Deadly outbreaks of “superbug” infections have been linked to endoscopes that cannot be effectively sterilized. Lawsuits are now being filed by victims who claim the design is defective and unreasonably unsafe
UPDATE: 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.
August 17, 2016 — The FDA is warning health care facilities not to use the System 83 endoscope-cleaning machine that was recalled last year by Custom Ultrasonics. Click here to read more.
July 27, 2017 — 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. Click here to read more.
July 14, 2016 — A new study has found that 5% of endoscopes remain contaminated even after they are cleaned according to the manufacturer’s instructions. Only 0.6% harbored bacteria that could be harmful. Click here to read more.
February 19, 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. Click here to read more.
January 15, 2015 — After finally gaining FDA approval for the scope, Olympus will recall the TJF-Q180V duodenoscope to make repairs intended to reduce the risk of bacterial infections. Click here to read more.
January 14, 2016 — Olympus knew their duodenoscopes could transmit infections in 2012 but did not warn doctors or the FDA for nearly three years, according to a Senate report. In the meantime, at least 250 people were infected in 25 outbreaks. Click here to read more.
January 4, 2016 — The FDA has approved new instructions for cleaning the Fujifilm ED-530XT duodenoscope to reduce the risk of infection. Click here to read more.
August 17, 2015 — The FDA has issued warning letters to all three major endoscope manufacturers, including warning Olympus Corp. for waiting years to report an outbreak of bacterial infections. Click here to read more.
August 12, 2015 — Colonoscopes and gastroscopes often remain contaminated with infection-causing microbes even after meticulous cleaning, according to a new study. Click here to read more.
June 29, 2015 — Olympus has been hit with a lawsuit from a woman who developed an antibiotic-resistant CRE infection after an outbreak at UCLA was traced to the company’s Q180V scope. Click here to read more.
June 4, 2015 — The Justice Department has issued subpoenas asking for “thousands of pages” of documents from three endoscope-manufacturers (Pentax, FujiFilm, and Olympus) and one hospital linked to a deadly outbreak of antibiotic-resistant “superbug” infections. Click here to read more.
May 29, 2015 — New concerns have been raised about the effectiveness of endoscope-cleaning machines used in over 1,000 hospitals and clinics. Click here to read more.
May 28, 2015 — Virginia Mason Medical Center has taken the unusual step of switching from a defendant into a plaintiff in a lawsuit filed by the widow of a man who died from an antibiotic-resistant “superbug” infection on a dirty medical scope made by Olympus Corp.
May 15, 2015 — As more hospitals are hit with lawsuits, an expert panel to the FDA has heard tragic testimony from victims of recent “superbug” outbreaks and they warn the scopes continue to pose health risks. Click here to read more.
May 11, 2015 — Lawmakers are criticizing the FDA for failing to act after the agency admitted receiving nearly 150 reports of infections on contaminated medical scopes since 2010. Click here to read more.
May 6, 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. Fortunately, the outbreak appears to be over. Click here to read more.
April 22, 2015 — Olympus Corp. warned hospitals in Europe about the risk of transmitting “superbug” infections on contaminated duodenoscopes in January 2013, but failed to warn hospitals in the United States. Click here to read more.
April 9, 2015 — 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, an estimated 15,000 patients are exposed to dirty duodenoscopes every year. Click here to read more.
April 6, 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. Click here to read more.
March 26, 2015 — Olympus Corp. has issued an urgent update on how to clean the duodenoscope that has recently been linked to deadly infections. Click here to read more.
March 26, 2015 — In the wake of several deadly outbreaks of “superbug” infections, the CDC has published an interim protocol for hospitals that need to clean and disinfect duodenoscopes. Click here to read more.
March 25, 2015 — A lawmaker from California is demanding answers from Olympus Corp., the manufacturer of medical scopes that have been linked to several outbreaks of infection. Click here to read more.
March 23, 2015 — A woman from Washington who was infected with a drug-resistant infection has filed a lawsuit against Olympus, the manufacturer of a duodenoscope that transmitted the infection during her ERCP. Click here to read more.
March 18, 2015 — Five lawsuits have been filed by victims of a deadly “superbug” infection outbreak linked to dirty medical scopes at UCLA’s Ronald Reagan Medical Center. Click here to read more.
March 5, 2015 — At least 67 patients were exposed and 4 developed antibiotic-resistant CRE infections after undergoing medical procedures involving an Olympus duodenoscope at Cedars-Sinai Medical Center in Los Angeles. Click here to read more.
UCLA Hospital: 179 Patients Exposed to CRE Infection
A deadly outbreak of infection at UCLA hospital has been traced to a specialized endoscope called a duodenoscope, which is used to look down a patient’s throat.
The devices are made by Olympus and are “very, very difficult to clean,” according to one doctor.
Seven people were infected, two have died, and at least 179 patients have been exposed to CRE, a type of antibiotic-resistant germ, while undergoing medical procedures at UCLA’s Ronald Reagan Medical Center in Los Angeles.
All of the patients were treated between October 3, 2014 and January 28, 2014.
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.”
What is CRE Infection?
Carbapenem-resistant Enterobacteriaceae (CRE) is a family of germs that have evolved a defense mechanism that essentially inactivates antibiotics. They cause infections that are extremely difficult to treat. An estimated 40-50% of CRE infections are fatal, according to the CDC.
What is a Duodenoscope?
Duodenoscopes are flexible tubes outfitted with tiny lights and advanced cameras (a type of endoscope). They are designed to be inserted down a patient’s throat to diagnose and treat pancreatic and bile duct diseases.
Every year, duodenoscopes are used in 500,000 procedures a year in the United States. They are most commonly used to drain bile and pancreatic ducts that are blocked by tumors or gallstones.
CRE Infection from Olympus ERCP Endoscope
The UCLA hospital system determined that CRE may have been transmitted to patients by two of seven scopes being used by the center, all made by Olympus Medical Systems Group.
The complex design of the endoscopes may hinder proper cleaning, according to the FDA.
Experts agree that the most problematic part is a movable “elevator” mechanism at the tip of the duodenoscope. Its moving parts have microscopic crevices where bodily fluids can remain “embedded” after standard cleaning.
Before the outbreak, the hospital was sterilizing the scopes according to the standards set by Olympus. They now use a more rigorous process “that goes above and beyond manufacturer and national standards” and uses a gas called ethylene oxide.
The Ethylene-Oxide (EtO) sterilization process takes 18 hours, rather than the one or two required for the regular cleaning process recommended by manufacturers. Because the gas is highly toxic and explosive, technicians must have proper ventilation because they can use it.
February 19, 2015 — The FDA has issued a Safety Communication to warn about design problems that could interfere with sterilization of duodenoscopes:
“The complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing [clean and disinfecting or sterilize reusable devices] … even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.”
Between January 2013 and December 2014, the FDA has received reports of 135 patients who were colonized or infected with bacteria after procedures involving duodenoscopes. It is possible that not all cases have been reported.
FDA Knew About Risk in 2009
This is not the first time the FDA has issued warnings about disease-transmission on endoscopes. Their first warning was in 2009, after an outbreak infected 16 people in France. Since then, at least five major outbreaks in the United States have occurred, yet the FDA has imposed no new safety requirements on hospitals or manufacturers. Click here to read more.
In September 2015, the FDA issued a Safety Warning about the risk of disease-transmission on bronchoscopes after receiving 109 reports of infection or contamination since 2010.
In February 2015, the widow of a Navy veteran who died of pneumonia filed a lawsuit (PDF) blaming his hospital for failing to sterilize the scope. In November, the complaint was amended to also blame the scope-washing machine made by Custom Ultrasonics. Click here to read more.