The FDA is Recommending Transition to Duodenoscopes with Innovative Designs, including designs with disposable caps or distal ends.

Update as of April 10, 2020: The FDA continues to recommend that hospitals and endoscopy facilities transition to innovative duodenoscope designs to help improve cleaning and reduce contamination between patients, including designs with disposable caps or distal ends. When using these innovative duodenoscopes, remember to follow the manufacturer’s instructions for the assembly of the caps and distal ends. The FDA is not aware of any patient injuries related to these innovative duodenoscope designs. However the manufacturers, Fujifilm, Pentax and Olympus have in total submitted 10 reports of device malfunctions, such as removable caps or ends falling off during endoscopic retrograde cholangiopancreatography (ERCP). Of these device malfunctions, only three occurred with models that are marketed in the United States.

Duodenoscopes play a vital role in the assessment and treatment of diseases and conditions of the pancreas and bile ducts, and are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures each year in the U.S. These devices have complex designs that include reusable hard-to-clean components. Failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient remaining in a duodenoscope when it is used on a subsequent patient. In rare cases, this can lead to patient-to-patient disease transmission.

The FDA takes the risk of patient infection very seriously and continues to take steps to help improve the effectiveness of duodenoscope reprocessing.

Patients: Important Recommendations

• Be aware that the risk of infection from inadequate reprocessing is relatively low.
• Do not cancel or delay any planned procedure without first discussing the benefits and risks with your health care provider.

Hospitals and Endoscopy Facilities: Important Recommendations

• Consider using duodenoscopes that have disposable components, if available at your facility; this design may lower but not eliminate risks of infection. When you do use them, carefully follow the manufacturer’s instructions for the assembly of the caps and distal ends.
• Ensure staff are meticulously following reprocessing instructions.
• Institute a quality control program that includes sampling and microbiological culturing, and other monitoring methods.
• Consider reprocessing with supplemental measures such as sterilization or use of a liquid chemical sterilant processing system consistent with the device’s labeling.
• Monitor your reprocessing procedures. Examples of monitoring are sampling and culturing using the Duodenoscope Surveillance Sampling & Culturing: Reducing the Risks of Infection developed by the FDA-Centers for Disease Control and Prevention-American Society of Microbiology Working Group on Duodenoscope Culturing.
• Develop schedules for routine inspection and periodic maintenance in accordance with the duodenoscope manufacturer’s instructions.

More to read at :https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication#disposable