Validation of the sterilisation process
Since you cannot see if an instrument is sterile, you need a high level of confidence in your sterilisation system.
Validation can give you that confidence. It is a required procedure that documents that your specific sterilisation processes, properly followed, can reliably produce an acceptable result. The aim is to achieve the minimum sterility assurance level or a one in a million chance of one micro-organism surviving the sterilising process.
Validation obtains, records and interprets information on your equipment, its performance and your sterilisation procedures. It evidences:
- commissioning of new equipment
- ongoing maintenance and performance testing of equipment
- calibration of gauges (6 to12 monthly)
- specific sterilisation cycles (items for sterilising, packaging, loading, time/temperature, drying, indicators, results, etc)
- protocols for cleaning, storage, inspection
- proper record-keeping.
Validation is ongoing. You must revalidate:
- when you get new equipment
- after major servicing or alteration to equipment or procedure
- annually if neither of the above applies.
The person who takes responsibility for the validation process must have the appropriate skills and knowledge.
A validation checklist is available from the AGPAL website in their list of resources for sterilisation.
Hints for surer, safer, more efficient sterilisation
Everyone involved in the sterilisation process should understand the principles of sterilisation and know how to apply them.
To get sterilisation right, you need the right equipment and the right procedures.
Every step matters. They must be done in the right way and in the right order.
Good signs help. Post a clear description of each sterilisation task wherever it is performed.
Effective worker feedback can make a good sterilisation process even better.
Make a habit of keeping everything in the workplace as clean as possible.
Hand washing is a simple, yet effective, way to reduce cross-contamination. Everyone in health care facilities should know the how, when and why of personal hygiene.
Always reprocess instruments on loan before use and before returning them.
Reprocessing specialised surgical and medical items needs specific expertise. Powered or insulated instruments, hoses, endoscopes and respiratory equipment and the like should never be reprocessed without proper facilities and staff training.
Suction tubing is difficult to sterilise properly because it is difficult to clean and can easily trap air. Use sterile single-use tubing.
Make sure you know the legal requirements for sterilisation. Relevant Australian Standards include:
- AS/NZS 4187 (2003) (National Standard for cleaning, disinfecting and sterilising in health care facilities)
- AS/NZS 4815 (2001) (National Standard for cleaning, disinfecting and sterilising in office-based health care facilities)
- AS 2182 (specifies complying bench-top sterilisers)
- AS 1410 (specifies complying pre-vacuum steam sterilisers).