Olympus Pushed Back at FDA on Cleaning Endoscopes to Kill Superbugs
Olympus, the leading maker of the endoscopes linked to recent superbug outbreaks at hospitals around the U.S., asked the Food and Drug Administration to water down guidelines on cleaning medical devices that the agency proposed four years ago.
The FDA published a draft of the new guidelines in May 2011; they still haven’t been finalized. They would set non-binding recommendations for manufacturers of many types of medical devices, including the complex, hard-to-clean instruments called duodenoscopes that recently harbored deadly drug-resistant bacteria at UCLA Medical Center and other hospitals. The day after the UCLA outbreak came to light, the FDA warned that the instruments involved may be impossible to fully sanitize.
The proposed FDA guidelines were intended to help medical device makers prove that their cleaning methods were effective and that instructions to the hospital staff would be adequate. Dozens of companies, individuals, and medical societies offered comments on the proposal, part of the normal course of wrangling over bureaucratic language.
In Olympus’s comments, the company suggested that it shouldn't be solely responsible for ensuring that the method of sanitizing scopes was effective. Instead, Olympus wanted a separate group of companies that make the equipment used to clean its devices to share that responsibility. Olympus and other scope manufacturers would have to show only that their products were compatible with the cleaning materials.
"For example, the endoscope manufacturer would identify the worst case conditions” under which the instrument would need to be cleaned, according to Olympus’s comment letter. Then the companies that make the cleaning systems would test how effective the process is “on behalf of the endoscope manufacturer.” The scope maker "would perform the material durability and compatibility analysis” to see how the scope withstood repeated cleanings.
Olympus is the leading maker of duodenoscopes, which are threaded through the mouth and the gastrointestinal tract to reach tiny ducts in the pancreas or gallbladder. Cleaning such devices has been a challenge for hospitals for years.
If the FDA adopts the change in its final guidelines, that could shift some of the blame for scopes that spread deadly pathogens away from device manufacturers and onto the companies that make the cleaning systems. Olympus is facing lawsuits in California and Washington state from patients or families who say patients were harmed when its devices transmitted drug-resistant infections.
At least 13 people have died and dozens more have been sickened in outbreaks in those states that have come to light since January. Other factors may have caused or contributed to the deaths because patients who get duodenoscopic procedures are often already ill.
Mark Miller, a spokesman for Olympus, didn’t respond to messages asking about the company’s 2011 comments on the FDA proposal. In an e-mail from March 4, he said Olympus didn’t comment on active legal matters. He noted that half a million procedures using duodenoscopes are performed in the U.S. each year, “and while any complication affecting a patient’s health is a serious matter, the reported incidence of infections is extremely low."
The FDA is "working diligently to get the final reprocessing guidance out as soon as possible," spokeswoman Leslie Wooldridge said in an e-mail, without specifying a time frame.
Olympus took issue with a further suggestion the FDA made in the 2011 draft guidelines: that difficult-to-clean devices "will need to be disassembled in order to be completely cleaned.” The company said that would be "limiting to industry's ability to innovate and design reusable devices to meet the needs of the clinician.” Olympus said it might not be possible to safely redesign endoscopes to be taken apart for better cleaning. "FDA should not be imposing guidance which limits and restricts device design, development and innovation, and future clinical applications," it said.
To understand how tricky the devices are to decontaminate, take a look at the 106-page cleaning manual. Olympus’s instructions warn that if the scopes “are not immediately cleaned after each patient procedure, residual organic debris will begin to dry and solidify,” making them harder to disinfect. Hospital staff are supposed to “pre-clean” the devices before they leave the room where the procedure took place.
The FDA said last week that the model of the Olympus scope linked to the superbug outbreak at UCLA Medical Center hadn’t been approved by the agency for sale, even though it has been marketed since 2010. The FDA had cleared earlier versions of the device, and Olympus "determined" that the new model didn't require a separate approval, Miller said in an e-mail. After the FDA requested a new application last year, Olympus submitted one that is still pending. The agency isn't pulling the devices off the market in the meantime because it is concerned about causing a shortage.
The three main makers of duodenoscopes “have had insufficient validation data” to prove that they can be properly cleaned, FDA officials said last week, according to the Los Angeles Times. The two additional companies that make the scopes, Pentax and Fujifilm, did not file comments on the FDA’s 2011 proposal.