Last week, FDA warned healthcare providers that the complex design of a piece of endoscopy eqiupment may make it hard to fully disinfect — which means that using it, even in accordance with the manufacturers’ instructions, might allow dangerous bacteria to spread between patients. The warning follows reports of seven patients from UCLA’s Ronald Reagan Medical Center becoming infected with the drug-resistant “nightmare bacteria” CRE (Carbapenem-Resistant Enterobacteriaceae) after undergoing procedures using ERCP endoscopes, or duodenoscopes. Of these seven patients, two died, and “the infection was a contributing factor in the death of two patients,” UCLA said in a statement. The health system notified 179 patients that they may have been exposed to CRE bacteria during diagnostic or treatment procedures performed between October 3rd and January 28th, and offered free home testing kits to see if they are infected.
In a piece for National Geographic’s Phenomena, Maryn McKenna notes that the UCLA episode follows outbreaks in other states, and that the weeks or months that can elapse between patients’ exposures and infection symptoms can make it hard to stop outbreaks quickly. She also interviewed CDC medical epidemiologist Dr. Alexander J. Kallen, who highlighted these alarming aspects of recent duodenoscope-associated CRE outbreaks (emphasis added):
… the outbreak we investigated in Illinois in 2013, which we reported in the Journal of the American Medical Association, is the first time that we know of where there was transmission of a highly resistant pathogen, from a scope, unrelated to an infection-control breach. You almost always see that someone forgot this step or that step. But in these last three outbreaks, there was persistent contamination despite not identifying a breach, and that is fundamentally different. It starts to raise the suspicion this is more a fundamental issue with these types of scopes, rather than just failures to adhere to recommendations for cleaning.
It appears that UCLA followed the FDA-validated disinfection instructions for the scopes, but two of the facility’s seven scopes harbored CRE bacteria anyway. Kallen also told McKenna that certain cleaning procedures might work to disinfect new equipment during FDA’s lab tests, but the same procedures might not be sufficient with older equipment as used and cleaned in practice. In any case, it’s a frigthening thought that a facility’s staff can do exactly what they’re supposed to do, but their patients can still end up with fatal infections.
FDA has recommendations for facilities, staff, and healthcare providers — and also for patients. “Discuss the benefits and risks of procedures using duodenoscopes with your physician,” the FDA Safety Communication suggests. “For most patients, the benefits of ERCP outweigh the risks of infection. ERCP often treats life-threatening conditions that can lead to serious health consequences if not addressed.”
As McKenna warned in her excellent and terrifying Medium piece “Imagining the Post-Antibiotics Future,” the spread of antibiotic-resistant bacteria means that medical procedures that are routine today, from dialysis to hip replacements, could become far more likely to result in fatal infections. FDA reports that US healthcare providers perform more than 500,000 ERCP procedures using duodenoscopes each year, because these are procedures are “the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions.” If cases of duodenoscope-linked CRE infections keep mounting, though, patients and providers might have to start rethinking treatments.
In his FY 2016 budget, President Obama has proposed a $1.2 billion federal investment in combating and preventing antibiotic resistance. That seems like reasonable sum to spend on something that could let us slow the arrival of the post-antibiotics future.