Sterilisation Information for the Skin Penetration Industry

Sterilisation is the only process which kills micro-organisms including bacteria (and their spores), fungi and viruses. According to health regulations all re-usable instruments which penetrate the skin must be sterilised.

Last updated: 05 August 2011

Instruments which require sterilisation include:

Cuticle cutters
Needles used by tattooist, beauty therapist, acupuncturist
Metal nail files (if they cause skin abrasions)
Any other instrument which penetrates or abrades the skin

Single-use items

Instruments which may penetrate the skin and can not be adequately cleaned and/or sterilised must be 'single-use'. That is they must only be used on one client and thrown away. They must never be re-used.

How do you sterilise ?

In Australia, sterilisation is conducted in accordance with AS/NZS 4815:2006. This Australian Standard outlines the critical steps involved in sterilisation.

What do you need to do before sterilisation ?

1. Ensure the premises is designed properly

Workflow for equipment processing should be from dirty – to clean – to sterile. The materials should be smooth and impervious, the floor non-slip, there should be adequate lighting, good ventilation, adequate storage space, a waste disposal area for clinical/biohazard waste and an approved sharps bin.
Equipment cleaning must not be conducted in a hand wash basin and all basins must have a supply of hot and cold water
Processing of equipment for cleaning and sterilisation should be conducted away from clients, preferably in a separate room

2. Equipment cleaning notes:

To protect against aerosol exposure from washing equipment soiled with contaminated materials such as blood and body fluids wear appropriate ‘Personal Protective Equipment”. That is, gloves, eye protection, fluid repellent masks and fluid resistant aprons or gowns should be worn whilst cleaning.
Equipment must be thoroughly cleaned before sterilisation.
Equipment cleaning should minimise the generation of aerosols. A deep double-bowl sink is recommended.
Tubing from equipment such as colonic lavage is difficult to clean and aerosols are likely to be generated from the cleaning process. To reduce these risks single-use tubing should be used and must be thrown away immediately after use.
The manufacturer’s instructions must be followed for the use of cleaning agents on instruments.
Good quality water must be used for cleaning. Water with a high mineral content is not suitable for rinsing as the instruments can become damaged by the mineral deposits

3. Equipment cleaning steps:

Rinse off any visible blood and body fluids with warm running water
Fill the sink with warm water and with the required detergent approved by the manufacturer
Dismantle /open all items for cleaning
Place in the sink
Wash all surfaces under water to minimise the generation of aerosols
Rinse in warm to hot running water
Some instruments need to be cleaned using an ultra-sonic cleaner. However plastic and similar items may not be suitable for ultra-sonic cleaning and cemented glass syringes, mirrors, and lenses will be damaged by repeated use.
Dry all items using a drying cabinet or with a lint free cloth (Instruments must be properly dried – residue moisture may impede the sterilisation process, and can damage instruments)
There should be a manual for staff on ‘cleaning procedures’

4. Packaging prior to sterilisation:

Instruments must be packaged and labelled prior to placing in a steriliser
Packaged items should be positioned in an upright position or in accordance with the manufacturer's instructions
Most packaging contains an indicator which shows that the load has been processed, not sterilised
Class 5 indicators show that the critical parameters e.g. time, temperature and moisture have been reached.
Class 6 indicators verify that the cycle e.g. 134^oC for 3.5min in steam has been reached.
Class 5 or 6 indicators need to be used in every sterilisation cycle if the steriliser has not been serviced properly (e.g due to remote location)
Exposed chemical indicators may change over time, therefore it is advisable to record the result in a permanent register
Biological/enzymatic indicators or ‘challenge tests’ ensure that the sterilisation process effectively kills at least 10^-6 of e.g. bacterial spores. Geobacillus stearothermophilus is the ‘challenge test’ organism used to verify sterilisation by steam under pressure. Biological indicators are usually used during performance and operational qualification and as part of recommissioning and performance requalification

Sterilisation

A Therapeutic Goods Administration (TGA) approved steriliser should be used in accordance with the Table below:

International Temperature Pressure-Time Relationship for Steam
Under-Pressure Sterilisation (minimum requirements)

^oC	kPa	mb	psi	Holding time (in min) for steam sterilisation
121	103	1030	15	15
126	138	1380	20	10
132	186	1860	27	4
134	203	2030	30	3

What sterilisation documentation do you need ?

Sterilisation (time, temperature and pressure) of each sterilisation cycle, operator name, date, steriliser No. or code, contents of load
Cleaning and maintenance procedures
Quality Management - in accordance with AS/NZS 4815:2006
Staff Training - in infection control and sterilisation management
Operators and maintenance manuals - must be on site at all times
Validation – the process of commissioning and performance qualification which is performed to evaluate the reliability of a sterilisation process. Validation needs to be carried out annually.
Where on-site technical support is not available to achieve calibration or validation, Class 5 or 6 indicator strips must be used in each load or a process challenge device must be used.

Important NOTES for sterilising

If a pack or its contents are wet, the pack is deemed unsterile and must NOT be used
The efficiency of the sterilisation process must be established during the validation process
Instruments must be dismantled or opened to ensure that all parts of the instrument are sterilised
Trays used for assembly of instrument sets for steam sterilisation must be perforated
Steam sterilisation is widely used as the steam under pressure provides fast destructive power to kill microorganisms and their spores
Existing sterilisers without process recorders need to be upgraded or replaced to ensure automatic parameter monitoring
UV light cabinets, microwave ovens, pasteurisation, disinfectants, pressure cookers, boiling and ultra-sonic cleaners DO NOT sterilise!

Warning

If unwrapped instruments are not used immediately after sterilisation they will become contaminated which renders them unsterile. To avoid this problem all instruments must be wrapped and packaged prior to sterilisation. This will maintain sterility and permit aseptic removal of the contents of the pack at the time of use.