December 17, 2019

FDA approves first fully disposable duodenoscope

Daily Briefing

    FDA on Friday approved the first fully disposable duodenoscope, which is designed to eliminate the potential risk of infection that is tied to reusable scopes. 

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    Background

    Scopes help physicians inspect the digestive tract, respiratory system, and other areas of the body without resorting to surgery. However, the reusable scopes can be a vector for infection. To clean reusable scopes, which contain sensitive equipment such as lights and cameras, health care providers must use disinfectants and carefully brush and wash the products.

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    But some pathogens make it through the cleaning process. FDA in 2013 learned about a potential link between multi-drug resistant bacteria and reusable scopes—even those that were properly sterilized and disinfected based on the instructions from manufacturers. According to FDA, as many as 350 patients at 41 medical facilities across the globe were infected by or exposed to contaminated gastrointestinal scopes between 2010 and 2015. Contaminated scopes killed at least 35 patients in the United States from 2013 to January 2017.

    FDA in 2013 started to collaborate with duodenoscope manufacturers FujifilmOlympus, and Pentax to address contamination risks. In 2015, the agency ordered the companies to conduct post-market surveillance studies to assess whether health care professionals can properly clean and disinfect duodenoscopes. FDA also ordered the companies to evaluate whether hospital professionals are adequately trained to follow reprocessing instructions.

    In addition, FDA in August 2019 issued a safety statement that advised health care facilities and manufacturers to transition to duodenoscopes with disposable endcap components to help reduce the spread of infection between patients.

    FDA approves fully disposable duodenoscope

    FDA on Friday approved Boston Scientific's fully disposable scope, called Exalt, as a single-use product designed for providers to view and access the upper gastrointestinal tract. According to FDA, Exalt is designed to function in the same manner as a traditional scope, but it carries a lower risk of infection because the device is intended to be discarded or recycled after one use.

    FDA granted Exalt a "breakthrough" device designation and worked closely with Boston Scientific to ensure the device is efficient and to expedite evidence showing the device's efficacy and safety, as well as to expedite FDA's review of the device. FDA noted that, to qualify for the breakthrough designation, the "device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients."

    According to the New York Times, six experts who used the disposable scope in a clinical trial involving 60 patients rated the device as satisfactory. A significant majority, 90%, of those experts said the disposable scope was as good as the reusable scope, the Times reports. However, just 2 % of the experts said they preferred the disposable scope over the reusable scope, and 8% rated the disposable scope as inferior to reusable scopes, according to the Times.

    Jeff Shuren, director of FDA's Center for Devices and Radiological Health, said, "Unlike duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn't need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing." He added, "The availability of a fully disposable duodenoscope represents another major step forward for improving the safety of these devices, which are used in more than 500,000 procedures in the U.S. each year."

    But that does not mean the device is without risks. FDA said the disposable device still carries risks of potential injuries, such as bleeding, burns, electric shock, and perforation. The device also does carry some risk of infection, FDA said.

    Device's future unclear

    Boston Scientific said it is planning a limited release of Exalt during the first quarter of 2020, but it remains unclear whether the new disposable scope will be widely adopted by health care providers, the Times reports. Exalt is expected to cost $3,000, and it is not certain whether insurers will cover the device, according to the Times. Health care systems already have a full inventory of durable, reusable scopes with disposable parts, which cost between $35,000 and $45,000, the Times reports.

    Further, the disposable scope could be a new source of medical waste if the device cannot be recycled, according to the Times. However, a Boston Scientific spokesperson said the company has planned to offer a recycling program for the device and is "currently finalizing plans with a medical waste recycle company to facilitate this process" (Caryn Rabin, New York Times, 12/13; Hale, FierceBiotech, 12/13; Mundell, U.S. News & World Report/HealthDay, 12/13; FDA release, 12/13).

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