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SELF-STUDY SERIES


Kills mycobacterium and all less- resistant organisms but not all spores.


Various test organisms used for validation.


Designed to kill up to 6 logs of mycobacterium.


6 logs = 106 = 1,000,000


Sponsored by


Table 1 — Comparison of flexible endoscope reprocessing methods High-Level Disinfection


Liquid Chemical Sterilization


Kills all organisms, including spores.


Various test organisms used for validation.


Designed to kill up to 6 logs of mycobacterium, including spores.


(10x10x10x10x10x10) 6 logs = 106


(10x10x10x10x10x10) = 1,000,000


SAL not applicable


Performed with manual soak method or automated reprocessor.


Provides a wet, high-level disin- fected item.


Effectiveness dependent on effec- tive cleaning and complete drying of device prior to storage.


Quality control monitoring tools:


• Physical parameters • HLD minimum effectiveness concentration indicator


SAL not applicable


Performed in automated liquid chemical sterilant reprocessing system.


Provides a wet, liquid sterilized item to be used immediately. If stored, must be reprocessed directly before use.


Effectiveness dependent on effec- tive cleaning. Device wet when used on patient. Complete drying required prior to storage as an HLD device.


Quality control monitoring tools:


• Physical parameters • HLD minimum effectiveness concentration indicator


Note: One method provides a spore test strip.


(EO) have been studied and characterized extensively. A terminal sterilization process with an SAL of 10-6


has the probability that


only one organism in one million survived. It is the predictable, linear behavior that allows the terminal sterilization ‘overkill’ process or ‘safety factor’ to be provided. Terminal sterilization process cycle time is based on the point at which the biological indicator of a resistant spore is dead, and the time is then doubled. It is this extra time and predictability of cycle that provides the safety factor for terminal sterilization processes that are run in a sterilizer. See Figure 1. In contrast, data shows that liquid processes don’t show a linear kill process.26 Table 1 provides a comprehensive com- parison of the chemical processes using liquid and gaseous chemical sterilants for consideration. For sterilization of flexible endoscopes, the following factors may also be considered in determining the best method for the health- care facility to use: • margin of safety (or ‘overkill’) of the pro- cesses


• efficacy of processes to penetrate long lumens/channels of the endoscopes


• endoscope manufacturer’s validation of the process as documented in the IFU


Low-Temperature Terminal sterilization


Kills all living organisms, including spores.


Specific spore type defined in stan- dards used for validation.


Designed to kill 12 logs of most resistant to the process spores as defined in standards. 12 logs = 1012


(10x10x10x10x10x10x10x10x10x 10x10x10) = 1,000,000,000,000


Linear process with a defined Sterility Assurance Level (SAL) of 10-6


or higher Performed in a sterilizer.


Provides a sterile, packaged item that maintains sterile barrier until used or packaging is compromised


Effectiveness dependent on effec- tive cleaning and complete drying of device prior to packaging.


Quality control monitoring tools:


• Physical parameters • External and internal chemical indicators • Biological indicators used in a process challenge device


• endoscope material compatibility with the chemical process


• length of the cycle • quality control system that is or is not available for the process


• cost of the process • evidence that the process is effective at halting endoscope related outbreaks


Summary Effective flexible endoscope reprocessing is a challenging task with many complexities and considerations. Patient outbreaks and evidence of patient-ready contaminated endoscopes have been well documented in the literature and standards. Users should understand that satisfactory cleaning, inspection and drying is always required and critically important for successful dis- infection, liquid sterilization or terminal sterilization. Terminal sterilization processes are designed and validated with an overkill or ‘safety’ factor and provide a significantly higher level of lethality compared to liquid processes. The type of process used for sterilization of a flexible endoscope should be based on the endoscope manufacturer’s IFU as the manufacturer has validated the reprocessing recommendations. Evidence shows that several of the duodenoscope-


40 October 2018 • HEALTHCARE PURCHASING NEWS • hpnonline.com


related outbreaks were effectively halted when the facility switched from high-level disinfection to a terminal sterilization pro- cess using EO. HPN


References:


1. Rutala W, Weber D. and the Healthcare Infection Control Advisory Committee (HICPAC) Centers for Disease Control and Prevention. Guideline for Disinfection and Sterilization in Health- care Facilities. 2008.


2. Murray P. Preventable Tragedies: Superbugs and How Ineffec- tive Monitoring of Medical Device Safety Fails Patients. US Senate. Health, Education, Labor and Pensions Committee. Minority Staff Report. Jan.13, 2016


3. Dirlam-Langley A, Ofstead C, et al. Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg. American Journal of Am J Am J Infect Control. Dec 2013 Vol. 41, (12): Pages 1188-1194


4. Wang P, et.al. Rates of infection after colonoscopy and osopha- gogastroduodenoscopy in ambulatory surgery centers in the US. BMJ GUT. 2018. 69(9):01-11.


5. Rutala W, Weber D. ERCP Scopes: What Can We Do to Prevent Infections? Infection Control & Hospital Epidemiology. 2015; 36: 643-648.


6. Ofstead CL, Wetzler HP, Heymann OL, Johnson EA, Eiland, JE, Shaw MJ. Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: Results of visual inspections, biochemical markers, and microbial cultures. American Journal of Infection Control. Feb 2016; 45(2): e26-e33.


7. Ofstead CL, Quick MR, Wetzler HP, Eiland JE, Heymann OL, Sonetti DA, Ferguson JS., Effectiveness of reprocessing for flexible bronchoscopes and endobronchial ultrasound bronchoscopes, CHEST 2018. 10.1016/j.chest.2018.04.045.


8. Ofstead CL, Wetzler HP, Eiland JE, Heyman OL., et al. As- sessing residual contamination and damage inside of flexible endoscopes over time. American Journal of Infection Control. 2016; 44(12):1675-1677.


9. U.S Food and Drug Administration. 522 Post market surveillance. FDA website accessed August 2018. https://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=355&c_id=3727


10. Ofstead CL, Wetzler H, Doyle E. et. Al. Persistent contamination on colonoscopes and gastroscopes detected by biological cultures and rapid indicators despite reprocessing performed in accordance with guidelines. American Journal of Infection Control. August 2015: 43(8): 794-801.


11. US Dept of Health and Human Services. Food and Drug Ad- ministration. Supplemental measures to enhance duodenoscope reprocessing. FDA Safety Communications. August 2015


12. ANSI/AAMI ST91: 2015 Flexible and semi-rigid endoscope reprocessing in health care facilities.


13. Epstein L, Hunter J, et. Al. New Delhi Metallo β-Lactamase- producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes. JAMA 2014. 312:1447-55


14. Nzryzhny I, Silas D, et. Al. Impact of ethylene oxide gas sterilization of duodenoscopes after a carbapenem-resistant Enterobacteriaceae outbreak. Gastrointestinal Endscopy. August 2016. 84(2):259-262.


15. Smith ZL, Oh YS, Saeian K, et al. Transmission of carbapenem- resistant Enterobacteriaceae during ERCP: time to revisit the current reprocessing guidelines. Gastrointestinal Endoscopy. 2014;81(4):1041-1045.


16. McCool S, Muto CA, Querry A, et al. High Level Disinfection (HLD) Failure in Gastrointestinal Scopes with Elevator Channels — Is it Time to Switch to Ethylene Oxide (ETO) Sterilization? Poster. ID Week; October 8-12, 2014; Philadelphia, PA.


17. Rubin ZA, Murthy RK. Outbreaks associated with duodeno- scopes: new challenges and controversies. Current Opinion in Infectious Diseases. Aug. 2016. 1:29(4): 407-14


18. Association of periOperative Registered Nurses. Guidelines for Processing Flexible Endoscopes. AORN 2016


19. SGNA (Society for Gastroenterology Nurses and Associates); Standards of Infection Prevention in Reprocessing Flexible Gastro- intestinal Endoscopes 2015. Standards in Infection Prevention in Gastroenterology Settings 2015. Guideline for Use of High-Level Disinfectants & Sterilants in Gastroenterology Setting. 2017


20. Cooper M, Hutfless S, et.al., Hospital level under-utilization of minimally invasive surgery in the United State: retrospective review. BJM 2014; 349: g4298


21. Yeung B, Chui P. Application of robotics in gastrointestinal en- doscopy: A review. World of J Gastro. 2016. Feb 22(5):1811-1825


22. US Department of Health and Human Services. Food and Drug Administration. Reprocessing Medical Devices in the Health Care Settings: Validation Methods for Labeling. Guidance for Industry and Food and Drug Administration Staff. March 17, 2015. https://


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