The manufacturer of a type of medical scope linked to the spread of deadly bacterial infections issued detailed new cleaning instructions for the devices Thursday, urging hospitals to implement the procedures “as soon as possible.”
The new safety protocols from Olympus America come after recent outbreaks at Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center in Los Angeles, where nearly a dozen patients contracted antibiotic-resistant “superbugs” from contaminated medical scopes and hundreds of others potentially were exposed.
At least two infected patients later died, and Olympus has faced lawsuits related to the outbreak.
The patients had been treated with a device known as a duodenoscope, which is used in hundreds of thousands of procedures each year in the United States to drain fluids from pancreatic and bile ducts blocked by cancer tumors, gallstones and other conditions. Doctors consider them a vital tool in detecting and treating medical problems early and in a minimally invasive way.
But the Food and Drug Administration, which itself has faced criticism for not addressing the problem sooner, has warned that the devices can be difficult to sanitize between uses and “may facilitate the spread of deadly bacteria.” The agency has been working with manufacturers of the devices in recent months to figure out more reliable ways to clean duodenoscopes and to examine potential design changes.
The updated instructions from Olympus on Thursday included a range of additional cleaning steps and the use of a new “small bristle cleaning brush,” which the company said it would send to facilities by early May. In a separate release, the FDA said it had reviewed the new cleaning protocols from Olympus and said that they “are robust and demonstrate consistent and reliable cleaning and high-level disinfection.”