Following the Medical Device Alert Ref: MDA/2012/024 issued on the 09 May 2012 with regard to the use of inappropriate accessory holders within automated endoscope reprocessors (AER) that may lead to contamination of devices, equipment and processing media by retained soil and corroded material from the endoscope accessory holder.
The MHRA have stated to use only CE-marked medical devices for holding endoscope accessories during reprocessing, where the holder is specifically designed and manufactured to be used for decontamination. Following an investigation of an incident report, the MHRA is aware that an inappropriate device was used to hold accessories together during processing through an AER. When used in a reprocessor such holders can deteriorate and contaminants may be introduced to the decontamination chemicals, reprocessor and the endoscope. The fine mesh of the holder may also trap contaminants such as soil and may invalidate the decontamination process.
In response, Ruhof confirms their Endo-Bag is manufactured and marketed under the CE guidelines and meets all CE requirements, is designed to withstand High Level Disinfectants and is manufactured with strong Non-Linting Nylon.
The Endo-Bag came from an idea supplied indirectly by Endoscopy nurses taking the Persil washing machine tablet bags they used at home to work, to use as a washing bag for scope buttons and values in the Endoscope washer disinfector. Unfortunately these bags lint, potentially blocking the washer disinfector and scope channels.
Ruhof then developed a bag that was non-linting and could withstand high-level disinfectants and was designed for this specific purpose.
The Endo-Bag is designed for keeping scope buttons and valves with the scope in the washer disinfector during the cleaning and disinfection process; also assisting in the traceability of the scope and its accessories. It can be used for any small item in any type of washer disinfector.
