Reprocessing semicritical items: Current issues and new technologies

American Journal of Infection Control

Volumn 44, Issue 5, 2016, Pages e53-e62

  Rutala, William A ^a,b   Weber, David J ^a,b  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

^b UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

cystoscopes; disinfection; Endoscopes; semicritical; sterilization

Indexed keywords

HYDROGEN PEROXIDE;

ARTICLE; CYSTOSCOPE; DISINFECTION; DUODENOSCOPE; ENTEROBACTERIACEAE INFECTION; EPIDEMIC; HYSTEROSCOPE; INSTRUMENT STERILIZATION; LARYNGOSCOPE; MEDICAL TECHNOLOGY; NASOPHARYNGOSCOPE; PROSTATE BIOPSY; TONOMETER; TRANSESOPHAGEAL ECHOCARDIOGRAPHY; URETEROSCOPE; WART VIRUS; CROSS INFECTION; DEVICES; DISEASE TRANSMISSION; HEALTH CARE FACILITY; HUMAN; MICROBIOLOGY; PREVENTION AND CONTROL; PROCEDURES; PROTOCOL COMPLIANCE;

CROSS INFECTION; DISEASE TRANSMISSION, INFECTIOUS; DISINFECTION; EQUIPMENT AND SUPPLIES; GUIDELINE ADHERENCE; HEALTH FACILITIES; HUMANS;

EID: 84971644729     PISSN: 01966553     EISSN: 15273296     Source Type: Journal    
DOI: 10.1016/j.ajic.2015.12.029     Document Type: Article

References (98)

1. Centers for Disease Control and Prevention National hospital discharge survey: 2010 table Procedures by selected patient characteristics-number by procedure category and age 2010 Centers for Disease Control and Prevention Atlanta, GA
2. A.F. Peery, E.S. Dellon, J. Lund, S.D. Crockett, C.E. McGowan, W.J. Bulsiewicz, and et al. Burden of gastrointestinal disease in the United States: 2012 update Gastroenterology 143 2012 1179 1187
3. L. Epstein, J.C. Hunter, M.A. Arwady, V. Tsai, L. Stein, M. Gribogiannis, and et al. New Delhi metallo-beta-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes JAMA 312 2014 1447 1455
4. K.A. Wendorf, M. Kay, C. Baliga, S.J. Weissman, M. Gluck, P. Verma, and et al. Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak Infect Control Hosp Epidemiol 36 2015 634 642
5. C.L. Ofstead, H.P. Wetzler, A.K. Snyder, and R.A. Horton Endoscope reprocessing methods: a prospective study on the impact of human factors and automation Gastroenterol Nurs 33 2010 304 311
6. J. Kovaleva, F.T. Peters, H.C. van der Mei, and J.E. Degener Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy Clin Microbiol Rev 26 2013 231 254
7. W.A. Rutala, and D.J. Weber How to assess risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines Infect Control Hosp Epidemiol 28 2007 146 155
8. D.J. Weber, and W.A. Rutala Lessons learned from outbreaks and pseudo-outbreaks associated with bronchoscopy Infect Control Hosp Epidemiol 33 2012 230 234
9. Centers for Disease Control and Prevention Immediate need for healthcare facilities to review procedures for cleaning, disinfecting, and sterilizing reusable medical devices Available from: http://emergency.cdc.gov/han/han00382.asp 2015 Accessed October 16, 2015
10. W.A. Rutala, and D.J. Weber New developments in reprocessing semicritical items Am J Infect Control 41 Suppl 2013 S60 6
11. E.H. Spaulding Chemical disinfection of medical and surgical materials C. Lawrence, S.S. Block, Disinfection, sterilization, and preservation 1968 Lea & Febiger Philadelphia (PA) 517 531
12. W.A. Rutala, and D.J. Weber Disinfection, sterilization and control of hospital waste J.E. Bennett, R. Dolan, M.J. Blaser, Principles and practice of infectious diseases 2015 Elsevier Saunders Philadelphia (PA) 3294 3309
13. W.A. Rutala, and D.J. Weber Disinfection and sterilization: an overview Am J Infect Control 41 Suppl 2013 S2 5
14. W.A. Rutala, and D.J. Weber Cleaning, disinfection and sterilization P. Grota, APIC text of infection control and epidemiology 4th ed 2014 Association for Professionals in Infection Control and Epidemiology, Inc Washington, DC 31.1 15
15. W.A. Rutala, D.J. Weber HICPAC Guideline for disinfection and sterilization in healthcare facilities, 2008 2008 Centers for Disease Control and Prevention Available from http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection-Nov-2008.pdf Accessed October 15, 2015
16. G. McDonnell, and P. Burke Disinfection: is it time to reconsider Spaulding? J Hosp Infect 78 2011 163 170
17. W.A. Rutala, M.F. Gergen, and D.J. Weber Disinfection of a probe used in ultrasound-guided prostate biopsy Infect Control Hosp Epidemiol 28 2007 916 919
18. Food and Drug Administration FDA-cleared sterilants and high level disinfectants with general claims for processing reusable medical and dental devices, March 2015 Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/ucm437347.htm 2015 Accessed October 15, 2015
19. W.A. Rutala, and D.J. Weber ERCP scopes: what can we do to prevent infections? Infect Control Hosp Epidemiol 36 2015 643 648
20. J. Bringhurst Disinfection and sterilization in physician practices and specialty clinics Am J Infect Control 2016 In press
21. Centers for Disease Control and Prevention Healthcare-associated hepatitis B and hepatitis C outbreaks reported to the Centers for Diseases Control and Prevention (CDC) 2008-2014 Available from: http://www.cdc.gov/hepatitis/outbreaks/healthcarehepoutbreaktable.htm 2015 Accessed October 15, 2015
22. B.T. Petersen, J. Chennat, J. Cohen, P.B. Cotton, D.A. Greenwald, T.E. Kowalski, and et al. Multisociety guideline on reprocessing flexible GI endoscopes: 2011 Infect Control Hosp Epidemiol 32 2011 527 537
23. D.N. Gerding, L.R. Peterson, and J.A. Vennes Cleaning and disinfection of fiberoptic endoscopes: evaluation of glutaraldehyde exposure time and forced-air drying Gastroenterology 83 1982 613 618
24. J. Kovaleva, J.E. Degener, and H.C. van der Mei Mimicking disinfection and drying of biofilms in contaminated endoscopes J Hosp Infect 76 2010 345 350
25. W.A. Rutala, and D.J. Weber Disinfection and sterilization in healthcare facilities Han J. SHEA practical healthcare epidemiology 2016 University of Chicago Press Chicago (IL)
26. D.J. Weber, and W.A. Rutala Role of environmental contamination in the transmission of vancomycin-resistant enterococci Infect Control Hosp Epidemiol 18 1997 306 309
27. P.K. Tosh, M. Disbot, J.M. Duffy, M.L. Boom, G. Heseltine, A. Srinivasan, and et al. Outbreak of Pseudomonas aeruginosa surgical site infections after arthroscopic procedures: Texas, 2009 Infect Control Hosp Epidemiol 32 2011 1179 1186
28. C.G. Roberts Studies on the bioburden on medical devices and the importance of cleaning W.A. Rutala, Disinfection, sterilization and antisepsis: principles and practices in healthcare facilities 2000 Association for Professionals in Infection Control and Epidemiology Washington, DC 63 69
29. M.J. Alfa, P. Degagne, and N. Olson Worst-case soiling levels for patient-used flexible endoscopes before and after cleaning Am J Infect Control 27 1999 392 401
30. Society of Gastroenterology Nurses and Associates Standards of infection control and reprocessing of flexible gastrointestinal endoscopes Gastroenterol Nurs 36 2013 293 303
31. L.F. Muscarella Risk of transmission of carbapenem-resistant Enterobacteriaceae and related "superbugs" during gastrointestinal endoscopy World J Gastrointest Endosc 6 2014 457 474
32. C.L. Ofstead, H.P. Wetzler, E.M. Doyle, C.K. Rocco, K.H. Visrodia, T.H. Baron, and et al. Persistent contamination on colonoscopes and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines Am J Infect Control 43 2015 794 801
33. Food and Drug Administration FDA orders recall under consent decree for all Custom Ultrasonics automated endoscope reprocessors November 13; Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472605.htm 2015 Accessed October 15, 2015
34. A. Carbonne, J.M. Thiolet, S. Fournier, N. Fortineau, N. Kassis-Chikhani, I. Boytchev, and et al. Control of a multi-hospital outbreak of KPC-producing Klebsiella pneumoniae type 2 in France, September to October 2009 Euro Surveill 15 2010
35. W.A. Rutala, and D.J. Weber Gastrointestinal endoscopes: a need to shift from disinfection to sterilization? JAMA 312 2014 1405 1406
36. W.A. Rutala, and D.J. Weber FDA labeling requirements for disinfection of endoscopes: a counterpoint Infect Control Hosp Epidemiol 16 1995 231 235
37. Food and Drug Administration Brief summary of the gastroenterology and urology devices panel meeting Food and Drug Administration 2015
38. A. Pajkos, K. Vickery, and Y. Cossart Is biofilm accumulation on endoscope tubing a contributor to the failure of cleaning and decontamination J Hosp Infect 58 2004 224
39. C.G. Roberts The role of biofilms in reprocessing medical devices W.A. Rutala, Disinfection, sterilization and antisepsis: principles, practices, current issues, new research, and new technologies 2010 Association for Professionals in Infection Control and Epidemiology Washington, DC 223 229
40. M.S. Neves, M. Gomes da Silva, G.M. Ventura, P.B. Cortes, R.S. Duarte, and H.S. de Souza Effectiveness of current disinfection procedures against biofilm on contaminated GI endoscopes Gastrointest Endosc 2015 10.1016/j.gie.2015.09.016
41. W. Ren-Pei, X. Hui-Jun, Ke Q., Dong W., Xing N., and L. Zhao-Shen Correlation between the growth of bacterial biofilm in flexible endoscopes and endoscope reprocessing methods Am J Infect Control 42 2014 1203 1206
42. D. Agrawal, and L.F. Muscarella Delayed reprocessing of endoscopes Gastrointest Endosc 73 2011 853 854
43. Olympus Urgent safety notification. Important updated labeling information: new reprocessing instructions for the Olympus TJF-Q180V Duodenoscope Available from: http://medical.olympusamerica.com/sites/default/files/pdf/150326-TJF-Q180V-Customer-letter.pdf Accessed February 19, 2016
44. W.A. Rutala, and D.J. Weber Outbreaks of carbapenem-resistant Enterobacteriaceae infections associated with duodenoscopes: what can we do to prevent infections? Am J Infect Control 44 2016 e47 51
45. C. Murphy Inactivated glutaraldehyde: lessons for infection control Am J Infect Control 26 1998 159 160
46. H. Carsauw, and N. Debacker Recall of patients after use of inactive batch of Cidex disinfection solution in Belgian hospitals Proceedings of the Fifth International Conference of the Hospital Infection Society; 2002 Sept 15-18; Edinburgh, Scotland 2002 Hospital Infections Society London, England
47. W.O. Collins A review of reprocessing techniques of flexible nasopharyngoscopes Otolaryngol Head Neck Surg 141 2009 307 310
48. M. Cavaliere, and M. Iemma Guidelines for reprocessing nonlumened heat-sensitive ear/nose/throat endoscopes Laryngoscope 122 2012 1708 1718
49. C.J. Alvarado, A.G. Anderson, and D.G. Maki Microbiologic assessment of disposable sterile endoscopic sheaths to replace high-level disinfection in reprocessing: a prospective clinical trial with nasopharygoscopes Am J Infect Control 37 2009 408 413
50. A. Elackattu, M. Zoccoli, J.H. Spiegel, and K.M. Grundfast A comparison of two methods for preventing cross-contamination when using flexible fiberoptic endoscopes in an otolaryngology clinic: disposable sterile sheaths versus immersion in germicidal liquid Laryngoscope 120 2010 2410 2416
51. M.L. Durand, D.J. Weber, and W.A. Rutala Healthcare-associated eye infections C.G. Mayhall, Hospital epidemiology and infection control 2012 Wolters Kluwer Philadelphia, PA 352 364
52. Centers for Disease Control and Prevention Recommendations for preventing possible transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus from tears MMWR Morb Mortal Wkly Rep 34 1985 533 534
53. W.A. Rutala, J.E. Peacock, M.F. Gergen, M.D. Sobsey, and D.J. Weber Efficacy of hospital germicides against adenovirus 8, a common cause of epidemic keratoconjunctivitis in health care facilities Antimicrob Agents Chemother 50 2006 1419 1424
54. R. Tyler, G.A. Ayliffe, and C. Bradley Virucidal activity of disinfectants: studies with the poliovirus J Hosp Infect 15 1990 164 166
55. S.A. Sattar, V.S. Springthorpe, Y. Karim, and P. Loro Chemical disinfection of non-porous inanimate surfaces experimentally contaminated with four human pathogenic viruses Epidemiol Infect 102 1989 493 505
56. C.L. Chronister Structural damage to Schiotz tonometers after disinfection with solutions Optom Vis Sci 74 1997 164 166
57. D. Koo, B. Bouvier, M. Wesley, P. Courtright, and A. Reingold Epidemic keratoconjunctivitis in a university medical center ophthalmology clinic; need for re-evaluation of the design and disinfection of instruments Infect Control Hosp Epidemiol 10 1989 547 552
58. J.A. Jernigan, B.S. Lowry, F.G. Hayden, S.A. Kyger, B.P. Conway, D.H. Gröschel, and et al. Adenovirus type 8 epidemic keratoconjunctivitis in an eye clinic: risk factors and control J Infect Dis 167 1993 1307 1313
59. A.A. Milki, and J.D. Fisch Vaginal ultrasound probe cover leakage: implications for patient care Fertil Steril 69 1998 409 411
60. J.M. Storment, M. Monga, and J.D. Blanco Ineffectiveness of latex condoms in preventing contamination of the transvaginal ultrasound transducer head South Med J 90 1997 206 208
61. S. Fritz, M.H. Hust, C. Ochs, I. Gratwohl, M. Staiger, and B. Braun Use of a latex cover sheath for transesophageal echocardiography (TEE) instead of regular disinfection of the echoscope? Clin Cardiol 16 1993 737 740
62. M. Hignett, and P. Claman High rates of perforation are found in endovaginal ultrasound probe covers before and after oocyte retrieval for in vitro fertilization-embryo transfer J Assist Reprod Genet 12 1995 606 609
63. G. Kac, I. Podglajen, A. Si-Mohamed, A. Rodi, C. Grataloup, and G. Meyer Evaluation of ultraviolet C for disinfection of endocavitary ultrasound transducers persistently contaminated despite probe covers Infect Control Hosp Epidemiol 31 2010 165 170
64. S. Amis, M. Ruddy, C.C. Kibbler, D.L. Economides, and A.B. MacLean Assessment of condoms as probe covers for transvaginal sonography J Clin Ultrasound 28 2000 295 298
65. V.J. Rooks, M.K. Yancey, S.A. Elg, and L. Brueske Comparison of probe sheaths for endovaginal sonography Obstet Gynecol 87 1996 27 29
66. C.S. Odwin, A.C. Fleischer, D.M. Kepple, and D.T. Chiang Probe covers and disinfectants for transvaginal transducers J Diagn Med Sonogr 6 1990 130 135
67. W.G. Benson Exposure to glutaraldehyde J Soc Occup Med 34 1984 63 64
68. S.M. Garland, and L. de Crespigny Prevention of infection in obstetrical and gynaecological ultrasound practice Aust N Z J Obstet Gynaecol 36 1996 392 395
69. G. Kac, M. Gueneret, A. Rodi, E. Abergel, C. Grataloup, N. Denarié, and et al. Evaluation of a new disinfection procedure for ultrasound probes using ultraviolet light J Hosp Infect 65 2007 163 168
70. C. Fowler, and D. McCracken US probes: risk of cross infection and ways to reduce it-comparison of cleaning methods Radiology 213 1999 299 300
71. D. Muradali, W.L. Gold, A. Phillips, and S. Wilson Can ultrasound probes and coupling gel be a source of nosocomial infection in patients undergoing sonography? An in vivo and in vitro study AJR Am J Roentgenol 164 1995 1521 1524
72. J.S. Casalegno, K. Le Bail Carval, D. Eibach, M.L. Valdeyron, G. Lamblin, H. Jacquemoud, and et al. High risk HPV contamination of endocavity vaginal ultrasound probes: an underestimated route of nosocomial infection? PLoS ONE 7 2012 e48137
73. W.A. Rutala, M. Gergen, and E.E. Sickbert-Bennett Effectiveness of a hydrogen peroxide mist (Trophon®) system in inactivating healthcare pathogens on surface and endocavitary probes Infect Control Hosp Epidemiol 2016 1 2 Feb 4; [Epub ahead of print]
74. E. Ryndock, R. Robison, and C. Meyers Susceptibility of HPV 16 and 18 to high-level disinfectants indicated for semi-critical ultrasound probes J Med Virol 2015 10.1002/jmv.24421
75. K. Vickery, V.Z. Gorgis, J. Burdach, and D. Patel Evaluation of an automated high-level disinfection technology for ultrasound transducers J Infect Public Health 7 2014 153 160
76. J.L. Gillespie, K.E. Arnold, J. Noble-Wang, B. Jensen, M. Arduino, J. Hageman, and et al. Outbreak of Pseudomonas aeruginosa infections after transrectal ultrasound-guided prostate biopsy Urology 69 2007 912 914
77. FDA Public Health Notification: reprocessing of reusable ultrasound transducer assemblies used for biopsy procedures, 2006 Available from: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotification/ucm062086.htm 2006 Accessed November 1, 2009
78. F. Lessa, S. Tak, S.R. Devader, R. Goswami, M. Anderson, I. Williams, and et al. Risk of infections associated with improperly reprocessed transrectal ultrasound-guided prostate biopsy equipment Infect Control Hosp Epidemiol 29 2008 289 293
79. J. Masood, S. Voulgaris, O. Awogu, C. Younis, A.J. Ball, and T.W. Carr Condom perforation during transrectal ultrasound guided (TRUS) prostate biopsies: a potential infection risk Int Urol Nephrol 39 2007 1121 1124
80. U.S. Food and Drug Administration FDA Public Health Notification: Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures Available from: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062086.htm Accessed February 19, 2016
81. E.A. Bancroft, L. English, D. Terashita, and L. Yasuda Outbreak of Escherichia coli infections associated with a contaminated transesophageal echocardiography probe Infect Control Hosp Epidemiol 34 2013 1121 1123
82. M. Seki, H. Machida, Y. Yamagishi, H. Yoshida, and K. Tomono Nosocomial outbreak of multidrug-resistant Pseudomonas aeruginosa caused by damaged transesophageal echocardiogram probe used in cardiovascular surgical operations J Infect Chemother 19 2013 677 681
83. Cleaning, Disinfecting, and Sterilizing TEE Transducers Available from: http://www.healthcare.philips.com/main/products/ultrasound/transducers/transducer-care/cleaning-and-disinfecting/tee-transducers.wpd Accessed October 15, 2015
84. P. Kanagala, C. Bradley, P. Hoffman, and R.P. Steeds Guidelines for transesophageal echocardiographic probe cleaning and disinfection from the British Society of Echocardiography Eur J Echocardiogr 12 2011 i17 23
85. S.G. Venticinque, V.S. Kashyap, and R.J. O'Connell Chemical burn injury secondary to intraoperative transesophageal echocardiography Anesth Analg 97 2003 1260 1261
86. W.A. Rutala, M.F. Gergen, and D.J. Weber Disinfection of an infrared coagulation device used to treat hemorrhoids Am J Infect Control 40 2012 78 79
87. L.F. Muscarella Recommendations to resolve inconsistent guidelines for the reprocessing of sheathed and unsheathed rigid laryngoscopes Infect Control Hosp Epidemiol 28 2007 504 507
88. L.F. Muscarella Prevention of disease transmission during flexible laryngoscopy Am J Infect Control 35 2007 536 544
89. L.F. Muscarella Reassessment of the risk of healthcare-acquired infection during rigid laryngoscopy J Hosp Infect 68 2008 101 107
90. T.R. Call, F.J. Auerbach, S.W. Riddell, D.L. Kiska, S.C. Thongrod, S.W. Tham, and et al. Nosocomial contamination of laryngoscope handles: challenging current guidelines Anesth Analg 109 2009 479 483
91. D. Williams, J. Dingley, C. Jones, and N. Berry Contamination of laryngoscope handles J Hosp Infect 74 2010 123 128
92. R.A. Phillips, and W.P. Monaghan Incidence of visible and occult blood on laryngoscope blades and handles AANA J 65 1997 241 246
93. McGrath MAC video larynoscope operator's manual Available from: http://www.vitaid.com/files/mcgrath-mac-operator-s-manual-0-english.pdf Accessed October 15, 2015
94. GlideScope Available from: http://www.verathon.com/assets/0900-4200-02-60.pdf Accessed October 15, 2015
95. A.M. Wendelboe, J. Baumbach, D.B. Blossom, P. Frank, A. Srinivasan, and C.M. Sewell Outbreak of cystoscopy related infections with Pseudomonas aeruginosa: New Mexico, 2007 J Urol 180 2008 588 592
96. W.A. Rutala, M.F. Gergen, J. Bringhurst, and D.J. Weber Effective high-level disinfection pf cystoscopes" Is perfusion of channels required? Infect Control Hosp Epidemiol 37 2016 228 231
97. J.Q. Clemens, R. Dowling, F. Foley, H.B. Goldman, C.M. Gonzalez, C. Tessier, and et al. Joint AUA/SUNA white paper on reprocessing of flexible cystoscopes J Urol 184 2010 2241 2245
98. J. Meyers, E. Ryndock, M.J. Conway, C. Meyers, and R. Robison Susceptibility of high-risk human papillomavirus type 16 to clinical disinfectants J Antimicrob Chemother 69 2014 1546 1550