ENDOSCOPE DECONTAMINATION UNITS
determines that the internal conditions within such cabinets are deemed to be satisfactory if the airborne aerobic mesophilic microbial contamination in the storage cabinet, determined by active air sampling, does not exceed 100 cfu/m3
,
corresponding to Class 8 of ISO 14644-1.19 Single room units do not physically
segregate dirty and clean activities, and consequently present a higher risk of inadvertent release of endoscopes not decontaminated to the required standards. In existing facilities, a single room application can be deemed acceptable, based on throughput and volume. Where used, procedures must be robustly managed to reduce the risk of inadvertent release. This is not possible with pass- through EWDs, as the scopes can only migrate to the next room upon completion of a passed and validated cycle. This paper recommends progression to a two-room design for facilities undertaking flexible endoscope decontamination.
Double room endoscope decontamination facility layout The preferred layout of an endoscope decontamination facility is to have two rooms, where there is a washroom and a clean endoscope storage room housing the EWDs separated by a wall. With this two-room layout, air will be supplied to the clean storage room through a ceiling-
‘‘
There will be a risk to staff associated with the use, handling, safe storage, and disposal of chemicals, detergents, and disinfectants, which will include components of peracetic acid, chlorine dioxide, hydrogen peroxide, and enzymatic detergents
mounted diffuser, and pass through to the washroom via a high-level pressure stabiliser mounted in the adjoining wall. Air is extracted from the washroom, either at low level adjacent to the EWD where the greatest risk of leakage exists, or at ‘draining board’ level behind the sinks where scopes are cleaned. The operational success of this facility will be dependent on the detail of its design and construction. The following points must be observed: 1) All decontamination equipment, such as water softeners, reverse osmosis (RO) water units, or water filtration, should be located outside the clean area, for example in the washroom. If water softeners and RO water units are used, consideration should be given to locating them within a nearby plant room, minimising heat gain. 2) The EWDs should be installed so that all parts that need to be routinely inspected or serviced are accessible from the washroom side. 3) The principal extract position in the
washroom should optimise the airflow distribution across the room, which will include extract adjacent to the EWD to support the air cascade. Extract will also be required at draining board level behind the sinks where scopes are cleaned. Such airflow will need balancing as part of a commissioning exercise. 4) Where peracetic acid is present, low- level extraction is required, as the gas vapours are heavier than air. 5) The clean endoscope storage room should have a solid ceiling. If a refurbished area has a non-removable existing tiled ceiling, the tiles should be sealed in position. The ceiling should be able to withstand cleaning, and have a completely sealed finish to maintain microbiological cleanliness. If ceiling access panels are unavoidable, they should be resealable. 6) The endoscope cleanroom ceiling void should not contain any equipment that requires routine service or maintenance. 7) Any ventilation ductwork passing through the endoscope cleanroom ceiling
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