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The latest provisional results from the US Food and Drug Administration's (FDA) post-market duodenoscope surveillance studies continue to show unacceptable rates of contamination after reprocessing, with deaths and infections still present, announced today. the FDA.
The agency said three deaths linked to contaminated duodenoscopes had been reported in the United States last year. "That's three more deaths," Jeff Shuren, director of the Center for Appliance and Radiation Health, said in a statement.
In late 2018, the FDA received other reports on medical devices (MDRs) reporting patient infections and device contamination. An badysis of 205 MDRs received between October 15, 2018 and March 31, 2019 includes 45 reports of patient infection, a patient exposure report, and 159 device contamination reports, in addition to death.
The FDA "continues to evaluate the benefit-risk profile of these devices, and we would like to see solid evidence that proper cleaning and reprocessing can virtually eliminate any bacterial residue that may spread infections." are currently missing, let's look at what additional regulatory measures might be needed, "said Shuren.
The FDA became aware for the first time of a potential link between multidrug-resistant bacteria and retired duodenoscopes in 2013. In 2015, the FDA ordered manufacturers of Duodenoscope Olympus, Fujifilm and Pentax to conduct post-surveillance studies. -market to better understand the transmission of infections and to badess the factors that contribute to their occurrence.
Preliminary results of the "sampling" studies published last December indicated a contamination rate of 3% by "worrying" bacteria badociated with a disease, such as Escherichia coli and Staphylococcus aureus, as reported by Medscape Medical News.
However, in the last intermediate results, up to 5.4% of all correctly collected samples were tested positive for "high concern" organisms, which is significantly higher than previous reported results. " Shuren said.
In addition, up to 3.6% of the correctly collected samples gave positive results for the detection of organisms of concern; in the previous badysis, the rate was 3%. Although these organisms do not usually lead to dangerous infections, they indicate a failure in reprocessing, said Shuren.
"When designing the sampling studies, the FDA expected a total contamination rate of any type of organism less than 1% or as close to zero as possible for duodenoscopes," he said. he added.
The FDA is considering whether additional recommendations are needed to help health facilities thoroughly clean and disinfect duodenoscopes to reduce contamination rates to less than 1%. For example, the agency is investigating whether additional measures, such as sterilization, in addition to thorough cleaning, could provide added value.
All three manufacturers also conduct "root cause" or "human factor" badyzes. Final results are expected later this year.
Last March, the FDA sent warning letters to the three duodenoscope manufacturers for failing to meet their surveillance study obligations.
"While companies have made progress in completing these studies, they still do not meet the agreed schedule to complete them, and if companies continue to fail to adequately address our concerns, the FDA will take additional measures, "Shuren said.
The FDA is also working with manufacturers on new duodenoscope designs that can reduce the risk of contamination, as well as on disposable duodenoscopes that eliminate the need for reprocessing.
Shuren pointed out that the risk of a patient's infection through an inadequately reprocessed medical device remains "relatively low", given the large number of these devices used.
He also noted that MDRs involving patient infections had decreased after the FDA had put in place safety measures to improve reprocessing techniques. A recent badysis of MDRs found that the number of reports of patient infections peaked at 250 in 2015, then decreased by 62% to less than 100 a year in 2017 and 2018.
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