News / May 19, 2021
One of the many benefits of being a member of the Association for the Advancement of Medical Instrumentation (AAMI) is being able to read and participate in the “AAMI Members Discussion Group.” This great tool allows AAMI members from around the world to post questions and get input, ideas and solutions from fellow members. This discussion group is open to all AAMI members and it is an invaluable and time-saving resource.
A recent exchange in the AAMI Members Discussion Group addressed the question of what to do with instruments that are found to still be contaminated after decontamination. This interesting exchange was started when an AAMI member posted this question:
“I was just wondering how others deal with instruments that have gone through the decontamination process and are found to have bone or other tissue during the assembly process. Do you send back only the instrument retaining the bone or tissue to go through the decontamination process again? Or do you send back the complete tray of instruments it came through in? For example bone in a rongeur or tissue in the serrations of a Debakey forcep.”
Posted by: Janet, Manager Sterile Processing
The first response that Janet received was:
“Since a dirty instrument can cause so much pain, stress and rework for both the OR and CSP I recommend it is best to put a big spot light on even the potential of a dirty instrument. If dirty instrument defects repeat, I would ‘Stop The Line’ call a huddle, show everyone and investigate the root cause. As a manager you should do this until you’re comfortable your complete staff understands the impact. Also don’t forget about your other shifts. Take a picture and let them learn.
If you did the ‘5 Why’s’ you might find that this defect actually starts at preclean at the point of use in the OR. Maybe the OR could separate or identify instruments used but are more difficult to clean.”
Posted by: Eddie, Manager CSR
The second response that Janet received was:
“Typically the rule of thumb that I have experienced is if one instrument is discovered as ‘dirty’ with bone then that single instrument is taken back to decontamination for reprocessing and then presented back to Assembly when complete while the assembly technician continues the tray. If the technician assembling that tray experiences additional ‘dirty’ items then the entire tray is brought back to Decontamination for reprocessing.
Personally, I would rather have a rongeur have a chunk of bone lodged rather than a bloody instrument as the bloody instrument could have spread to other portions of the tray but if a bloody instrument is discovered the entire tray is sent back to Decontamination.
Working with the OR is crucial to ensure they are properly conducting point of use decontamination but Sterile Processing personnel need to make sure they are doing their due diligence in producing a quality product as well – it takes more than one group to be successful.”
Posted by: Nicholas, Training and Development Specialist
The third response that Janet received was:
“We send the complete tray back for reprocessing. All of our trays are labeled with the initials of the tech that cleaned the tray and it goes right back to them. If they missed tissue/bone in one instrument what else did they miss?”
Posted by: Melinda, CST, CRCST Manager, Central Sterile
While all 3 responses are well thought-out and informative, they all fail to address the larger problem raised by Janet’s initial question. Specifically, Janet’s question concerns ‘visual’ debris that is discovered on/in instruments that have already gone through the decontamination and cleaning process. What Janet fails to question is what about all of the ‘invisible’ debris that remains on/in instruments after the decontamination and cleaning process?
The human eye is simply not capable of seeing microscopic debris/biofilm on the surface of an instrument. Accordingly, CS/SPD departments that rely on a simple ‘visual’ inspection of their instruments prior to sterilization are running the risk of returning contaminated instruments to the OR. As was pointed out in an article in HPN:
“It’s the sad reality of what people in CS/SPD face. They are held accountable for returning clean, sterile, moisture free instruments up to the OR and yet they are dealing with instruments whose cleaning IFUs have never been validated and they have to rely on visual inspection, which is not an acceptable technique.”1
The only way to insure that your instruments are free of microscopic debris and biofilm is to only use instruments whose cleaning IFUs have been ‘validated.’ Failure to demand validated cleaning IFUs from instrument manufacturers is a tremendous patient safety issue. Healthcare facilities have a legal, ethical, financial and moral obligation to only use instruments whose IFUs have been validated using FDA validation protocols.
1 “Validated? It’s complicated” by Kara Nadeau, HPN, April 2017
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