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Superbug Outbreak Prompts FDA to Issue New Rules for Cleaning Medical Scopes

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In response to 2 patient deaths and nearly 200 potential infections at the Ronald Reagan UCLA Medical Center, the U.S. Food & Drug Administration (FDA) has updated its guidelines for sanitizing the medical scopes suspected to have passed the CRE superbug.

Update: PENTAX Updates Duodenoscope Cleaning Instructions

February 19, 2016 – Following multiple reports of drug resistant bacteria linked to endoscopes used for ERCP procedures, PENTAX Medical has been working with the FDA to validate the reprocessing procedures for the ED-3490TK Video Duodenoscope. These instructions include new procedures for cleaning, high level disinfection and sterilization.

What’s the Problem?

Under the FDA’s new requirements, medical device manufacturers will be expected “to conduct validation testing to show with a high degree of assurance that their cleaning and disinfection or sterilization instructions will consistently reduce microbial contamination.”

The regulations were updated in response to multiple outbreaks of the superbug carbapenem-resistant enterobacteriaceae, or CRE, which is suspected to have been passed via contaminated duodenoscopes. In the announcement, Dr. William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health, said the new guidelines were a step toward full transparency between device manufacturers and the healthcare community. “Doing so should provide greater assurance to patients that the devices used on them are safe and effective,” Maisel said.

The new guidelines specify 6 criteria manufacturers should follow when reusing medical devices to reduce the risk of infections:

  • Labeling should reflect the intended use of the device
  • Reprocessing instructions for reusable devices should advise users to thoroughly clean the device
  • Reprocessing instructions should indicate the appropriate microbicidal process for the device
  • Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed
  • Reprocessing instructions should be comprehensive
  • Reprocessing instructions should be understandable

Since the superbug outbreak at UCLA in January, other facilities around the country have reported CRE infections. On March 4, Cedars-Sinai Medical Center in LA announced that 4 of its patients had been infected following endoscopic procedures that involved use of duodenoscopes. The same day, Hartford Hospital in Connecticut announced that 281 patients may have been exposed to a strain of E. coli through various procedures.

Olympus Issues New Reprocessing Instructions for Duodenoscopes

March 26 – Olympus Corp. has provided customers with new instructions for sanitizing the duodenoscopes linked to the CRE outbreaks. FDA said it is reviewing Olympus’ new guidelines as part of a broader evaluation of the duodenoscope.

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