Scope News

Duodenoscopes Updates I: In April of this year the FDA issued its latest Safety Communication on duodenoscopes. The patient infection risks that are caused by the cleaning and sterilization challenges of these scopes are not new. In 2012 the FDA first learned about the potential association between multi-drug resistant bacteria and duodenoscopes.1

A recent article in the New York Times on the infection risks associated with duodenoscopes pointed out that “Since 2012, however, hundreds of patients in the United States and Europe have been infected in dozens of outbreaks linked to contaminated duodenoscopes. Among the infectious agents is carbapenem-resistant Enterobacteriaceae [CRE], bacteria that do not respond to a powerful class of antibiotics. The infection has a 50 percent mortality rate.”2

The more that the FDA has investigated the problem, the more clear it has become that these cases of life-threatening CRE infections are occurring despite confirmation that reprocessing personnel were following the manufacturers’ cleaning, disinfection and sterilization instructions (IFUs). The investigation by the FDA has also found that the manufacturers have never validated their IFUs to prove that those instructions actually worked to thoroughly decontaminate, clean (i.e., remove all organic debris) and sterilize their duodenoscopes.3

The reason that the scope manufacturers had never validated their cleaning and sterilization IFUs to prove that they actually work is that when the scopes were initially approved for sale by the FDA, the FDA did not require the manufacturers to validate their cleaning and sterilization IFUs. All of that changed in March of 2015 when the FDA finally started to require manufacturers to validate their IFUs and include the validation report with their 510(k) submission for new product/device approval.

The New York Times article went on to point out that “Alarmed medical experts are urging the Food and Drug Administration to force the manufacturers to develop scopes that can be properly sterilized — or to take all duodenoscopes off the market.”4

The infection data are overwhelming and irrefutable, and the need is urgent,” William A. Rutala, the director of the statewide program for infection control and epidemiology at the University of North Carolina, said in an email. 5

In another recent study, data from three major hospitals documented the fact that seventy-one percent (71%) of their reusable medical scopes deemed ready for use on patients after reprocessing tested positive for bacteria. This study was published in March of 2018 in the American Journal of Infection Control and it underscores the infection risk posed by a wide range of endoscopes. The study documents a critical lack of progress by manufacturers, reprocessing personnel and regulators in reducing patient risk caused by scopes that remain contaminated after reprocessing. Sadly, this is after major news reports of superbug outbreaks and patient deaths from contaminated scopes going all the way back to 2012.6

The study found bacteria and other organic debris in scopes used for colonoscopies, lung procedures, kidney stone removal and other routine procedures. Researchers said the findings confirm earlier work showing that these issues aren’t simply confined to duodenoscopes.

“Sadly, in the 10 years since we’ve been looking into the quality of endoscope reprocessing, we haven’t seen improvement in the field,” says Cori Ofstead, the study’s lead author and an epidemiologist in St. Paul, Minnesota, referring to how the devices are prepared for reuse.

“If anything, the situation is worse because more people are having these minimally invasive procedures and physicians are doing more complicated procedures with endoscopes that, frankly, are not even clean,” Ofstead says.7

Recent tests performed by the manufacturers at the demand of the FDA found that one in 20 duodenoscopes retained disease-causing microbes like E. coli even after proper cleaning. The agency had expected that fewer than one in 200 would retain bacteria after cleaning. Dr. David Jay Weber, medical director of the statewide program at U.N.C., said the finding was “Astounding,” and called on the FDA to set a deadline for manufacturers to fix the problem.8

“Would you go on an airplane if the pilot said, ‘By the way, there is a 5 percent chance the engines will fail’?” Dr. Weber said. “Would you go in a car if the manufacturer said, ‘There are airbags, but 5 percent of the time they won’t deploy’?”9

While the FDA’s on-going actions concerning the safety of duodenoscopes is very important, the sad reality is that non-validated duodenoscopes are not the only reusable medical devices that are causing patient harm and even death. The vast majority of the surgical instrument manufacturers have never validated their cleaning IFUs either.

 

The first step in reducing your patients’ risk of exposure to a contaminated instrument is to only use instruments whose cleaning and sterilization IFUs have been validated. In the absence of validated IFUs, you and your staff can be doing everything right according to the manufacturer’s IFUs and still be returning contaminated instruments to the O.R. where they can cause great patient harm.

 

1. FDA Safety Communication: “The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions” April 12, 2019 https://www.fda.gov/medical-devices/safety-communications/fda-continues-remind-facilities-importance-following-duodenoscope-reprocessing-instructions-fda

2. New York Times: “Why These Are Medical Instruments So Tough to Sterilize? Roni Caryn Rabin, August 6, 2019

3. FDA Safety Communication: “The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions” April 12, 2019 https://www.fda.gov/medical-devices/safety-communications/fda-continues-remind-facilities-importance-following-duodenoscope-reprocessing-instructions-fda

4. New York Times: “Why These Are Medical Instruments So Tough to Sterilize? Roni Caryn Rabin, August 6, 2019

5. Op. Cite.

6. “Residual moisture and waterborne pathogens inside flexible endoscopes: Evidence from a multisite study of endoscope drying effectiveness” Cori L. Ofstead, MSPH, Otis L. Heymann, BA, Mariah R. Quick, MPH, John E. Eiland, RN, MS, Harry P. Wetzler, MD, MSPH. American Journal of Infection Control, March, 2018.

7. Op. Cite.

8. New York Times: “Why These Are Medical Instruments So Tough to Sterilize? Roni Caryn Rabin, August 6, 2019

9. 0p. Cite.