endoscopic retrograde cholangiopancreatography duodenoscope ERCP

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The FDA announced new guidelines in order to prevent the transmission of infectious disease from reusable medical devices, like endoscopes. This follows the need to improve safety after a recent outbreak of drug-resistant bacteria transmitted from an endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope.

“As part of its regulatory review for reusable medical devices, the FDA reviews the manufacturer’s reprocessing instructions to determine whether they are appropriate and able to be understood and followed by end users,” the FDA said in a statement. “The guidance also recommends that manufacturers consider reprocessing challenges early in device design.”

The duodenoscopes is used in roughly half a million procedures in the U.S. annually. While most reusable devices are thoroughly tested and label to ensure patients are not inadvertently exposed to dangerous pathogens, the complex designs of some devices make it difficult to remove all possible contaminants.

“A device manufacturer’s reprocessing instructions are critical to protect patients against the spread of infections,” FDA explained in an accompanying press statement. “The guidance lists six criteria that should be addressed in the instructions for use with every reusable device to ensure users understand and correctly follow the reprocessing instructions.”

Those criteria are:

  • 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.

Ultimately, the device disinfection and sterilization process will now require further validation in order to ensure quality control.

About the FDA
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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