FDA issues warning about scopes linked to superbug outbreak

Not long after news broke of two patient deaths linked to an outbreak of antibiotic-resistant bacteria Carbapenem-resistant Enterobacteriaceae (CRE) at a California hospital, the Food and Drug Administration on Thursday issued a warning that the design of a specialized endoscope may impede effective cleaning.

The outbreak at UCLA's Ronald Reagan Medical Center, which officials say may have affected as many as 179 patients, is the latest in a string of recent CRE outbreaks linked to duodenoscopes, which are used in endoscopic retrograde cholangiopancreatograph (ERCP) procedures performed on patients with digestive system disorders, gallstones and certain types of cancers. Despite the hospital's efforts to sanitize the duodenoscopes in accordance with manufacturer guidelines, the "nightmare bacteria" CRE remained a contamination threat, FierceHealthcare reported, leading some to call for stricter government regulations regarding use of the scopes in ERCP procedures.

The FDA responded with a new set of guidelines for healthcare staff that describe how to properly reprocess reusable duodenoscopes. It also issued the following recommendations tailored specifically for healthcare providers: 

  • Inform patients of the benefits and risks associated with ERCP procedures.
  • Discuss with your patients what they should expect following the ERCP procedure and what symptoms should prompt additional follow-up.
  • Consider taking a duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP, and you suspect that there may be a link between the duodenoscope and the infection.
  • Submit a report to the manufacturer and to the FDA via MedWatch if you suspect that problems with reprocessing a duodenoscope have led to patient infections.

The FDA's warning is in sharp contrast to its response to the previous outbreaks, which occurred in Seattle, Chicago and Pittsburgh hospitals. While the agency emphasized it was monitoring the situation, it stopped short of issuing a warning about or recall of duodenoscopes, FierceHealthcare previously reported.

There also may have been a CRE outbreak in a Philadelphia hospital last year, CBS Philly reported, citing a Philadelphia Department of Health document that the station says does not reveal the name of the hospital. The outbreak infected eight people, and two patients with underlying conditions died, according to the news outlet.

In spite of the concern surrounding recent outbreaks, CRE poses little threat to the public at large, David Perlin, an infectious disease scientist and executive director of the Public Health Research Institute at Rutgers, told National Public Radio. "It's not something that is likely to spread around the community or is a cause for alarm," he said.

But a CNN report emphasizes that patients who are scheduled to have a procedure that involves a duodenoscope should talk with their doctors about the FDA's warning and about what steps the hospital takes to disinfect the scopes--and if necessary remind their providers that the manufacturer's sterilization guidelines may not be enough.

This recommendation echoes an L.A. Times report that one UCLA patient's family blames the duodenoscope manufacturer--not the hospital--for their 18-year-old son's CRE infection in October. The hospital also told the newspaper it has had no new infections since it switched to using a process known as gas sterilization for its duodenoscopes.

The recent CRE outbreaks comes amid growing concern among world leaders and public health officials about the threat of antibiotic-resistant superbugs. Two recent reports backed by the British government predicted these superbugs could cause 10 million deaths a year and cost $100 trillion per year by 2050, and called for a global innovation fund to power research and prevention, while President Barack Obama's recent budget proposal called for $1.2 billion to fight antibiotic resistance, FierceHealthcare has reported. 

To learn more:
- here's the FDA warning
- read the CBS Philly report
- check out the CNN report
- read the L.A. Times article