 2002. MMWR Morb Mortal Wkly Rep 2002;51:927929.
6.National Creutzfeldt-Jakob Disease Surveillance Unit. Variant Creutzfeldt-Jakob Diseases Current Data, July 2009. Edinburgh, Scotland: University of Edinburgh; 2009.
7.Belay, ED, Maddox, RA, Williams, ES, Miller, MW, Gambetti, P, Schonberger, LB. Chronic wasting disease and potential transmission to humans. Emerg Infect Dis 2004;10:977984.
8.Kong, Q, Huang, S, Zou, W, et, al. Chronic wasting disease of elk: trans-missibility to humans examined by transgenic mouse models. J Neurosa 2005;25:79447949.
9.Centers for Disease Control and Prevention (CDC). Fatal degenerative neurologic illnesses in men who participated in wild game feasts— Wisconsin, 2002. MMWR Morb Mortal Wkly Rep 2003;52:125127.
10.Mawhinney, S, Pape, WJ, Forster, JE, Anderson, CA, Bosque, P, Miller, MW. Human prion disease and relative risk associated with chronic wasting disease. Emerg Infect Dis 2006;12:15271535.
11.Brown, P, Brandel, J-P, Preese, M, Sato, T. Iatrogenic Creutzfeldt-Jakob disease: the waning of an era. Neurology 2006;67:389393.
12.World Health Organization (WHO). WHO infection control guidelines for transmissible spongiform encephalopathies. Geneva, Switzerland: WHO; 2000. Available at: http://www.who.int/csr/resources/publications/bse/whocdscsraph2003.pdf. Accessed January 3, 2010.
13.Brown, P, Preece, M, Brandel, JP, et al.Iatrogenic Creutzfeldt-Jakob disease at the millennium. Neurology 2000;55:10751081.
14.Brown, P. Environmental causes of human spongiform encephalopathy. In: Baker, H, Ridley, RM, eds. Methods in Molecular Medicine: Prion Diseases. Totowa, NJ: Humana Press; 1996:139154.
15.Brown, P, Gibbs, CJ, Rodgers-Johnson, P, et al.Human spongiform encephalopathy: the National Institutes of Health series of 300 cases of experimentally transmitted disease. Ann Neurol 1994;35:513529.
16.Rutala, WA, Weber, DJ. Creutzfeldt-Jakob disease: recommendations for disinfection and sterilization. Clin Infect Dis 2001;32:13481356.
17.McDonnell, G. Prion disease transmission: Can we apply standard precautions to prevent or reduce risks? J Perioper Pract 2008;18:298304.
18.Tamai, Y, Kojima, H, Kitajima, R, et al.Demonstration of the transmissible agent in tissue from a pregnant woman with Creutzfeldt-Jakob disease. N Engl J Med 1992;327:649.
19.Zanusso, G, Ferrari, S, Cardone, F, et al.Detection of pathologic prion protein in the olfactory epithelium in sporadic Creutzfeldt-Jakob disease. N Engl J Med 2003;348:711719.
20.Geertsma, RE, van Asten, JAAM. Sterilization of prions: requirements, complications, implications. Zentralbl Steril 1995;3:385394.
21.Bernoulli, C, Siegfried, J, Baumgartner, G, et al.Danger of accidental person-to-person transmission of Creutzfeldt-Jakob disease by surgery. Lancet 1977;1(8009):478479.
22.Nevin, S, McMenemey, WH, Behrman, S, Jones, DP. Subacute spongiform encephalopathy—a subacute form of encephalopathy attributable to vascular dysfunction (spongiform cerebral atrophy). Brain 1960;83:519569.
23.Foncin, J-F, Gaches, J, Cathala, F, Sherif, E, LeBeau, J. Transmission iatrogene interhumaine possible de maladie de Creutzfeldt-Jakob avec atteinte des grains du cervelet. Rev Neurol (Paris) 1980;136:280.
24.Barash, JA, Johnson, BT, Gregorio, DI. Is surgery a risk factor for Creutzfeldt-Jakob disease? Outcome variations by control choice and exposure assessments. Infect Control Hosp Epidemiol 2008;29:212218.
25.Hamaguchi, T, Noguchi-Shinohara, M, Nakamura, Y, et al.Ophthalmic surgery in prion diseases. Emerg Infect Dis 2007;13:162164.
26.Chamberland, ME. Emerging infectious agents: do they pose a risk to the safety of transfused blood and blood products? Clin Infect Dis 2002;34:797805.
27.Fichet, G, Comoy, C, Duval, C, et al.Novel methods for disinfection of prion-contaminated medical devices. Lancet 2004;364:521526.
28.Fichet, G, Comoy, E, Dehen, C, et al.Investigations of a prion infectivity assay to evaluate methods of decontamination. J Microbiol Methods 2007;70:511518.
29.Yan, ZX, Stitz, L, Heeg, P, Roth, K, Mauz P-S. Low-temperature inacti-vation of prion-protein on surgical steel surfaces with hydrogen peroxide gas plasma sterilization. Zentralbl Steril 2008;16:2634.
30.Jackson, GS, McKintosh, E, Flechsig, E, et al.An enzyme-detergent method for effective prion decontamination of surgical steel. J Gen Virol 2005;86:869878.
31.Taylor, DM. Inactivation of transmissible degenerative encephalopathy agents: a review. Vet J 2000;159:1017.
32.Rogez-Kreuz, C, Yousfi, R, Soufflet, C, et al.Inactivation of animal and human prions by hydrogen peroxide gas plasma sterilization. Infect Control Hosp Epidemiol 2009;30:769777.
33.Yan, Z, Stitz, L, Heeg, P, Pfaff, E, Roth, K. Infectivity of prion protein bound to stainless steel wires: a model for testing decontamination procedures for transmissible spongiform encephalopathies. Infect Control Hosp Epidemiol 2004;25:280283.
34.Solassol, J, Arlotto, M, Lehmann, S. Detection of prion after decontamination procedures: comparative study of standard Western blot, filter retention, and scrapie-cell assay. J Hosp Infect 2004;57:156161.
35.Rutala, WA, Weber, DJ. Management of equipment contaminated with Creutzfeldt-Jakob disease. In: Rutala, WA, ed. Disinfection, Sterilization and Antisepsis: Principles and Practices in Healthcare Facilities. Washington, DC: Association for Professionals in Infection Control and Epidemiology; 2001:167172.
36.Fichet, G, Antloga, K, Comoy, E, Deslys, JP, McDonnell, G. Prion inactivation using a new gaseous hydrogen peroxide sterilization process. J Hosp Infect 2007;67:278286.
37.Peretz, D, Supattapone, S, Giles, K, et al.Inactivation of prions by acidic sodium dodecyl sulfate. J Virol 2006;80:322331.
38.Dickinson, AG, Taylor, DM. Resistance of scrapie agent to decontamination. N Engl J Med 1978;299:14131414.
39.Hartley, EG. Action of disinfectants on experimental mouse scrapie. Nature 1967;213:1135.
40.Walker, JT, Dickinson, J, Sutton, JM, Marsh, PD, Raven, NDH. Implications for Creutzfeldt-Jakob disease (CJD) in dentistry: a review of current knowledge. J Dent Res 2008;87:511519.
41.Taylor, DM, Fernie, K, McConnell, I. Inactivation of the 22A strain of scrapie agent by autoclaving in sodium hydroxide. Vet Microbiol 1997;58:8791.
42.Brown, P, Rohwer, RG, Green, EM, Gajdusek, DC. Effect of chemicals, heat, and histopathologic processing on high-infectivity hamster-adapted scrapie virus. J Infect Dis 1982;145:683687.
43.Kimberlin, RH, Walker, CA, Millson, GC, et al.Disinfection studies with two strains of mouse-passaged scrapie agent: guidelines for Creutzfeldt-Jakob and related agents. J Neurol Sci 1983;59:355369.
44.Taylor, DM, Fraser, H, McConnell, I, et al.Decontamination studies with the agents of bovine spongiform encephalopathy and scrapie. Arch Virol 1994;139:313326.
45.Vadrot, C, Darbord, J-C. Quantitative evaluation of prion inactivation comparing steam sterilization and chemical sterilants: proposed method for test standardization. J Hosp Infect 2006;64:143148.
46.Baxter, HC, Campbell, GA, Whittaker, AG, et al.Elimination of transmissible spongiform encephalopathy infectivity and decontamination of surgical instruments by using radio-frequency gas-plasma treatment. J Gen Virol 2005;86:23932399.
47.Ernst, DR, Race, RE. Comparative analysis of scrapie agent inactivation methods. J Virol Methods 1993;41:193201.
48.Sutton, JM, Dickinson, J, Walker, JT, Raven, NDH. Methods to minimize the risks of Creutzfeldt-Jakob disease transmission by surgical procedures: where to set the standard? Clin Infect Dis 2006;43:757764.
49.Zobeley, E, Flechsig, E, Cozzio, A, Enari, M, Weissmann, C. Infectivity of scrapie prions bound to a stainless steel surface. Mol Med 1999;5:240243.
50.Taylor, DM, Diprose, MF. The response of the 22A strain of scrapie agent to microwave irradiation compared to boiling. Neuropathol Appi Neu-robiol 1996;22:256258.
51.Taylor, DM, McConnell, I. Autoclaving does not decontaminate formol-fixed scrapie tissues. Lancet 1988;1(8600):14631464.
52.Taylor, DM. Inactivation of prions by physical and chemical means. J Hosp Infect 1999;43 (Suppl):S69S76.
53.Rutala, WA; 1994, 1995, and 1996 APIC Guidelines Committee. APIC guideline for selection and use of disinfectants. Association for Professionals in Infection Control and Epidemiology. Am J Infect Control 1996;24:313342.
54.Rutala, WA, Weber, DJ. FDA labeling requirements for disinfection of endoscopes: a counterpoint. Infect Control Hosp Epidemiol 1995;16:231235.
55.Merritt, K, Hitchins, VM, Brown, SA. Safety and cleaning of medical materials and devices. J Biomed Mater Res 2000;53:131136.
56.Alfa, MJ, Jackson, M. A new hydrogen peroxide-based medical-device detergent with germicidal properties: comparison with enzymatic cleaners. Am J infect Control 2001;29:168177.
57.Jacobs, P. Cleaning: principles, methods and benefits. In: Rutala, WA, ed. Disinfection, Sterilization, and Antisepsis in Healthcare. Champlain, NY: Polyscience Publications; 1998:165181.
58.Stephenson, J. Halting the spread of human prion disease—exceptional measures for an exceptional problem. J Hosp Infect 2007;65:1418.
59.Lipscomb, IP, Pinchin, H, Collin, R, Kevil, CW. Effect of drying time, ambient temperature and pre-soaks on prion-infected tissue contamination levels on surgical stainless steel: concerns over prolonged transportation of instruments from theatre to central sterile service departments. Hosp Infect 2007;65:7277.
60.Baier, M, Schwarz, A, Mielke, M. Activity of an alkaline ‘cleaner’ in the inactivation of the scrapie agent. J Hosp Infect 2004;57:8084.
61.Yoshioka, M, Murayama, Y, Miwa, T, et al.Assessment of prion inactivation by combined use of Bacillus-derived protease and SDS. Biosci Biotechnol Biochem 2007;71:25652568.
62.Lawson, VA, Stewart, JD, Masters, CL. Enzymatic detergent treatment protocol that reduces protease-resistant prion load and infectivity from surgical-steel monofilaments contaminated with a human-derived prion strain. J Gen Virol 2007;88:29052914.
63.United Kingdom Department of Health. New technologies working group report on prion inactivating agents. London, UK: Department of Health; 2008:130.
64.Fichet, G, Harrison, J, McDonnell, G. Reduction of risk of prion transmission on surgical devices with effective cleaning processes. Zentralbl Steril 2007;15:418437.
65.McLeod, AH, Murdoch, H, Dickinson, J, et al.Proteolytic inactivation of the bovine spongiform encephalopathy agent. Biochem Biophys Res Commun 2004;317:11651170.
66.McDonnell, G, Fichet, G, Kaiser, H, et al.Cleaning investigations to reduce the risk of prion contamination on manufacturing surfaces and materials. Eur J Parenter Pharm Sci 2005;10:6772.
67.Dickinson, J, Murdoch, H, Dennis, MJ, et al.Decontamination of prion protein (BSE301V) using a genetically engineered protease. J Hosp Infect 2009;72:6570.
68.Rohwer, RG. Virus like sensitivity of the scrapie agent to heat inactivation. Science 1984;223:600602.
69.Fernie, K, Steele, PJ, Taylor, DM, Somerville, RA. Comparative studies on the thermostability of five strains of transmissible-spongiform-en-cephalopathy agent. Biotechnol Appi Biochem 2007;47:175183.
70.Murdoch, H, Taylor, D, Dickinson, J, et al.Surface decontamination of surgical instruments: an ongoing dilemma. J Hosp Infect 2006;63:432438.
71.Sattar, SA, Springthorpe, VS. New methods for efficacy testing of disinfectants and antiseptics. In: Rutala, WA, ed. Disinfection, Sterilization and Antisepsis: Principles and Practices in Healthcare Facilities. Washington, DC: Association for Professionals in Infection Control and Epidemiology; 2001:174186.
72.McDonnell, G, Amato, R, Malchesky, PS, Muzic, DS, Marchant, RE. Use of Dacron as an alternative for evaluating oxidizing sterilants in the AOAC sporicidal tests. J AOAC Int 2000;83:269275.
73.Ascenzi, JM, Ezzell, RJ, Wendt, TM. A more accurate method for measurement of tuberculocidal activity of disinfectants. Appi Environ Microbiol 1987;53:21892192.
74.Rutala, WA, Cole, EC. Ineffectiveness of hospital disinfectants against bacteria: a collaborative study. Infect Control 1987;8:501506.
75.Cole, EC, Rutala, WA, Alfano, EM. Comparison of stainless steel peni-cylinders used in disinfectant testing. J Assoc Off Anal Chem 1988;71:288289.
76.Cole, EC, Rutala, WA, Nessen, L, Wannamaker, NS, Weber, DJ. Effect of methodology, dilution, and exposure time on the tuberculocidal activity of glutaraldehyde-based disinfectants. Appi Environ Microbiol 1990;56:18131817.
77.Steelman, VM. Activity of sterilization processes and disinfectants against prions (Creutzfeldt-Jakob disease agent). In: Rutala, WA, ed. Disinfection, Sterilization, and Antisepsis in Healthcare. Champlain, NY: Polyscience Publications; 1998:255271.
78.Flechsig, E, Hegyi, I, Enari, M, Schwarz, P, Collinge, J, Weissmann, C. Transmission of scrapie by steel-surface-bound prions. Mol Med 2001;7:679684.
79.Lemmer, K, Mielke, M, Pauli, G, Beekes, M. Decontamination of surgical instruments from prion proteins: in vitro studies on the detachment, destabilization and degradation of PrPsc bound to steel surfaces. J Gen Virol 2004;85:38053816.
80.Langeveld, JPM, Wang, JJ, Van de Wiel, DFM, Shih, GC, et al.Enzymatic degradation of prion protein in brain stem from infected cattle and sheep. J Infect Dis 2003;188:17821789.
81.Race, RE, Raymond, GJ. Inactivation of transmissible spongiform encephalopathy (prion) agents by Environ LpH. J Virol 2004;78:21642165.
82.Riemer, C, Bamme, T, Mok, SWF, Baier, M. 3-methyl-4-chIorophenol for prion decontamination of medical devices. Infect Control Hosp Epidemiol 2006;27:778780.
83.Brown, P, Rohwer, RG, Gajdusek, DC. Newer data on the inactivation of scrapie virus or Creutzfeldt-Jakob disease virus in brain tissue. J Infect Dis 1986;153:11451148.
84.Brown, P, Gibbs, CJ Jr, Amyx, HL, et al.Chemical disinfection of Creutzfeldt-Jakob disease virus. N Engl J Med 1982;306:12791282.
85.Solassol, J, Pastore, M, Crozet, C, Perrier, V, Lehmann, S. A novel copper-hydrogen peroxide formulation for prion decontamination. J Infect Dis 2006;194:865869.
86.Manuelidis, L. Decontamination of Creutzfeldt-Jakob disease and other transmissible agents. J Neurovirol 1997;3:6265.
87.Tateishi, J, Tashima, T, Kitamoto, T. Practical methods for chemical inactivation of Creutzfeldt-Jakob disease pathogen. Microbiol Immunol 1991;35:163166.
88.Taylor, DM. Resistance of the ME7 scrapie agent to peracetic acid. Vet Microbiol 1991;27:1924.
89.Taguchi, F, Tamai, Y, Uchida, A, et al.Proposal for a procedure for complete inactivation of the Creutzfeldt-Jakob disease agent. Arch Virol 1991;119:297301.
90.Brown, SA, Merritt, K. Use of containment pans and lids for autoclaving caustic solutions. Am J Infect Control 2003;31:257260.
91.Rabano, A, de Pedro-Cuesta, J, Molbak, K, et al.Tissue classification for the epidemiological assessment of surgical transmission of sporadic Creutzfeldt-Jakob disease: a proposal on hypothetical risk levels. BMC Public Health 2005;5:9.
92.Favero, MS. Current issues in hospital hygiene and sterilization technology. J Infect Control (Asia Pacific Ed.) 1998;1:810.
93.Favero, MS, Bond, WW. Chemical disinfection of medical and surgical materials. In: Block, SS, ed. Disinfection, Sterilization, and Preservation. Philadelphia, PA: Lippincott Williams & Wilkins; 2001:881917.
94.Committee on Health Care Issues, American Neurological Association. Precautions in handling tissues, fluids, and other contaminated materials from patients with documented or suspected Creutzfeldt-Jakob disease. Ann Neurol 1986;19:7577.
95.Association of perioperative Registered Nurses (AORN). Recommended practices for cleaning and caring for surgical instruments and powered equipment. In: AORN, ed. Standards, Recommended Practices, and Guidelines. Denver: AORN; 2006:555563.
96.Association for the Advancement of Medical Instrumentation (AAMI). Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: AAMI; 2006:ANSI/AAMI ST79.
97.Kampf, G, Blob, R, Martiny, H. Surface fixation of dried blood by glu-taraldehyde and peracetic acid. J Hosp Infect 2004;57:139143.
98.Brown, P, Liberski, PP, Wolff, A, et al.Resistance of scrapie infectivity to steam autoclaving after formaldehyde fixation and limited survival after ashing at 360°C: practical and theoretical implications. J Infect Dis 1990;161:467472.
99.Brown, P, Wolff, A, Gajdusek, DC. A simple and effective method for inactivating virus infectivity in formalin-fixed tissue samples from patients with Creutzfeldt-Jakob disease. Neurology 1990;40:887890.
100.CLSI. Protection of laboratory workers from occupationally acquired infections; approved guideline—third edition. CLSI document. Wayne, PA: CLSI; 2005:M29A3.
101.Rutala, WA, Weber, DJ; Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities, 2008. Atlanta, GA: CDC. Published November 2008. http://cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf. Accessed January 3, 2010.
102.Rutala, WA, Weber, DJ. How to assess disease transmission when there is a failure to follow recommended disinfection and sterilization principles. Infect Control Hosp Epidemiol 2007;28:519524.
103.Bourvis, N, Boelle, P-Y, Cesbron, J-Y, Valieron, A-J. Risk assessment of transmission of sporadic Creutzfeldt-Jakob disease in endodontic practice in absence of adequate prion inactivation. PLoS One 2007;2(12):el330.
104.Stricof, RL, Lillquist, PP, Thomas, N, Belay, ED, Schonberger, LB, Morse, DL. An investigation of potential neurosurgical transmission of Creutzfeldt-Jakob disease: challenges and lessons learned. Infect Control Hosp Epidemiol 2006;27:302304.
105.Peden, AH, Head, MW, Ritchie, DL, Bell, JE, Ironside, JW. Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 2004;364:527529.
106.Llewelyn, CA, Hewitt, PE, Knight, RSG, et al.Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion. Lancet 2004;363:417421.
107.Wroe, SJ, Pal, S, Siddique, D, et al.Clinical presentation and pre-mortem diagnosis of variant Creutzfeldt-Jakob disease associated with blood transfusion: a case report. Lancet 2006;368:20612067.
108.Fourth case of transfusion-associated vCJD infection in the United Kingdom. Euro Surveill 2007;12(1):E070118.4.
109.Azarpazhooh, A, Filiery, ED. Prion disease: the implications for dentistry. J Endod 2008;34:11581166.
110.Tulio, A, Buckley, R, Painter, M. CJD and the eye. Eye (Lond) 2000;14:259260.
111.Kirkpatrick, WNA, Waterhouse, N. Pharyngoplasty and the risk of variant CJD transmission. Br J Plast Surg 2001;54:552561.
112.Maheshwar, A, De, M, Browning, ST. Reusable versus disposable instruments in tonsillectomy: a comparative study of outcomes. Int J Clin Pract 2003;57:579583.
113.Weber, DJ, Rutala, WA. Managing the risk of nosocomial transmission of prion diseases. Curr Opin Infect Dis 2002;15:421425.
114.Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens; final rule. Fed Regist 1991;56:6400364182.
115.Tyler, KL. Prions and prion diseases of the central nervous system (transmissible neurodegenerative diseases). In: Mandeli, GL, Bennett, JE, Dolin, R, eds. Principles and Practices of Infectious Diseases. Philadelphia: Chur-chill Livingstone; 2000:19711985.
116.Brown, P, Will, RG, Bradley, R, Asher, DM, Detwiler, L. Bovine spongiform encephalopathy and variant Creutzfeldt-Jakob disease: background, evolution, and current concerns. Emerg Infect Dis 2001;7:616.
117.Association for peri-Operative Registered Nurses (AORN). Recommended practices for sterilization in the perioperative practice setting. In: AORN, ed. Standards, Recommended Practices, and Guidelines. Denver: AORN; 2006:629643.
Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

Infection Control & Hospital Epidemiology
  • ISSN: 0899-823X
  • EISSN: 1559-6834
  • URL: /core/journals/infection-control-and-hospital-epidemiology
Please enter your name
Please enter a valid email address
Who would you like to send this to? *
×

Metrics

Altmetric attention score