Medical Device Alert (immediate action) Flexible and rigid endoscopes. MDA/2004/028, UK
Examples of inadequate decontamination include:
• the use of connection sets that are not designated for a particular endoscope and the automated endoscope reprocessor (AER)
• failure to decontaminate all channels including those that have not been used during the procedure
• where required, failure to manually decontaminate auxiliary channels prior to automated reprocessing
• the flushing, but not high level disinfecting, of auxiliary channels e.g. elevator wire channel or auxiliary irrigation channel.
These practices could result in an increased risk of transmission of infection between patients.
All endoscope channels must be decontaminated after each procedure even if they have not been used during that procedure (e.g. auxiliary irrigation channels).
Some endoscopes (particularly older models) have channels that are not accessible to automated decontamination processes. The channels of these models must be manually cleaned and disinfected according to the manufacturer's instructions.
The effective use of an AER requires the endoscope to be connected correctly to the machine using designated connection sets for that particular model of endoscope. These connection sets are normally supplied by the manufacturer of the reprocessing equipment. All decontamination processes using AERs must be validated.
ACTION: • Carry out an immediate assessment of all endoscope decontamination processes. In particular:
o Identify endoscopes that have channels that cannot be decontaminated in an AER. These channels must be manually cleaned and disinfected following the manufacturer's instructions after every use of the endoscope; it is not acceptable to omit either phase from the process.
o Identify scopes with channels that may not be used during every procedure (e.g. auxiliary irrigation channel). These channels must be included in the decontamination cycle (manual or automated) after every use of the endoscope.
o Ensure that connection sets are fully compatible with both the endoscope and the AER.
o Check that all channels of the endoscope are accessible to the decontamination process and that the process is validated for each type of endoscope.
• If inadequate decontamination is identified contact the consultant in communicable disease control (CCDC) at your local health protection unit and consider the need for screening patients.
• Follow the endoscope and AER manufacturers' advice and instructions for use regarding the decontamination of endoscopes.
• When specifying for purchase and before purchasing a new endoscope check that it can be reprocessed using the decontamination processes available.
• Do not put endoscopes into service without a validated reprocessing procedure being in place.
Further advice is available in:
Medical Devices Agency. Device Bulletin DB2002(05) 'Decontamination of endoscopes' 2002. www.mhra.gov.uk
British Society of Gastroenterology (2003). 'Endoscopy guidelines'. http://www.bsg.org.uk
NHS Estates (1997). Health Technical Memorandum 2030 'Washer Disinfectors'. http://www.nhsestates.gov.uk
Controls Assurance Standards. 'Decontamination of reusable medical devices', 'Medical devices management'. http://www.hcsu.org.uk
To see full article CLICK HERE
Dispozitiv medical Alerta (acþiune imediatã) flexibile ºi rigide endoscopes. MDA/2004/028, Marea Britanie - Medical Device Alert (immediate action) Flexible and rigid endoscopes. MDA/2004/028, UK - articole medicale engleza - startsanatate