Iso Ts 15883-5

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Hilda Bagnoli

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Aug 3, 2024, 3:20:28 PM8/3/24

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Chemdye Lumenia L122 Kit consists of a challenge device (Chemdye Lumenia CCDER122) and cleaning indicators (Chemdye Lumenia CDWE) for monitoring cleaning performance in Automated Endoscope Reprocessors.

The challenge device consists of three polytetrafluoroethylene (PTFE) tubes of high strength and durability, one with an inner diameter of 1 mm and two with an inner diameter of 2 mm, all of them 2 m long. Each PTFE tube has an input terminal in one of its ends for plugging it to the Automated Endoscope Reprocessor and a device in the other end that simulates an endoscopes lumen and where the Chemdye Lumenia CDWE cleaning indicators are placed (one in the inner cavity of the device and the other one in an external slot).

Chemdye Lumenia CDWE cleaning indicator was especially designed for monitoring these processes. It consists of a test soil, developed in accordance with the requirements described in ISO/TS 15883-5:2005 standard, arranged on a self-adhesive thermolabile synthetic support.

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With this test, it has been shown that if the instrument is not properly prepared, the washer disinfector has an important failure rate. This treatment should not be considered sufficient, it is necessary a pre-treatment in case of severe dirt (as was Annex N): the higher is the quality obtained in the preparation, the greater is the success rate of the washer disinfector.

The Annex N test of standard 15883-5 was carried out, evaluating the effectiveness of cleaning performance of BICARMED SafeCleanBOX machine compared to manual cleaning and ultrasonic treatment. The standard declares to evaluate on a visual inspection basis, but protein residues were also measured with the ProReveal machine on 5 of the 57 particular instruments (Poole suction tube, micro-invasive forceps, core and handle, trocar, hemostatic forceps). 3 technologies have been used: BICARMED SafeCleanBOX machine, ultrasound tank and manual cleaning sinks.

Excluding manual cleaning due to its obvious limitations, we compared the results of BICARMED and ultrasound: from the point of view of persistent dirty, they are comparable. Our study then analyzed the results from the point of view of complex geometry: BICARMED SafeCleanBOX was clearly superior, since ultrasound is a directional technology and not effective inside the cavities.

Manual cleaning with brush is very slight and limited and can damage the instrument. Utrasound one is not effective (it does not completely remove) on mucus, on the canal, cauterized blood, cement residues and geometric complexities, undercuts and / or cavities, it is not compatible with optics and with not-immersive instruments. While BICARMED SafeCleanBOX machine is effective even where ultrasound fails. It does not completely remove only some invisible residues.

L'ISO 15883-5:2005 inclut les terrains d'essai et les mthodes pouvant servir dmontrer l'efficacit du nettoyage des laveurs-dsinfecteurs (LD) conformment la srie de normes ISO 15883.L'inclusion des terrains d'essai et des mthodes dans l'ISO 15883-5:2005 n'indique pas qu'elles fournissent une sensibilit identique lors de la dtermination de l'efficacit de la phase de nettoyage.Les critres d'acceptabilit sont mentionns et fonds sur un contrle visuel et/ou un critre d'valuation microbiologique dfini pour chaque mthode. Lorsqu'une dtection chimique des souillures rsiduelles est requise, les mthodes peuvent tre compltes par la dtermination spcifique d'un composant rsiduel du terrain d'essai appliqu.

Les critres d'acceptabilit sont mentionns et fonds sur un contrle visuel et/ou un critre d'valuation microbiologique dfini pour chaque mthode. Lorsqu'une dtection chimique des souillures rsiduelles est requise, les mthodes peuvent tre compltes par la dtermination spcifique d'un composant rsiduel du terrain d'essai appliqu.