FDA updates duodenoscope surveillance protocols

Published: 27-Feb-2018
Regulatory

The US Food and Drug Administration will host a webinar in March focusing on new voluntary duodenoscope reprocessing protocols

The US Food and Drug Administration (FDA) has announced the availability of voluntary, standardised duodenoscope surveillance sampling and culturing protocols. The Centers for Disease Control and Prevention (CDC) and American Society for Microbiology (ASM) along with other endoscope culturing experts are backing the initiative.

These protocols are an update to the Interim Duodenoscope Surveillance Protocol released by CDC in March 2015.

Hospitals and health care facilities that use duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take these additional steps to further reduce the risk of infection and increase the safety of these medical devices.

Duodenoscopes are flexible, lighted tubes that are used to treat patients undergoing endoscopic retrograde cholangiopancreatography (ECRP). These procedures often are life-saving and are the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions.

Disinfection procedure

More than 500,000 ERCPs are performed each year in the United States. Duodenoscopes undergo a multi-step cleaning and high-level disinfection procedure called reprocessing so that they can be reused between patients. However, the complex design of duodenoscopes makes it difficult to remove contaminants compared to other types of endoscopes. If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient. In rare cases, this can lead to patient-to-patient infection.

Microbiological sampling and culturing of duodenoscopes involves sampling duodenoscope channels as well as the distal end of the endoscope and then culturing those samples with the goal of detecting bacterial contamination that may be present on the duodenoscope after reprocessing.

The FDA, CDC, ASM and other endoscope culturing experts will meet in a webinar (March 22, 2018) from 1-2:30pm (Eastern Time) to learn more about the voluntary duodenoscope surveillance sampling and culturing protocols.

The webinar has been designed to help facilities monitor the quality of their reprocessing procedures.

  • Companies:
  • US Food and Drug Administration (FDA)
  • Centers for Disease Control and Prevention
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