FDA Issues Cleaning Precautions for Duodenoscopes

August 04, 2015

The US Food and Drug Administration (FDA) today recommended four additional steps healthcare facilities can take to clean infection-prone duodenoscopes beyond meticulously following the manufacturer's instructions.

The FDA acknowledged that not every healthcare facility may have the resources and expertise to implement these precautionary measures. It also cautioned that the risk of transmitting an infection with a contaminated duodenoscope cannot be completely eliminated. However, "the benefits of these devices continue to outweigh the risks in appropriately selected patients," the agency said.

The cleaning recommendations arose from a hearing conducted in May by the gastroenterology and urology devices panel of the FDA's Medical Devices Advisory Committee. The agency convened the panel in the wake of at least six outbreaks of infections, some of them multidrug resistant and some lethal, that were attributed to duodenoscopes used in endoscopic retrograde cholangiopancreatography. Some of these outbreaks occurred despite hospitals and other facilities strictly adhering to manufacturers' reprocessing instructions and recommendations from professional organizations. The devices' small, hidden parts make them hard to sterilize.

The FDA suggests implementing one or more of the following measures to minimize the risk of spreading an infection with duodenoscopes:

Microbiological culturing: Here, biological samples from the channels and distal end of the scope are cultured to spot any bacterial contamination that lingers after ordinary reprocessing. Until the results come in, the device is quarantined. Duodenoscopes can be cultured after each reprocessing or at a fixed interval, such as once a month.

Ethylene oxide gas sterilization: This step, which follows routine cleaning and high-level disinfection, does not rely on heat. Accordingly, ethylene oxide gas lends itself to sterilizing heat-sensitive instruments such as duodenoscopes.

Liquid chemical sterilant processing system: Again, such a chemical bath comes after routine cleaning and high-level disinfection. Healthcare facilities should use only liquid chemical sterilant processing systems approved by the FDA.

Repeat high-level disinfection: In this approach, healthcare facilities manually subject a duodenoscope to multiple high-level disinfection cycles, or else run them through an automated endoscope reprocessor. These machines expose outside and inside surfaces to chemical solutions that kill microorganisms.

More information on today's announcement is available on the FDA's website.

To report problems with duodenoscopes, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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