Olympus Corp. announced on Friday that it will voluntarily recall and redesign its specialized medical scopes that have been linked to a number of deadly superbug outbreaks in the U.S.
The company is a leading producer of duodenoscopes, flexible tubes that are used in thousands of procedures across the country to diagnose and treat gastrointestinal tract disorders.
The device, however, has been linked to series of outbreaks of antibiotic-resistant infections that caused illness to hundreds of patients.
The scope's intricate design allows it to fix blocked pancreatic and biliary ducts but this also makes the instrument difficult to disinfect and sterilize between uses even when cleaning instructions were correctly followed. The design could be attributed to the transmission of infectious agents, which include antibiotic-resistant infections.
The company said that it will voluntarily recall 4,400 of its TJF-Q180V model duodenoscopes starting February and replace the instrument's design with one that would make it less vulnerable to contamination.
"Olympus will implement a corrective action in the U.S. for current TJF-Q180V duodenoscopes," Olympus said. "These changes involve new parameters that were reviewed by FDA prior to 510(k) clearance."
The company will recall the original model from health care facilities to replace the elevator channel sealing mechanism at the instrument's tip with a new sealing mechanism that would reduce the risk of the fluid leaking into the elevator channel.
Olympus estimates it will be able to make the necessary correction to the mechanisms in all of its TJF-Q180V models that are currently used in U.S. health care facilities by August this year. Hospitals can continue using the scope until then but are advised to "meticulously follow" the cleaning instructions.
Olympus likewise said that it will inspect each of the medical scopes annually to monitor them for wear and tear.
The Food and Drug Administration (FDA) approved Olympus' plan on Friday. In a statement, FDA's Center for Devices and Radiological Health chief scientist William Maisel stressed the importance of keeping medical devices safe and protecting patients from bacterial infections are a top priority.
"The Olympus TJF-Q180V's new design, as well as the new annual inspection program, is intended to reduce the risk of fluid leakage into the elevator channel, which in turn can reduce patient exposure to bacteria and other potential infections," Maisel said.