It’s hard to overrate the importance of endoscopes in hospitals and other care facilities, where they’re used to diagnose and manage not just gastrointestinal (GI) health but a variety of other patient conditions, too. Keeping them safe, functional, and cost-effective requires diligent management, a big part of which is stringent, clearly defined leak testing. We’ll offer a guide to doing just that in this rundown of endoscope leak testing instructions and best practices.
Endoscopes are delicate tools, used for highly sensitive procedures. Keeping them in top working condition with regular and diligent leak testing helps ensure the accuracy of clinical findings and the safety of patients. It can also save facilities considerable money in the long term, as minor fixes are usually less costly than extensive repair or a full replacement.
Big or small, any endoscope leak can have serious consequences, including compromised patient safety and the need for costly replacements. Leaks can also cause inaccuracies in diagnostic results and the risk of less effective treatment, which can result in diminished outcomes, missed interventions, and even loss of revenue and reputational harm from unwanted downtime.
In addition, some level of endoscopic leak testing is needed to comply with health and safety regulations like the AAMI/ANSI ST91:2021 sterilization standards. Failure to follow those rules could result in fines, loss of accreditation, fewer reimbursement dollars, and other negative consequences. For that reason, many organizations include leak testing as part of a larger sterile processing continuum that includes detailed tracking of all devices and assets.
Each endoscope should be tested for leaks after each use — and before the cleaning process — or after any event that could cause damage. New (and newly repaired) endoscopes should always be leak tested before being used.
There are two main types of endoscope leak testing: wet and dry. In dry testing, the endoscope is inflated then monitored for leaks via drop in pressure. In wet testing, the endoscope is inflated and then submerged in water, where leaks are indicated from escaping air bubbles.
Wet leak testing is a more in-depth procedure, and considered to be more effective in locating leaks. In this guide, we’ll focus on the wet endoscopic leak testing procedure.
The first steps in endoscopic leak testing are making sure you have all the tools, equipment, and protective gear you need to proceed without interruption, and then conducting a careful preliminary visual inspection.
The most important tool in leak testing is a pressurizer. These are available as automatic machines or hand-held/manual devices. Whichever type you use, make sure to confirm in advance that it has the right settings and adapters for the endoscope you’re testing, especially if it wasn’t provided by the original manufacturer.
You’ll also need personal protective equipment (PPE) like gloves and goggles as per your organization’s guidelines, plus a sink of clean water that’s big enough to submerge and manipulate the endoscope. Larger facilities and departments may also want to keep a selection of spare parts like bending sections, O-rings, and insertion tubes on hand for faster repairs.
Before you begin leak testing, it’s important to conduct a visual inspection of the endoscope. Include everything, and remember that movable parts are usually the fastest to wear out. If you see any significant damage or irregularities at this point — think dents or faulty seals — those should be promptly repaired. Don’t risk further harm to the endoscope by carrying out the entire test.
Now that you’ve conducted a pre-test and gathered the tools you need, it’s time to get started. Here are the specific endoscope leak testing instructions steps you’ll need to follow.
First, connect the endoscope to the pressure device you’re using. Tightly connect all seals — and especially the water cap — to prevent any unnecessary air leaks. A vital part of successful leak testing, the water cap is also highly susceptible to wear and breakdown, so take care to keep it in good shape, and don’t hesitate to replace it when it wears out.
Next, inflate the endoscope to the manufacturer’s recommended pressure level. Once it’s inflated, check the dial to see if it’s holding pressure. Any drop at this point usually indicates a leak. If it’s a slow leak, you should be able to pinpoint it during the test. If it’s a fast or big leak, you may be able to find it without further testing.
Pro Tip: An old, out-of-date, or damaged pressurizer can also give false impressions of leaks. Like any tool, pressure devices wear out and need replacement over time.
Because it’s made up of more flexible material, the bendable section of the endoscope — the part with the bending rubber and the caps that hold it in place — is most vulnerable to leaks and damage. Making sure it’s straightened out, submerge this section first and let it sit for a couple of minutes.
Next, proceed to slowly bend it in each direction while submerged, watching for bubbles that would indicate leaks. If you find a leak at this point, halt the test until this part of the endoscope can be repaired or replaced .
If no leaks are detected in the bending section, it’s time to submerge the endoscope. Make sure that it’s completely beneath the surface, and the water is clear enough to fully see it. Remember, surface bubbles will gather on the endoscope when first submerged. Don’t mistake these for leaks! Clear them off before carrying out the rest of the test.
Now that the endoscope is fully submerged, slowly manipulate each part, including buttons, dials, and tubes. Activate the controls as if you were actually using the device, watching for air bubbles that may indicate leaks. If you see bubbles, stop the process to locate them and determine whether there’s a leak before proceeding.
Pro Tip: Be thorough but careful — endoscopes are delicate tools, and easily damaged during harsh treatment or excessive bending.
Next, check for more hard-to-spot internal leaks by flushing the channels through each connection port while the endoscope is still submerged. Using water from a syringe, flush the channels at least four times — the first two or three will release bubbles that were trapped during submersion, so they need to be cleared out before any true leaks are revealed.
When you’re done flushing, remove the endoscope from the water, then release the pressure and disconnect it from the pressurizer. Remember not to deflate the endoscope until after you’ve removed it from the water.
Pro tip: Don’t rush it! The longer the endoscope is submerged, the more accurate the test results will be.
Because unwanted moisture can easily lead to harmful bacteria, drying is one of the most important steps in endoscope leak testing, and critical for patient safety. Drying is done either with the use of a drying cabinet, or a manual process that includes applying filtered and pressurized air.
Deep Dive: Drying is a “hot topic,” according to the Association for the Advancement of Medical Instrumentation (AAMI), which points to studies showing that a whopping 95% of processed endoscopes retain residual liquids. Forced-air drying significantly reduces that rate; the organization also advises against avoiding syringes or alcohol during the drying process.
Rather than a separate step, comprehensive documentation and reporting should be carried out throughout the entire leak inspection process. The results of each step above should be noted during testing, within a larger report that includes the data, endoscope model number, and the name of the person carrying out the test — along with any leaks and their precise location. Any repairs or other actions taken as a result of the leak test should also be recorded.
Pro Tip: Today’s most sophisticated instrument tracking systems include detailed documentation capabilities as part of their core function, greatly reducing the chance of errors, lapses, or missed events.
At Censis, we know how challenging it can be to ensure efficient and accurate endoscope leak detection. That’s why we designed ScopeTrac™ Advanced to improve not just the quality of your endoscope leak testing procedure, but also every other aspect of tracking, managing, and reprocessing this essential clinical asset, including easy compliance with regulations like AAMI ST91 standards.
Compatible with most clinical devices, software, and EMR platforms, ScopeTrac Advanced is a fully automated and highly scalable system for managing every endoscope and disinfection asset through the entire procedural cycle, while also improving the accuracy of recording and documentation and the overall user experience, too.
Contact us today to learn more or request a quote.
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The two most common leak detection tests for endoscopes are wet and dry testing. Wet testing involves pressurizing the endoscope then submerging it in clear water to detect leaks via bubbles, while dry testing means conducting the leak inspection by monitoring the pressure gauge. Dry testing is faster but considered to be less accurate, while wet testing is usually recommended by the manufacturer and more aligned with current clinical standards.
The pressurizer is the most important instrument used for endoscope leak detection. Although pressurizers are available in both automatic or hand-held/manual versions, you should always use the one provided by the original manufacturer, if available. The pressurizer should also be checked to make sure it has the right settings and adapters for the endoscope being tested.
Leak detection is important to keep endoscopes in top working condition. Leaks can lead to inaccurate clinical findings and less effective treatments, and can introduce contaminants that jeopardize patient safety. Because small fixes are usually less costly than major repairs or replacements, leak testing is also an important cost-saving measure. In addition, well-documented leak testing is required under certain safety regulations, and is an essential part of larger efforts to track and manage endoscopes and other sensitive instruments.
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For more detailed leak testing and endoscope tracking FAQs, see: https://censis.com/solutions/scopetrac-advanced/
ANSI/AAMI ST91:2021 Standards (PDF): https://www.aami.org/st91
Drying and Storage of Flexible Endoscopes: An Area of Growing Concern: https://www.aami.org/docs/default-source/bi-t/bit/drying-storing-endoscopes---bit-may-june-2020.pdf