Effective reprocessing of reusable endoscopes after surgery allows the device to be safely used for other patients. However, failure to maintain the endoscope properly or reprocessing it after use may result in the transfer of pathogens from patient to patient through the device. Bronchoscope is one of the devices with greater risk of microbial transmission recognized by the FDA.
In June, the FDA updated its recommendations based on 867 reports it received between July 2015 and January 2021. These reports describe infections or equipment contamination associated with reusable flexible bronchoscopes. There were seven reports of deaths. It is not clear whether the pathogen transferred through bronchoscopy is related to death, but "a patient participated in a multi-drug resistance cluster, of which bronchoscopy was determined to be common."
Boston Scientific has brought its EXALT D type disposable duodenoscope to the market and has obtained a license to sell a device that eliminates the risk of cross-contamination. EXALT B disposable bronchoscope is a disposable device designed for bedside surgery, such as secretion management, airway intubation and biopsy in intensive care units and operating rooms.
According to data from Boston Scientific, more than 1.2 million bedside surgeries involving bronchoscopy are performed each year in the United States. The FDA created a tailwind for manufacturers’ efforts to convert procedures to disposable devices in June. At that time, it advised healthcare providers to consider using disposable bronchoscopes, “when the risk of infection transmission increases or does not support immediate bronchoscopy In the case of processing."
Boston Scientific sees a huge opportunity. "We will launch bronchoscopy in the second half of 2021, and we believe this will be a good $2 billion market for us," CEO Michael Mahoney told investors on a conference call in February.
Mahoney predicts that bronchoscopy will “follow a pre-COVID path very similar to our urological scopes and our telescopes and endoscopes.” In the same conference call, Mahoney stated that the number of Spyglass Discover that has been cleared in 2020 The introduction of the catheter is progressing smoothly.
COVID-19 has hindered the launch of disposable duodenoscopes because Boston Scientific’s sales team lacked the physician access rights needed to support the conversion from reusable devices to disposable devices. The situation has improved in the past two quarters, and Mahoney described "rising and traction" last month, indicating that EXALT Model B will enter a more favorable environment.
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The setback did not remove the obstacles faced by competitors in catching up with market leader Intuitive's Da Vinci, which was two decades ahead.
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AdvaMed believes that the percentage of blacks holding leadership positions in equipment companies has more than doubled since 2015, from 1.3% to 3.2%. However, none of the largest medical technology companies currently has a CEO of color.
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The setback did not remove the obstacles faced by competitors in catching up with market leader Intuitive's Da Vinci, which was two decades ahead.
Photo by Fauxels (Studio) on Pexels
AdvaMed believes that the percentage of blacks holding leadership positions in equipment companies has more than doubled since 2015, from 1.3% to 3.2%. However, none of the largest medical technology companies currently has a CEO of color.
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