MDA/2004/028 - Flexible and rigid endoscopes

1. Page 1

Ref. MDA/2004/028
Issued: 23 June 2004

IMMEDIATE ACTION
ACTION
UPDATE
INFORMATION REQUEST

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PROBLEM:
The MHRA is aware of cases of inadequate decontamination of endoscopes, which have been cleaned and disinfected using manual and/or automatic processes.

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:
• 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.
• 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.
• Ensure that connection sets are fully compatible with both the endoscope and the AER.
• 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.

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ACTION (continued):
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'. www.bsg.org.uk
NHS Estates (1997). Health Technical Memorandum 2030 'Washer Disinfectors'. www.nhsestates.gov.uk
Controls Assurance Standards. 'Decontamination of reusable medical devices', 'Medical devices management'. www.hcsu.org.uk

DISTRIBUTION:
Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by:

TRUSTS to:

• Liaison officers (for onward distribution)
• Clinical governance leads
• Decontamination leads
• Director of infection prevention and control
• Endoscopy suite managers
• Gastroenterologists
• Health and safety officers
• Infection control doctors
• Infection control nurses
• Intensive care units
• Medical directors
• Nurse endoscopists
• Nursing executive directors
• Out patient departments
• Physicians
• Purchasing managers
• Risk managers
• Sterilise services managers
• Surgeons
• Theatre managers
• Theatre nurses
• Urologists

HEALTHCARE COMMISSION (CHAI) to:

• Headquarters (for onward distribution)
• Clinics
• Hospitals in the independent sector
• Private medical practitioners

PRIMARY CARE TRUSTS to:

• Liaison officers (for onward distribution)
• Clinical governance leads
• Community hospitals
• Directors of public health
• Endoscopy suites
• General medical practitioners undertaking endoscopy
• Lead nurses

HEALTH PROTECTION AGENCY to:

• Liaison officers (for onward distribution)
• Consultants in communicable disease control
• Health protection nurses

CONTACTS:
Enquiries to the MHRA should quote reference number 2004/005/005/291/427 and be addressed to:

© Crown Copyright 2004