Whitepaper

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The importance of testing the waterproof integrity of flexible
endoscopes and the relevance to patient cross infection risks.
Background and aims:
Flexible medical endoscopes are an important and integral part of diseasediagnosis and treatment, but are also sources of patient cross infection.
The aim of this paper is to raise awareness to the risks of inappropriate
leak testing and patient safety impact.
Leak testing is a vital processing step that detects fluid invasion in
an endoscope. Endoscopes that are inadequately leak tested can pose arisk for transmission of infection or injury to patients. Moreover, if
not detected, fluid invasion of an endoscope can damage the endoscopeand increase repair costs. Leak testing of endoscopes is the most misunderstood and routinely missed step in endoscope reprocessing.
The design of endoscopes incorporates an internal area where all of thecomponents necessary for safe operation are housed. This includes but is
not limited to: fiber bundles, wiring harnesses, CCD chips, angulation wires,channel systems, support frameworks and other components. This area isdesigned to remain dry and is not subjected to contact with detergents,
disinfectants or rinse water.
The endoscope is a complex mix of materials and these many parts

have to be joined together in a way that is patient safe as well as watertight and able to be properly cleaned.

Process
The process of testing the endoscope can be called many different things
depending on manufacture and/or facility. Leak test, sheath integrity test,
waterproof test and bubble test are all used to describe the same function. The object of the exercise is threefold:
1 To eliminate the risk of cross infection between patients by contaminated fluid leaks during the procedure.
2 To minimize the level of damage caused to an endoscope by submersion
in fluids with a leak in the endoscope.
3 To minimize the cost of repairs caused by submersion in fluids with aleak in the endoscope.

Endoscopes contain lots of ‘O’-rings as well, that can be a source of leaks.
The same goes for the relatively soft bending section rubber and thinmembranes that cover video switches.
Fluid can enter the inside of the endoscope through leaks in any of theexternal or internal structure or through damaged ‘O’ rings. Holes can beminiscule in size and present an extreme challenge to the conventional leaktest method.
Larger holes that present as a gross leak are easily identified and theendoscope can be quarantined and removed from patient contact. Smaller
leaks are much more difficult to find and potentially pose the greatest risk
to patient contamination.

This whitepaper is based on the original scientific paper of Nick G. Bromiley AGTS, CFER, CSPDT, ARIA. Principal Technical Specialist & Trainer, Endoscopes at Medivators Inc.

For more info visit: www.dovideqmedical.com

Whitepaper

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Manual test
Manual wet leak tests are the most common method of testing, yet
are conducted by individuals who may not understand the ramifications of using a leaking endoscope in patient procedures, and may nothave been trained on the importance of each of the steps in the process.
One tester leaves the scope attached to the leak tester for two minutes,
the other for only thirty seconds. Longevity is crucial to the accuracy ofthe test.
One employee detects a leak when the scope goes down from 220mbto 200mb and the other only at 180mb or through the air bubbles in thewater bath.

Automated test
An automated electronic leak testing device detects small leaks during
pre-cleaning, before they turn into a major repair or a total loss. It also
saves a redundant cleaning cycle because of a faulty endoscope and acontaminated cleaning device.
Most importantly, it enables a reliable and reproducible leak testing regardless of brand or type of scope.

Conclusion
This process is not reproducible and highly dependent on the particular employee and therefore a major risk to patient safety and compliance. Afterthe manual check and pre-cleaning , the scope is placed in the automateddisinfector and does not pass the disinfector’s leak test. The cause may
be a leaking scope, a defective seal or an incorrect connection that causes
microleaks that cannot be detected by the human eye.

Leak testing is crucial to the success of the reprocessing cycle, in theevent that an endoscope with a leak is used for a patient procedure, therisk of cross infection due to patient contamination with this fluid is enormous. It is recommended to use an automated system to add a reliable
and reproducible test to the reprocessing cycle.

If such a problem occurs, the disinfection process needs to be interrupted
to find and fix the problem, which always costs extra time. The undetectedleaks can cause damage to the scope and incur major repair costs.

Interested in automatedleaktesting?

When a small leak goes undetected, fluid can accumulate inside the endoscope during each procedure and each reprocessing cycle. If the leak is in
one of the more common places, such as the bending section, rubber, fluid
can accumulate in the tip of the endoscope near the source of the leak andpotentially leak out during subsequent procedures.

Many hospitals have already expressed interest in our LeakControl
or have these testers in use. The leak tester can be set up to suiteach user.
Contact Dovideq today for a quote.

This fluid has not been in contact with disinfectants and may be many
procedures old. It may not be detected until enough fluid causes problems
with the video system.

This whitepaper is based on the original scientific paper of Nick G. Bromiley AGTS, CFER, CSPDT, ARIA. Principal Technical Specialist & Trainer, Endoscopes at Medivators Inc.

For more info visit: www.dovideqmedical.com