Responding to a series of outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) linked to duodenoscopes, the Centers for Disease Control and Prevention (CDC) has developed an interim protocol for culturing the devices before use to create a greater margin of safety for patients.
But as others have noted, the approach is not foolproof and could be costly if facilities determine that they must purchase more scopes to adopt the protocol. Duodenoscopes are priced in the $40,000 range, according to researchers who came up with a similar protocol at the ECRI Institute in Plymouth Meeting, PA. The CDC protocol provides a plan to determine how scopes may be sampled and how to test the samples in a lab. (To access the protocol, go to http://1.usa.gov/1MwdevG.)
“Like other proposed solutions to the problem of duodenoscope-related CRE infections, we recognize that there are both pros and cons associated with using screening cultures,” Michael Bell, MD, deputy director of the CDC’s Division of Healthcare Quality Promotion, said in a blog post. “There can be concerns about cost, as using this method will mean that the duodenoscopes will not be available for use while waiting for the results of the cultures. This could mean that a facility would need to buy additional scopes in order to be sure they have the equipment available when needed. Additionally, the failure to grow bacteria from the areas sampled may not guarantee that there are no bacteria present anywhere on the scope.”
The CDC continues to work with the Food and Drug Administration (FDA), medical specialty societies, and other endoscope experts to develop a more long-range solution. The various partners are working to determine which duodenoscope models are potentially affected; evaluate duodenoscope cleaning, drying, and disinfection; and assess the feasibility of using microbiologic sampling cultures to evaluate a facility’s duodenoscope cleaning methods and identify if bacterial contamination remains after disinfection, Bell said.
ECRI Institute has an idea
The ECRI Institute, a highly respected independent research group, also stepped forward with a solution that will allow the medically necessary procedures to continue at considerably less risk to patients. The problem is that ERCP (endoscopic retrograde cholangiopancreatography), which is performed on some half million U.S. patients annually, poses a risk of transmission of CRE because the bug has found a way to survive in intricately designed, hard-to-clean duodenoscopes. The scopes are primarily used for ERCP.
The ECRI Institute advises, in a nutshell, not to use the duodenoscopes until they culture negative. ECRI issued a Hazard Report (https://www.ecri.org/resource-center/Pages/Superbug.aspx) that details the method, which would keep these important procedures available to patients at reduced risk of a CRE infection. In addition, ECRI recommends that facilities conduct regular CRE surveillance through duodenoscope culturing, regardless of which reprocessing method they use (e.g.., high-level disinfection using a liquid chemical germicide or sterilization using ethylene oxide). This step could be done in many ways, but until further culture recommendations are available, ECRI recommends different approaches. One is to culture every duodenoscope after reprocessing is completed and wait to release the cultured scopes until negative results are received. Culture incubation typically takes up to 48 hours. “We believe this will provide the highest assurance of preventing CRE infections,” ECRI reported.
The problem is that this approach might require increasing duodenoscope inventories by two- or three-fold. Because few facilities will have the luxury of stocking enough scopes to have a few idle awaiting culture results, plan B would be to culture scopes weekly, starting at the end of the day Friday so the bacteria may grow over the weekend.
“This will not provide the high degree of assurance that culturing after each reprocessing cycle provides,” ECRI notes. “It also bears the risk of unknowingly using contaminated scopes between culturing intervals. However, weekly culturing will be less likely to require increases to duodenoscope inventories. It will also limit the risk of potentially exposing a large number of patients to contaminated scopes as compared to less frequent culturing.”
If a duodenoscope culture is positive, ECRI recommends repeating reprocessing using your standard method and re-culturing the instrument. If this next reprocessing results in a positive culture, consider sending the duodenoscope back to the manufacturer for further assessment or retiring it.
Notify your infection preventionist of all positive CRE cultures, ECRI advises. If you get positive cultures back on more than one scope, consider the possibility of a CRE reservoir in the reprocessing equipment or other sources, ECRI notes.
FDA issues safety update
One specific model of duodenoscopes made by Olympus does not have a 510(k) clearance, but the FDA has said providers should not cancel procedures based on the fact that Olympus has a pending 510(k) application for the device (the TJF-Q180V) and continues to market the product while the application is under review.
On March 26, the FDA issued a safety communication to alert users of the TJF-Q180V duodenoscope of new, validated manual reprocessing instructions. (To access the instructions, go to http://1.usa.gov/1917Odx.) The high-level disinfection procedure and pre-cleaning step can be put in place immediately. The new manual cleaning instructions can be implemented when a new brush becomes available. At press time, Olympus anticipated shipping the new brush no later than May 8, 2015. Jennifer Corbett Dooren, an FDA press officer, says, “The FDA decided to issue the safety communication now, before the brushes are available, so that facilities can adopt the new high-level disinfection steps immediately and begin training their reprocessing personnel.”
Removing the device from the market could lead to a shortage of duodenoscopes to meet U.S. clinical demand, the agency said. According to the advisory, the agency has
received, in the past two years, 75 reports involving possible microbial transmission from all reprocessed duodenoscopes, including multidrug-resistant bacterial infections.
“The FDA’s analysis indicates that the reported duodenoscope-associated infections have occurred in patients who have had procedures with duodenoscopes from all three manufacturers,” the agency said. “At this time, FDA has no evidence that the lack of a 510(k) clearance was associated with the infections.”
Also, the FDA has issued final guidance for makers of reusable duodenoscopes and other reprocessed medical devices aimed at ensuring that their cleaning and disinfection or sterilization instructions consistently reduce microbial contamination. (Joy Daughtery Dickinson, Executive Editor of Same-Day Surgery, contributed information to this story. To see the final guidance, go to http://1.usa.gov/1L2Gi0H. For information about why the devices haven’t been removed from the market, see story in this issue. For more information on duodenoscopes, see “FDA says to inform patients about risk of endoscopy linked to CRE infections,” April SDS, p. 45. )
• ECRI Institute CRE and Duodenoscope Resource Center. There is no charge to use this resource. Web: http://bit.ly/1EhdkDF.