The Food and Drug Administration is taking heat from Congress for several missteps associated with medical scopes that infected several people with deadly, drug-resistant superbugs.
The agency admitted earlier this week that it didn’t clear one of the medical scopes connected with superbug infections at two California hospitals.
The FDA also told the Washington Examiner Friday it didn’t approve the cleaning procedures for the scopes. Affected hospitals have said they cleaned the scopes per the manufacturer’s instructions, but they got contaminated anyways.
The instruments are called duodenoscopes, which are narrow tubes with a camera on one end inserted into the body to look for signs of disease or cancer. The scopes can gather tissue samples or deliver treatments to a part of the body.
Duodenoscopes are commonly used in place of more invasive medical procedures, and are employed in approximately 500,000 procedures a year, according to the FDA. The agency has not recommended hospitals do away with the procedures, just install more rigorous cleaning methods.
One of the scopes in question was manufactured by Olympus and did not have clearance from the agency. Olympus got clearance for an earlier version of the device, but then made some modifications to it, the agency said on Wednesday.
The agency wanted Olympus to apply for clearance, which the company did in October, and a decision is still pending. The FDA said it didn’t pull the device from shelves because there might not be enough scopes to meet clinical demand.
FDA said earlier this week it didn’t believe the lack of clearance was associated with the infections, and that scopes from other manufacturers led to some infections but didn’t elaborate on how many. In addition to Olympus, FujiFilm and Pentax manufacture the scopes.
Traditionally, the FDA also doesn’t review the cleaning instructions for duodenoscopes, said spokeswoman Leslie Wooldridge. The scopes are very hard to clean, as they have tiny nooks and crannies that can trap human fluids, such as blood, that can infect the next patient that uses the scope.
A manufacturer must tell the FDA they validated cleaning instructions to ensure healthcare workers can follow them. The agency could request or review that data on a case-by-case basis, Wooldridge said.
However, now that the scopes are the center of a superbug outbreak, Wooldridge said the agency is working with the three manufacturers on the instructions.
The lapses drew the ire of several lawmakers.
“It appears the FDA has known for at least two years that the design of duodenoscopes could result” in these outbreaks, said a letter from 11 Republican and Democratic House members to FDA Commissioner Margaret Hamburg.
The lawmakers cited figures that the agency received 75 reports of sterilization problems from duodenoscopes from 2013 to 2014.
The letter — spearheaded by Reps. Peter Roskam, R-Ill., and Ted Lieu, D-Calif. — asked the FDA when it learned of the sterilization problems and what it has done to combat superbugs.
Michael Carome of the advocacy group Public Citizen also called the lapses “not surprising but very troubling.”
“Maybe there is a problem with the design of this device. Even with the best of cleaning instructions they can’t succeed,” Carome, a physician and director of the organization’s health research group, told the Examiner.
The outbreak has so far infected 11 people and resulted in two deaths, with Los Angeles hospitals Cedars-Sinai and University of California-Los Angeles Medical Center reaching out to more than 100 patients to see if they are infected.
One expert says the public health isn’t in immediate danger, as this type of bacteria can only be spread through contaminated surfaces or from person-to-person contact, and not through the air like influenza.
However, outbreaks such as these could continue to crop up in hospitals, and can seriously injure or kill patients with weak immune systems, said Dr. David Perlin, executive director and professor at the Public Health Research Institute at Rutgers University.
“What we need to do is be able to sterilize better,” he told the Examiner.
