Bronchoscope Infections: The Lung-Scope Warning the FDA Updated Twice

When people hear that a reusable scope gave someone a hospital infection, they usually picture an ERCP — the duodenoscope procedure at the center of the Olympus cases. That focus is understandable, but it leaves out a whole category of the same problem. The bronchoscope, a thin flexible scope guided through the mouth or nose into the windpipe and lungs, is one of the most-used devices in a hospital, and it carries the same built-in vulnerability: it is reused from patient to patient, and it is hard to clean. The U.S. Food and Drug Administration has warned about it, updated that warning, and pointed to safer designs. This article explains, in plain English, what a bronchoscope is, what the FDA actually found, the documented Olympus bronchoscope outbreak that traced to a specific design flaw, and how the legal theories behind the duodenoscope cases apply just as squarely to the lung scope.

What Is a Bronchoscope, and Why Does It Get Contaminated?

A bronchoscope is a long, flexible instrument with a light and camera that a pulmonologist passes into the airways to see inside the lungs, take biopsies, drain fluid, or clear a blockage. It is a reusable device, so after each procedure it is cleaned, disinfected, and used again on the next patient. That model only works if reprocessing removes everything the previous patient left behind — the same assumption that fails with the duodenoscope.

The trouble is physical. A bronchoscope has a long, narrow working channel and small movable parts, and those spaces are difficult to scrub, rinse, and dry completely. When moisture and organic material linger, bacteria can form biofilm — a slick, protective layer that shields organisms from disinfectant. The FDA has documented that reusable endoscopes, including bronchoscopes, can remain contaminated after reprocessing, echoing its finding that roughly 1 in 20 duodenoscopes still tested positive for contamination even after correct cleaning. Whatever survives on the scope can then be introduced directly into the next patient’s lower airway — a place that is supposed to be nearly sterile.

What Did the FDA Find About Bronchoscopes?

The FDA first issued a safety communication about reprocessed flexible bronchoscopes in 2015, warning that these devices had been associated with patient infections and reminding facilities to follow cleaning instructions precisely. In June 2021, the agency issued an updated communication after reviewing its adverse-event data — more than 860 medical device reports describing contamination or infection connected to reusable flexible bronchoscopes. That volume of reports is not a handful of isolated mishaps; it is a pattern the agency considered significant enough to act on twice.

The organisms named most often in those reports were Mycobacterium, Pseudomonas, Serratia, and Klebsiella — the same families of hardy, sometimes drug-resistant bacteria that turn up in scope-related outbreaks generally. For a lung patient, that list is alarming for a specific reason: many bronchoscopy patients already have compromised lungs or weakened immune systems, so an organism that a healthy person might shrug off can become a pneumonia, a bloodstream infection, or worse. The danger is not only that the scope was dirty; it is who is on the other end of it.

The Olympus Bronchoscope Outbreak That Traced to a Design Defect

The most instructive bronchoscope case in the public record is not a duodenoscope story at all — and it points at Olympus. In the early 2000s, Johns Hopkins Hospital in Baltimore experienced a large outbreak of Pseudomonas aeruginosa linked to its flexible bronchoscopes. Investigators, including a Centers for Disease Control and Prevention epidemic intelligence officer, eventually traced the source to a loose biopsy-port cap on the scopes — a small part that was supposed to seal but could be twisted off, creating a hidden pocket where bacteria collected out of reach of normal cleaning. The findings were published in The New England Journal of Medicine in 2003.

The scale was serious. The hospital contacted more than 400 patients who may have been exposed, roughly 100 tested positive for the organism, and exposure to the contaminated scopes was reported to have possibly contributed to the deaths of three patients. The bronchoscopes involved were manufactured by Olympus, and the manufacturer recalled the affected devices. It is a near-exact rehearsal of the pattern that would later define the duodenoscope litigation: a hard-to-clean feature, bacteria surviving where cleaning could not reach, patient-to-patient spread from a single device, and a recall after the harm was already done. It also sits alongside the elevator-mechanism problem we cover in our explainer on the duodenoscope elevator design defect — different part, same failure mode.

How Bronchoscope Cases Mirror — and Differ From — the Duodenoscope Cases

The mechanics are cousins. A duodenoscope reaches the bile ducts through the gut; a bronchoscope reaches the lungs through the airway. Both are reusable, both have channels and parts that resist cleaning, and both have been documented spreading infection from one patient to the next. Bronchoscopes join the urological scopes — cystoscopes and ureteroscopes as the “other” contaminated scopes the FDA has warned about beyond the headline duodenoscope.

The differences are mostly about the patient and the setting. Bronchoscopy is often performed on people who are already very sick — ICU patients on ventilators, transplant recipients, patients with lung cancer or severe pneumonia — which raises the stakes of any contamination and can also make the source harder to spot, because a new infection may be written off as a complication of the underlying illness. That is exactly why the connection to a scope is so often missed in the moment; our guide to the signs an infection was caused by a scope walks through the clinical clues that point back to the device.

The FDA’s Recommendations: Sterilization and Single-Use

In its updated communication, the FDA did more than repeat “follow the instructions.” It urged facilities to consider sterilization instead of high-level disinfection for bronchoscopes where feasible, because sterilization has a greater margin of safety. It recommended considering a single-use bronchoscope in higher-risk situations — for immunocompromised patients, for patients carrying a multidrug-resistant organism, or when a scope cannot be reprocessed promptly. And it reminded staff never to reprocess or reuse a device that is labeled single-use.

Those recommendations matter legally, not just clinically. When a regulator identifies a feasible safer alternative — a disposable device that eliminates the reprocessing failure point — it becomes harder to defend continuing to rely on a design that keeps causing infections. That is the same argument at the heart of our discussion of single-use duodenoscopes as the safer design the FDA recommended. The existence of a safer option is a recurring theme across the entire scope-infection story.

Why a Bronchoscope Infection Can Support a Legal Claim

A bronchoscope infection case generally moves on the same two tracks as a duodenoscope case, and they can run together. The first is product liability against the device manufacturer, on the theory that the scope was defectively designed — a part that traps bacteria, a channel that cannot be reliably cleaned — or that the company failed to warn adequately about the risk. The second is negligence against the hospital or facility for how it cleaned, dried, stored, and tracked the equipment. Our overview of hospital reprocessing negligence explains how those duties are divided and where they break down.

None of that decides an individual claim on its own. What decides a particular case is specific and personal: the organism cultured from the patient, which bronchoscope model and reprocessing equipment were used, whether the facility logged a cluster of similar infections, and how the timeline in the medical record lines up with the procedure. As with every scope case, these are built one chart at a time — and the records that prove them are exactly the materials that get archived or discarded on routine retention schedules.

A Trial Lawyer’s Read

“People assume the scope cases are only about ERCP, but the bronchoscope record is right there in the FDA’s own files, and the Olympus biopsy-port outbreak is one of the cleanest examples of a design defect I’ve ever read,” says Alex Alvarez, Managing Partner of The Alvarez Law Firm and a Board Certified Civil Trial Lawyer. “A part that a nurse couldn’t get off, but that twisted right off by hand once someone knew to try — that’s not user error. That’s the device. When I see an unusual infection after a lung procedure, the first question is what scope was used and what the hospital’s own logs show.”

The medical detail is what turns a lung infection into a fact pattern. “With a bronchoscopy patient, the hard part is separating a scope-acquired infection from the illness that brought them in,” notes Herb Borroto, M.D., J.D., the firm’s Medical-Legal Expert, who holds both a medical degree and a law degree. “I look at the organism and its resistance pattern, the date the culture was drawn, and whether other patients at the same facility grew the same bug in the same window. If a distinctive Pseudomonas or Mycobacterium shows up after the procedure and matches a cluster, the record starts telling a story. My job is to read whether the documents support that story or rule it out.”

What to Do Now

If you or a loved one developed a serious infection — pneumonia, a bloodstream infection, sepsis, or a drug-resistant organism — after a bronchoscopy or other lung procedure, the specific organism in the records and the identity of the scope are reasons to have the facts reviewed while those records still exist. Culture results, device-tracking logs, and reprocessing files are archived or discarded on routine schedules, and knowing what to look for can be the difference between a preserved case and a lost one. The same is true after an ERCP, colonoscopy, or bladder procedure with a reusable scope.

A short, no-obligation review can tell you whether your situation fits the pattern and whether a filing deadline may be approaching. We represent patients nationwide. Free case review. No Fees Unless We Recover Money for You.

Frequently Asked Questions

Can you get an infection from a bronchoscope?

Yes. A bronchoscope is a reusable device passed into the airways and lungs, and it can carry bacteria from one patient to the next if it is not fully cleaned between uses. The FDA has issued and then updated a safety communication warning that reprocessed flexible bronchoscopes have been associated with infections, and it reviewed hundreds of medical device reports describing contamination or infection linked to these scopes. The organisms most often reported included Mycobacterium, Pseudomonas, Serratia, and Klebsiella.

Why does a bronchoscope get contaminated even after cleaning?

Like a duodenoscope, a bronchoscope has long, narrow internal channels and small movable parts that are difficult to clean and dry, and biofilm and moisture can shelter bacteria that survive routine high-level disinfection. In one large documented outbreak, a loose biopsy-port cap on Olympus bronchoscopes trapped Pseudomonas aeruginosa where standard cleaning could not reach it. Because the same instrument is reused, whatever survives on it can be delivered into the next patient’s airway.

Has the FDA recommended single-use bronchoscopes?

The FDA has recommended that facilities consider sterilization instead of high-level disinfection for bronchoscopes when feasible, and consider using a single-use bronchoscope in higher-risk situations — for example, patients who are immunocompromised or infected with a multidrug-resistant organism, or when a scope cannot be reprocessed promptly. The FDA also reminds staff never to reprocess or reuse a device labeled single-use.

Can you sue over a bronchoscope infection?

A bronchoscope infection case generally rests on the same two theories as a duodenoscope case: product liability against the manufacturer for a device alleged to be defective, and negligence against the hospital for how it cleaned and tracked its equipment. Whether any individual has a claim depends on the specific facts — the organism cultured, which scope was used, the reprocessing records, and the timeline in the chart. A lawyer evaluates those records against the applicable filing deadline, which varies by state.

Sources

• U.S. Food & Drug Administration — “Flexible Bronchoscopes and Updated Recommendations for Reprocessing: FDA Safety Communication” (June 2021 update to the 2015 communication; review of medical device reports, most-reported organisms, and recommendations on sterilization and single-use devices). fda.gov
• Srinivasan A, Wolfenden LL, Song X, et al. “An Outbreak of Pseudomonas aeruginosa Infections Associated with Flexible Bronchoscopes.” New England Journal of Medicine, 2003;348:221–227 (Johns Hopkins outbreak traced to a loose biopsy-port cap on Olympus bronchoscopes). nejm.org
• U.S. Food & Drug Administration — “Infections Associated with Reprocessed Duodenoscopes” (post-market surveillance sampling and contamination-after-reprocessing findings for reusable duodenoscopes). fda.gov
• U.S. Centers for Disease Control and Prevention — “Guideline for Disinfection and Sterilization in Healthcare Facilities” (high-level disinfection vs. sterilization of flexible endoscopes; biofilm and reprocessing challenges). cdc.gov

This article is for general informational purposes only and is not legal or medical advice. It summarizes public health information, regulatory communications, and published reports as of the publication date; medical guidance and regulatory status can change, and this article does not describe the outcome of any client’s case. The presence of a particular organism, or the existence of a past outbreak or recall, is evidence to be evaluated, not proof of any individual’s claim. Nothing here creates an attorney-client relationship, and no result is promised or implied. Past results do not guarantee future outcomes. Deadlines and legal standards vary by state and by the facts of each case. If you believe you may have a claim, consult a licensed attorney promptly.