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Federal regulations are to follow the FDA-cleared label claim for high-level disinfectants. The FDA-cleared labels for high-level disinfection with >2% glutaraldehyde at 25oC range from 20-90 minutes, depending upon the product based on three tier testing which includes AOAC sporicidal tests, simulated use testing with mycobacterial and in-use testing. Category IC.

  1. Several scientific studies and professional organizations support the efficacy of >2% glutaraldehyde for 20 minutes at 20ºC; that efficacy assumes adequate cleaning prior to disinfection, whereas the FDA-cleared label claim incorporates an added margin of safety to accommodate possible lapses in cleaning practices. Facilities that have chosen to apply the 20 minute duration at 20ºC have done so based on the IA recommendation in the July 2003 SHEA position paper, “Multi-society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes 12, 17, 19, 26, 27, 49, 55, 57, 58, 60, 73, 76, 79-81, 83-85, 93, 94, 104-106, 110, 111, 115-121, 124, 125, 233, 235, 236, 243, 265, 266, 609
  2. When using FDA-cleared high-level disinfectants, use manufacturers’ recommended exposure conditions. Certain products may require a shorter exposure time (e.g., 0.55% ortho-phthalaldehyde for 12 minutes at 20oC, 7.35% hydrogen peroxide plus 0.23% peracetic acid for 15 minutes at 20oC) than glutaraldehyde at room temperature because of their rapid inactivation of mycobacteria or reduced exposure time because of increased mycobactericidal activity at elevated temperature (e.g., 2.5% glutaraldehyde at 5 minutes at 35oC). Category IB. 83, 100, 689, 693, 694, 700
  3. Select a disinfectant or chemical sterilant that is compatible with the device that is being reprocessed. Avoid using reprocessing chemicals on an endoscope if the endoscope manufacturer warns against using these chemicals because of functional damage (with or without cosmetic damage). Category IB. 69, 113, 116
  4. Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused. As soon as is feasible, phase out nonimmersible endoscopes. Category IB. 108, 113-116, 137, 725, 856, 882
  5. After high-level disinfection, rinse endoscopes and flush channels with sterile water, filtered water, or tapwater to prevent adverse effects on patients associated with disinfectant retained in the endoscope (e.g., disinfectant induced colitis). Follow this water rinse with a rinse with 70% – 90% ethyl or isopropyl alcohol. Category IB. 17, 31-35, 38, 39, 108, 113, 115, 116, 134, 145-148, 620-622, 624-630, 1017
  6. After flushing all channels with alcohol, purge the channels using forced air to reduce the likelihood of contamination of the endoscope by waterborne pathogens and to facilitate drying. Category IB. 39, 113, 115, 116, 145, 147
  7. Hang endoscopes in a vertical position to facilitate drying. Category II. 17, 108, 113, 115, 116, 145, 815
  8. Store endoscopes in a manner that will protect them from damage or contamination. Category II. 17, 108, 113, 115, 116, 145
  9. Sterilize or high-level disinfect both the water bottle used to provide intraprocedural flush solution and its connecting tube at least once daily. After sterilizing or high-level disinfecting the water bottle, fill it with sterile water. Category IB. 10, 31-35, 113, 116, 1017
  10. Maintain a log for each procedure and record the following: patient’s name and medical record number (if available), procedure, date, endoscopist, system used to reprocess the endoscope (if more than one system could be used in the reprocessing area), and serial number or other identifier of the endoscope used. Category II. 108, 113, 115, 116
  11. Design facilities where endoscopes are used and disinfected to provide a safe environment for healthcare workers and patients. Use air-exchange equipment (e.g., the ventilation system, out-exhaust ducts) to minimize exposure of all persons to potentially toxic vapors (e.g.,

    AUTOCLAVE INDICATOR TAPE

87 Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

glutaraldehyde vapor). Do not exceed the allowable limits of the vapor concentration of the chemical sterilant or high-level disinfectant (e.g., those of ACGIH and OSHA). Category IB, IC. 116, 145, 318, 322, 577, 652

  1. Routinely test the liquid sterilant/high-level disinfectant to ensure minimal effective concentration of the active ingredient. Check the solution each day of use (or more frequently) using the appropriate chemical indicator (e.g., glutaraldehyde chemical indicator to test minimal effective concentration of glutaraldehyde) and document the results of this testing. Discard the solution if the chemical indicator shows the concentration is less than the minimum effective concentration. Do not use the liquid sterilant/high-level disinfectant beyond the reuse-life recommended by the manufacturer (e.g., 14 days for ortho-phthalaldehyde). Category IA. 76, 108, 113, 115, 116, 608, 609
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