GAITHERSBURG, Maryland - A panel of FDA counseling experts suggested that underpaid and intimidated workers with little training and supervision are one of the key factors in the ongoing duodenal saga.
With the mission of providing recommendations for reducing the risk of infection following reprocessing of duodenoscopes involving manual cleaning and disinfection or sterilization, some members of the FDA's Medical and Hospital Device Advisory Committee on Thursday have argued that the same design exists for complex (narrow Channels, small screws, doors, levers, etc.) allow duodenoscopes to inject image contrast agents, allow a "side view" through a camera, capture microbes, and make devices as good as impossible. to clean
Duodenoscopes are essential for some rescue operations. Contaminated devices, however, have been associated with fatal infections known as "superbugs" .
The chairman of the committee, dr. Frank Lewis Jr., emeritus executive director of the American Board of Surgery, said the lack of proper training and supervision of workers is the "dominant factor" in the problems of field reprocessing. the application. Many of these technicians are low-wage and low-skilled workers who are asked to follow textbooks that can span hundreds of paces, and some are forced to work faster.
Keynote speaker Cori Ofstead, MSPH, a human factors and quality assurance expert based in St. Paul, Minnesota, recently reported surveys among reprocessing specialists at the International Chemicals Association of Canada, which led the core service team. After reprocessing, health revealed endoscopes, 17% left out the steps and 40% said they were victims of daily observation or intimidation.
Panelist Gary Socola, CEO of Highpower Validation Testing & Lab Services of Rochester, New York, said only four US states. UU. They require the certification of these technicians.
"The training is excellent and people want to learn, we just have to make it," he said.
Since the FDA has no training experience, Lewis recommended that the agency collaborate with manufacturers, the Joint Commission, and other relevant agencies (including Centers for Medicare and Medicaid Services) on medication strategies. Improvement of training and working conditions.
Microbiologist Michelle Alfa, Ph.D. from the University of Manitoba in Winnipeg, Canada, stated that microbes can survive by cleaning the duodenoscope if a lever mechanism is not positioned at 45 ° during reprocessing, but left in the cell. Low Position. , He also emphasized the importance of automatic or forced air drying and claimed that "wet storage" was the "beginning of the biofilm".
Another expert added that organizations are currently choosing their own quality control protocols and evidence-based policies.
The baby or the bathwater?
Dr. Stephen Wilcox of Design Science in Philadelphia agreed with many speakers that mineral processing engineers were "almost impossible", but insisted that the problem was technology-based.
"Reprocessing is so complex that it's very difficult to perform well," Wilcox said.
His first recommendation was to completely eliminate conventional duodenoscopes and switch to disposable devices, or secondly to simplify the devices so they are easier to remove, he said. He also recommended to check the effective reprocessing efficiency with endoscopes (flexible tubes with cameras that can be used in a duodenoscope to assess damage and to search for deposits).
Lewis said the panel is limited by the current state of the art, either through incremental changes (transition to disposable tips ) or through more substantial changes. Two or three manufacturers are actively working on the design of disposable areas, but none has yet been approved.
And panelists agreed that it was too early to know if non-traditional duodenoscopes, including those with exchangeable tips, could reduce pollution rates given the limited data available for comparison.
The costs could also play a role in any transition from conventional duodenoscopes, they suggested.
Ashley Faulx, MD, a gastroenterologist at Cleveland's Case Western Reserve University, said switching to single-use duodenoscopes (if approved) or interchangeable ends could be of interest to an outbreak hospital.
"I think it would be a very bad idea for everyone to be called to do that," he said, noting that such a mandate could restrict access to endoscopic retrograde cholangiopancreatography (ERCP) procedures.
How clean is clean?
When asked about the use of high-level disinfection in comparison to sterilization, most people said that high-level disinfection provided "sufficient safety margin".
Sterilization offers greater safety margin, but has its own challenges. (The Advisory Panel made recommendations to the FDA on Wednesday and Thursday to resolve issues related to ethylene oxide sterilization of medical devices.)
Jason Dominitz, MD, a gastroenterologist at the Veterans Health Administration in Seattle, said sterilization would restrict access.
But Isaac Benowitz, a pediatrician and epidemiologist at CDC, said that all available data suggest that highly effective disinfection was "rarely successful" and recommended that it be sterilized.
"For decades, we've made incremental changes and improvements to disinfectants and equipment at a high level, and we still talk about it," said Benowitz.
Panel members questioned a technical issue regarding the number of simulated cycles of use and cleaning required for durability testing (an FDA proposal for 250 cycles) and called for more data collection.
The problem with duodenoscopes
In 2015, dozens of patients developed abdominal infections after ERCP surgery with duodenoscopes.
Since 2015, the FDA has held several meetings, issued cautionary letters, issued safety information, and advised companies to review their clean-up processes after the procedure, but the issues persist.
More recently, the agency has licensed two disposable endoscopic duodenoscopes for use. In August, he advised hospitals and clinics to replace conventional hard- capped duodenoscopes with disposables until disposable devices become available.
Duodenoscopes are introduced in the mouth and throat, in the stomach and small intestine or in the duodenum. They can be used to remove gallstones or tumors, insert stents to release a blockage and restore intestinal flow, Shani said. Haugen, PhD, FDA devices and radiological health centers.
They have articulated lifting mechanisms at their distal ends, which are extremely difficult to clean, but, as experts have argued, other air channels in the device may include microbes.
In September 2013, the CDC exchanged information with the FDA regarding an association between these products and infections with multidrug-resistant organisms such as carbapenem-resistant enterobacteria.
Since then, several health centers have reported infections associated with duodenoscopes.
In February 2015, the FDA issued safety communication on the design of ERCP duodenoscopes and cleaning problems. In October 2015, the Agency mandated the three manufacturers of duodenoscopes (Olympus, Fujifilm and Pentax) to conduct post-marketing surveillance studies.
In May 2015, members of the FDA Advisory Committee on Gastroenterology Devices agreed that the duodenoscopes available at that time were truly dangerous, but did not recommend hiring them because in some cases the risks were even greater. , The alternatives to duodenoscopes are open or laparoscopic surgical drains or percutaneous transhepatic drains.
The FDA continues to insist that for the "adequate population" the benefits of duodenoscopes always outweigh the risks.
While data from medical devices reporting infection rates associated with contaminated duodenoscopes have been decreasing since 2015, according to Haugen's presentation, reports of contaminated duodenoscopes have increased . The increase in pollution rates could be due to improved sampling and cultivation in health care facilities, he said.
An analysis of the data from 2015 to 2019 in the United States and abroad revealed two deaths, a significant fall of the peak of 39 deaths in the fall of 2016, Haugen said. Of the total of 79 deaths, 69 occurred in the United States.
Haugen noted that these reports can not identify causes and that adverse events are often unreported.
Preliminary results from mandatory post-marketing FDA trials published in July 2019 showed that "very high concern organisms" were present in about 4-6% of the products.
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