The Olympus scope design defect is the root of the infection crisis. But hospitals can make it dramatically worse — by skipping cleaning steps, using expired disinfectant, or failing to dry scopes between patients. When reprocessing fails, patients get infections that could have been prevented.
This page explains what scope reprocessing is, what the national standards require, where hospitals most often fall short, and how a hospital can share responsibility with Olympus when a patient is seriously hurt.
"Reprocessing" is the formal word for the full cycle hospitals use to prepare a reusable endoscope between patients. It is not the same as simply wiping the outside of the scope. Full reprocessing is a multi-step process that can take an hour or more per scope when done correctly.
Every step has to be done in order, with the right chemicals, at the right temperature, for the right amount of time. Skipping or short-cutting any one step can leave behind biological material and live bacteria that the next patient will then be exposed to.
The industry standard comes from a document called ANSI/AAMI ST91, published by the Association for the Advancement of Medical Instrumentation. Every U.S. hospital that reprocesses flexible endoscopes is expected to follow ST91 or an equivalent protocol.
Done at the bedside, right after the procedure, to wipe and flush visible debris before it dries.
The scope is pressurized to check for leaks that would let fluid enter sealed parts.
Technicians brush every channel, flush with enzymatic cleaner, and hand-clean every valve and port.
The scope is immersed in a chemical sterilant for a set time and temperature.
Sterile water rinse, forced-air drying of channels, and storage in a ventilated cabinet.
ANSI/AAMI ST91 is the national U.S. standard for processing flexible and semi-rigid endoscopes. It is published by the Association for the Advancement of Medical Instrumentation (AAMI), approved by the American National Standards Institute (ANSI), and referenced by the FDA, the Joint Commission, and most state health departments.
ST91 specifies, in detail: the training required for reprocessing technicians, the step-by-step procedure for every stage of reprocessing, the minimum drying and storage conditions, the surveillance testing hospitals should run to catch scopes that are still contaminated after cleaning, and the record-keeping required to prove each scope was cleaned properly before each use.
Hospitals are not legally required to follow ST91 word-for-word, but failure to follow it is strong evidence of negligence when a patient is harmed. Patient attorneys and expert witnesses regularly use ST91 as the benchmark against which a hospital's actual practices are measured.
In case after case, the same handful of failures show up. These are the reprocessing problems that investigators, medical-legal experts, and our own review of hospital records find most often.
Manual cleaning is the single most important step — and the most time-consuming. Technicians have to push specialized brushes through every channel, multiple times, with the scope held at specific angles. When the endoscopy department is busy and scopes are needed quickly for the next procedure, this step often gets rushed or shortened. Studies have found that skipping or shortcutting manual cleaning is one of the biggest drivers of scope contamination.
High-level disinfectants lose their strength as they're used. Hospitals are supposed to test the chemical regularly and swap it out when it falls below effective concentration. In practice, this is sometimes neglected. A disinfectant that looks fine but has lost its potency will not kill the bacteria hiding in a scope's channels.
Water left inside a scope's channels lets bacteria grow back, even after disinfection. Scopes have to be actively dried with forced air — not just hung up and allowed to drip. A 2018 study by Ofstead and colleagues found that scopes at multiple sites were being stored with substantial residual moisture, which is exactly the condition bacteria need to regrow.
Surveillance culturing means periodically swabbing a scope after cleaning and sending the swab to the lab to see if any bacteria grow. If bacteria grow, the scope should be pulled from service and investigated. Many hospitals do not run surveillance cultures at all, or only run them on duodenoscopes and not on colonoscopes and gastroscopes. Without surveillance, a contaminated scope can stay in use for months.
Scopes should be traceable — which patient got which scope on which day. When that traceability is lost, hospitals cannot identify which patients may have been exposed if a scope is later found to be contaminated. Poor tracking is a failure in its own right and a major barrier to detecting outbreaks early.
Here is one of the hardest parts of the scope contamination story: even hospitals that follow Olympus's cleaning instructions to the letter have had patients die from contaminated scopes. That is because the instructions themselves cannot overcome the design defect in the scope.
This is the reality that made the Virginia Mason and UCLA outbreaks so disturbing: these were excellent, well-resourced hospitals doing exactly what Olympus told them to do. And their patients still died.
Legally, this matters in two ways. First, it means Olympus cannot hide behind hospitals — the scope was defective whether the hospital cleaned it perfectly or not. Second, it does not excuse hospitals that fell short. A hospital that did less than the bare minimum is still responsible for the extra risk it added to a device that was already risky.
This is why nearly every serious scope-infection case involves both a product liability claim against the manufacturer and a negligence claim against the hospital or facility.
Product liability law and medical negligence law both allow a patient to recover from more than one responsible party. When a contaminated scope causes serious harm, the typical case names both Olympus (as the scope manufacturer) and the hospital (as the entity that actually handled the scope). The facts determine how the responsibility is shared.
For selling a reusable scope with a known contamination-prone design, failing to warn hospitals and regulators about early outbreaks, and continuing to ship the product even after the evidence piled up. This is product liability, and the 2018 DOJ plea — Olympus's own guilty admission — is a matter of public record.
For failing to follow its own reprocessing protocols, skipping surveillance cultures, not fully drying scopes, or allowing scopes to stay in service after failed tests. Where the hospital's actions fall short of the ANSI/AAMI ST91 standard and contributed to a patient's infection, the hospital can share responsibility with the manufacturer.
A strong scope-infection case does not require you to prove whether it was "more" Olympus's fault or "more" the hospital's fault. You need to show that both contributed to your injury, and courts and juries work out the share of responsibility between them.
Our team handles both sides of this — product liability against the manufacturer and negligence against the hospital. Together with Herb Borroto, M.D., J.D., we review every intake with an eye toward both defendants, so nothing is left on the table.
Clear answers to the questions patients ask most when they're trying to figure out who should be held responsible.
Often, it's both. The scope design is the root cause — Olympus can't walk away from that just because a hospital exists in the middle. But hospitals have an independent duty to clean reusable scopes properly. When a hospital skips a step, uses expired chemicals, or ignores a scope that failed a surveillance test, the hospital adds its own negligence on top of the underlying design defect. In many cases, both defendants can be named and both can be held responsible for a share of the harm.
Yes, in most situations. U.S. product liability and medical malpractice law lets the person who was hurt sue every party whose negligence contributed to the same injury. Each party's share of responsibility is worked out as the case proceeds. What matters up front is identifying every party whose failure contributed to your infection — Olympus, the hospital, sometimes the outpatient surgery center, sometimes the reprocessing technician's employer.
You don't have to figure this out on your own. Hospitals keep detailed reprocessing records — which scope was used on which patient, which reprocessing technician handled it, which batch of disinfectant was used, whether surveillance cultures were taken, whether tests came back positive. These records can be obtained during a case. Our medical-legal expert, Herb Borroto, M.D., J.D., knows what to look for and what kinds of failures matter.
The kind of evidence that matters most includes hospital reprocessing logs, training records for scope-cleaning staff, surveillance culture results, the hospital's written reprocessing protocol, the scope manufacturer's instructions-for-use, and the patient's medical records showing the infection timeline and pathogen. In a strong case, these records line up to show that either (a) the hospital didn't follow the instructions, or (b) even the instructions were not enough — or both.
Every factual claim on this page is supported by a verifiable public source. Click any source below to read the original.
When the scope is defective and the hospital cut corners, both should answer. Our team reviews every case for both sides of the liability picture. No Fees Unless We Recover Money for You.
