- An FDA analysis of medical device reports received between Oct. 15, 2018 and March 31, 2019 found three reports of death, 45 reports of patient infection and 159 reports of device contamination tied to inadequate reprocessing of duodenoscopes used in procedures involving the pancreas and bile duct, the agency said.
- FDA also released interim results from post-market studies by device makers showing contamination rates in the scopes significantly higher than preliminary findings released in December — 5.4% of all samples tested positive for “high concern” bacteria more often associated with diseases such as E. coli or Staphylococcus aureus, versus 3% reported previously. Another 3.6% of samples tested positive for “low concern” bacteria in the latest data.
- Manufacturers Olympus, Fujifilm and Pentax have not complied with agreed-upon timetables for completing the post-market studies, FDA said, prompting the agency to threaten additional action, on top of warning letters issued a year ago.
Duodenoscopes are flexible, lighted devices used in minimally invasive procedures to diagnose and treat conditions of the pancreas and bile duct. The scopes are difficult to clean because they contain many small working parts. If cleaning instructions are not followed carefully, tissue or fluid from one patient can remain in a duodenoscope and transfer infection to another patient, FDA said.
The latest medical device reports detailing infections and deaths tied to duodenoscope contamination are a setback after what seemed to be progress made over the past few years toward preventing patient infections, including those from multi-drug resistant bacteria. The agency said its analysis indicated that reports of infections peaked in 2015 at 250 and declined by 62% to fewer than 100 per year in 2017 and 2018.
Safety measures implemented since 2015 designed to reduce contamination levels to “as close to zero as possible” have yielded improvements, FDA said, but three deaths from bacteria infections tied to the devices are “three deaths too many.”
In addition to taking steps to improve reprocessing techniques, FDA in 2015 also ordered Olympus, Fujifilm and Pentax to conduct two post-market surveillance studies to find the cause of the problem. The three manufacturers are required to sample and culture reprocessed duodenoscopes in clinical use to assess what issues are leading to contamination. Second, each is responsible for a human factors study to determine whether hospital staff are following reprocessing instructions.
Now, interim results from those studies have come back with contamination levels that are significantly higher than preliminary results showed in December. At that time, FDA said the contamination rate was far higher than the assumption of less than 0.4% on which the culturing trials were designed.
Also in December, the U.S. Justice Department announced that Olympus and a former senior executive pleaded guilty for not reporting adverse event related to duodenoscope infections. The company was fined $80 million plus an additional $5 million in criminal forfeiture based on a plea agreement.
With its release of the interim post-market data, FDA also signaled its impatience with the duodenoscope makers for failing to comply with timelines for completing the post-market studies. Warning letters were issued in March 2018 to the three companies for failing to meet their study commitments. “If the companies continue to fail to adequately respond to our concerns, the FDA will take additional action,” the agency said.
FDA said it is looking at other ways to reduce contamination risks, as well, that include recommendations to healthcare facilities for high-level disinfection of duodenoscopes and supplemental measures such as sterilization. The agency also is working with manufacturers to develop easier-to-clean duodenoscope designs and on disposable versions.
“We’d like to see strong evidence that proper cleaning and reprocessing can virtually eliminate any bacteria residue that can spread infections. Currently, that evidence is lacking, and we’re considering what additional regulatory actions may be necessary,” FDA said.
The agency said it is consulting with the Centers for Disease Control and Prevention and other federal health partners for guidance on infection control and reprocessing of duodenoscopes. On May 16-17, FDA plans to discuss this issue at a meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC) to seek input on improving the safety of reprocessed devices.