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 info@iccs-home.com.
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