Monitoring The Sterilization Process

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Monitoring The
Sterilization Process.
Are We Over The Top ?
Dr Brian Kirk,
Senior Technical Services Specialist, Sterilization 3M Health Care

Are We Over The Top?
NO ! Get it wrong and you kill the patient!
Clothier Report, 1972 Inquiry into the death of 5 patients receiving contaminated infusion fluids inadequately sterilized. Conclusion;
“The committee considers that too many people believe that sterilization (of fluids) is easily achieved with simple plant operated by men of little skill under minimum supervision, a view of the task which is wrong in every respect.”

6 Ja©nu3aMry 2016. All Rights Reserved. 3M Confidential.


Are We Over The Top?
Get it wrong and you harm the patient !

Dancer et al, 2012

Post surgical site infection resulting from contaminated surgical orthopaedic and ophthalmology sets arising from incorrect control of the sterilization process.


Inspection of the sterilization plant

highlighted inadequate maintenance of

autoclave components and poor handling

practices by staff. This was compounded

by lapses in inspection of surgical sets by

theatre staff 6 Ja©nu3aMry 2016. All Rights Reserved. 3M Confidential.


Are we over the top?
No. No, No !!!
Get it wrong and the whole process can be compromised. Bowie, J.H., 1961. Reported on an evaluation of a number of porous load sterilizers in use in Scottish Hospitals. Conclusion; “Our findings suggest that a great many high vacuum sterilizers already installed in hospitals are not in proper functioning order.”
55 years on, has this changed ?

6 Ja©nu3aMry 2016. All Rights Reserved. 3M Confidential.


Lessons from History
Some of the incidents described earlier gave rise to the body of standards which we all follow today.
Unfortunately memory fades, times change. We get complacent because of lack of incident and new generations see old ideas as unfashionable and antiquated.
However the basic principles do not change.
Despite its unpopularity, we should take heed of the lessons from history.
It can never be “over the top” to exercise due diligence when it comes to sterilization monitoring and control.

6 Ja©nu3aMry 2016. All Rights Reserved. 3M Confidential.


Sterility, Sterilization and Sterility Assurance
Sterility – State of being free from viable micro-organisms
Sterilization – Validated Process used to render product sterile
Validation - Documented procedure for obtaining, recording and interpreting results required to establish that a process will consistently yield product complying with a predetermined specification
• Specification = Sterile Product
• EN 556-1:2001 (E), Sterilization of Medical Devices – Requirements for medical devices to be designated “Sterile” – Part 1 : Requirements for terminally sterilized Medical Devices.
• EN ISO 14937:2000 – Sterilization of Health Care Products – General requirements for characterization of sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
• Why Validation – Because we cannot test for Sterility !

Sterility Assurance is Achieved By;
Specifying; Writing a detailed specification explaining what equipment is used, the process steps followed and how it is monitored
Reference to standards and regulatory requirement of great help in this process
Validating ; Documenting and carrying out a procedure which provides data showing we get what we want ie a sterile, safe, efficacious product. Involves three steps – Installation Qualification, Operational Qualification and Performance Qualification
Routinely Monitoring; Taking actions to ensure ongoing process efficacy.

Why Monitor ?
Sterilization processes are special so require validation rather than final product testing. • We cannot test for Sterility
Each sterilization process is a unique event and so requires monitoring for process efficacy. • Recorded Evidence for every load.
This is reflected in Sterilization Standards (11135, 11137, 17665) which require validation and then routine monitoring procedures to be in place.

6 Ja©nu3aMry 2016. All Rights Reserved. 3M Confidential.


What should be monitored – Critical Process Variables (CPV)

Variables that contribute to the inactivation of micro-organisms and are critical in achieving successful sterilization.






Moisture Humidity Conc’n Pressure



Yes But

not CPV

Ethylene Oxide

Yes But not CPV

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What do we need to monitor and how?
The microbiocidal efficacy of sterilization processes is achieved by application of certain critical variables
• Eg time of exposure, temperature, presence of moisture, concentration (for chemical sterilization).
In order to have an assurance of sterility we must monitor the application of the critical variables to ensure they have been achieved
Monitoring is achieved using sensors based on: Physical Biological Chemical
• Indicator devices

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Monitoring The Sterilization Process