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# ‘High Concern’ Duodenoscope Contamination Rates Rise
- URL: https://www.fdaweb.com/high-concern-duodenoscope-contamination-rates-rise/
- Published: 2019-04-12T12:00:00.000Z
- Updated: 2026-09-15T01:20:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143859

As a follow-up to a 12/2018 safety communication on preliminary findings from studies on marketed duodenoscopes, a [new update](https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm635828.htm?ref=fdaweb.com) says the findings now show that up to 5.4% of all properly collected samples tested positive for “high concern” organisms, which is significantly higher than the earlier 3% reported. Olympus, Fujifilm and Pentax were ordered to conduct postmarket surveillance studies to better understand the transmission of infections and assess the factors that contribute to their occurrence. “High concern” bacteria are more often associated with disease, such as *E. coli* or *Staphylococcus aureus*, the agency says.

FDA says that the rates of contamination after the cleaning and reprocessing of duodenoscopes are worrisome and that “improvements are necessary and we are committed to taking additional steps to reduce infections and contamination even further. The FDA previously instructed the manufacturers to conduct root cause analyses following the preliminary results announced last December to better understand these culturing results. These analyses are currently underway with an analysis of the newly collected samples, and final results are expected later in 2019.”

In the meantime, the agency says it is “exploring additional steps to take to reduce contamination rates. We have been consulting with the Centers for Disease Control and Prevention and other federal health partners to obtain their input and guidance on the issue of infection control and reprocessing of these difficult to clean scopes. Next month, the FDA plans to discuss this issue at the [Healthcare Infection Control Practices Advisory Committee (HICPAC)](https://www.cdc.gov/hicpac/?ref=fdaweb.com) meeting to seek input on improving the safety of reprocessed devices. 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%.”