EFHSS Questions and Answers - Question Q00692

Is there a published acceptable standard for the % of instruments that may be rejected by the user because of visible contamination on an item after it has undergont the decontamination process? If there isnt a published standard, I would be interested to know what others would consider a reasonable level of rejected instruments. I know that no instrument should be sent from an SSD with any visible contamination, but in the real world sometimes people make mistakes! Thanks.

Paul.
Cleaning is, to my opinion the most important link in the chain of decontamination. Visual Verifying is the routine, but as you know, the cleaning process shall be valid! (periodic validated).
The visual Quality control is a process of decision. Taking decision must be simple and easy. It should not be a challenge, neither compromise.
UK's HTM 2010, ISO 11134, ISO13683, US's ST-46, Australian AS 4187 may guide, direct you understanding the approach and requirements.
You should ask yourself why does the user reject reject the goods? Are they realy contaminated? Who trained and educated both of you? Is it an interpretation issue?

Happy New year
miki

The answer to question Q00692 is not an answer at all. The fact that a tray was rejected by the user due to a contaminated instrument being in the set needs to be addressed. I think this is something that occurs at all facilities. I would be very curious to know how frequently it occurs. The processing department I work in tracks number of dirty instruments reported monthly. Since there are humans doing this job there will always be errors, acceptable or not! Is there any benchmarking information on this topic?

Dear Paul,

The end users MUST reject all sets with any visibly contaminated instruments.
This may be up to 100% of sets produced, if the Sterile processing department fails to properly clean the instruments before assembling the instrument sets.
Random checks in my department indicate that considerably less than 1% of sterilized sets have stained, dirty, or broken instruments in the sets.
May I recommend that all sets be soaked in an enzymatic detergent before placing the instruments into the washer/decontaminator? At my institution, sets are regularly processed in an ultrasonic washer before putting the set into the washer/decontaminator.
This helps eliminate the possibility of dirty instruments being found in the Instrument Processing area.

The sterilization cycles are set up assuming the instruments being processed are clean. The reason that instruments MUST be clean prior to sterilization is because the sterilant MUST reach all surfaces that are to be sterilized. Any blood, oil, or other debris prevents the sterilant from reaching the surface to be sterilized. Live bacteria and viruses are protected from the sterilant by the dirty instrument. DRY HEAT is actually processing dirty instruments, and dry heat sterilization requires considerably higher temperatures and longer times to sterilize the instruments. That is why instruments MUST be meticulously cleaned prior to sterilization.
If the debris on a dirty instrument is loosened during the procedure, the new patient can be infected by the infections the prior patient had. Remember that fewer than 50% of infectious patients are identified as being infected prior to a procedure being performed on them.
Sterilizers are not 'cleaners' and there is no such thing as "STERILE DIRT" when instruments are processed using normal sterilization cycles.

Warm Regards,
Pete Bobb