1887

Abstract

Simethicone is an over-the-counter product that is frequently used by clinicians during endoscopic procedures to reduce foaming and improve visualization. Published studies have found simethicone residue on endoscopes after cleaning and disinfecting the devices as per the manufacturer’s instructions. Some literature suggests that simethicone residue may reduce disinfection efficacy and increase the risk of patient infections.

However, there appears to be a lack of direct evidence in the literature to either disprove this or correlate simethicone presence with an increased microbial risk.

: Research was conducted to evaluate the impact of simethicone on disinfection efficacy.

Bacteria were grown in a microtitre plate assay in the presence of a range of simethicone concentrations and then treated with a disinfectant. Bacterial growth was assessed by spotting each microtitre well onto an agar plate.

The results demonstrated that, under the conditions tested, simethicone did not reduce the efficacy of Cidex ortho-phthalaldehyde disinfectant, which demonstrated at least a 6-log unit reduction in bacterial viability. Additional experiments showed that direct exposure to 66 mg ml of simethicone reduced bacterial viability.

These results indicate that simethicone may not reduce the bactericidal efficacy of disinfectant during reprocessing, under certain conditions.

Funding
This study was supported by the:
  • Oak Ridge Institute for Science and Education (Award Research Participation Program)
    • Principle Award Recipient: NotApplicable
  • This is an open-access article distributed under the terms of the Creative Commons Attribution License. This article was made open access via a Publish and Read agreement between the Microbiology Society and the corresponding author’s institution.
Loading

Article metrics loading...

/content/journal/jmm/10.1099/jmm.0.001902
2024-10-04
2024-11-10
Loading full text...

Full text loading...

/deliver/fulltext/jmm/73/10/jmm001902.html?itemId=/content/journal/jmm/10.1099/jmm.0.001902&mimeType=html&fmt=ahah

References

  1. Ofstead CL, Wetzler HP, Heymann OL, Johnson EA, Eiland JE et al. Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: results of visual inspections, biochemical markers, and microbial cultures. Am J Infect Control 2017; 45:e26–e33 [View Article] [PubMed]
    [Google Scholar]
  2. Pajkos A, Vickery K, Cossart Y. Is biofilm accumulation on endoscope tubing a contributor to the failure of cleaning and decontamination?. J Hosp Infect 2004; 58:224–229 [View Article] [PubMed]
    [Google Scholar]
  3. Tian H, Sun J, Guo S, Zhu X, Feng H et al. The effectiveness of drying on residual droplets, microorganisms, and biofilms in gastrointestinal endoscope reprocessing: a systematic review. Gastroenterol Res Pract 2021; 2021:6615357 [View Article] [PubMed]
    [Google Scholar]
  4. Alfa MJ, Singh H. Impact of wet storage and other factors on biofilm formation and contamination of patient-ready endoscopes: a narrative review. Gastrointest Endosc 2020; 91:236–247 [View Article] [PubMed]
    [Google Scholar]
  5. USFDA Reprocessing medical devices in health care settings: validation methods and labeling; guidance for industry and food and drug administration staff. US Food & Drug Administration; 2015
  6. ANSI/AAMI ST91:2021 flexible and semi-rigid endoscope processing in health care facilities. Arlington, VA: AAMI; 2021
  7. ANSI/AAMI ST98:2022 cleaning validation of health care products--requirements for development and validation of a cleaning process for medical devices. Arlington, VA: AAMI; 2022
  8. EH S Chemical disinfection of medical and surgical materials. In Lawrence CB. ed Disinfection, Sterilization, and Preservation Philadelphia: Lea & Febiger; 1968 pp 517–531
    [Google Scholar]
  9. Rutala WA WD Healthcare infection control practices advisory committee (HICPAC). Guideline for disinfection and sterilization in healthcare facilities. US Centers for Disease Control and Prevention 2008
    [Google Scholar]
  10. Speer T, Vickery K, Alfa M, Sáenz R. Minimizing the risks of simethicone in endoscope reprocessing. J Clin Gastroenterol 2023; 57:153–158 [View Article] [PubMed]
    [Google Scholar]
  11. Barakat MT, Huang RJ, Banerjee S. Simethicone is retained in endoscopes despite reprocessing: impact of its use on working channel fluid retention and adenosine triphosphate bioluminescence values (with video). Gastrointest Endosc 2019; 89:115–123 [View Article] [PubMed]
    [Google Scholar]
  12. Ofstead CL, Hopkins KM, Eiland JE, Wetzler HP. Widespread clinical use of simethicone, insoluble lubricants, and tissue glue during endoscopy: a call to action for infection preventionists. Am J Infect Control 2019; 47:666–670 [View Article] [PubMed]
    [Google Scholar]
  13. Ofstead CL, Wetzler HP, Johnson EA, Heymann OL, Maust TJ et al. Simethicone residue remains inside gastrointestinal endoscopes despite reprocessing. Am J Infect Control 2016; 44:1237–1240 [View Article] [PubMed]
    [Google Scholar]
  14. Devereaux BM, Taylor ACF, Athan E, Wallis DJ, Brown RR et al. Simethicone use during gastrointestinal endoscopy: position statement of the Gastroenterological Society of Australia. J Gastroenterol Hepatol 2019; 34:2086–2089 [View Article] [PubMed]
    [Google Scholar]
  15. Day LW, Muthusamy VR, Collins J, Kushnir VM, Sawhney MS et al. Multisociety guideline on reprocessing flexible GI endoscopes and accessories. Gastrointest Endosc 2021; 93:11–33 [View Article] [PubMed]
    [Google Scholar]
  16. Balan GG, Sfarti CV, Chiriac SA, Stanciu C, Trifan A. Duodenoscope-associated infections: a review. Eur J Clin Microbiol Infect Dis 2019; 38:2205–2213 [View Article] [PubMed]
    [Google Scholar]
  17. Kovaleva J. Endoscope drying and its pitfalls. J Hosp Infect 2017; 97:319–328 [View Article] [PubMed]
    [Google Scholar]
  18. Mehta AC, Muscarella LF. Bronchoscope-related “superbug” infections. Chest 2020; 157:454–469 [View Article] [PubMed]
    [Google Scholar]
  19. CDC Factors affecting the efficacy of disinfection and sterilization. Guideline for disinfection and sterilization in healthcare facilities: US Centers for Disease Control and Prevention; 2008
  20. Herruzo R, Vizcaíno MJ, Herruzo I. An exception to the rule “no association between antibiotic resistance and decreased disinfectant microbicidal efficacy”: Orthophthalaldehyde (OPA) and Pseudomonas aeruginosa isolated from ICU and paraplegic patients. J Prev Med Hyg 2017; 58:E42–E47 [PubMed]
    [Google Scholar]
  21. Kovaleva J, Peters FTM, van der Mei HC, Degener JE. Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Rev 2013; 26:231–254 [View Article] [PubMed]
    [Google Scholar]
  22. Houri H, Aghdaei HA, Firuzabadi S, Khorsand B, Soltanpoor F et al. High prevalence rate of microbial contamination in patient-ready gastrointestinal endoscopes in Tehran, Iran: an alarming sign for the occurrence of severe outbreaks. Microbiol Spectr 2022; 10:e0189722 [View Article] [PubMed]
    [Google Scholar]
  23. USFDA Use duodenoscopes with innovative designs to enhance safety: FDA safety communication. n.d https://www.fda.gov/medical-devices/safety-communications/use-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication
  24. AAMI TIR12:2020/(R)2023 designing, testing, and labeling medical devices intended for processing by health care facilities: a guide for device manufacturers. Arlington, VA: AAMI; 2023
  25. USFDA Content and format of premarket notification [510(k)] submissions for liquid chemical sterilants/high level disinfectants. US Food & Drug Administration; 2000
  26. AOAC Inc Official methods of analysis of the association of the official analytical chemists. Arlington, VA: AOAC Inc; 1990
/content/journal/jmm/10.1099/jmm.0.001902
Loading
/content/journal/jmm/10.1099/jmm.0.001902
Loading

Data & Media loading...

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error