INFECTION CONTROL SOLUTIONS
CYCLE RECORD COMPLIANCE WITHOUT THE NEED OF A PRINTER
The Mocom range of sterilisers meets the intended requirements of Australian Standard/s without the need for a printer. Mocom are internationally recognised as experts in the design and manufacture of sterilisers and hold compliance certificates for all relevant international standards. The Supreme, Futura and Classic series have been specifically designed by Mocom to meet onscreen parametric release requirements. AS4815 is the applicable Australian standard currently for General Practice (“office-based practice”). A summary of the sections that refer to Parametric Release (i.e. the “authorised person” checking that all the required parameters have been met before “releasing” the load for use) are as follows: Table 7.1 - Cycle monitoring (every load) – this says you must have: • Print-out of cycle parameters or • Direct observation and recording of cycle parameters (i.e. writing them down every 10 seconds!) or • Class 4, 5 or 6 chemical indicator (where no print-out is available). And… • Class 1 chemical indicator in each load of unwrapped items. • Class 1 external chemical indicator on the outside of every packaged item in the load. And optionally: • Biological/enzymatic indicator(s). • Chemical indicator-on tray or inside pack(s) (Class 1, 4, 5 or 6). • Process challenge device(s) reflective of the type of loads processed. Clause 7.7.4.1 says in relation to the physical parameters to be monitored: • They shall include time and temperature, and, where applicable, pressure. • The parameters shall be automatically measured and permanently recorded (by print-out or non-volatile electronic record). • The monitoring must identify that critical physical parameters have been met (cycle type / time / temp / pressure) • At the end of each cycle, the operator shall …verify that correct cycle parameters were met and record it to permit later identification (of the operator). • For existing steam sterilizers (with no printer), …a Class 4, 5 or 6 chemical indicator shall be used with each load.
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