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.

Alexandria Clark

When most people think of New England, they think of clam chowder and pilgrims. They don’t usually think about the soil and the possibility that it holds the key to fighting antibiotic-resistant bacteria. The newest antibiotic to be discovered in nearly 30 years, and one that is being touted by health experts as a ‘paradigm shift’ in the fight against the growing resistance to drugs, has been under our feet all along.

Scientists in Massachusetts had always suspected the surrounding soil was rich with potential new antibiotics, but they were never able to figure out a way to grow 99 percent of the microbes in laboratory conditions. No microbe growth, no life-saving drugs.

Finally a team of scientists from Northwestern University figured out a way to use an electronic chip to get those little microbes in the soil to grow, allowing the scientists to then isolate their antibiotic compounds. The compound that seems to have the greatest life-saving potential is Teixobactin.

Pharmacist

Are Antibiotic-Resistant Bacteria a Thing of the Past?

Teixobactin has been found to treat numerous common bacterial infections such as clostridium difficile colitis, tuberculosis and septicemia. The experimental drug actually cured mice infected with normally antibiotic-resistant staphylococci bacteria, an infection which usually kills 90 percent of the rodents. Teixobactin could be the answer to a major problem currently existing with most antibiotics, which are becoming less and less effective at killing resistant strains of bacteria. The World Health Organization has classified antimicrobial resistance as a serious threat to every region of the world.

In fact, according to a new report commissioned by U.K. Prime Minister David Cameron and published as a Review on Antimicrobial Resistance, drug-resistant infections currently kill more than 50,000 individuals every year in Europe and the United States. Globally, the death rate for these infections is estimated at 700,000 per year. Experts in the health industry have weighed in on the crisis and predict that, if not stopped, these “superbugs” could one day be responsible for more deaths than cancer. If scientists can’t find new methods to treat these resistant bacteria, it is estimated that the global death rate could increase from 700,000 to 10 million by 2050.

These startling figures certainly highlight the joy rippling through the scientific community over this latest discovery. But the reality is it will likely be another 10 years before Teixobactin makes it to market. The drug has yet to be tested on humans, and before those tests can even begin, several other measures must be taken. But Forbes recently reported that NovoBiotic Pharmaceuticals, the company working on Teixobactin, hopes to cut time to market in half.

The post Dirt from New England Holds Key to Fighting Antibiotic-Resistant Bacteria appeared first on Citizens Report.