In light of the recent outbreak of the CRE superbug at the California hospital the FDA has issued a warning regarding the use of the suspect endoscope which is used in the procedure that seems to be the source of the infection.
The hospital reports that as many as 179 patients may have been exposed during the exams that utilized the duodenoscopes. The exam is used on patients with digestive system problems, including gallstone and specific cancers. There have been two deaths reported by this hospital.
The FDA warning addresses proper methods of sterilizing the scopes. It also recommends discussing the risks of the procedure with the patient in light of recent events. Their recommendations are as follows:
The hospital reports that as many as 179 patients may have been exposed during the exams that utilized the duodenoscopes. The exam is used on patients with digestive system problems, including gallstone and specific cancers. There have been two deaths reported by this hospital.
The FDA warning addresses proper methods of sterilizing the scopes. It also recommends discussing the risks of the procedure with the patient in light of recent events. Their recommendations are as follows:
- 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 infection.
There may also have been an outbreak of the superbug infection in a Philadelphia hospital last year where a total of eight patients were infected and two died.
UCLA has addressed the sterilization techniques used and have switched to a gas sterilization system to be used in the future. The FDA stresses that this infection is not a threat outside of the hospital setting. However, the spread of "superbugs" is a global concern and a British government report warns that 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 superbugs."
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 superbugs."
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