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Friday 15 Nov 2019 , 11:53 am

New Innovations to Derange the Duodenoscope Market, Making it Safer

Duodenoscopes that are used in ERCP procedures are difficult to clean as it contain many small particles of diseases if not cleaned and disinfected properly. Though the benefits of the device are much higher than the risks, disposable Duodenoscopes are disrupting the market.
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Three patients’ died and 45 were infected between October 2018 and March 2019, due to inadequate reprocessing of duodenoscopes. This data was revealed in U.S. Food and Drug Administration (FDA) analysis of medical device report that was published earlier this year. The report also had a mention of 159 cases of device contamination.

ED34-i10T is a HD+ Duodenoscope (Source: Pentax Medical)

Even though the risks remain high, the benefits of the device outweigh them. In a statement, FDA said, “While the risk of infection transmission cannot be completely eliminated, the benefits of these devices continue to outweigh the risks in appropriately selected patients.” Recently duodenoscope manufacturers Fujifilm, Pentax, and Olympus tested the device at the FDA’s behest and found that one in 20 duodenoscopes retained particles of diseases such as E. coli and pseudomonas aeruginosa.

Duodenoscopes are used to diagnose and treat problems in the pancreas and bile ducts during the process, endoscopic retrograde cholangiopancreatography (ERCP). These are very difficult to clean and if not disinfected properly, tissue or fluid from one patient can remain in it and transmit infection.

To prevent any death or mishap in future, it is crucial to develop more rigorous cleaning/disinfection processes. The process must include implementation of standardized cleaning process, assessment after cleaning, accurate disinfection or sterilization, proper attention for drying and storage, surveillance to assess germ levels after disinfection or sterilization.

Another option to reduce the risk of serious cross-contaminations is to opt for single-use duodenoscopes. Danish medical device manufacturer, Ambu is planning to bring single-use devices. Not just Ambu but other manufactures are also in the research. Recently, Boston Scientific completed clinical trial assessing the performance of its single-use duodenoscope named EXALT Model D during ERCP and presented its positive results at the United European Gastroenterology Week Congress.

So, this is a clear indication that the market of these single use duodenoscope will create competition in coming years. Disposable duodenoscopes will rule the market in the coming years, but the concern is that re-usable duodenoscopes have approximate $150m market globally and the need right now is to dispose these.

In the US, more than 500,000 duodenoscopes are used in ERCP procedures per year. One duodenoscope with annual maintenance costs $1,451 per scope and it last for about three years. Many hospitals have invested huge amount in re-usable duodenoscopes and it is still a question on how quickly surgeons will be able to use disposable duodenoscopes. Having said that, the transition to disposable duodenoscope will surely be cost-effective, but may lack eco-friendly credentials. After all considerations, it is mandatory for healthcare specialists to ensure safety and benefits for a patient’s health.

FDA—in its safety communication—recommends patients to discuss the benefits and risks of procedures using duodenoscopes with physician. Also, it is must to ask a doctor what to expect following the procedure and when to seek medical attention. While following ERCP, many patients may experience mild symptoms such as a sore throat or mild abdominal discomfort. It’s mandatory to call a doctor if, after a procedure patient has a fever or chills, or other symptoms that may be a sign of a more serious problem.

Neha Mule

Neha writes articles on sectors including medicine, food, materials, and science & technology. A qualified statistician, she has the ability to observe and analyze the trends in global markets and write compelling articles that help CXOs in decision making. She is a bookworm and loves to read fiction, lifestyle, science and technology. Neha comes with 6 years of experience in content writing and editing that involves blog writing, preparation of study materials and OERs.

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