The U.S. Food and Drug Administration (FDA) announced on Friday that the company Olympus Corp (OCPNY) will voluntarily recall from health facilities the Olympus TJF-Q180V duodenoscope, since it was demonstrated it had caused bacterial infections to several patients who received endoscopic retrograde cholangiopancreatography, a procedure that is performed in order to identify problems related to the bile and the pancreas.
It was explained that every year duodenoscopes are used more than 500,000 times in the United States, because they are presented as a great alternative to traditional surgery for patients who need a drain of pancreatic fluids or who have cancerous tumors or gallstones, blocking their biliary ducts, since this method can be less invasive, as the FDA said in a press release on Friday.
Previously the usage of duodenoscopes has been linked with the transmission of agents that cause infections that can be resistant to antibiotics. In October last year, the FDA ordered some manufacturers to make post-market analysis in order to determine if the duodenoscopes were safe enough for patients. In the same year, Virginia Mason Medical Center from Seattle sued Olympus after several people were infected with deadly bacteria because of the duodenoscopes.
“This is a significant step in the effort to combat infections spread through duodenoscopes. The FDA has undertaken an in-depth investigation into the factors that may play a role in infection transmission associated with duodenoscopes, and is now requiring manufacturers to study the devices in the clinical setting where they are being used,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health in a press release, last year.
Olympus America, which has approximately 85% percent of the market sales of duodenoscopes, has already published a letter directed to health care professionals, where it is affirmed that the tech maker is going to remove and evaluate the duodenoscopes that are in the American market, to replace some parts that appear to be causing the infections.
It is calculated that between 2012 and 2015 about 141 patients in the U.S. were infected as a consequence of procedures related to duodenoscopes. That being said, researchers who were investigating the effects of the tool have declared that it is important that the FDA and manufacturers are taking actions to protect patients. It was confirmed that Olympus will contact health care facilities and will replace the duodenoscopes in approximately four days.
Source: FDA Press Release