The FDA has reported new data from safety surveillance studies tracking contamination and infection rates linked to reprocessed duodenoscopes manufactured by Olympus, Fujifilm and Pentax. The agency found up to 5.4% of samples taken from the reusable devices tested positive for what the agency describes as "high concern" organisms, including Escherichia coli or Staphylococcus aureus.
Those interim results are higher than a 3% contamination rate the agency disclosed in a safety communication last December. That report also described additional hits of up to 3% related to "low concern" organisms, which, while unlikely to cause serious infections, still demonstrate reprocessing failures. The latest results now peg that number at 3.6%.
However, in terms of overall infection rates, the FDA says it has been making progress and seeing dramatic declines. Patient deaths have previously been reported, in a safety scare spanning years, related to the drug-resistant bacteria that can remain hidden within the reusable endoscopes and survive the cleaning process.
Commonly used to visualize the upper gastrointestinal tract, pancreas and bile duct in minimally invasive procedures, the FDA said it has been working to prevent new infections by evaluating duodenoscope cleaning instructions and standardizing surveillance methods.
"But we’re continuing to evaluate the benefit-risk profile of these devices, and we’d like to see strong evidence that proper cleaning and reprocessing can virtually eliminate any bacteria residue that can spread infections," said the FDA’s Jeffrey Shuren, director of the Center for Devices and Radiological Health, in an agency statement. "Currently, that evidence is lacking, and we’re considering what additional regulatory actions may be necessary."
The FDA has also been consulting with the Centers for Disease Control and Prevention and other federal agencies, and plans to discuss the issue at a CDC advisory committee meeting. In addition, the agency said it is working with manufacturers on new designs to reduce risks or the need for reprocessing entirely.
"We are considering whether additional recommendations will be necessary to help health care facilities with proper cleaning and high-level disinfection of duodenoscopes to lower contamination rates to less than 1%," Shuren said, including whether sterilization measures in addition to cleaning are needed.
"This will take careful consideration because we know some sterilization methods could damage the duodenoscope over time and lead to a shorter lifespan for the expensive device," he said.
The agency previously instructed manufacturers to conduct root cause analyses after December’s preliminary culture results. The final results from the surveillance studies, including an analysis of newly collected samples, are expected by the end of the year.
"Let me be clear, the percent of contaminated samples based on these interim results shows that improvements are necessary and we are committed to taking additional steps to reduce infections and contamination even further," Shuren said.
The FDA had ordered the trio of duodenoscope manufacturers to begin conducting two postmarket studies in 2015, including taking samples and cultures from reprocessed devices in clinical use, as well as performing a human factors study to examine whether hospital staff are correctly following cleaning instructions.
But in March 2018, the agency sent warning letters to Olympus, Fujifilm and Pentax for failing to comply with study commitments. In the most recent statement, Shuren said the three companies were still behind in meeting the agreed-upon timetable. "If the companies continue to fail to adequately respond to our concerns, the FDA will take additional action," he said.
Last December, Olympus Medical Systems pleaded guilty to failing to file required adverse event reports regarding serious infections linked to its duodenoscopes. The Tokyo-based company was fined $80 million and ordered to forfeit an additional $5 million under the plea agreement, which includes an onus to enact "extensive compliance reforms," according to the U.S. Department of Justice.
Prior to three superbug outbreaks involving at least 30 patients, Olympus had received an independent analysis of one of its scope’s design, no...
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