2018-04-11 18:51:28 UTC

2018 Interim duodenoscope surveillance and culturing protocols

April 11, 2018

FDA, CDC and ASM compare 2018 and 2015 protocols to reduce further the risk of infection and increase safety of duodenoscopes.

On March 22, 2018 the U.S. Food & Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and American Society for Microbiology (ASM), hosted a webinar to review new standardized protocols for duodenoscope surveillance sampling and culturing. The new protocols, released at the end of February, update interim protocols released by the CDC in March 2015

The 2018 protocols were developed by the FDA, CDC, ASM, duodenoscope manufacturers and other experts. AGA assisted in the review of these protocols and provided critical feedback. 

The AGA Center for GI Innovation and Technology continues to engage with stakeholders around this issue and is committed to collaborating on a solution to ensure zero device-associated infections. AGA encourages health care facilities that utilize duodenoscopes to:

  1. Continue to meticulously follow manufacturer reprocessing instructions.
  2. Take additional steps, including those outlined in these protocols, to further reduce the risk of infection and increase the safety of these medical devices.

The 2018 protocols differ from the 2015 interim guidelines in meaningful ways. During the webinar, changes to sampling (Table 1.) and culturing (Table 2.) methods were discussed. 

Presentation slides and a recording of the webinar may be accessed here

Table 1. Sampling methods comparison
Sampling methods 2018 2015 interim
Instrument channel Flush-brush-flush with sterile water (e.g., DI or RO water) Flush with sterile water
Elevator recess Brush with sterile water; flush with sterile water Brush with PBS/Tween-80
Distal cap seam Swab the seam between the distal end cap and the distal end None specified
Sample handling Samples are combined Samples are separate (may be combined)
Neutralization of samples Neutralizer added to samples None specified

 

Table 2. Culturing methods comparison
Culturing methods 2018 2015 interim
Options
Plating with membrane filtration
Plating with centrifugation
Liquid culture with membrane filtration
Liquid culture with centrifugation
Plating with membrane filtration 
Plating with centrifugation 
Liquid culture with membrane filtration
Liquid culture with centrifugation
Plating method 1 blood agar plate per duodenoscope Blood and MacConkey agar plates per duodenoscope
Controls None specified (other than routine lab media controls) 3 controls: positive and 2 negative controls
Culture incubation conditions 35 - 37°C for 72 hours 35 - 37°C for 48 hours