FW:Microbiological Surveillance and Duodenoscopes

[Glenys Harrington]

Dear All,

Im cross posting my response below following some enquiry about Microbiological Surveillance and Duodenoscopes on Ozbug see below

Regards

Glenys

Glenys Harrington

Consultant

Infection Control Consultancy (ICC)

PO Box 5202

Middle Park

Victoria, 3206

Australia

M: +61 404 816 434

infexion@ozemail.com.au

ABN 47533508426

Hi Denis,

The specific area of the duodenoscope that is of concern in relation to the CRE situation in the USA is the forceps elevator and its recess.

I think you will find that those following the GENSA guidelines will only be taking samples from air, water and instrument channels.

The forceps elevator and the recess are not part of the air, water or instrument channel. They are part of the distal end of the duodenoscope.

I have made the following image for you below and attached pdf

Some of the new duodenoscopes have sealed the area around the forceps elevator wire.

This makes it difficult to clean around and under the moving parts such as the elevator forceps and its recess.

Cleaning must be done manually and the forceps elevator needs to be moved up and down several times – see explanation in the attached USA Olympus letter to customer Important Safety information/Feb 19th 2015 which this is readily available in the public domain.

FDA have stated the following on February 19, 2015:

Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible. In addition, a recent FDA engineering assessment and a growing body of literature have identified design issues in duodenoscopes that complicate reprocessing of these devices. For example, one step of the manual cleaning instructions in device labeling is to brush the elevator area. However, the moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush. Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm

In addition to the above even when a duodenoscope is placed into an automated endoscope reprocessed(AER) the AERs are not set up to flush/inject fluid into the forceps elevator recess space.

Additional images

This CBS news report shows well the forceps elevator of a duodenoscope in action and its recess.

http://www.cbsnews.com/news/specialized-endoscope-design-raises-risk-for-infection/

There are good images in this online report from Dr. Bret T. Petersen discusses CRE infection and ERCP

https://www.youtube.com/watch?v5VgoDJ31V_0

See images in CDC Interim Duodenoscope Sampling Method re sampling the forceps elevator, recess and elevator channel

http://www.cdc.gov/hai/settings/lab/lab-duodenoscope-sampling.html

What needs to occur in the first instance in Australia is for Endoscopy Units to ensure that this meticulous cleaning of the forceps elevator and its recess with the recommended manufacturers cleaning brushes (not with a toothbrush like this place – http://edition.cnn.com/videos/health/2015/02/21/sgmd-gupta-superbug-scope.cnn ) is being undertaken.

See attached example of cleaning instructions Olympus TJF-Q180V Cleaning Quick reference.

Hope this information is helpful.

regards

Glenys

Glenys Harrington

Consultant

Infection Control Consultancy (ICC)

PO Box 5202

Middle Park

Victoria, 3206

Australia

M: +61 404 816 434

infexion@ozemail.com.au

ABN 47533508426

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