Earlier this year, "superbugs" made national headlines following several outbreaks of infections linked to duodenoscopes used during ERCP. Here are 13 things for gastroenterologists to know about antibiotic resistant infections in the healthcare industry.
1. Antibiotic resistant infections, commonly referred to as superbugs, are infectious organisms that have adapted to commonly used antibiotics, according to the CDC. Annually, approximately 2 million become infected with antibiotic resistant bacteria, and 23,000 of these people die as a result.
2. The CDC ranked the top 18 drug-resistant threats in 2013, and categorized these threats.
1. Clostridium difficile
2. Carbapenem-resistant Enterobacteria
3. Neisseria gonorrhoeae
4. Multidrug-resistant Acinetobacter
5. Drug-resistant Campylobacter
6. Fluconazole-resistant Candida
7. Extended spectrum Enterobacteriaceae
8. Vancomycin-resistant Enterococcus
9. Multidrug-resistant Pseudomonas aeruginosa
10. Drug-resistant non-typhoidal Salmonella
11. Drug-resistant Salmonella Serotype Typhi
12. Drug-resistant Shigella
13. Methicillin-resistant Staphylococcus aureus (MRSA)
14. Drug-resistant Streptococcus pneumoniae
15. Drug-resistant tuberculosis
16. Vancomycin-resistant Staphylococcus aureus
17. 17. Erythromycin-resistant Group A Streptococcus
18. 18. Clindamycin-resistant Group B Streptococcus
3. The CDC's two top-ranked drug-resistant threats are a common concern in the GI field. C. difficile, spore-forming, Gram-positive anaerobic bacillus, causes life-threatening diarrhea, and potentially sepsis. There are nearly half a million CDI infections per year and 15,000 deaths. CDIs result in excess of $1 billion in medical costs each year. The first line of treatment for mild to moderate CDI is typically metronidazole. Severe CDI is generally treated with vancomycin, according to the American College of Gastroenterology.
4. Fecal micriobiota transplantation is increasingly used for the treatment of refractory CDI. Major health systems, such as Mayo Clinic in Rochester, Minn., and Cleveland Clinic, are now offering FMT programs. Last year, researchers opened OpenBiome, a nonprofit stool bank that prepares fecal samples for use in FMT.
5. CRE, the CDC's second highest ranked drug-resistant threat, are a family of bacteria with high levels of antibiotic resistance. Species of Klebsiella and Escherichia coli are part of the CRE family. There are approximately 7,900 CRE Klebsiella infections and 1,400 CRE E. coli infections per year. CRE infection can contribute to death in up to half of patients who become infected. CRE have become resistant to nearly all available antibiotics.
6. Earlier this year, there was a rash of CRE outbreaks at several medical centers. Ronald Reagan UCLA Medical Center in Los Angeles discovered an outbreak in January and began to notify 179 patients who could have been exposed to CRE from October to January. Of seven patients infected, two died.
7. Shortly after the UCLA Medical Center news broke, Cedars-Sinai Medical Center in Los Angles reported four patients had contracted CRE. Both the UCLA and Cedars-Sinai outbreaks were linked to duodenoscopes used to perform ERCPs. The same scope was used on the four Cedars-Sinai patients between August 2014 and January 2015.
8. UCLA Medical Center and Cedars-Sinai were not the first hospital to report superbug infections linked to duodenoscopes. At least 35 patients at Virginia Mason Medical Center in Seattle fell ill from infections linked back to ERCP scopes used between 2012 and 2014.
9. The FDA released a safety communication shortly after this year's outbreaks. The communication addressed the concerns that the design of duodenoscopes was responsible for the outbreaks. The FDA stated "the complex design of ERCP endoscopes may impede effective reprocessing."
10. FUJIFILM, Olympus and Pentax all manufacture the scopes in question. Olympus faces lawsuits from a UCLA patient infected with CRE and Virginia Mason Medical Center. Shortly after the news of the outbreaks, it was uncovered that the Olympus duodenoscope model TJF-Q180V does not have FDA 510(k) clearance. The device now has a pending 510(k) application, and the FDA does not plan to remove the device from the market for fear that such action could lead to a shortage of duodenoscopes. The agency does not believe the lack of 510(k) clearance is associated with infections. Infections have been reported in cases involving all three major manufacturers of duodenoscopes.
11. In the wake of these outbreaks, several organizations have rallied to offer guidelines on reprocessing duodenoscopes. The FDA just released further guidance following its initial safety communication released in February. The ECRI Institute issued its own report on how to minimize the risk of infection. The American Gastroenterological Association Center for GI Innovation held a "Getting to Zero" meeting in regards to infections associated with duodenoscope procedures. The meeting was attended by GI experts, epidemiology and infectious disease experts, as well as representatives from Fujifilm, Pentax, the FDA, CDC and ECRI Institute.
12. Ronald Reagan UCLA Medical Center recently announced it would be testing a new type of scope cleaning machine. The Langford IC Systems cleaning machine has never been used for scopes before, but following the outbreak the company reached out to UCLA and pitched the product. The Langford IC Systems cleaning machine does not require an upfront capital cost from hospitals; rather, the company charges $35 each time it is used.
13. The CDC's proposed $264 million Antibiotic Resistance Solutions Initiative is designed to facilitate action in every state, improve outbreak detection and prevention and improve antibiotic stewardship.