Hospital Waste Autoclave


All of the hospital infectious waste that is generated is processed through the San-I-Pak hazardous waste autoclave.
An efficacy test was performed on the autoclave.
A recent validation on a high containment waste autoclave was performed using a total of 10 gowns wrapped sequentially to provide a torturous path for steam penetration. Temperature recorders and chemical integrators were placed in the center of the load to monitor the sterilization effect.
A similar test was used on the San-I-Pak, but only 5 gowns were employed.
The details of the test are as follows:
50mL tubes containing CI's. One is placed inside of a glove Data logger placed inside of a glove A second data logger is added The first gown is wrapped around the load A total of 5 gowns are wrapped sequentially
The load is placed in a red bag The red bag is sealed The red bag is placed inside of the clear liner bag The clear bag is tied The load is placed in the chamber
The initial vacuum is drawn to 24"Hg Exposure phase is 40 minutes at 287oF Cycle complete Red bag was breached. Clear bag was intact CI at gown layer 4 showed zero exposure

Needless to say that the CI's at the center of the load showed zero exposure. It should also be noted that this was a small load that was placed in the chamber all by itself. In reality there will be larger loads, piled up on top of each other to fill the chamber.
This will effectively produce a much more serious challenge to a process that already fails to decontaminate.

The data loggers recorded a maximum temperature approximately 100oF lower than the chamber temperature.
This is just another example of improperly validated waste decontamination efforts. The good news is that this autoclave is capable of properly decontaminating the waste using parameters that would be derived from a proper validation. The administration were informed. You would think that they would be happy to be shown how to do it right. However, there answer was, "We have gone through extensive talks with CDPH to ensure that our San-I-Pak is working to their standards".
California medical waste regulations clearly stipulate that monthly efficacy tests are required with a biological indicator that is placed in the center of the load.
The official verbage on this can be found under:
California Health and Safety Code, Sections 117600 - 118360, Chapter 8 - Treatment, 118215 - Methods, Section (2), Paragraph (D)

The biological indicator Bacillus Stearothermophilus, or other indicator of adequate sterilization as approved by the department, shall be placed at the center of a load processed under standard operating conditions at least monthly to confirm the attainment of adequate sterilization conditions.

Check for yourself

This regulation is not being followed on this autoclave since the monthly test is being performed with a BI placed on the outside of the bag. This is about as much use as a chocolate fire guard, a weightlifting snowman or a one legged man in an a*s kicking competition!

The general concensus with improper testing is that it is a matter of ignorance rather than negligence. Well, that is all fine and dandy, but that isn't true at this facility.
The person responsible for the testing was informed that the BI is supposed to be placed in the center of the waste, and his eloquent response equated to "screw you".

Other pages on this site show how anal a CDPH inspector can be.
The inspector would not recognise the validity of a BI test at 300oF based on the fact that no specific testing had been done at this temperature.
Well, that argument has been beaten to death. However, I am a great believer in fair play so read on......

From the San-I-Pak web site the "3M 1276 Attest Steam Pack" is the recommended test kit.
Well, the next step was to contact a 3M technical service representative, with the question regarding the use of the "3M 1276 Attest Steam Pack" above 275oF?


The 3M response was...... "We do not have test data to provide to you for usage at that temperature".

The obvious next step was to contact the CDPH and ask them if the "3M 1276 Attest Steam Pack" is considered to be the equivalent of the center of a red bag and if the BI contained in the test pack was considered valid above the documented temperature.

The CDPH response was:
1) "We do not consider this test pack to be the equivalent to the middle of the load. If using this pack, it must be placed in the middle of the load".
2) "We would not approve of its use at 287F".


This translates into it being a non-valid test. Does anyone wonder what those 'extensive talks' could possibly have been about?

For further information on why so many facilities do not know how to validate their autoclaves properly check out the mis-information provided by San-I-Pak.



Myth #1 - "By loading the test kit last, near the door of the unit, it may be easily retrieved upon completion of the processing cycle."

Myth Buster - The test kit needs to be placed at the most difficult location for the steam to penetrate. The steam enters from the door so by placing the test next to the door isn't really a suitable challenge.

Myth #2 - "Note: This pack has been designed by 3M to duplicate the Bowie Dick Towel Pack Testing of autoclaves. The test simulates a load of waste, therefore does not require insertion into the actual waste."

Myth Buster - The Bowie-Dick test is a porous load that allows air removal and steam penetration. A red bag is NOT porous and therefore presents a very different challenge than does a porous load.
Therefore it should be obvious that the test DOES NOT simulate an actual waste load.

Myth #3 - "San-I-Pak has been tested with the most stringent, recognized methods throughout the United States."

Myth Buster - If this is true, then the United States has a serious problem. Unless the center of the load is being tested, you are just wasting your time and giving a false sense of security to the customers.

Myth #4 - "San-I-Pak employs parametric monitoring, which is superior to Biological Test."

Myth Buster - Biological testing is required to determine the parameters to be used. Parametric release is a common method of releasing waste since it is not practical to test BI's and hold on to the waste until the BI is incubated. To claim that parametric monitoring is superior only indicates that there is a lot of confusion at this company.
It would be like a home builder claiming that paint is superior to wood!
From the company web site - "At San-I-Pak we take great pride in being recognized as the world leader in on-site waste treatment systems and for setting industry standards for proper waste treatment and disposal. It's a result of years of innovation, high customer satisfaction and an outstanding return-on-investment rate for our clients through the services and equipment we provide."

"San-I-Pak, Inc. is a California based corporation with over 1,000 waste treatment units installed worldwide. We have installations throughout North and South America, Europe, Asia and the Middle East and we're the authorized supplier for several international service and purchasing organizations."

This is quite scary for a world leader since that is at least 1000 locations where untreated infectious waste is ending up in landfills.
There is much that can be learned from our very own wizard of Westwood.

"You can't live a perfect day without doing something for someone who will never be able to repay you." - John Wooden
The 'someone' in this case would be our future generations.
The 'something' is not ignorantly and needlessly contaminating the environment.

"Failure is not fatal, but failure to change might be." - John Wooden
This should be self explanatory.
A particular favourite of mine from another genius that can be pointed towards anyone that can make a difference.

"Twenty years from now you will be more disappointed by the things that you didnít do than by the things you did do" - Mark Twain

Now, there is a chance that all of this information is just a waste of time, and that would be if the Mayan calendar is correct.
Well, if their prediction is wrong and you are reading this after December 21st, 2012, then it is time for you to make a difference.