Endoscopic Retrograde Cholangiopancreatography (ERCP) duodenoscopes are side-viewing illuminated tubes often used during gastrointestinal endoscopies. They are inserted into the mouth of the patient, down into the stomach, and provide a view of the duodenum just at the top of the intestines. These devices are reusable, but they are complex, increasing the risk that certain parts of the device are not adequately cleaned between uses.The complexity of duodenoscopes makes cleaning difficult. In the healthcare world, Automated Endoscope Reprocessors (AERs) are often used to decontaminate items such as the duodenoscope, but due to the complex design of duodenoscopes, cleaning is made more difficult. According to a new U.S. Food and Drug Administration (FDA) notice, healthcare facilities are recommended to stop using certain AERs for the purpose of reprocessing a duodenoscope.
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How ERCP Duodenoscopes are Dangerous
Because of the complexity of duodenoscopes’ design and the difficulty in cleaning, there has been potential links to infections after use. The FDA details that certain AERs should not be used to clean ERCP duodenoscopes.
The FDA recommends that healthcare facilities take the following actions:
- Identify an alternative reprocessor and transition accordingly
- Manually clean ERCP duodenoscopes per manufacturer instructions
- Ensure compatibility between new reprocessing method and duodenoscopes in the facility
- Implement and monitor program training and adherence, including documentation on tests, processes, equipment, and quality monitors used
- Ensure staff understands the importance of their role in making sure program is enforced
Injured After Use of a Duodenoscope?
If you were injured due to infection or if you lost your loved one because of an infection caused by an improperly cleaned device, you may be able to take legal action. At Peterson & Associates, P.C., our team of Kansas City defective medical device attorneys has the skill and insight necessary to represent clients in a wide range of matters. We know that when a medical product is defective and harms someone else, the manufacturer should be responsible for any injuries the party has suffered. You may be able to seek compensation.
Call our firm today at 816-888-8888 to discuss your potential case.