Bloomberg Businessweek (Europe)
The FDA backs off its recall of a medical device linked to superbug outbreaks
Devices linked to superbug outbreaks are still on the market “I’ve never seen a recall get changed like that”
In November 2015 the U.S. Food and Drug Administration instructed the maker of a medical scope cleaning device tied to a deadly superbug outbreak to take the machines off the market “as soon as possible.” After manufacturer Custom Ultrasonics offered to correct flaws, the FDA repeated itself in a February letter, writing in bold text: “FDA orders Custom Ultrasonics to immediately recall all System 83 Plus devices by removing them from use.” It cited doubts about whether the 2,800 System 83 Plus machines in use at hospitals across the U.S. could properly clean duodenoscopes, which are used to look inside the small intestine and are particularly hard to disinfect.
At the end of April, Custom Ultrasonics wrote customers saying that, in fact, they could keep using their System 83 Plus machines to clean endoscopes, as long as they weren’t used on duodenoscopes. The FDA says it’s pulled back its recall order and is working with the Ivyland, Pa., company to ensure its equipment is “validated in a timely manner,” says agency spokeswoman Deborah Kotz. (Under FDA rules, a device is considered “validated” once a manufacturer has proved it works as advertised.) The change in recommendation was “based on information provided by the company,” Kotz says. “We have nothing more to share on this at this time.”
Robert Blanchard, director of product management and sales for Custom Ultrasonics, declined to comment on the FDA letters or its change in position. Edward Teitel, a Houston doctor and attorney who advises Custom Ultrasonics, says the actual duodenoscopes, not the machines used to clean them, are the root cause of difficulties in disinfecting them.
Teitel adds that the FDA has reversed itself on recalls in the past “as more information becomes available.” But medical professionals say the sharp tone of the FDA’s initial letters makes its silence about its decision to back down on Custom Ultrasonics puzzling. “In the 20 years that I’ve been in the business, I’ve never seen a recall get changed like that,” says Mark Duro, director of sterile processing operations at New England Baptist Hospital in Boston, which doesn’t use Custom Ultrasonics equipment.
Using Custom Ultrasonics machines to clean duodenoscopes was one of several factors that “likely contributed” to the spread of drug-resistant bacterial infections, according to a
report issued in January by Senate Democrats. As many as 350 patients may have been affected at dozens of hospitals since 2010, according to documents released in April by the House Committee on Oversight and Government Reform. Dozens of infected patients later died.
Some outbreaks occurred at hospitals that don’t use Custom Ultrasonics equipment, and other brands of cleaning machines have had trouble disinfecting duodenoscopes. An expert panel convened by the FDA in 2015 concluded that duodenoscopes aren’t reliably safe. One model manufactured by Olympus was recalled in January. The FDA has recommended additional protocols including repeat washing, testing for contamination, or using ethylene oxide gas to sterilize the scopes. Custom Ultrasonics machines clean instruments with water, disinfectant, and sound waves. A study presented at a medical conference on May 22 suggests Custom Ultrasonics devices are more effective at cleaning endoscopes than their competitors’.
The FDA’s scrutiny of Custom Ultrasonics precedes the recent outbreaks. Inspections as long ago as 1991 found “significant violations” of federal rules meant to ensure quality manufacturing and timely reporting of harm to patients, according to a civil complaint filed in 2006 by federal prosecutors in Philadelphia. In 2007, Custom Ultrasonics settled the government case; the company, which denied in court filings that its products had caused or contributed to patient injury, didn’t admit any wrongdoing.
It’s not clear how many hospitals still use Custom Ultrasonics devices. Nine out of 16 U.S. hospitals that had superbug cases linked to duodenoscopes were identified in the Senate staff report as using Custom Ultrasonics machines. Only one, Hartford Hospital in Connecticut, confirmed it had replaced the machines after the recall.
UCLA Medical Center in Los Angeles and Massachusetts General Hospital in Boston both say they’re switching to other vendors. Others declined to specify what equipment they’re using; one, Thomas Jefferson University Hospital in Philadelphia, said the Senate report was incorrect and it had never used Custom Ultrasonics.
Lawrence Muscarella, a former director for infection control for Custom Ultrasonics who left in 2013, says the FDA’s change of course “appears to be sending the wrong message.” Patients should be told if their hospital is using equipment that has raised safety concerns, he adds: “It’s OK for hospitals to do that, provided the patient is told of this, so the patient is aware of the care that they’re getting.”
The bottom line Hospitals have gotten conflicting signals from U.S. regulators about machines used to disinfect medical scopes.