The Food and Drug Administration released a report in March informing doctors that certain scopes were sent to market without undergoing an evaluation. The model, recently identified as the cause of widespread bacterial infections, had been used for years without agency approval.

Devices Marketed Without FDA Review

Patients underwent scope procedures with devices that weren’t submitted to the FDA for approval.
Image: AMS vans

Although Olympus Corporation began selling duodenoscopes in 2010, each model was not individually approved by the FDA. The manufacturer claimed that the models weren’t submitted for careful examination because the design closely matched other products on the market.

But the Olympus TJF-Q180V actually differed from existing models. It was later discovered that the TJF-Q180V included a sealed channel that would be hard to fully disinfect when adhering to current cleaning standards.

In March 2014, the FDA delivered a letter compelling Olympus to apply for approval in order to sell the device. The agency subsequently issued a safety announcement to warn doctors and patients about the device’s potential to spread hidden bacteria.

Sending Out Safety Alerts

The FDA sent out an announcement that showed health professionals are unable to completely disinfect certain duodenoscope models.
Image: CNN

In March, the health department worked to track down 179 people that visited UCLA Medical Center and caught bacterial infections from dirty scopes between Oct. 2014 and Jan. 2015. The agency issued a safety alert to inform medical staff that cleaning “may not entirely eliminate” the risk of infection.

“Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible,” the FDA said. “Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection.”

But UCLA isn’t the only hospital where contaminated scopes spread antibiotic-resistant infections. Eleven deaths at a hospital in Seattle, along with four infections at Cedars-Sinai Medical Center and 281 patients exposed to E.coli at Hartford Hospital proves that ineffective scope sanitation isn’t an isolated issue.

The FDA is working with the CDC and conducting “reviews of reprocessing validation data from each of the three manufacturers marketing duodenoscopes in the [U.S.] — FUJIFILM, Olympus and Pentax.”

The agency advised medical professionals to inform patients about the risk associated with scope procedures. However, individuals who had a medical procedure with a duodenoscopy and caught an infection might be eligible for legal assistance and compensation.

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The post FDA Never Approved Olympus Duodenoscope Model appeared first on Citizens Report.

Doctors linked a deadly CRE bacteria outbreak at the UCLA medical center to a dirty duodenoscope device.

A number of patients at UCLA Medical Center were suffering from a deadly superbug, but doctors couldn’t identify the problem.

After launching an in-depth investigation, the hospital staff uncovered the cause of the infection. The life-threatening bacteria, known as CRE, had crept into an Olympus duodenoscope that doctors reused time and again.

Bacterial Infection Continued To Spread At UCLA

UCLA doctors unknowingly spread the CRE bacteria when they reused a duodenoscope device that carried the infection.
Image: CBS Local

As patients at the widely respected medical institution grew sicker,  a team of health professionals delved into months of investigation.

Doctors at UCLA were stumped, but Dr. Zachary Rubin, the director of clinical epidemiology and infection prevention, finally discovered the culprit.

Rubin collected a team of 1o professionals to track every patient who had been diagnosed with CRE in the last year. The team found 34 patients affected by CRE, but couldn’t make the connection.

Investigators traced the infections to a potential liver transplant patient who visited the hospital in September 2014. It turned out that she unknowingly introduced CRE, the deadly carbapenem-resistant Enterobacteriaceae, to the institution.

Doctors Linked The Deadly Illness To Dirty Scopes

CRE is an antibiotic-resistant bacteria that killed three people in the UCLA outbreak.
Image: California Department of Public Health

When the duodenoscope entered the patient’s intestine, the bacteria crawled into the crevices of the device. The scope was cleaned and reused on multiple patients, continually spreading the bacteria.

Doctors had disinfected the scope, made by Olympus, and followed the manufacturer’s standard protocol. The hospital had purchased the new scopes, priced at $40,000, only 7 months ago.

The dirty scope, number 47, had infected eight patients. Three of them died. The outbreak sparked a public health outcry, but there is still no mechanism to effectively disinfect duodenoscopy devices.

Restitution for Affected Patients

There is no effective method to completely clean and sanitize duodenoscopes.
Image: International Medical Equipment

It’s possible for individuals to be infected with CRE without experiencing symptoms. The infection, treated for years with antibiotics, has evolved to develop drug resistance.

CRE kills nearly half of infected patients. However, CRE is only one bacteria that could become lodged in the device during one of the 700,000 duodenoscopic procedures performed in the U.S. each year.

Federal attorneys and health professionals are pressing duodenoscope manufacturers, questioning their knowledge of the device’s likelihood to spread infection and examining the effectiveness of their safety measures. In addition, patients and families affected by the UCLA outbreak are taking legal action against Olympus for negligence and fraud.

Patients and families affected by a serious bacterial infection after undergoing an endoscopy procedure may be entitled to compensation.

Request a free case evaluation to learn more.

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