Hospital Detective: the deadly "superbug" was hiding in plain sight
The hunt for the deadly “superbag” that struck 22 patients in a Dutch hospital began shortly before noon on a spring day in 2012. In the laboratory point of the tiny village of Zutervud, the technician carefully peeled off the tip of the sphere protecting the duodenoscope (gastroscope) camera. He was intensely watched by a small group of hospital officials and the directors of Olympus Corp., the device's 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 sealed. Rubber rings designed to block the path of bacteria, have cracks and abrasions. Bacteria that infected the patients were found immediately.
Researchers employed by Olympus and the hospital concluded that the gastroscope design made it possible for bacteria to spread from one patient to another. In their report, they called on Olympus to investigate and make its results available.
Over the next three years thereafter, 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 departments about what they learned in 2012. After each outbreak, Olympus claimed that its equipment did not cause infection and blamed the hospitals, which allegedly did not properly clean the equipment. Olympus controls 85% of the US market for gastrointestinal medicine equipment.
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“The silence of Olympus 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 the outbreaks of superbags. The investigation was launched after the Los Angeles Times reported in February about an epidemic that killed three people at the Ronald Reagan Medical Center. The US regulatory authorities have warned all American hospitals that the number of infections is increasing throughout the country, and this may be due to the design features of 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 extensive engineering and technical experience and close cooperation with medical specialists. Medical equipment today accounts for almost 75% of this Tokyo-based 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 interacted with doctors to invent a device called a duodenoscope (gastroscope) more than four decades ago. It uses a procedure known as ERCP (endoscopic retrograde cholangiopancreatography). Doctors introduce a flexible hose through the patient's throat into the digestive tract to diagnose cancer, gallstones and other diseases.
Doctors carry out almost 700,000 of these procedures annually in the United States and more than 2 million procedures worldwide, said a representative from Olympus. "Many of these patients have serious illnesses, which makes them more vulnerable to infection."
Since 2010, two rivals Olympus (Pentax and Fujifilm) have been selling advanced duodenoscopes, which ensures their best cleaning. Olympus presented a similar model, known as the Q180V. The company said that this equipment with a price of $ 40,000 is a technical triumph. They also modified the new equipment to make it easier to clean. But the new design has created new problems. In 2012, the outbreak of the disease in the Netherlands, at the Erasmus University Medical Center in Rotterdam, became 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 Technical University. After his report linking the design of the equipment with a bacterial outbreak, European clinics were warned about possible contamination. But no one made a similar warning in the United States — on the largest equipment market, Olympus.
A few months later, the University of Pittsburgh Medical Center tested positive for a superbag, known as the CRC, which is so resistant to antibiotics that health officials call it a “nightmarish bacterium.” Half of the patients infected with it die.
At the Pittsburgh Hospital, it was discovered that many patients infected with the superbag had contact with Olympus equipment. The hospital quickly stopped using such equipment and warned the company to check their equipment.
31 duodenoscopes tested in five hospitals tested positive for bacteria - even after they were cleaned by hand and machine washed with a powerful disinfectant. One device contaminated with CRC turned out to be directly related to one of 18 infections. At the hospital, they said that they could only permanently link one case, because some patients underwent similar procedures in other hospitals.
A representative from Olympus, who analyzed the test results, responded that the equipment could be completely cleaned and the hospital used the wrong type of automatic washing machine. A representative persuaded the hospital to replace the car with the Olympus model, which costs about $ 25,000. But the equipment tested positive for bacteria, even after it was cleaned in a new machine. The medical center began to sterilize duodenoscopes with a toxic gas using an expensive and much more labor-intensive method. Due to the longer cleaning time, Pittsburgh ordered several more items of Olympus equipment, doubling its revenue.
A few months later, in October 2013, patients who underwent procedures using Olympus equipment at the Seattle Virginia Medical Center began to develop serious infections. Eighteen infected died. The hospital administration called Olympus.
"Company representatives monitored how the hospital staff cleaned the equipment and did not express any concerns," said Dr. Andrew Ross, head of the department of gastroenterology. 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 reported to the FDA that it offered its own visit for consultation, but the hospital refused. After that, the Virginia Medical Center sued Olympus, accusing it of fraud and claiming that it "deceptively concealed ... the risks and shortcomings of the equipment." Olympus did not admit the charges, stating that the hospital did not follow the cleaning instructions.
An investigation by federal, state and county officials concluded this year that the doctors followed the proper cleaning procedure and that the cleaning procedure provided for by Olympus was not sufficient.
When doctors at the Ronald Reagan Medical Center at the University of California began to suspect equipment problems in December 2014, they called their equipment salesman, Olympus, Vincent Hernandez. He was one of the best sellers, he bragged about registering with LinkedIn that the company spent $ 14.6 million on providing security in 2014.
Hernandez and Olympus technicians visited the hospital. Company representatives observed how University of California staff cleaned the 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 members said they did not warn the University of California about outbreaks of equipment related diseases in the Netherlands, Pittsburgh and Seattle, because they were not aware of them. The university medical center soon experienced a shortage of equipment, since 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 could not guarantee the delivery time, because the equipment is in high demand.
The head of the University of California endoscopy, Dr. Raman Muthusamy, 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 similarity. “There have been cases in Pittsburgh. There was an investigation at the Virginia Medical Center. There was an investigation in Rotterdam, ”he said. “You wonder why Olympus did not inform us about this earlier? I am suspicious of this matter. ”
The family of 11-year-old Jeffrey Hughes Santa Monica says they had the right to know about the potential risks. Jeffrey, who fought cancer for three years, underwent a procedure on Olympus equipment and he developed an infection. He died a month later. His parents sued Olympus in a Los Angeles federal court. His mother, Annie Hughes, said: "Olympus knew about this as early as 2012. At least they should have told us about the risks." Olympus rejects responsibility for the boy’s death, saying that it could have been caused by existing diseases.
Olympus held out until 2015 with the publication of a detailed report on the outbreak and the 2012 investigation in the Netherlands. In it, the company again asserts that the hospital may not properly clean the equipment. "Olympus" concludes: "The cause of the infection of patients cannot be finally 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 gathered a group of medical experts at its headquarters near Washington to look into the infection situation. Doctors from Rotterdam, Seattle and Los Angeles gathered for two days of hearings. One by one they told how their flashes were unfolding. Dr. Margaret Bock, an infectious diseases doctor at the medical center in Rotterdam, showed officials and medical experts photos taken inside the Olympus equipment after the Dutch outbreak. She pointed to the brown dirt that Olympus employees had discovered under a glass lid that closed the probe chamber, closed for cleaning. She showed a picture of a rubber seal on the big screen. It was heavily worn.
“The solution must be found in a redesign,” said Margaret Bock. “I think that many infections will still occur ... This is the tip of the iceberg. ”Olympus executives sat in the back of the room. None of them rose to answer ...
A SOURCE:
medicalxpress.com/news/2015-12-deadly-superbug-plain-sight.html
© 2015 Los Angeles Times Distributed by Tribune Content Agency, LLC.
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 sealed. Rubber rings designed to block the path of bacteria, have cracks and abrasions. Bacteria that infected the patients were found immediately.
Researchers employed by Olympus and the hospital concluded that the gastroscope design made it possible for bacteria to spread from one patient to another. In their report, they called on Olympus to investigate and make its results available.
Over the next three years thereafter, 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 departments about what they learned in 2012. After each outbreak, Olympus claimed that its equipment did not cause infection and blamed the hospitals, which allegedly did not properly clean the equipment. Olympus controls 85% of the US market for gastrointestinal medicine equipment.
')
“The silence of Olympus 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 the outbreaks of superbags. The investigation was launched after the Los Angeles Times reported in February about an epidemic that killed three people at the Ronald Reagan Medical Center. The US regulatory authorities have warned all American hospitals that the number of infections is increasing throughout the country, and this may be due to the design features of 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 extensive engineering and technical experience and close cooperation with medical specialists. Medical equipment today accounts for almost 75% of this Tokyo-based 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 interacted with doctors to invent a device called a duodenoscope (gastroscope) more than four decades ago. It uses a procedure known as ERCP (endoscopic retrograde cholangiopancreatography). Doctors introduce a flexible hose through the patient's throat into the digestive tract to diagnose cancer, gallstones and other diseases.
Doctors carry out almost 700,000 of these procedures annually in the United States and more than 2 million procedures worldwide, said a representative from Olympus. "Many of these patients have serious illnesses, which makes them more vulnerable to infection."
Since 2010, two rivals Olympus (Pentax and Fujifilm) have been selling advanced duodenoscopes, which ensures their best cleaning. Olympus presented a similar model, known as the Q180V. The company said that this equipment with a price of $ 40,000 is a technical triumph. They also modified the new equipment to make it easier to clean. But the new design has created new problems. In 2012, the outbreak of the disease in the Netherlands, at the Erasmus University Medical Center in Rotterdam, became 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 Technical University. After his report linking the design of the equipment with a bacterial outbreak, European clinics were warned about possible contamination. But no one made a similar warning in the United States — on the largest equipment market, Olympus.
A few months later, the University of Pittsburgh Medical Center tested positive for a superbag, known as the CRC, which is so resistant to antibiotics that health officials call it a “nightmarish bacterium.” Half of the patients infected with it die.
At the Pittsburgh Hospital, it was discovered that many patients infected with the superbag had contact with Olympus equipment. The hospital quickly stopped using such equipment and warned the company to check their equipment.
31 duodenoscopes tested in five hospitals tested positive for bacteria - even after they were cleaned by hand and machine washed with a powerful disinfectant. One device contaminated with CRC turned out to be directly related to one of 18 infections. At the hospital, they said that they could only permanently link one case, because some patients underwent similar procedures in other hospitals.
A representative from Olympus, who analyzed the test results, responded that the equipment could be completely cleaned and the hospital used the wrong type of automatic washing machine. A representative persuaded the hospital to replace the car with the Olympus model, which costs about $ 25,000. But the equipment tested positive for bacteria, even after it was cleaned in a new machine. The medical center began to sterilize duodenoscopes with a toxic gas using an expensive and much more labor-intensive method. Due to the longer cleaning time, Pittsburgh ordered several more items of Olympus equipment, doubling its revenue.
A few months later, in October 2013, patients who underwent procedures using Olympus equipment at the Seattle Virginia Medical Center began to develop serious infections. Eighteen infected died. The hospital administration called Olympus.
"Company representatives monitored how the hospital staff cleaned the equipment and did not express any concerns," said Dr. Andrew Ross, head of the department of gastroenterology. 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 reported to the FDA that it offered its own visit for consultation, but the hospital refused. After that, the Virginia Medical Center sued Olympus, accusing it of fraud and claiming that it "deceptively concealed ... the risks and shortcomings of the equipment." Olympus did not admit the charges, stating that the hospital did not follow the cleaning instructions.
An investigation by federal, state and county officials concluded this year that the doctors followed the proper cleaning procedure and that the cleaning procedure provided for by Olympus was not sufficient.
When doctors at the Ronald Reagan Medical Center at the University of California began to suspect equipment problems in December 2014, they called their equipment salesman, Olympus, Vincent Hernandez. He was one of the best sellers, he bragged about registering with LinkedIn that the company spent $ 14.6 million on providing security in 2014.
Hernandez and Olympus technicians visited the hospital. Company representatives observed how University of California staff cleaned the 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 members said they did not warn the University of California about outbreaks of equipment related diseases in the Netherlands, Pittsburgh and Seattle, because they were not aware of them. The university medical center soon experienced a shortage of equipment, since 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 could not guarantee the delivery time, because the equipment is in high demand.
The head of the University of California endoscopy, Dr. Raman Muthusamy, 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 similarity. “There have been cases in Pittsburgh. There was an investigation at the Virginia Medical Center. There was an investigation in Rotterdam, ”he said. “You wonder why Olympus did not inform us about this earlier? I am suspicious of this matter. ”
The family of 11-year-old Jeffrey Hughes Santa Monica says they had the right to know about the potential risks. Jeffrey, who fought cancer for three years, underwent a procedure on Olympus equipment and he developed an infection. He died a month later. His parents sued Olympus in a Los Angeles federal court. His mother, Annie Hughes, said: "Olympus knew about this as early as 2012. At least they should have told us about the risks." Olympus rejects responsibility for the boy’s death, saying that it could have been caused by existing diseases.
Olympus held out until 2015 with the publication of a detailed report on the outbreak and the 2012 investigation in the Netherlands. In it, the company again asserts that the hospital may not properly clean the equipment. "Olympus" concludes: "The cause of the infection of patients cannot be finally 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 gathered a group of medical experts at its headquarters near Washington to look into the infection situation. Doctors from Rotterdam, Seattle and Los Angeles gathered for two days of hearings. One by one they told how their flashes were unfolding. Dr. Margaret Bock, an infectious diseases doctor at the medical center in Rotterdam, showed officials and medical experts photos taken inside the Olympus equipment after the Dutch outbreak. She pointed to the brown dirt that Olympus employees had discovered under a glass lid that closed the probe chamber, closed for cleaning. She showed a picture of a rubber seal on the big screen. It was heavily worn.
“The solution must be found in a redesign,” said Margaret Bock. “I think that many infections will still occur ... This is the tip of the iceberg. ”Olympus executives sat in the back of the room. None of them rose to answer ...
A SOURCE:
medicalxpress.com/news/2015-12-deadly-superbug-plain-sight.html
© 2015 Los Angeles Times Distributed by Tribune Content Agency, LLC.
Source: https://habr.com/ru/post/367491/
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