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FDA's scope reprocessing guidelines most cost-effective for infection prevention
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A cost-utility analysis of four different endoscopic retrograde cholangiopancreatography duodenoscope reprocessing strategies for preventing patient transmission of carbapenem-resistant Enterobacteriaceae showed the approach recommended by the FDA is the most cost-effective.
“Contaminated endoscopes cause more health care-associated infection outbreaks than any other medical device,” Christopher V. Almario, MD, MSHPM, and Brennan M. R. Spiegel, MD, MSHS, from Cedars-Sinai Medical Center in Los Angeles, and colleagues wrote. “There are limited treatment options for [multidrug-resistant organisms] and CRE infections, and multiple recent CRE outbreaks associated with contaminated duodenoscopes have been the focus of widespread media attention, including at our own institutions.”
Christopher V. Almario
Brennan M. R. Spiegel
Almario, Spiegel and colleagues used decision analysis software to compare the cost-effectiveness of the following strategies for reducing the risk for CRE transmission among patients hospitalized for symptomatic common bile duct stones:
- FDA-recommended reprocessing methods introduced in March 2015, which include additional brushing and flushing of the forceps elevator recess area;
- “culture and hold” strategy, where scopes are cultured after ERCP and then held until cultures test negative for growth after 48 hours;
- ethylene oxide gas sterilization; or
- stopping ERCP and performing laparoscopic cholecystectomy with common bile duct exploration.
Incremental cost per quality-adjusted life year gained served as the primary outcome measure.
The base-case model showed that, compared with the FDA-recommended strategy, “culture and hold” cost an incremental $4,228,170 per quality-adjusted life year gained, and compared with “culture and hold,” ethylene oxide gas sterilization cost an incremental $50,572,348 to gain one additional quality-adjusted life year. Stopping ERCP and performing laparoscopic cholecystectomy with common bile duct exploration was more expensive and marginally less effective than all other strategies. Sensitivity analysis showed “culture and hold” became more cost-effective than the FDA-recommended strategy only when the pretest probability of CRE was higher than 24%, a rate “much higher than currently reported.”
“Future research should formally investigate the effectiveness of CRE-elimination using these methods and determine whether other reprocessing strategies should be considered,” the researchers wrote. “In light of the current uncertainty regarding the best management of CRE risk, limited treatment options for CRE-infected patients, and high mortality associated with CRE infection, our results may assist health care administrators, health care centers, and endoscopy clinics in deciding how to reduce CRE risk for what can otherwise be a lifesaving procedure.” – by Adam Leitenberger
Disclosures: The researchers report no relevant financial disclosures.
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