Drug resistant bacteria versus advanced medical technology: No contest
The duodenoscope implicated now in several deadly outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) is an otherwise terrific device for management of biliary or pancreatic duct disorders. Unfortunately, the same features that allow the scope to guide fine instruments into miniscule spaces also provide sanctuary for bacterial pathogens, protecting them from all standard approaches to disinfection. To quote yesterday’s FDA safety communication:
“…reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.”
Translation: you pays your money and you takes your chances.
There aren’t any great options for further reducing the (albeit small) risk for infection transmission from these devices. Some hospitals that have experienced outbreaks have switched to ethylene oxide gas, which is time-consuming and may still fail if organic debris remains in the tiny spaces that are so difficult to clean mechanically. Microbiological surveillance (culturing scopes after disinfection) is time-consuming, costly, and has unknown sensitivity for detection of transmission risk.
This problem is just one example of the limitations that antimicrobial resistance and infection control practice place on advanced healthcare delivery. Each year we see advances in our ability to provide life-saving care—but each of these advances can be easily circumvented by a simple lapse in infection control practice, or an untreatable bacterial pathogen.
As for this particular device, there must be a safer approach that doesn’t sacrifice utility. In a world where you can buy a robot hat-backpack that feeds you tomatoes while you jog, there must be a way to design a duodenoscope that can be effectively cleaned.
It would be interesting to see the wordings in the Consent documents that patients sign before undergoing ERCP. Do they differ from those for plain upper endoscopy in regard to hazards of post-procedure infection?
ReplyDeletewould we get on an airplane if it was unsafe as these duodenoscopes? They need to be clean or they shouldn't be used.
ReplyDeleteIt is safe to assume that benign transmission of bacteria has been occurring for years with these scopes, but CRE has provided us with an easily detectable and recognizable pathogen marker to demonstrate this transmission. I agree Dan, that scopes need to be redesigned to facilitate better cleaning and disinfection (or sterilization).
ReplyDeleteI think scopes should not only be redesigned but the cleaning process should be constantly reviewed. This will ensure that we are always ahead of these superbugs!
ReplyDeleteBy the way, would it be naive to suggest that future scopes be made of disposable single use parts?