Sterilisation 101

CLASSIFICATIONS

There are 3 classifications of instruments. Solids, Hollow B and Hollow A instruments. These are defined as:
Solids - are instruments like Forceps, Scissors and Needle-Holders.
Hollow B - are instruments that have a large diameter and small shallow depth, like a kidney dish for example.
Hollow A - instruments are the hardest instrument to achieve sterility in, they have a very small diameter, either at one end of the instrument or both, and a long length. For example, Trocar or a large amount of Gauze can be defined as Hollow A.

To achieve sterility with these 3 styles of instruments, Australian standards (AUS\NZ: 4815) recognise 2 classes of sterilisers: S class and B class.
S Class Sterilisers – are recognised by standards as being able to achieve sterility in Solids and Hollow B instruments.
B Class Sterilisers – are recognised by standards as being able to achieve sterility in all classes of instruments.

CHAMBER SIZES

Most brands of steriliser on the market are available in two different chamber sizes.
Commonly these are 18L & 24L.
You can make it easier to choose the right chamber size for your practice demands by using this guide:

1-3 cycles a day, an 18L chamber suit your daily requirements.
3-5 cycles a day, either chamber size of 18L or 24L will suit. Although keep in mind if you are processing 5 cycles a day in an 18L, this would equate to only 4 cycles a day in a 24L due to the additional chamber space.
5-10 cycles a day, a 24L is recommended.

WHAT TYPE AND SIZE OF STERILISER DOES MY CLINIC REQUIRE?

Do you require an S Class, or a B Class to process hollow instruments?

Firstly, review the instruments you are currently processing. Even if you only process a particular style of instrument once a month or less, it should still be taken into consideration. What’s inside the Doctor's Procedure kit? Is there anything that would be defined as Hollow A?
If you have any instruments defined as Hollow A, then a B Class steriliser is required for your practice under Australian Standards (AUS\NZ: 4815).
If your clinic does not process any kind of Hollow A instrument, then an S Class steriliser will be suitable.

Now you know which class you require, it’s time to decide on the chamber size.
It's important to assess how many cycles you process daily and use the guide above to assist in the choosing the right chamber size.
Purchasing a steriliser for your practice is a long term investment. Sometimes, it’s not always what your practice is doing today, but how this may change in the future that needs to be considered. Meaning, if you are currently processing 3-4 cycles a day in an 18L chamber, is the same 18L chamber going to big enough to handle your clinic requirements 5 years from now.
Also consider, do you need a steriliser capable of processing large loads, or does your practice need something smaller because you mostly use disposable instruments?

CYCLE RECORDING?

To comply with Australian Standards (AUS\NZ: 4815), a record of your sterilisation cycles must be produced and stored for safe keeping.
This can be performed by having a printer connected to your steriliser. Printers are still very common, but Data Recording of the cycle electronically has also become popular as more practices decide to go paperless. This is normally performed by having an electronic recording system connected to your steriliser instead of the printer.
Most brands of steriliser on the market will provide you with an option for how you would like to record your cycle data at time of purchase.
Please ensure to let your Sales Rep know when discussing your options about your preference for record keeping.
Note: Sterilisers must provide a printout or data log of the cycle to comply with Australian Standards (AUS\NZ: 4815). Sterilisers without a printer or data logger are obsolete and should not be used.

STERILISER WARRANTY?

Most brands of steriliser on the Australian market are supplied with a Manufacturer’s Warranty. The Warranty period will differ between brands, so it is important to ask your Sales Rep about the Warranty period and the details of warranty inclusions like Parts & Labour. Normally, Extended Warranties are available for an additional cost at time of purchase.

What does the warranty cover?
A Manufacturer’s Warranty is a guarantee from the Manufacturer that the unit is free of defects that could have been introduced during the assembly of the device.
If ever unsure of your warranty terms, please ensure to ask your Sales Rep before purchasing your new steriliser.

HOW DO I INSTALL A STERILISER?

Your steriliser must be installed according to manufacturer’s instructions. This is performed by a Trained Service Technician. Different brands of steriliser will have their own approved Service Network of trained technicians. Your Sales Rep will be able to provide you with a list of Approved Service Companies for the brand you are purchasing from. Some medical suppliers provide this service for you as part of the sales process and will organise the installation for you on your behalf.

HOW DO I LEARN HOW TO USE THE STERILISER?

When your steriliser is installed, the Technician installing the steriliser or youe sales rep, will provide training to your staff that will be operating the unit. Practices need to ensure that staff involved in processing equipment for reuse have received adequate training and are competent in the sterilisers operation.

MAINTENANCE?

Each brand of steriliser will have different daily, weekly, monthly, quarterly & annualmaintenance that needs to be performed. During the training provided at time of installation, the requirements of your steriliser will be covered.
To Comply with Australian Standards (AUS\NZ: 4815) you are required to have your steriliser Annually Serviced, Calibrated and Validated. This will normally be performed by the Approved Service Company that installed your steriliser.
Your steriliser must be validated by a trained technician only.

DOES THE STERILISER MEET AUSTRALIAN STANDARDS?

RACGP guidelines state that “Under Therapeutic Goods Association regulations, all new devices sold in Australia must perform the essential functions of their intended purpose”. This means that when you purchase a steriliser from an Australian medical supplies provider, your steriliser should meet TGA standards. “Purchasers should also ensure that the manufacturer has obtained pressure vessel compliance relevant to the practice’s state or territory”.
If unsure if the steriliser you are purchasing complies with these guidelines, do not hesitate to ask your Sales Rep before purchasing. They should be able to produce the required documentation for your unit to show compliance.

References:
1. Infection prevention and control standards. For general practices and other office-based and community-based practices, 2014, 5th edn, RACGP.
2. Queensland Health, ‘Easi-Sterilise: Validation of Benchtop Sterilisers’, Version 2.1. Queensland Government. 2011. Available from: <www.health.qld.gov.au/__data/assets/pdf_file/0038/654878/benchtop-validate.pdf>. [10 September 2014].

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