The Federal Food and Drug Administration (FDA) issued final rules regarding the cleaning and disinfecting of endoscopes and duodenoscopes which have been linked to the Carbapenem resistant enterobacteriaceae (CRE) infections throughout the United States. The FDA endoscope guidance addressed the manufacturers of the instruments will now be required to validate their recommended sanitizing instructions prior to obtaining approval by the FDA. Medical professionals are also advised to routinely check the instruments to ensure the instruments have been properly disinfected.
What Is The FDA Endoscope Guidance?
The new instructions from the FDA are in response to the superbug CRE which was linked to contaminated duodenoscopes in Los Angeles and recent outbreaks throughout the United States of CRE and antibiotic resistant bugs. CRE can be transmitted person to person, travel instrument to person or remain alive on hard surfaces and contaminate those who come in contact with CRE. The FDA endoscope guidance is to ensure the medical instruments are properly disinfected by medical professionals. The FDA endoscope guidance also seeks to ensure manufactures of the medical devices are providing sanitizing instructions which work.
What Is CRE?
CRE is a gram negative antibiotic resistant bacteria which can be extremely difficult to eradicate due to its resistance to antibiotics. CRE is the most antibiotic resistant due to its’ gram negative structure. MRSA and CDiff are also in the superbug family and while serious are easier to treat due to their gram positive structure.
The name CRE is derived from antibiotic drug class Carbapenem which is known as the drug of last resort when treating serious bacteria infections.
The CRE Outbreak at U.C.L.A.
Patients were exposed to the CRE bug at U.C.L.A. and Cedars Sinai between October 2014 and January 2015. The patients were undergoing procedures using the endoscopic retrograde cholangiopancreatography (ERCP) and involves a duodenoscope. The design of the duodenoscope leaves it susceptible to contamination if the instrument is not properly sanitized. The latest figures involving the Los Angeles outbreak:
- 2 deaths
- 11 infections
- 250 patients exposed to CRE, patients have been notified and offered testing for the CRE superbug
- To date three lawsuits have been filed against Olympus, the manufacturer of the endoscope / duodenoscope
- The Olympus TJF-Q180V Duodenoscope has been used since 2010, but without FDA clearance
The FDA Advisory Committee, Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, will meet May 14 -15, 2015 to review the risk of patients to CRE after an endoscopic retrograde cholangiopancreatography (ERCP) is used.
Recommended Reading:
CRE Exposures In United States
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