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Study Shows Difficulty Quantifying Contamination Proble

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A systematic review of adenosine triphosphate as a surrogate for bacterial contamination of duodenoscopes used for endoscopic retrograde cholangiopancreatography

Lovisa B. Olafsdottir, MD

, 

Julia Whelan, MS, AHIP

, 

Graham M. Snyder, MD, SMCorrespondence information about the author MD, SM Graham M. SnyderEmail the author MD, SM Graham M. Snyder

 

DOI: https://doi.org/10.1016/j.ajic.2017.12.007

 

 

Article Info

 

 

• Abstract

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Highlights

 

• •This systematic review identified 10 studies with concomitant ATP and culture samples.
• •Four studies quantified the relationship between these methods and found poor correlation.
• •A decrease in ATP measurements was seen after each reprocessing stage.
• •ATP does not effectively substitute for culture surveillance of duodenoscopes.
• •ATP may be an indicator of the quality of manual cleaning.

 

Background

Bacterial culture is the accepted standard to measure the adequacy of high-level disinfection (HLD) of duodenoscopes. Adenosine triphosphate (ATP) bioluminescence assays have been suggested as an alternative method of evaluating the quality of reprocessing. We systematically reviewed published research describing the correlation between ATP and bacterial cultures.

Methods

The primary outcome was the correlation or concordance between concomitantly sampled ATP and bacterial contamination obtained from the instrument channel and/or elevator mechanism of the duodenoscope. A secondary outcome included the reduction in ATP measurements between paired samples before and after stages of duodenoscope reprocessing.

Results

Ten studies were included in the analysis. Four studies reported the relationship between concomitantly sampled ATP and cultures. Three studies reported receiver operating characteristic curves (1 study additionally reported a Wilcoxon rank sum test), and 1 study reported Spearman correlation coefficients and paired dichotomous measurements of ATP and bacterial contamination. All analyses suggested a poor relationship between the 2 measures. Studies measuring ATP before and after manual cleaning and before and after HLD reported a reduction in ATP after the reprocessing stage.

Conclusion

Current research does not support the direct substitution of ATP for bacterial culture surveillance of duodenoscopes. Serial ATP measurement may be a useful tool to evaluate the adequacy of manual cleaning and for training of endoscopic reprocessing staff.

This study from AJIC confirms what others have shown: ATP testing of contaminated duodenoscopes (and other scopes) is not adequate to be a subsititute for bacterial culturing of these scopes. 

But, the contamination issue is also fundamentally plagued by the difficulity determining the number or extent of contaminated scopes (duodenoscopes, colonoscopes, gastroscopes, ureteroscopes, cystoscopes, bronchoscopes...) given the FALSE NEGATIVE results of culturing these scopes for bacteria. Many scopes are contaminated, yet are culture negative.

The problem plaguing FDA and AAMI is made more difficult by their inability to get a grasp on the extent of the contamination issue, especially with duodenoscopes, but also with other scopes.

When will the industry simply move past obviously inadequate HLD systems to reprocess these scopes and SIMPLY RECOGNIZE THAT THE VP4 TERMINAL STERILIZATION PROCESS FROM TSO3 SOLVES THE CONTAMINATION ISSUE, and STERILIZATION SHOULD NOT JUST BE RECOMMENDED AS IT IS NOW, TERMINAL STERILIZATION SHOULD BE IMPLEMENTED!

THE FDA SHOULD RECOGNIZE THE EFFICACY OF THE VP4 NOW TO STERILIZE THESE SCOPES! It should be of interest to the FDA that the VP4 is also incredibly efficient and cost effective, but this is not their primary responsibility and should not delay approval!

The second step for the FDA in moving the industry to terminal sterilization should then be to work with TSO3 and the industry, including OEM's and FDA, to make recommendations regarding implementation of sterilization and to improve the durability of these scopes.

THERE IS A SOLUTION TO THE SCOPE CONTAMINATION ISSUE, AND THE VP4 IS IT!!