FDA Found That 1 in 20 Scopes Is Still Contaminated After Cleaning — Even When Hospitals Follow the Rules

The FDA's own testing found that roughly 1 in 20 closed-channel duodenoscopes remained contaminated after being cleaned according to manufacturer instructions. This isn't an estimate — it comes from the agency's own swab surveillance studies of scopes in active hospital use.

What the FDA Data Actually Shows

In 2019, the FDA published results from a large-scale swab surveillance program in which it tested duodenoscopes collected from hospitals that were following current cleaning guidelines. The results showed a contamination rate of approximately 3–5% — meaning that even under compliant conditions, between 1 in 20 and 1 in 33 scopes still harbored living bacteria after cleaning.

The bacteria found in contaminated scopes included some of the most dangerous drug-resistant organisms known to medicine: CRE (carbapenem-resistant Enterobacteriaceae), which the CDC has called an "urgent threat"; Pseudomonas aeruginosa; and other so-called superbugs that are resistant to most or all available antibiotics. When these bacteria survive on a scope and are transferred to the next patient during a procedure, the resulting infection can be extremely difficult to treat.

The contamination was concentrated in the elevator mechanism — a small hinged channel near the tip of duodenoscopes that is used during procedures to guide instruments. This channel is narrow, recessed, and largely inaccessible to standard cleaning brushes, making it a persistent hiding place for bacteria even when the rest of the scope is cleaned properly.

Why the Design Makes Cleaning So Hard

Unlike most surgical instruments, duodenoscopes cannot be sterilized with high heat (autoclaving) because the process would destroy their fiber-optic components. Instead, hospitals rely on liquid chemical disinfection — a process called high-level disinfection — to kill bacteria between uses.

The problem is that liquid disinfectants cannot reliably penetrate the closed elevator channel. Bacteria that lodge in the narrow gap between the elevator and the channel wall are effectively shielded from the disinfectant. Even when a hospital follows every step of the manufacturer's cleaning protocol correctly, bacteria in this space can survive and remain on the scope when it's used on the next patient.

This isn't a problem that stems from hospitals cleaning incorrectly. It is a fundamental design limitation that Olympus — which manufactures roughly 85% of all duodenoscopes used in the United States — was aware of for years before the scope of the problem became public.

What Hospitals Are Supposed to Do

In response to its own surveillance findings, the FDA has issued a series of increasingly detailed guidance documents over several years. These added steps include:

• Mandatory visual inspection of the elevator channel using a 10x magnification tool after every cleaning
• Forced-air drying of the elevator channel to prevent moisture that promotes bacterial growth
• Extended cleaning and culturing protocols at hospitals with known outbreak histories
• A recommendation — not a mandate — to transition to duodenoscopes with disposable tips that eliminate the contamination risk entirely

As of 2026, not all hospitals have made the transition to disposable-tip scopes. Many continue to use the same style of reusable, closed-channel duodenoscopes that produced the contamination rates in the FDA's surveillance study.

What This Means If You Had a Scope Procedure

If you had an ERCP, colonoscopy, bronchoscopy, or upper endoscopy at a hospital in the United States and developed a serious infection in the days or weeks that followed, there is a possibility the scope used in your procedure was not fully clean — even if the hospital followed the cleaning guidelines.

Many people who developed scope-related infections didn't connect their symptoms to the procedure right away. The infection often presents days after discharge, and it's frequently attributed to other causes before the scope is considered. Warning signs to look for:

• Fever, chills, or sweating that started in the days after a scope procedure
• Severe abdominal pain not fully explained by the procedure itself
• Being told you had an antibiotic-resistant infection — CRE, MRSA, Pseudomonas aeruginosa, or a similar organism
• Sepsis or bloodstream infection following what was supposed to be a routine endoscopic procedure
• Extended or repeated hospitalizations in the weeks after a scope procedure

Who May Have a Case

You may qualify for a free case review if:

• You had an endoscopic procedure — ERCP, colonoscopy, bronchoscopy, or upper endoscopy — at a hospital in the United States
• You developed a serious infection in the days or weeks following that procedure
• Your infection involved a drug-resistant or antibiotic-resistant bacteria
• Your infection required hospitalization, additional treatment, or caused lasting harm
• A family member died from an infection traced back to an endoscopic procedure

We represent patients nationwide. Filing deadlines vary by state and do not pause while new FDA data continues to accumulate. If you have questions about your situation, now is the right time to ask them.

Free case review. No Fees Unless We Recover Money for You.

Sources

• U.S. Food & Drug Administration — "Duodenoscope Reprocessing: Surveillance and Continuing Concerns," 2019. Swab surveillance study reporting 3–5% contamination rate after compliant cleaning. fda.gov
• U.S. Food & Drug Administration — Duodenoscope reprocessing guidance and safety communications, 2015–2023, including requirements for 10x magnification inspection and forced-air drying. fda.gov
• U.S. Senate Committee on Health, Education, Labor, and Pensions — "Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients," 2016. Documents duodenoscope outbreaks and manufacturer reporting failures.
• Drugwatch — "Olympus Scope Lawsuit 2026: Infection, Sepsis & Injury Claims." drugwatch.com
• Nigh Goldenberg Raso & Vaughn — "Olympus Endoscope Recalls." nighgoldenberg.com