Boston Scientific recently announced FDA clearance of EXALT Model B Single-use bronchoscope, intended for bedside procedures in intensive care units or in the operating room. As a single-use device with high-quality imaging and suction capabilities, the bronchoscope is ready to go out of the box, which means it mitigates the risk of infection posed by ineffective reprocessing of the device between patients. In the midst of the COVID-19 pandemic, when healthcare personnel are working hard to prevent viral transmission within healthcare facilities, outreach is likely to be particularly helpful.
Device reprocessing takes time and effort, requiring personnel to handle potentially infectious equipment and the possibility of insufficient treatment to destroy all pathogens. If all devices are related to reprocessing, there is a risk of shortages, which means delayed procedures and side effects on patient outcomes. Single-use devices are available at any time, which means that there is unlikely to be a shortage of oscilloscopes as long as sufficient stock is maintained. While it may not be feasible to use single-use oscilloscopes exclusively, they can form a very useful part of a clinical arsenal, especially during a pandemic.
Medgadget I had the opportunity to speak with Dave Pierce, executive vice president and president of MedSurg and president of endoscopy at Boston Scientific, about the new bronchoscope.
Conn Hastings, Medgadget: Congratulations on receiving FDA clearance for the EXALT B. Please give us an overview of the device and its features.
Dave pierce, Boston Scientific: The EXALT Model B Bronchoscope is a single-use bronchoscope developed as an alternative to reusable bronchoscopes. When designing the device, we prioritized high-quality imaging and superior suction performance, a critical factor in bedside procedures where strong suction is required. The endoscope is designed to provide a sense of familiarity on a single-use platform, eliminating the need to reprocess and repair the endoscope. In speaking with clinicians, we know that having single-use endoscopes in stock is important to ensure that a new, sterile bronchoscope is available and ready to use when needed at the point of care. The simple EXALT Model B setup can also be quickly completed by nurses or technicians who do not require special training.
Medgadget: What kinds of procedures can the device perform? How does the system adapt to the different anatomies of patients?
Dave pierce: The EXALT Model B Bronchoscope can be used for a wide variety of bronchoscopy procedures, including management of secretions, intubation of the airways, percutaneous tracheostomy, placement of double-lumen endotracheal tubes, and biopsies. The three sizes (slim, regular, and large) allow clinicians to use the device in a variety of procedures, care settings, and patient anatomies. For example, the top suction of the oversized EXALT Model B endoscope can be beneficial for patients requiring challenging aspiration of blood clots and management of secretions, the suction capabilities of the regular-size endoscope were designed to support most of bedside ICU procedures and by placing a double lumen tube, the slim-sized endoscope can provide suction that other proven single-use and reusable endoscopes have not.
Medgadget: What inspired you to develop a single-use bronchoscope?
Dave pierce: Our product portfolio is largely influenced by what we see and hear from physicians regarding the largest unmet needs in the industry, and we listen carefully to physicians to ensure that we are addressing those needs as we develop our products. With the EXALT Model B bronchoscope, what we understood from clinicians was the importance of suction and viewing functionality in a single-use device. Suction is one of the main reasons doctors perform bronchoscopy in the ICU, so suction capacity was critical for Model B.
We were pleased that internal bench testing showed that the EXALT Model B has superior suction power compared to proven commercially available single-use and reusable bronchoscopes of comparable sizes. In fact, the EXALT Model B Regular scope demonstrated 78 percent more suction power in the water compared to other 5.0mm scopes. *
Medgadget: Since the device is single use, is it good value for money?
Dave pierce: In addition to the benefit of eliminating the risk of infection due to inefficient reprocessing, single-use devices provide value associated with on-site availability. The intense process of cleaning and disinfecting a reusable endoscope is time consuming, which means that endoscopes that undergo reprocessing are not available for long periods of time. With that being the case, a hospital can only complete a finite number of procedures in a given period of time with its inventory of reusable devices. Procedures can be delayed or further spaced due to the lack of sterile endoscopes available, so there is inherent value in having a new, unused device ready to go at any time. Reusable oscilloscopes also create an operational burden for hospitals, as reprocessing devices immobilizes staff for extended periods of time and requires significant financial and time-consuming investments to properly train and accredit these employees in the process.
Medgadget: In the era of COVID-19, how does the device help protect patients and healthcare personnel from infection?
Dave pierce: The EXALT Model B Bronchoscope does not require reprocessing, eliminating the risk of potential infection caused by ineffective reprocessing, as well as the challenges associated with transporting and maintaining reusable scopes. While the device was in active development prior to COVID-19, the pandemic accelerated its need. Especially in the ICU, where there is already an increased risk of infection and a compelling need to prevent disease transmission in patients who are most at risk, COVID-19 presented an additional safety challenge for medical professionals. The EXALT Model B Single-Use Bronchoscope gives staff and patients confidence by eliminating the risk of infection due to ineffective reprocessing, COVID-19 or otherwise, at a time when these conversations are at their most high.
The FDA has recommended that healthcare providers use single-use bronchoscopes when there is an increased risk of spreading an infection, especially when a patient is immunosuppressed, or if immediate reprocessing of a bronchoscope is not possible. For COVID-19 patients, the American Association for Interventional Bronchology and Pulmonology issued a similar statement encouraging the use of single-use bronchoscopes if available.
* Data on file: Boston Scientific benchtop study testing 15 units of each of 9 single-use scope models and 1 of 4 reusable scope models (each tested 15 times with a new suction valve) under constant pressure for 30 seconds testing two different viscosity substances. The volume of substance aspirated through the bronchoscope was the primary outcome. One-way ANOVA was used to test statistical significance between scopes with an alpha of 0.05. Bench test results may not necessarily be indicative of clinical performance.
Product page: EXALT Model B