Mocom

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.

So, the “parameters” that the authorised operator must verify prior to “release” of the load are: 1. The correct (intended) cycle was run (identifying the cycle name and number) 2. The target sterilising time was achieved 3. The target sterilising temp was reached and was within limits 4. The target sterilising pressure was reached and within limits 5. The cycle was completed fully and had a “positive” result 6. The operator who released the load can be identified

AND 7. The packs are dry 8. The packs are intact 9. The correct cycle was run for the pack/s being processed

The Mocom range presents all of the required physical parameters on the screen at the end of each cycle, then requires the operator to identify themselves, before the steriliser opens the door. This cycle and operator detail are recorded within the steriliser for later download. This “onscreen parametric release” functionality in the Mocom range of sterilisers meets all the requirements for authorised parametric release without the need for a printer. The operator must select their name and enter their (unique) pin number in order to open the door of the steriliser, adding an extra layer of security and preventing unauthorised (or accidental) release of a load. You may have experienced other steriliser brands that show a “completed” screen without detail at the end of the cycle, but the Mocom “completed” screen includes all parametric release data and still will not open the steriliser door without recording the authorised operator. In our view this more than meets the requirements and intent of the standard. In our view, Onscreen Parametric Release is only acceptable if the authorised operator can identify all parameters and the operator can be identified and securely recorded permanently. We strongly agree with the view that “Completed” is not enough (unless a Class 4,5,6 Indicator is used and recorded). Below is a typical Mocom Futura “Completed” cycle screen and the Operator Screens that follow, showing that points 1 – 6 listed above confirm that this data is presented to the operator at completion of a cycle, therefore no printer is required.