Surgical Endoscopy

, Volume 24, Issue 7, pp 1581–1588

Use of flexible endoscopes for NOTES: sterilization or high-level disinfection?

  • Georg O. Spaun
  • Trudie A. Goers
  • Richard A. Pierce
  • Maria A. Cassera
  • Sandy Scovil
  • Lee L. Swanstrom



Natural orifice translumenal endoscopic surgery (NOTES) involves the use of flexible endoscopes to perform intra-abdominal or intra-thoracic surgeries. Surgery in the operating room usually involves sterile instrumentation, whereas in the endoscopy suite high-level disinfection seems to be sufficient. Our objective was to assess the necessity for endoscope sterilization for clinical NOTES and to develop an endoscope processing protocol based on a score for the available processing options.


Score and processing protocol development for clinical NOTES endoscopes was based on a comprehensive review of the available relevant literature. Options for sterilization for flexible endoscopes in the Good Samaritan Hospital, Legacy Health in Portland, Oregon, were analyzed for patient safety, potential for recontamination, cost, and validation.


Literature survey indicated that there is controversy surrounding the necessity for sterilization of surgical endoscopes. However, standard of practice seems to call for sterile instrumentation for surgery and it is possible to terminally sterilize flexible endoscopes. Within our institution, a score was created to rank the available sterilization options. We successfully introduced a protocol for sterilization of endoscopes for use in clinical NOTES procedures. The protocol involved mechanical cleaning and high-level disinfection per Multi-Society Guidelines, with subsequent terminal sterilization using a validated peracetic acid protocol.


It remains controversial whether sterile instrumentation is truly needed for surgery. It is difficult but possible to terminally sterilize flexible endoscopes. We recommend sterile instrumentation for clinical NOTES until well-designed, randomized, clinical trials are available and guidelines are published.


Natural orifice translumenal endoscopic surgery NOTES Flexible endoscope Sterilization High-level disinfection 


  1. 1.
    Rutala WA, Weber DJ Guideline for disinfection and sterilization in healthcare facilities. Accessed 2 July 2009
  2. 2.
    Collinge J (1999) Variant Creutzfeldt-Jakob disease. Lancet 354(9175):317–323CrossRefPubMedGoogle Scholar
  3. 3.
    Rutala WA, Weber DJ (2004) Disinfection and sterilization in health care facilities: what clinicians need to know. Clin Infect Dis 39(5):702–709CrossRefPubMedGoogle Scholar
  4. 4.
    Beilenhoff U, Neumann CS, Rey JF, Biering H, Blum R, Cimbro M, Kampf B, Rogers M, Schmidt V (2008) ESGE-ESGENA Guideline: cleaning and disinfection in gastrointestinal endoscopy. Endoscopy 40(11):939–957CrossRefPubMedGoogle Scholar
  5. 5.
    Rutala WA, Weber DJ (1999) Infection control: the role of disinfection and sterilization. J Hosp Infect 43(Suppl):S43–S55CrossRefPubMedGoogle Scholar
  6. 6.
    Nelson DB, Muscarella LF (2006) Current issues in endoscope reprocessing and infection control during gastrointestinal endoscopy. World J Gastroenterol 12(25):3953–3964PubMedGoogle Scholar
  7. 7.
    Banerjee S, Shen B, Nelson DB, Lichtenstein DR, Baron TH, Anderson MA, Dominitz JA, Gan SI, Harrison ME, Ikenberry SO, Jagannath SB, Fanelli RD, Lee K, van Guilder T, Stewart LE (2008) Infection control during GI endoscopy. Gastrointest Endosc 67(6):781–790CrossRefPubMedGoogle Scholar
  8. 8.
    Spaun GO, Swanstrom LL (2008) Quo vadis NOTES. Eur Surg 40(5):211–219CrossRefGoogle Scholar
  9. 9.
    American Society for Gastrointestinal Endoscopy (2003) Multi-Society Guideline for reprocessing flexible gastrointestinal endoscopes. Gastrointest Endosc 58(1):1–8Google Scholar
  10. 10.
    Nelson DB, Jarvis WR, Rutala WA, Foxx-Orenstein AE, Isenberg G, Dash GP, Alvarado CJ, Ball M, Griffin-Sobel J, Petersen C, Ball KA, Henderson J, Stricof RL (2004) Multi-Society Guideline for reprocessing flexible gastrointestinal endoscopes. Dis Colon Rectum 47(4):413–420 discussion 420–421CrossRefPubMedGoogle Scholar
  11. 11.
    Rutala WA, Weber DJ (2004) Reprocessing endoscopes: United States perspective. J Hosp Infect 56(Suppl 2):S27–S39CrossRefPubMedGoogle Scholar
  12. 12.
    Patterson P (2009) CDC sterilization, disinfection guideline. OR Manager 25(1):14–16Google Scholar
  13. 13.
    Rogez-Kreuz C, Yousfi R, Soufflet C, Quadrio I, Yan ZX, Huyot V, Aubenque C, Destrez P, Roth K, Roberts C, Favero M, Clayette P (2009) Inactivation of animal and human prions by hydrogen peroxide gas plasma sterilization. Infect Control Hosp Epidemiol 30(8):769–777CrossRefPubMedGoogle Scholar
  14. 14.
    Dufresne S, Leblond H, Chaunet M (2008) Relationship between lumen diameter and length sterilized in the 125L ozone sterilizer. Am J Infect Control 36(4):291–297CrossRefPubMedGoogle Scholar
  15. 15.
    Muscarella LF (2006) Inconsistencies in endoscope-reprocessing and infection-control guidelines: the importance of endoscope drying. Am J Gastroenterol 101(9):2147–2154CrossRefPubMedGoogle Scholar
  16. 16.
    Sullivan JB, Krieger GK (2001) Clinical environmental health and toxic exposures, environmental health hazards of business, industry, sites, and locations. Lippincott Williams & Wilkins, Philadelphia, p 602Google Scholar
  17. 17.
    Steris. System 1 Sterile Processing System (2009) Accessed 10 August 2009
  18. 18.
    Abraham JB, Abdelshehid CS, Lee HJ, Box GN, Deane LA, Le T, Jellison F, Borin JF, Manipon A, McDougall EM, Clayman RV (2007) Rapid communication: effects of Steris 1 sterilization and Cidex ortho-phthalaldehyde high-level disinfection on durability of new-generation flexible ureteroscopes. J Endourol 21(9):985–992CrossRefPubMedGoogle Scholar
  19. 19.
    Alfa MJ, Howie R (2009) Modeling microbial survival in buildup biofilm for complex medical devices. BMC Infect Dis 9:56CrossRefPubMedGoogle Scholar
  20. 20.
    Hall-Stoodley L, Costerton JW, Stoodley P (2004) Bacterial biofilms: from the natural environment to infectious diseases. Nat Rev Microbiol 2(2):95–108CrossRefPubMedGoogle Scholar
  21. 21.
    Bryers JD (2008) Medical biofilms. Biotechnol Bioeng 100(1):1–18CrossRefPubMedGoogle Scholar
  22. 22.
    Marion-Ferey K, Pasmore M, Stoodley P, Wilson S, Husson GP, Costerton JW (2003) Biofilm removal from silicone tubing: an assessment of the efficacy of dialysis machine decontamination procedures using an in vitro model. J Hosp Infect 53(1):64–71CrossRefPubMedGoogle Scholar
  23. 23.
    Buss AJ, Been MH, Borgers RP, Stokroos I, Melchers WJ, Peters FT, Limburg AJ, Degener JE (2008) Endoscope disinfection and its pitfalls–requirement for retrograde surveillance cultures. Endoscopy 40(4):327–332CrossRefPubMedGoogle Scholar
  24. 24.
    Vesley D, Melson J, Stanley P (1999) Microbial bioburden in endoscope reprocessing and an in-use evaluation of the high-level disinfection capabilities of Cidex PA. Gastroenterol Nurs 22(2):63–68CrossRefPubMedGoogle Scholar
  25. 25.
    Alfa MJ, Sitter DL (1994) In-hospital evaluation of ortho-phthalaldehyde as a high level disinfectant for flexible endoscopes. J Hosp Infect 26(1):15–26CrossRefPubMedGoogle Scholar
  26. 26.
    Chu NS, Favero M (2000) The microbial flora of the gastrointestinal tract and the cleaning of flexible endoscopes. Gastrointest Endosc Clin N Am 10(2):233–244PubMedGoogle Scholar
  27. 27.
    Rutala WA, Weber DJ (1995) FDA labeling requirements for disinfection of endoscopes: a counterpoint. Infect Control Hosp Epidemiol 16(4):231–235CrossRefPubMedGoogle Scholar
  28. 28.
    Pineau L, Villard E, Duc DL, Marchetti B (2008) Endoscope drying/storage cabinet: interest and efficacy. J Hosp Infect 68(1):59–65CrossRefPubMedGoogle Scholar
  29. 29.
    Rejchrt S, Cermak P, Pavlatova L, McKova E, Bures J (2004) Bacteriologic testing of endoscopes after high-level disinfection. Gastrointest Endosc 60(1):76–78CrossRefPubMedGoogle Scholar
  30. 30.
    Ott DE (1997) Microbial colonization of laparoscopic gas delivery systems: a qualitative analysis. JSLS 1(4):325–329PubMedGoogle Scholar
  31. 31.
    Rutala WA, Clontz EP, Weber DJ, Hoffmann KK (1991) Disinfection practices for endoscopes and other semicritical items. Infect Control Hosp Epidemiol 12(5):282–288CrossRefPubMedGoogle Scholar
  32. 32.
    Lechevallier E, Saussine C, Traxer O, Mignard JP (2008) Sterilization and disinfection of endoscopes in urology. Prog Urol 18(12):955–958CrossRefPubMedGoogle Scholar
  33. 33.
    Phillips J, Hulka B, Hulka J, Keith D, Keith L (1977) Laparoscopic procedures: The American Association of Gynecologic Laparoscopists’ Membership Survey for 1975. J Reprod Med 18(5):227–232PubMedGoogle Scholar
  34. 34.
    Huezo CM, DeStefano F, Rubin GL, Ory HW (1983) Risk of wound and pelvic infection after laparoscopic tubal sterilization: instrument disinfection versus sterilization. Obstet Gynecol 61(5):598–602PubMedGoogle Scholar
  35. 35.
    Ayliffe GA, Babb JR, Bradley CR (1992) “Sterilization” of arthroscopes and laparoscopes. J Hosp Infect 22(4):265–269CrossRefPubMedGoogle Scholar
  36. 36.
    Loffer FD (1980) Disinfection vs. sterilization of gynecologic laparoscopy equipment. The experience of the Phoenix Surgicenter. J Reprod Med 25(5):263–266PubMedGoogle Scholar
  37. 37.
    McDonnell G (2008) Prion disease transmission: can we apply standard precautions to prevent or reduce risks? J Perioper Pract 18(7):298–304PubMedGoogle Scholar
  38. 38.
    Axon AT, Beilenhoff U, Bramble MG, Ghosh S, Kruse A, McDonnell GE, Neumann C, Rey JF, Spencer K (2001) Variant Creutzfeldt-Jakob disease (vCJD) and gastrointestinal endoscopy. Endoscopy 33(12):1070–1080CrossRefPubMedGoogle Scholar
  39. 39.
    Rutala WA, Weber DJ (2001) Creutzfeldt-Jakob disease: recommendations for disinfection and sterilization. Clin Infect Dis 32(9):1348–1356CrossRefPubMedGoogle Scholar
  40. 40.
    Spaulding EH (1978) Fiberoptic endoscopes: disinfection or sterilization? Microbiological aspects of the dilemma. Same Day Surg 2(3):35–39PubMedGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  • Georg O. Spaun
    • 1
  • Trudie A. Goers
    • 1
  • Richard A. Pierce
    • 1
  • Maria A. Cassera
    • 1
  • Sandy Scovil
    • 1
  • Lee L. Swanstrom
    • 1
  1. 1.Legacy HealthPortlandUSA

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