In most product-injury cases, the hardest thing to prove is that a safer version of the product could have been built. In the reusable duodenoscope story, that argument was made years ago — by the manufacturers themselves, and by the FDA. A single-use duodenoscope that never has to be cleaned, and therefore can never carry one patient's bacteria to the next, was cleared for sale in December 2019. The FDA had already told hospitals, months earlier, to start moving away from the older fixed-endcap reusable design because it was too hard to clean reliably. That timeline is not just medical history. In a product-liability case, the existence of a feasible safer design is one of the questions a court asks first — and here the safer design was on the market, endorsed by the regulator.
Why Reusable Duodenoscopes Are So Hard to Clean
A duodenoscope is a long, flexible tube threaded through the mouth to the top of the small intestine so a physician can treat problems in the bile and pancreatic ducts — the procedure called ERCP (endoscopic retrograde cholangiopancreatography). At the tip is a hinged part called the elevator, a tiny movable lever that steers instruments and tools into the ducts. The elevator mechanism, and the recesses around it, are the problem. They have crevices and channels that trap tissue, fluid, and bacteria, and on the older “fixed-endcap” design those crevices cannot be fully opened up for cleaning. Standard high-level disinfection — the reprocessing step performed between patients — was never designed for a part this intricate.
The U.S. Food & Drug Administration put this plainly. In post-market surveillance sampling and culturing studies it required of the manufacturers, the FDA found that even “patient-ready” reusable duodenoscopes — scopes that had gone through the full cleaning process and were about to be used — still tested positive for bacteria at rates far higher than anyone expected, including high-concern organisms associated with disease. The agency concluded that a meaningful share of contamination was not a fluke or a one-time human error but a limitation built into the fixed-endcap design itself. Our page on Olympus endoscope design defects walks through how that design flaw maps onto the specific scope models.
What the FDA Actually Recommended — and When
On August 29, 2019, the FDA issued a public recommendation that health care facilities and manufacturers begin transitioning away from fixed-endcap reusable duodenoscopes toward newer designs: duodenoscopes with disposable components (such as a removable, single-use endcap) and, ideally, fully disposable duodenoscopes. The agency's stated reason was direct — the older design is difficult to reprocess, contamination persists even when instructions are followed, and users frequently could not complete reprocessing successfully. This was not a recall and it did not force any scope off the market. It was a safety recommendation aimed at the design of the device.
Two developments followed quickly. The FDA cleared the first duodenoscope with a disposable elevator component, reducing the number of hard-to-clean parts that had to be disinfected by hand. And on December 13, 2019, Boston Scientific received FDA clearance for the EXALT Model D — the first fully single-use, disposable duodenoscope, which the FDA had earlier granted a Breakthrough Device Designation. A single-use scope is opened sterile, used once, and thrown away. There is no reprocessing step to get wrong, and no shared device to carry bacteria from one patient to the next.
How Much Safer Is Single-Use?
The infection risk that comes from a failed cleaning cycle is designed out entirely. A device used on exactly one patient cannot transmit a prior patient's carbapenem-resistant Enterobacterales, Pseudomonas, or E. coli, because there is no prior patient. That is the core safety difference, and it is not a marketing claim — it is a structural fact about a device that is never reused.
The contrast with the reusable design is stark in the FDA's own data. Where fixed-endcap reusable scopes showed post-cleaning contamination in the range of several percent for high-concern organisms, the FDA reported that a newer model with a removable disposable component drove that rate down close to half a percent in interim surveillance results. The American Gastroenterological Association has gone further, describing disposable duodenoscopes as, in its words, “the inevitable future” of the field. Herb Borroto, M.D., J.D., the firm's Medical-Legal Expert, notes that this is the rare situation where the safety fix is not a matter of trying harder to clean a flawed device — it is a different device that removes the failure point altogether.
Why a Safer Alternative Design Matters in a Lawsuit
This is where the medical history becomes legally important. When someone is harmed by a product and claims the product was defectively designed, courts generally apply a risk-utility test. Under the framework described in the Restatement (Third) of Torts: Products Liability § 2(b), a product is defective in design when the foreseeable risks of harm could have been reduced or avoided by adopting a reasonable alternative design — and the failure to adopt it made the product not reasonably safe. In plain terms: was there a safer way to build this that the maker could have used?
For reusable duodenoscopes, the answer is unusually well documented. A disposable-component design and a fully single-use design both existed, both were FDA-cleared, and the FDA itself recommended moving toward them. Alex Alvarez, Managing Partner and a Board Certified Civil Trial Lawyer (certified by the National Board of Trial Advocacy), points out that in most design-defect cases the plaintiff has to build the “there was a safer way” argument largely from scratch through experts. In the scope cases, the regulator and the industry had already put much of that record on paper. This does not decide any individual case — liability still turns on the specific scope model, the specific procedure, causation, and the applicable state law — but it is a materially stronger starting point than most product cases have. Our explainer on product liability versus medical malpractice covers how the design-defect theory sits alongside a claim against the hospital.
If the Safer Scope Existed, Why Were People Still Getting Infected?
Because a recommendation is not a requirement, and clearance is not adoption. The FDA's 2019 guidance asked hospitals to transition; it did not ban the reusable scope or set a deadline. Single-use duodenoscopes cost far more per procedure than a reusable scope that a hospital already owns, and adoption has been gradual and uneven. Many facilities kept running their existing reusable inventory — including fixed-endcap models — well after safer options were on the market. That is why infections tied to reusable scopes have continued to be reported, and why the litigation over them is still active. Our latest litigation status update tracks where the cases stand.
There is also a hospital-side question that runs parallel to the design question. A facility that chose to keep reprocessing a fixed-endcap scope, and then failed to follow the reprocessing instructions correctly, may face its own exposure separate from the manufacturer. We cover that in hospital reprocessing negligence.
How the Design History Connects to Your Records
The single most useful fact in tying this history to a specific patient is the make and model of the scope used in the procedure. A fixed-endcap reusable model tells a very different story than a disposable-component or single-use device. That information usually lives in the procedure note or the device-tracking log, not in the summary a patient is handed at discharge. Our guide to the TJF-Q180V versus TJF-Q190V explains how to read the model number and why the distinction matters — the older Olympus TJF-Q180V used a fixed sealing design that was the subject of extensive FDA and Congressional scrutiny, while the later TJF-Q190V was introduced with a disposable distal endcap in line with the FDA's preferred direction.
Frequently Asked Questions
Are single-use duodenoscopes safer than reusable ones?
A single-use duodenoscope is used once on one patient and then discarded, so there is no reprocessing step to fail and no way for one patient's bacteria to be carried to the next. The FDA has stated that persistent contamination on reusable, fixed-endcap duodenoscopes is a known problem even when cleaning instructions are followed, which is why it recommended transitioning to disposable-component and fully disposable designs.
Does a safer alternative design help a product-liability case?
In a product-liability design-defect claim, one central question is whether a reasonable, feasible alternative design existed that would have reduced the risk. The FDA's clearance of a single-use duodenoscope in December 2019 and its recommendation that hospitals move away from fixed-endcap reusable scopes document that a safer alternative was available. Whether that helps a specific case depends on the facts, the scope model used, and the timing of the procedure.
Did the availability of a disposable duodenoscope end the reusable-scope lawsuits?
No. Most hospitals continued using reusable duodenoscopes after single-use and disposable-component options became available, and infections tied to reusable scopes have continued to be reported. Patients harmed by a reusable duodenoscope may still have a claim regardless of whether a disposable option was on the market at the time.
Where This Leaves Patients and Families
If you had an ERCP and developed a serious infection afterward, the design history above is part of the backdrop to any case — but the case itself starts with your specific facts: which scope was used, what organism was cultured, what the treatment looked like, and when it all happened relative to your state's filing deadline. A short conversation early is usually more useful than a long one later.
- See whether your situation fits the case profile: 3-part qualification test.
- Understand the design flaw at the heart of the cases: Olympus endoscope design defects.
- Learn how the hospital's role fits in: hospital reprocessing negligence.
- Read the current status of the litigation: Mid-June 2026 litigation status.
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Sources
- U.S. Food & Drug Administration — “FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection” (August 29, 2019). fda.gov
- U.S. Food & Drug Administration — “FDA clears first duodenoscope with disposable elevator piece.” fda.gov
- Boston Scientific — “Boston Scientific Receives FDA Clearance For World's First Single-Use Duodenoscope, EXALT™ Model D” (December 13, 2019). news.bostonscientific.com
- U.S. Food & Drug Administration — Duodenoscope surveillance sampling and culturing (522 postmarket surveillance studies). fda.gov
- American Gastroenterological Association — “Challenges and Opportunities in Duodenoscope-Related Infections: Disposable Duodenoscopes are the Inevitable Future.” gastro.org
- American Law Institute — Restatement (Third) of Torts: Products Liability § 2(b) (reasonable alternative design). ali.org
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