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General device and reprocessing information only, not medical advice. Always follow the endoscope manufacturer’s instructions for use (IFU).
Short answer
An endoscope leak test checks whether an endoscope’s sealed interior has been breached, usually by pressurizing it with air and looking for a loss of pressure or escaping bubbles. CDC, summarizing HICPAC’s essential steps, places it after precleaning and before manual cleaning, and says it is done after each use. FDA recommends not using a scope that has failed a leak test.
Definition and scope
A flexible endoscope has a sealed outer body and internal channels. A leak test looks for damage that lets fluid pass through that barrier. CDC describes the purpose as helping to “identify damage to external surfaces or channels that can lead to persistent contamination or to further damage.” This page covers what the test is for and where it sits in a program; the exact method, equipment and test settings belong to each manufacturer’s IFU and are deliberately not reproduced here.
Where leak testing sits in the reprocessing sequence
CDC’s 2021 paper on gastrointestinal flexible endoscopes lists the HICPAC essential steps in this order:
- Precleaning immediately after the procedure.
- Leak testing after each use and before manual cleaning.
- Manual cleaning, including brushing and flushing channels and ports, before high-level disinfection or sterilization.
- Visual inspection for cleanliness and defects.
- Disinfection or sterilization with close attention to the manufacturer IFU.
The position matters. Testing before manual cleaning means damage is found before the scope is handled further. The full sequence, and where programs commonly fail, is covered in endoscope reprocessing.
Why a failed leak test matters
The FDA’s May 2022 MedSun newsletter, reporting on infections and contamination associated with reprocessed urological endoscopes, says some reports point to possible inadequate reprocessing or maintenance issues, “for example, device failed leak testing”. The same item recommends that providers not use damaged devices or those that have failed a leak test, “as they could be a potential source of contamination”, and that they follow the reprocessing steps in the manufacturer’s IFU, which for these devices include leak testing. It also advises routine inspection and periodic maintenance schedules in line with the manufacturer’s instructions. The newsletter is an FDA awareness item, not a regulation, and it concerned urological endoscopes specifically.
Leak testers as regulated devices
Some facilities use dedicated equipment. In FDA’s device classification database, product code PCV is “Endoscopic Leak Tester”, a Class 2 device under 21 CFR 876.1500 (gastroenterology and urology panel). FDA’s definition says it automatically detects leaks by assessing differences in air pressure inside the pressurized endoscope, without requiring visual observation of bubbles when the scope is immersed in water. The product code confirms a tester’s regulatory category; it does not say which tester suits which endoscope, which only the scope IFU can.
Checklist for lab, clinic and supply staff
- Confirm the leak-testing method for each endoscope model in that model’s IFU, since CDC and FDA both defer to the manufacturer’s instructions.
- Confirm the written sequence puts leak testing after each use and before manual cleaning, matching the HICPAC order above.
- Confirm staff know a scope that fails a leak test, like a damaged one, is not used (FDA, 2022).
- If an automatic leak tester is used, confirm its FDA classification (PCV, 21 CFR 876.1500).
- Confirm inspection and maintenance schedules follow the manufacturer’s instructions.
Related supply planning is in the endoscopy center supply checklist, and a related regulated device is covered in automated endoscope reprocessor (AER).
Common misunderstandings
“A passed leak test means the scope is disinfected”
No. Leak testing checks integrity only. It is one step of five and does not replace manual cleaning, inspection or disinfection or sterilization.
“Leak testing is optional if the scope looks fine”
The HICPAC steps call for it after each use, and FDA’s reprocessing options for urological endoscopes both include a leak test.
“One method fits every endoscope”
Methods and requirements come from each manufacturer’s IFU. Reusable accessory components may have separate reprocessing instructions, as FDA notes. For the background on the instrument itself, see what is an endoscope.
FAQ
When is an endoscope leak test done?
After each use and before manual cleaning, according to the HICPAC essential steps as summarized by CDC (2021).
What happens if an endoscope fails a leak test?
FDA recommends not using devices that have failed a leak test, because they could be a potential source of contamination. Follow the manufacturer’s IFU for what to do next.
What is endoscope leak testing for?
To help identify damage to external surfaces or channels that can lead to persistent contamination or further damage (CDC, 2021).
Sources
- Benowitz I, Moulton-Meissner H, Epstein L, Arduino M. Gastrointestinal Flexible Endoscopes: Infection Control Risks, Lessons Learned from Outbreaks, and CDC Guidance. CDC Stacks, 2021. stacks.cdc.gov/view/cdc/104184. Checked 2026-10-31.
- FDA. MedSun Newsletter, May 2022, vol. 22 issue 5. fda.gov/media/158169. Checked 2026-10-31.
- FDA device classification database via openFDA, product code PCV (Endoscopic Leak Tester), 21 CFR 876.1500. api.fda.gov/device/classification. Checked 2026-10-31.
