The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued a medical device alert concerning endoscope accessory holder manufactured by all manufacturers.
Following investigation of an incident report, the MHRA is aware that the use of inappropriate accessory holders within automated endoscope reprocessors (AER) may lead to contamination of devices, equipment and processing media by retained soil and corroded material from the endoscope accessory holder.
The MHRA explained that the inappropriate 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.
The MHRA also provided the following advice:
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/MedicalDeviceAlerts/index.htm
Posted 10 May 2012