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FDA Safety Advisory to Facilities April 12

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https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm635828.htm

Worth reading in its entirely... But these notes are especially important:

"Audience:

• Users and reprocessors of duodenoscopes including:
  • Gastroenterologists
  • Gastrointestinal surgeons
  • Endoscopy nurses
  • Staff working in endoscopy reprocessing units in health care facilities
  • Infection control practitioners
  • Personnel conducting endoscope culturing (e.g., clinical diagnostic and laboratory staff)
  • Facility risk managers
• Patients considering Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures

 

• Be aware that FDA has previously issued a Safety Communication and provided a detailed list of supplemental duodenoscope reprocessing measures that can be implemented to reduce the risk of infection transmission, such as: microbiological culturing, sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection. Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices.

  Information for Patients

  You may be aware of incidents where inadequately reprocessed reusable medical devices were used on patients. The risk of infection from inadequate reprocessing is relatively low, and the FDA recommends that you do not cancel or delay any planned procedure without first discussing the benefits and risks with your health care professional.

  Before you have a medical procedure, it is always a good idea to learn more about the procedure and steps the health care facility takes to keep patients safe.

• The FDA is actively working with reprocessing experts, medical device manufacturers, and other government agencies to advance innovative ways to decrease infection related to duodenoscopes.

  In May 2019, the FDA plans to engage the infection control community at the Healthcare Infection Control Practices Advisory Committee (HICPAC) meeting to update the public on the FDA's work and engagement and seek input on improving the safety of reprocessed devices."