Mar 14, 2015

CRE Contamination of Endoscopes: Florida Facilities Report Infections

By on 8:23 AM

With the recent increase in reports of contamination, infection and several deaths as a result of the "superbug" known as carbapenem-resistant Enterobacteriaceae (CRE), the federal government is taking immediate steps to improve the reprocessing processes of reusable medical devices including endoscopes.

On March 12, the Food and Drug Administration (FDA) released final guidance (pdf) on reprocessing reusable medical devices. This guidance provides manufacturers with recommendations on how to validate their reprocessing instructions to better ensure devices remain safe and effective for reuse.

While the most recent reports about CRE infections are tied to hospitals in California, these issues are happening nationwide, including Florida. On March 3, a Palm Beach Post report stated that "Years before two patients died in Los Angeles from the deadly bacteria known as CRE, at least 22 people had died in Florida from the antibiotic-resistant super germ spread by a widely used medical device." The report goes on to reflect the issues that facilities, including ambulatory surgery centers (ASCs), face when providing endoscopic services to patients.

The Centers for Disease Control and Prevention (CDC) reported that this major outbreak, which occurred in Highlands County, was identified as a "reprocessing lapse or failure to properly clean duodenoscopes."

According to the Florida Health Department, there is no ruling or statute that requires physicians to inform patients that they have CRE or have been exposed to the bacteria.

Facilities, including acute care hospitals and ASCs, should take this increasing threat of the highly resistant CRE issue very seriously. They should ensure that reprocessing technicians are highly skilled and very carefully monitored for compliance as the nation continues to identify more cases of this deadly bacterial threat.

If you have questions about how to maintain compliance and ensure your facility is practicing proper infection prevention measures, contact infection prevention consultant Phenelle Segal, president of Infection Control Consulting Services at (215) 692-3485 or e-mail

Phenelle Segal, RN, CIC, FAPIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS), which is based in Delray Beach, Florida. Phenelle has more than 30 years experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes to implement and maintain an infection control program that: complies with The Joint Commission (TJC), Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies, respond to situations of noncompliance, and improve the processes for reducing risk.


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