On August 17, the U.S. Food and Drug Administration (FDA) issued a warning to Olympus. Olympus (Olympus) has not reported the cases of endoscopic drug-resistant bacteria in U.S. hospitals in a timely manner. Submit improvements within 15 working days.
The warning shows that in May 2012 Olympus had mastered cases of patients using the company's endoscopic infection, but did not report it within the stipulated 30 days, but dragged on until 2015 before reporting to the FDA.
According to the â€œUSA Todayâ€ website reported in June, as of April 2015, at least six major hospitals in the United States had caused infection with drug-resistant bacteria when using endoscopes produced by Olympus.
Olympus Corporation is one of the representative companies of precision and optical technology in Japan and the world. Founded in Japan in 1919, Olympus Corporation has a history of 96 years. Its subsidiaries are located in various regions including Asia, Europe and the United States. The fiber endoscope, which plays an extremely important role, was developed by Olympus. Today's medical products cover digestive endoscopes, surgical endoscopes, and endoscopic instruments. However, the endoscopic products that they produce have been problematic in recent years.
According to the Chicago Tribune report on February 20, 2015, two people have died at the University of California, Los Angeles, and five others have been infected with carbapenem-resistant Enterobacteriaceae (CRE), a drug-resistant intestinal disease. Pathogenic bacteria, the patient mortality rate of 50%), according to statistics from the hospital, from January to October last year, more than 170 other patients may have been infected.
Attorney Peter Kuffman said that Aaron Youngâ€™s family, an 18-year-old patient, is considering suing the endoscope manufacturer Olympus USA and the related division of Olympus Japanâ€™s head office. According to the contents of the lawsuit, the patient received duodenal endoscopy twice in October 2014 and January 2015, which may have infected the CRE strain. According to Yang's family, the company has concealed the medical endoscopic equipment it sells, and has filed a lawsuit.
According to the Los Angeles Times report on May 28th, the endoscopic infection at the University of California, Los Angeles, Los Angeles has increased to eight cases, including three deaths. According to statistics from the Cedars-Sinai Medical Center in March, four patients have been diagnosed with an infection due to the use of Olympus-endoscopy-infected bacteria, and 67 people may already have Olympus endoscopy. Mirror infection risk.
In addition, other hospitals in the United States have similar cases of "superbugs," which are suspected to be related to the cleaning of endoscopes.
Reportedly, on March 30, 2015, an outbreak of a major E. coli outbreak occurred in a hospital in Washington, USA. Thirty-two patients undergoing ERCP had severe pancreatic and biliary infections, and more than 30% of patients died. .
Since 2012, 44 people have been infected at Chicagoâ€™s Lutheran General Hospital. Eleven people have died at the Virginia Mason Medical Center in Seattle and at least 32 have been infected.
After the FDA issued a warning, the Hartford Hospital in Connecticut stated that 281 patients were at risk of having an infection.
Endoscope contamination has been repeatedly warned
In recent years, patient injuries caused by endoscopic contamination have occurred in the United States one after another. This has caused the U.S. government to attach great importance. According to FDA data, Olympus duodenal endoscopy accounts for almost 85 percent of the US market. %.
Since 2009, the U.S. government has urged relevant agencies to issue warnings and take relevant measures for endoscope cleaning in medical institutions. Prior to this, Chicago, Seattle, Los Angeles, Pittsburgh and other cities suffered a series of outbreaks due to duodenal endoscopy. The US federal government immediately issued a warning to the FDA.
In April 2009, Arjun Srinivasan, a staff member of the US CDC, proposed to the US FDA executives that "a fatal antibiotic-resistant infection and duodenum in Florida hospital broke out. The endoscope is contaminated.â€ The staff at the state hospital did not clean the endoscope in the correct way, which may lead to bacterial proliferation and cross-contamination. Srinivasan said, "This type of problem may not only exist in Florida, but requires extensive attention and joint efforts from manufacturers, the Centers for Disease Control and Prevention, and the US FDA."
In November 2009, the U.S. FDA issued a "Safety Notice" in conjunction with the United States CDC and posted it on the official website of the U.S. Food and Drug Administration. The circular reminded health agencies and medical personnel of the importance of cleaning facilities and called for all endoscopic observations. All mirrors must be properly disinfected before use. The notice also specifically states that the pores of the duodenal endoscope cannot be treated only by the automatic washer-disinfector, and must be cleaned manually with a special brush.
According to today's US report on May 28, Olympus is the largest manufacturer of duodenal endoscopy in the United States. It is associated with infections in tens of patients. The drug-resistant infection has a mortality rate of 40% or more. .
In January 2014, the U.S. CDC released a public report again that the outbreak of CRE in Chicago resulted in suspected transmission of infected contaminated duodenal endoscopes. This is the first public warning of duodenal endoscopy since 2009. . The report states that endoscope manufacturers should consider the possibility of bacterial infections and evaluate preventive maintenance procedures.
However, Olympus does not seem to pay enough attention to the problem of endoscopic infection. On August 17, 2015, a warning letter from the FDA pushed it to the cusp.
From March to April 2015, the US FDA conducted a comprehensive investigation of Olibas America, the base of Hachioji, Tokyo, and Aizubas, a subsidiary of Fukushima Prefecture, and found that the manufacturer did not comply with the law. Report any death or serious injury that may result from the device to the FDA within 30 days.
According to the FDA's official website, as early as May 2012, 16 patients had been diagnosed with P. aeruginosa due to endoscopic examinations of Olympus. Some of these patients had abscesses, but Olympus did not Failed to report the infection results of all patients within the stipulated 30 days, but delayed reporting to FDA until 2015. In addition, the company did not ensure that the scope of adequate cleaning, still follow the old model cleaning instructions prompted doctors, resulting in effective disinfection and cleaning of new endoscopes.
The FDA issued a warning to Olympus and requested it to submit preventive measures within 15 business days. There are institutions and medical experts who point out that there may be bacterial residues in the camera's camera and ancillary equipment gaps. The patientâ€™s litigation lawyer also stated that â€œOlympus should have strict guidelines for the cleaning and reprocessing of its endoscopic equipment, including careful manual cleaning.â€ According to the Los Angeles Times, Olympus representative Mark Miller stated that he was checking the contents of the warning to complete the FDA's requirements within the deadline.
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