Few other areas in the ambulatory setting are as fraught with potential for patient harm as the cleaning, disinfection and sterilization of instruments and medical equipment. These are complex, multi-step procedures with many opportunities to err. It is essential for ambulatory facilities that perform invasive procedures to understand the ins and outs of cleaning, disinfection and sterilization.
All manufacturers' guidelines and recommendations should be available for each piece of equipment and instruments that are complex or require special considerations to process. Surveyors want to know that ambulatory facilities have the most current version, are aware of the contents, and are following guidelines. Be sure to [properly process] evaluate the cleaning, disinfection and sterilization requirements for any new instrument or piece of equipment that is being considered for use. It's also important to have the capability to perform the required process.
Cleaning is the most important step in processing instruments or equipment. Items that are not physically clean cannot be successfully disinfected or sterilized. Be sure all the cleaning equipment needed is readily available; an enzymatic cleaner is usually the best product for cleaning instruments. Be sure staff are trained to clean thoroughly and properly — no shortcuts! Brushes for various endoscopes must be present and should not be worn or damaged. Brushes are either reusable or disposable and are specific for each type of scope. One size won't work in all scopes. Disposable brushes are to be used ONCE and discarded. Reusable brushes are to be used per manufacturer instructions for processing and discarding.
It is a good idea to post the manufacturer's processing policy above the cleaning sink for cleaning scopes or any complex instrument. Staff are more likely clean correctly if the directions are clearly posted. Always rinse and rough dry before soaking.
Be aware of the pitfalls of high-level disinfection (HLD) of heat-sensitive equipment. It is fine when done correctly. However, the many elements of this process make it easy to miss a critical step. Be sure the instrument or equipment manufacturer lists high-level disinfection as an appropriate processing method. Disposable items cannot be reprocessed or reused (unless reprocessed by an FDA-approved third party reprocessing vendor) — it's the law.
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Thoroughly preclean the item. First perform the leak test on scopes; if it passes, brush all channels, remove, clean and flush all attachments.
Use a product that is approved by the FDA as a "high-level disinfectant." Just because a germicidal product states on the label that it is for instruments doesn't mean it is a high-level disinfectant. The following link includes a list of approved products: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm133514.htm
• High-level disinfectants require a well-ventilated space and use of personal protective equipment (PPE) to protect workers.
• HLD containers must be dated upon opening unless they are emptied with the first use.
• The solution must be dated with the expiration date, according to manufacturer's guidance.
• Different brands of similar chemicals may have different use-life periods. Always check the label.
• The solution must be tested for minimum effective concentration before each use and the results should be logged.
• When a new bottle of test strips is opened, they must be validated per the manufacturer.
• The solution must be discarded on the expiration date, regardless of test strip results.
• Items must be fully submerged in the solution. Syringes and other objects floating on the solution will not be disinfected. It is not acceptable to cover items with a towel or other object to submerge them.
• Flush the solution through all the channels of scopes, avoiding air bubbles.
• Clean and soak reusable cleaning brushes with the scope after each use.
• If using an automated endoscope reprocessor, be sure all channels are connected with the correct connector to the machine. Pictures should be posted of the correct connections for each type of scope. The solution must be dated and checked for potency before each use.
• Use a timer to ensure proper contact time. Do not soak items longer than necessary. Check the HLD solution temperature and record results. Be sure the temperature meets the manufacturer's recommendations. Contact vendor for suggestions if the solution is too cold.
• Carefully remove from the solution and rinse with tap or sterile water, depending on the intended use of the item. Most HLD manufacturers require triple rinsing. This includes all scope channels. Retained HLD can cause patient harm.
• For scopes, use alcohol for a final rinse and blow all channels to aid drying of the lumens. Hang vertically in a closed cabinet. Blow all channels with compressed air.
The same cleaning considerations of instruments and equipment apply to sterilization. Keep in mind: if it isn't clean, it cannot be sterilized.
• Soak all instruments for sterilization in a properly mixed enzymatic cleaner. Change after each use. Enzymatics have NO disinfectant properties.
• Thoroughly brush items until clean under the surface of the water to prevent splashing.
• Rinse with tap water and dry.
• Package in appropriate sterilization packaging for the item. Include internal and external indicators. Wrappers and sterilization containers are approved for specific uses — steam, gas, gas plasma, immediate use, or regular loads. Do not use interchangeably.
• The new term for "flash" sterilization is "immediate-use" sterilization. Do not use for inadequate instrument inventory. Surveyors are looking for this. Keep track of what, why, and when this is done.
• Process in sterilizer, per the manufacturer's recommendations.
• Check mechanical, chemical, and biological indicators. If any fail, pull the load.
• Maintain a load log with the date, load number, sterilizer, time run, and confirmation that all indicators are okay.
Storage of Sterile Supplies
• Store supplies in closed cabinets or sterile storage room with controlled access.
• Store 8"-10" from floor, 18" from ceiling, and 2" from outside walls. Solid bottom shelf.
• Do not overfill drawers.
• Do not wrap rubber bands around sterile supplies. Use drawer dividers instead.
• Place newly sterilized items behind older ones.
• Do not stack sterile items more than one or two high.
• Sterility is event-related, not time-related. Date and note load number on packages. There is no expiration date as long as the wrapper is intact, sans damage and moisture.
Test your knowledge! (answers are found several lines below the final question)
1. True or False: Thorough cleaning is required prior to HLD or sterilization.
2. True or False: Washing with an enzymatic cleaner disinfects instruments, making them safe to handle.
3. True or False: Scope leak testing should be done immediately after HLD.
4. True or False: If the dipstick of the HLD fails, but the solution has not reached the expiration date, it is safe to continue using.
5. True or False: If an item in the HLD won't sink, it is okay to put a towel or other item on it to make it sink.
6. True or False: Store disinfected scopes in the case to prevent damage.
7. True or False: It is okay to use "immediate-use sterilization" when the surgeon wants to do back-to-back cases all morning.
8. True or False: Different wrappers or containers are needed for steam and gas plasma sterilization.
9. True or False: Label all sterile packages with the load number, date processed, and expiration date 30 days after processing.
10. True or False: You should be concerned about the tech that can turn around scopes in under 15 minutes when your high-level disinfectant requires a 20-minute soak time.
Answers: 1.) True 2.) False 3.) False 4.) False 5.) False 6.)False 7.)False 8.) True 9.) False 10.) True
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