Will Disposable Caps Solve Dirty Scope Problem?

When it comes to the medical field, everyone is searching for those ‘silver bullet’ solutions that offer repeatable, consistent success and reduces operating expenses. Some of the most expensive tools and procedures are often the most conclusive when it comes to diagnosis. No one wants to accept a drop in performance, so the search for reusable medical devices continues. The most significant hurdle in this field of research is finding ways to reduce the infection risk, but the FDA and federal government believe they might have found a new solution in disposable caps for duodenoscopes.

What is a Duodenoscope and Why do They present an Infection Risk?

A duodenoscope is a flexible, lighted tube that is used to thread into the mouth, down the throat, into the stomach, and into the top of the small intestine. These tubes are used during a procedure called endoscopic retrograde cholangiopancreatography (ERCP). ERCP is a potentially life-saving treatment used to diagnose and treat issues in the pancreas and bile ducts. In the United States alone, there are more than 500,000 of these performed every year.

Because of the route these tubes travel, they prevent a high risk of infection even when they are cleaned before reuse. To someone with a compromised immune system, an infection from a procedure like this could become fatal. Duodenoscopes are complicated instruments and have many tiny moving parts. This makes it difficult to clean and guarantee disinfection.

What is the FDA Doing to Address this Public Health Risk?

The food and drug administration (FDA) takes infection control extremely seriously and has ordered multiple studies across the entire industry to figure out how widespread sources of infection like this are and how they can be addressed. If not thoroughly cleaned, duodenoscopes can spread infection from one patient to another.

In the fall of 2013, the CDC released findings that there was a likely connection between a multi-drug resistant form of bacteria and duodenoscopes. Upon investigation, the FDA discovered that these infections were occurring even when the proper cleaning and sterilization regulations were being followed.

To address these dangers, the FDA has looked for new ways of making the cleaning process more thorough and easier to perform. In 2017, they cleared the first of a new approach to the sterilization process: disposable distal caps for duodenoscopes. The motivation for these new caps is to provide easier access for in-depth cleaning and reprocessing.

“We believe the new disposable distal caps represents a major step towards lowering the risk of future infections associated with these devices,” said William Maisel, MD, acting director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health.

If the disposable caps prove effective, the philosophy behind them could be used to help clean other scope medical devices. These new caps are just one phase of the FDA’s efforts to reduce the risk of infection. Representatives from multiple health care facilities have met and implemented other strategies including: