CRE outbreak and
Found in Scopes
n the past few years there have been multiple reports of patient exposure to multi-drug resistant organisms, such as carbapenem-resistant Enterobacteriaceae (CRE), from contaminated duodenoscopes.
The tip of the duodenoscope has crevices that could harbor pathogenic bacteria.
In 2013, Advocate Lutheran General Hospital in Park Ridge, Illinois confirmed 38 cases of CRE transmission (you can read more about this case in our
February 2014 MicroBytes
Last month, Ronald Reagan UCLA Medical Center in Los Angeles notified 179 patients of possible exposure and has identified seven patients with infections. Sadly, the infections were contributing factors to the death of two patients.
More recently, Cedars-Sinai in Los Angeles notified 71 patients of possible exposure and has identified four patients with CRE transmission to date.
The transmission of CRE occurred from contaminated duodenoscopes used to perform endoscopic retrograde cholangiopancreatography (ERCP) procedures.
An ERCP is a test that combines the
use of a flexible, lighted scope (
) with X-rays to examine the ducts that drain the liver, gallbladder, and pancreas. Over 500,000 of these procedures are performed each year, resulting in the need to reprocess each duodenoscope multiple times a year.
The complex design of the duodenoscope results in difficult to access parts and hard to clean areas. Debris from previous patients may not be completely removed during cleaning, which allows for organisms to survive the disinfection process. As demonstrated by the recent outbreaks, multi-drug resistant organisms can be transmitted from patient to patient by the contaminated duodenoscopes.
Of significant concern to many labs and infection control departments are how to monitor reprocessed duodenoscopes for microorganisms that may survive the decontamination process and what actions should be taken if organisms are found.
The FDA and CDC recently released several communications and interim guidance documents concerning the current issues with duodenoscopes. The CDC has provided an interim guidance for epidemiological and surveillance studies to find the root cause. Rather than focus attention solely on the detection of CRE, the CDC recommends labs look for the presence of large numbers of bacteria and for “high concern” organisms. The high concern organisms are not normal skin or environmental flora and represent potential pathogens, such as
The method provided by the CDC includes a method for presence/absence testing as well as a quantitative culture method for obtaining colony counts from samples. Links to the CDC interim guidance documents are provided below.
Newly updated cleaning instructions from Olympus, the major manufacturer of duodenoscopes, is referenced below.
Olympus now recommends raising and lowering the elevator mechanism three times while the device is immersed in a disinfectant.
In addition, an area around the elevator (pictured above) must be cleaned with two different-sized brushes, one that hospitals already use and one that Olympus will ship by May 8.
Reprocessing of re-usable medical devices is an issue the FDA has been working on for several years. In 2011, the FDA issued a draft guidance on reprocessing medical devices. The FDA continues to work with medical device manufacturers, the CDC, and several other partners to improve medical device reprocessing. More information and guidance on medical device reprocessing can be found in the links below.
These recent outbreaks further highlight the need to combat antibiotic resistance. President Obama made antibiotic-resistant organisms a top priority for his administration by increasing federal funding to prevent antibiotic-resistance to $1.2 billion by 2016. The president also signed
Executive Order 13676
in September of 2014 to aid in the detection, prevention, and control of antibiotic resistant organisms.
For more information from the FDA and CDC, please check online at
or follow the additional links below.
Reusable Device Reprocessing Resources for Health Care Facilities
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication – Design May Impede Effective Cleaning
Interim Duodenoscope Surveillance Protocol
Interim Duodenoscope Sampling Method
Interim Duodenoscope Culture Method
New Cleaning and Reprocessing Instructions from Olympus