Clinicals & Documentation
Download National Organization Guidelines & Processes
Ofstead CL, Heymann OL, Quick MR, Johnson EA, Eiland JE, Wetzler HP.
Am J Infect Control. 2017 Aug 1;45(8):888-895. doi: 10.1016/j.ajic.2017.03.016. Epub 2017 Jun 15.
RESULTS: “Researchers examined 16 ureteroscopes after manual cleaning and sterilization using hydrogen peroxide gas. Every ureteroscope had visible irregularities, such as discoloration, residual fluid, foamy white residue, scratches, or debris in channels.”
Ofstead CL, Wetzler HP, Heymann OL, Johnson EA, Eiland JE, Shaw MJ.
Am J Infect Control. 2017 Feb 1;45(2):e26-e33. doi: 10.1016/j.ajic.2016.10.017.
RESULTS: “At final assessment, all endoscopes (N = 20) had visible irregularities. Researchers observed fluid (95%), discoloration, and debris in channels.” …”Eighty-five percent of endoscopes required repair due to findings.”
Ofstead CL, Wetzler HP, Johnson EA, Heymann OL, Maust TJ, Shaw MJ.
Am J Infect Control. 2016 Nov 1;44(11):1237-1240. doi: 10.1016/j.ajic.2016.05.016. Epub 2016 Aug 3
RESULTS: Residual fluid was observed inside 19 of 20 endoscopes. Fluid photographed in 8 endoscopes resembled simethicone solutions. FTIR analysis confirmed the presence of simethicone in 2 endoscopes.
Ofstead CL, Wetzler HP, Eiland JE, Heymann OL, Held SB, Shaw MJ.
Am J Infect Control. 2016 Dec 1;44(12):1675-1677. doi: 10.1016/j.ajic.2016.06.029. Epub 2016 Sep 7
Abstract: Researchers evaluated flexible endoscope damage and contamination levels at baseline and 2 months later. Postcleaning test results exceeded benchmarks for all gastroscopes and no colonoscopes. Microbial growth was found in samples from 47% of fully reprocessed endoscopes at baseline and 60% at follow-up. Borescope examinations identified scratches, discoloration, debris, and fluid inside endoscopes. Irregularities changed over time. Study evaluations allowed damaged and contaminated endoscopes to be identified and re-reprocessed or sent for repairs.
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“These SSIs were likely related to surgical instrument contamination with P. aeruginosa during instrument reprocessing. Retained tissue in inflow/outflow cannulae and shaver handpieces could have allowed bacteria to survive sterilization procedures.”
ST79, 7.3 - Manufacturers’ written IFU
The device manufacturer’s current written IFU should be accessible, reviewed, and followed. If there are no specific
written IFU in the labeling, then the manufacturer should be contacted and requested to provide a documented
method of cleaning.
Stryker’s IFU <Click to View
Recommends a scope an endoscope to inspect their arthroscopic shaver hand piece.
Arthrex’s IFU <Click to View
Recommends using a scope to inspect their arthroscopic shaver hand piece.
“Consider inspecting the inside of the devices (arthroscopic hand pieces) following cleaning to ensure that they have been cleared of any tissue or fluids. There may be multiple ways to accomplish this. As one example, the facility that brought this situation to our attention uses a 3mm video scope to inspect the channels of the shaver hand piece.”
“Thoroughly disinfect duodenoscopes between uses and have in place a comprehensive quality program for reprocessing.”
“Implement a comprehensive reprocessing quality control program. Your reprocessing program should include written procedures for monitoring, training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.”
“Recent media reports describe instances of patients being notified that they may be at increased risk for infection due to lapses in basic cleaning, disinfection, and sterilization of medical devices. These events involved failures to follow manufacturers’ reprocessing instructions for critical and semi-critical items and highlight the need for healthcare facilities to review policies and procedures that protect patients.”
ST79, 220.127.116.11 - Verification of the cleaning process
“After completing the cleaning process, personnel should visually inspect each item carefully to detect any visible soil.”
May/June 2015, page 76 - 78
"With today’s lumen inspection systems, departments can now visually confirm that the insides of instruments are as clean as the outside and improve the standard of care.”
Multi-Center Lumen Inspection Survey, Poster presented at the 2015 IAHCSMM National Convention
• Number of Participating Hospitals - 71
• Number of Instruments Inspected with a 1 mm or 2mm waterproof lumen inspection system - 860
• Outcome: 7 out of 10 of the inspected instrument lumens were still dirty after decontamination