GAITHERSBURG, Md. -- Bullied, low-wage workers with poor training and oversight are one of the key factors in the ongoing contaminated duodenoscope saga, an expert advisory panel to the FDA suggested.
Tasked with following duodenoscopes -- which involves manual cleaning and disinfection or sterilization -- some members of the FDA's General Hospital and Personal Use Panel of the Medical Devices Advisory Committee argued on Thursday that the same intricate design (narrow channels, tiny screws, doors, levers, etc.) that allows duodenoscopes to inject image contrasting agents and provide "side visualization" through a camera can also easily trap microbes and makes the devices nearly impossible to clean.
Duodenoscopes are essential for certain life-saving procedures, but contaminated devices have been .
Panel chair Frank Lewis Jr., MD, executive director emeritus for the American Board of Surgery, called the lack of adequate worker training and oversight the "dominant factor" behind the problems in reprocessing the scopes. Many of these technicians are low-wage, low-literacy workers who are asked to follow manuals that may include hundreds of steps, and some are bullied into working more quickly.
Guest speaker Cori Ofstead, MSPH, an expert on human factors and quality assurance from St. Paul, Minnesota, said recent surveys of reprocessing professionals from the International Association of Healthcare Central Service Materiel Management, showed that only 36% of technicians did any visible inspection of endoscopes after reprocessing, 17% skipped steps, and 40% reported experiencing or observing bullying on a daily basis.
Panelist Gary Socola, CEO of Highpower Validation Testing & Lab Services in Rochester, New York, noted that only four states in the U.S. require certification for these technicians.
"There's very good training out there ... and people want to learn, we just have to make that possible," he said.
Because the FDA has no jurisdiction over training, Lewis recommended that the agency work with manufacturers, the Joint Commission, and other relevant agencies (including the Centers for Medicare & Medicaid Services) on strategies for improving training and worker conditions.
Another speaker, microbiologist Michelle Alfa, PhD, from the University of Manitoba in Winnipeg, Canada, explained that microbes can survive a duodenoscope cleaning if a lever mechanism isn't placed at a 45° angle during reprocessing and is instead left in the down position. She also stressed the importance of automated or forced air drying, stating that "wet storage" is the "beginning of biofilm."
And yet another expert said organizations currently choose their own quality-monitoring protocols and evidence-based guidelines to follow.
The Baby or the Bath Water?
Panelist Stephen Wilcox, PhD, of Design Science in Philadelphia, agreed with many of the public speakers that reprocessing technicians are put "in an almost impossible situation," but insisted the problem was technology-driven.
"The reprocessing is so complex that it's very difficult to do well," Wilcox said.
His first recommendation was to get rid of traditional duodenoscopes completely and move to disposable ones or secondarily, simplify the devices to make them easier to reprocess, he said. He also recommended verifying the level of effective reprocessing through borescopes (flexible tubes with cameras that can be inserted into a duodenoscope to assess damage and search for debris).
On whether incremental (transitioning to disposable tips) or more substantial changes were recommended, Lewis said the panel was limited by the current state of technology. Two or three manufacturers are "actively working" on the design of fully disposable scopes, but none have been approved yet.
And panelists agreed that it was too soon to tell whether non-traditional duodenoscopes, including those with replaceable tips, could reduce contamination rates, given limited data for comparison.
Cost could also be a factor in any transition away from traditional duodenoscopes, they suggested.
Ashley Faulx, MD, a gastroenterologist at Case Western Reserve University in Cleveland, said that switching to disposable duodenoscopes (if and when approved) or to those with replaceable tips may be attractive to a hospital that has experienced an outbreak.
"But to mandate that everybody does it, I think, would be a really bad idea," she said, noting that such a mandate could reduce access to endoscopic retrograde cholangio-pancreatography (ERCP) procedures.
How Clean Is Clean?
When asked about the use of high-level disinfection versus sterilization, most members felt that high-level disinfection provides an "adequate margin of safety."
Sterilization offers a higher margin of safety but carries its own challenges. (The advisory committee also provided recommendations to the FDA on Wednesday and Thursday on how to address issues around ethylene oxide sterilization of medical devices.)
Jason Dominitz, MD, a gastroenterologist at the Veterans Health Administration in Seattle, held that requiring sterilization would limit access.
But Isaac Benowitz, MD, a pediatrician and epidemiologist for the CDC, said all the data he's seen suggest high-level disinfection is "rarely done properly" and urged switching to sterilization.
"We've been making incremental changes and improvements in high level disinfection and devices for decades and we're still here talking about it," said Benowitz.
Panelists punted on a technical question related to how many cycles of simulated use and cleaning were required in durability testing (an FDA proposal calls for 250 cycles), and called for more data collection.
The Trouble With Duodenoscopes
In 2015, dozens of patients developed abdominal infections after ERCP procedures using the duodenoscopes.
Since 2015, the FDA has held several meetings, issued warning letters, safety communications, and ordered companies to overhaul their post-procedural cleaning processes, but problems persist.
More recently, the agency cleared two duodenoscopes with disposable parts for use and in August recommended that hospitals and clinics plan to transition away from traditional duodenoscopes with fixed end caps toward those with single-use parts until entirely disposable devices are available.
Duodenoscopes are inserted through the mouth and wind down the throat, through the stomach and into the small intestine or duodenum and can be used to remove gall stones or tumors, insert stents to break up a blockage, and restore flow through the intestine, explained Shani Haugen, PhD, of the FDA's Centers for Devices and Radiological Health.
They have hinged elevator mechanisms at their distal tips, which can be incredibly challenging to clean but, as experts testified, other air channels in the device can also trap microbes.
In September 2013, the CDC shared information with the FDA regarding a link between these devices and multi-drug resistant organism infections, such as carbapenem-resistant Enterobacteriaceae.
Since then, multiple healthcare facilities have reported infections related to duodenoscopes.
In February 2015, the FDA released a safety communication regarding the design of ERCP duodenoscopes and cleaning challenges and in October, 2015, the agency ordered all three duodenoscope makers (Olympus, Fujifilm, and Pentax) to perform postmarket surveillance studies.
In May 2015, members of an FDA advisory committee on gastroenterology devices agreed that the duodenoscopes available at that time were indeed unsafe, yet did not recommend discontinuing their use as the alternative options, in some cases, carry even greater risk. Alternatives to duodenoscopes are open or laparoscopic surgical drainage or percutaneous transhepatic drainage.
The FDA continues to emphasize that for the "appropriate population," the benefits of duodenoscopes still outweigh their risks.
While medical device reporting data of infection rates associated with contaminated duodenoscopes have fallen since 2015, , according to Haugen's presentation. The increased contamination rates may be due to improved sampling and culturing by healthcare facilities, she noted.
An analysis of data from 2015 to 2019 in and outside of the U.S. found two death reports, a sharp reduction from the peak of 39 deaths in the fall of 2016, Haugen said. Of the 79 total death reports, 69 occurred in the U.S.
Haugen noted that causality can't be established with these reports and that adverse event rates are often under-reported.
Interim results of FDA's mandated postmarket studies reported in July 2019 found that "high concern organisms" were found in about 4-6% of devices.