Hospital detective: deadly "superbag" was hiding in plain sight

The hunt for the deadly “superbug”, which hit 22 patients in a Dutch hospital, began shortly before noon on a spring day in 2012. In the laboratory of the tiny village of Zuterwood, the technician carefully peeled off the tip of the sphere protecting the camera of the duodenoscope (gastroscope). He was watched tightly by a small group of hospital officials and production managers at Olympus Corp., the device manufacturer.
The technician found trouble right away: he noticed a brown, dirty film on the inside of the flexible hose of the gastroscope - the part that was supposed to be airtight. Rubber rings designed to block the path of bacteria, had cracks and abrasions. The bacteria that affected the patients were found immediately.

Researchers hired by Olympus and the hospital concluded that the design of the gastroscope makes it possible for bacteria to spread from one patient to another. In their report, they called on Olympus to conduct an investigation and make its results available.

Over the next three years, 21 people died and at least two dozen were seriously affected by related infections in Pittsburgh, Seattle, and Los Angeles. It is not known how many other patients were infected. The US Food and Drug Administration (FDA) has identified 10 outbreaks, seven of which were related to Olympus equipment.

Olympus is still selling its devices and has not warned US agencies about what they learned in 2012. After each outbreak, Olympus claimed that its equipment did not cause infection and blamed hospitals that allegedly did not clean the equipment properly. Olympus controls 85% of the American market for equipment for gastrointestinal medicine.

“Olympus' silence on this important issue was unethical, irresponsible, and dangerous,” said Dr. Andrew Ross, chief gastroenterologist at the Seattle Medical Center, where 18 patients died and another 21 were infected.

US prosecutors and congressional investigators are investigating how Olympus is and two smaller manufacturers have responded to outbreaks of superbugs. The investigation began after the Los Angeles Times reported in February of an epidemic that killed three people at Ronald Reagan Medical Center. US regulatory authorities have warned all US hospitals that there is an increasing number of infections across the country, and this may be due to the design features of the gastroscopes.

Many people think of cameras when they hear the name Olympus. But doctors know Olympus as a supplier of medical devices, one of the giants of the market with a good reputation, with great engineering and technical experience and close cooperation with medical specialists. Medical equipment today accounts for nearly 75% of this Tokyo company with $ 7 billion in annual revenue. The company's sales grew by 18% to $ 1.4 billion over the past 6 months, and the company's profit grew by 60%, to $ 294 million.

Olympus worked with doctors to invent a device called a duodenoscope (gastroscope) more than four decades ago. It uses a procedure known as ERPC (endoscopic retrograde cholangiopancreatography). Doctors inject a flexible hose through the patient's throat into the digestive tract to diagnose cancer, gallstones, and other diseases.

Doctors carry out nearly 700,000 of these procedures annually in the US and more than 2 million procedures worldwide, said an Olympus spokesman. “Many of these patients have serious illnesses, which makes them more vulnerable to infection.”

Since 2010, two Olympus rivals (Pentax and Fujifilm) have been selling advanced duodenoscopes, which ensures their best cleaning. Olympus introduced a similar model known as the Q180V. The company said this $ 40,000 equipment is a technical triumph. They also refined new equipment to make it easier to clean. But the new design created new problems. In 2012, an outbreak in the Netherlands, at the medical center at the University of Erasmus in Rotterdam, was the first sign of trouble.

“Just one bacterium is enough to get inside, and it will multiply,” said the Dutch investigator, Arjo Loew, a mechanical engineer at Delft University of Technology. After his report, which linked the design of the equipment to a bacterial outbreak, European clinics were warned of a possible infection. But no one made a similar warning in the US - on the largest Olympus equipment market.

A few months later, the University of Pittsburgh Medical Center tested positive for a superbug known as “CRC,” which is so resistant to antibiotics that health officials call it a “nightmare bacterium.” Half of the patients infected by her die.
Pittsburgh Hospital found that many patients infected with superbug had contact with Olympus equipment. The hospital quickly stopped using such equipment and warned the company about the need to check their equipment.

The 31 duodenoscopes tested in five hospitals tested positive for bacteria - even after they were cleaned by hand and with a machine rinse with a powerful disinfectant. One device contaminated with “CRC” turned out to be specifically associated with one of the 18 cases of infection. The hospital said that only one case could be permanently attached, because some patients underwent similar procedures in other hospitals.

An Olympus representative who analyzed the test results replied that the equipment could be completely cleaned and the hospital was using the wrong type of automatic washing machine. A representative persuaded the hospital to replace the car with an Olympus model, which costs about $ 25,000. But the equipment gave a positive result on the bacteria even after it was cleaned in a new machine. The medical center began to sterilize duodenoscopes with toxic gas, using an expensive and much more time-consuming method. Due to the longer cleaning time, Pittsburgh ordered several more Olympus equipment, doubling its revenue.

A few months later, in October 2013, serious infections began to develop in patients undergoing the Olympus equipment at the Seattle Virginia Medical Center. Eighteen infected died. The hospital administration called Olympus.

"The company’s representatives controlled how hospital staff washed equipment and didn’t express any concerns," said Dr. Andrew Ross, head of the gastroenterology department. Over the next few weeks, the medical center sent its eight pieces of equipment to Olympus (alternately) - for check.

In 2014, almost a year later, Olympus told the FDA that it was offering its own visit for a consultation, but the hospital refused. After that, the Virginia Medical Center sued Olympus, accusing her of fraud and claiming that she “deceptively concealed ... the risks and shortcomings of equipment”. Olympus did not admit the allegations, stating that the hospital did not follow cleaning instructions.

An investigation conducted by federal, state, and county officials this year concluded that the doctors followed the correct cleaning procedure and that the cleaning procedure provided for by Olympus was insufficient.

When doctors at Ronald Reagan University of California Medical Center began to suspect equipment problems in December 2014, they called their Olympus equipment dealer, Vincent Hernandez. He was one of the best sellers, he boasted of registering with LinkedIn, that the company spent $ 14.6 million on security in 2014.
Hernandez and Olympus technicians visited the hospital. Company representatives watched employees at the University of California clean equipment. None of them expressed concern about the cleaning and did not mention previous outbreaks. In documents submitted to the court, Hernandez and two other staff said they did not warn University of California of equipment outbreaks in the Netherlands, Pittsburgh, and Seattle because they were not aware of them. The university medical center soon experienced a shortage of equipment, as new cleaning methods required more time. When the university requested the purchase of additional equipment, Olympus announced that the price had increased. The company also stated that it cannot guarantee delivery times, as the equipment is in high demand.

Dr. Raman Muthusamy, head of the endoscopy department at the University of California, said he was not aware of the investigation in the Netherlands. But, when he read the report of the Dutch researcher, he was struck by the resemblance. “There have been cases in Pittsburgh. There was an investigation at the Virginia Medical Center. There was an investigation in Rotterdam, ”he said. “Are you surprised why Olympus did not inform us about this before? I have suspicions about this. ”

The family of 11-year-old Jeffrey Hughes Santa Monica says they had the right to know about potential risks. Jeffrey, who had been fighting cancer for three years, had procedures on Olympus equipment and developed an infection. He died a month later. His parents sued Olympus in Los Angeles federal court. His mother, Annie Hughes said: “Olympus knew about this back in 2012. At least they should have told us about the risks.” Olympus rejects responsibility for the death of the boy, saying that it could be caused by existing diseases.

Olympus lasted until 2015 with the publication of a detailed report on the outbreak and the 2012 investigation in the Netherlands. In it, the company again claims that the hospital may not clean the equipment properly. Olympus concludes: "The cause of the infection of patients cannot be definitively determined." In February 2015, immediately after a new outbreak was registered at the University of California, Olympus sent an alert to its customers. In it, for the first time, she revealed that she was aware of 95 complaints related to her equipment.

In May 2015, the FDA convened a team of medical experts at its headquarters near Washington to study the infection situation. Doctors from Rotterdam, Seattle and Los Angeles gathered for two days of hearing. One by one they told how their flashes unfolded. Dr. Margaret Bock, an infectious disease specialist at the Rotterdam Medical Center, showed officials and medical experts photos taken inside Olympus equipment after a Dutch outbreak. She pointed to the brown mud that Olympus employees had discovered under a glass lid covering the probe’s chamber, which was closed for cleaning. She showed the image of the rubber seal on the big screen. It was badly worn.

“A solution must be found in a design change,” said Margaret Bock. “I think many infections will still occur .... This is the tip of the iceberg. ”The leaders of Olympus sat in the back of the room. None of them rose to answer ...

© 2015 Los Angeles Times Distributed by Tribune Content Agency, LLC.

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