A growing number of people have died from infections after medical procedures with non-sterile endoscopes. Lawsuits allege that some scopes are so complex that they cannot be sterilized.
Gas Relief Drops Linked to Infection Risk
August 31, 2016 — In a surprising new study, researchers have found that gas relief drops may be contributing to infections on colonoscopes that remain dirty after being disinfected. Click here to read more.
Olympus Failed to Warn U.S. Hospitals About Scope Infections
July 27, 2016 — Top executives at Olympus Corp. decided not to warn American hospitals about “superbug” infection outbreaks linked to their scopes, according to emails unsealed as part of a lawsuit.
What is the problem?
Even when hospitals follow the manufacturer’s instructions for cleaning an endoscope, bodily fluids can remain embedded in its intricate moving parts. If the scope is used on a patient who has antibiotic-resistant bacteria in their body, the scope can transmit this harmful bacteria to other patients.
FDA Safety Warning: Complex Design is Hard to Clean
The FDA has issued a Safety Communication to warn that the complex design of some scopes makes them extremely difficult to clean, disinfect, or sterilize:
“Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.”
Experts agree that the problem is a movable “elevator” channel at the top of the scope, which has moving parts and microscopic crevices. The devices are “very, very difficult to clean,” according to one doctor at UCLA, where an outbreak of infection occurred.
Infection Outbreak at UCLA Hospital Exposes 179 Patients
Two people have died, seven have been infected, and at least 179 people have been exposed to antibiotic-resistant CRE infections after a common medical procedure at UCLA’s Ronald Reagan Medical Center in Los Angeles between October 3, 2014 and January 28, 2014.
Attorneys for one 18 year-old victim say Olympus changed the design of the scope, but did not update the cleaning protocol. The victim was hospitalized for 83 days and was “very close to death.” According to the Los Angeles Times:
“These outbreaks are raising questions about whether hospitals, medical-device companies and regulators are doing enough to protect patient safety. Some consumer advocates are also calling for greater disclosure to patients of the increased risks for infection before undergoing these procedures.”
The outbreak at UCLA was traced to the TJF-Q180V duodenoscope made by Olympus. Within weeks of the outbreak, lawsuits were filed by five victims and lawmakers demanded answers from Olympus and the FDA. UCLA officials said the scopes remained dirty even after following Olympus’ cleaning instructions. In response, Olympus issued an urgent update to the instructions and the CDC issued an interim protocol for hospitals.
More Hospital Report Infection Outbreaks
- Virginia Mason Hospital: In May 2015, another seven “superbug” infections have been linked to a deadly outbreak at Virginia Mason Medical Center in Seattle, Washington, bringing the total number to 39 infections since 2010.
- Cedars-Sinai Medical Center: In March 2015, Cedars-Sinai Medical Center in Los Angeles confirmed that at least 67 patients were exposed and 4 developed antibiotic-resistant infections after undergoing medical procedures involving an Olympus duodenoscope.
- Allegheny General Hospital: In April 2015, a woman from Pennsylvania has filed a lawsuit after she was diagnosed with an antibiotic-resistant “superbug” infection transmitted on an Olympus duodenoscope during a procedure at Allegheny General Hospital in Pittsburgh.
- And more
Olympus TJF-Q180V Duodenoscope Recall
In January 2016, the Senate Health Committee released a report (PDF) finding that Olympus knew their duodenoscopes could transmit infections in 2012 but did not warn doctors or the FDA for another three years. In the meantime, at least 250 people were infected in 25 outbreaks.
On January 15, 2016, Olympus issued a recall for the TJF-Q180V duodenoscope to make design changes that should reduce the risk of infections. Changes include tightening the seal around the “closed” elevator mechanism channel to prevent patient fluids and tissues from leaking inside. The FDA also finally approved the scope — it has been on the market without approval since 2010.
FDA Updates Warnings and Cleaning Recommendations
Olympus and the FDA have been aware of the problem for years. Olympus warned hospitals in Europe about the risk of “superbug” outbreaks in January 2013. The FDA also received nearly 150 reports of endoscope infections since 2010.
In August 2015, the FDA recommended that hospitals take additional steps to clean the scopes, and ordered manufacturers to study how they are sterilized. The agency also issued warning letters to scope-makers for waiting years to report infection outbreaks.
The FDA has asked duodenoscope manufacturers to confirm that the cleaning instructions actually work. In January 2016, Fuji revised instructions for its most popular scope, the ED-530XT, which the FDA also said was on the market without approval.
As more hospitals report “superbug” outbreaks, data from one hospital suggests that 3% of scopes may remain contaminated after high-level disinfection. If this data is extrapolated nationwide, an estimated 15,000 patients are exposed to dirty duodenoscopes every year.
Pentax Updates Cleaning Instructions for Duodenoscope
In February 2016, Pentax has issued new instructions for cleaning the ED-3490TK Video Duodenoscope to reduce the risk of bacteria hiding in microscopic crevices and transmitting infections among patients.
Types of Endoscopic Procedures
An endoscope is a thin tube with a light and a camera on the tip. The scope is inserted into a patient’s body to help doctors diagnose medical conditions. Types of endoscopes include:
- Arthroscope (joints)
- Bronchoscope (lungs and airways)
- Colonoscope (colon and intestines)
- Cytoscope (bladder)
- Duodenoscope (upper intestines, pancreatic/bile ducts)
- Esophascope (esophagus)
- Laparoscope (abdominal organs)
- Laryngoscope (voice box)
- Proctoscope (rectum and colon)
- And more
Bronchoscope Infection Lawsuit Filed in Washington
The Seattle Times reports that the widow of a Navy veteran who died from antibiotic-resistant pneumonia has filed a lawsuit (PDF) blaming the VA hospital for failing to adequately sterilize bronchoscopes that were used to examine his lungs. The lawsuit was recently amended to blame the scope-washing machine made by Custom Ultrasonics. Click here to read more.
FDA Asks Hospitals to Stop Using Recalled Scope-Cleaning Machine
In November 2015, Custom Ultrasonics recalled 2,800 endoscope-cleaning machines because they might not work, which could lead to outbreaks of infection.
The FDA has been aware of the problem since 2012. Senate investigators found that the machines were being used at many hospitals where outbreaks of infection occurred.
In February 2016, the FDA asked hospitals to transition to another reprocessing method as soon as possible. In August 2016, FDA asked hospitals not to use the System 83 machine to clean duodenoscopes.
5% of Scopes Remain Contaminated After Cleaning
A study published in Gastrointestinal Endoscopy has confirmed that a small percentage of medical endoscopes remain contaminated even when hospitals strictly follow the manufacturer’s cleaning instructions. Out of approximately 4,000 specimens, 5% of the scopes had microbial contamination after being disinfected, and 0.6% harbored bacteria that could cause an infection. Click here to read more.