Boston Scientific recently announced FDA clearance of the EXALT Model B single-use bronchoscope, intended for bedside procedures in intensive care units or in the operating room. As a single-use device that boasts high quality imaging and suction capabilities, the bronchoscope is ready to go out of the packaging, which means it mitigates the risk of infection posed by ineffective device reprocessing between patients. In the midst of the COVID-19 pandemic, when healthcare staff are working hard to prevent viral transmission within healthcare facilities, the scope will likely prove particularly useful.
Device reprocessing takes time and effort, requiring staff to handle potentially infectious pieces of equipment and chances of insufficient treatment to destroy all pathogens. If all devices are tied up with reprocessing, there is a risk of a shortage, meaning delayed procedures and knock-on effects on patient outcomes. Single-use devices are available at a moment’s notice, meaning there is unlikely to be a shortage of scopes as long as sufficient stock is kept. While it likely wouldn’t be feasible to employ single-use scopes exclusively, they may form a very helpful part of a clinical arsenal, especially during the pandemic.
Medgadget had the opportunity to speak with Dave Pierce, Executive Vice President and President, MedSurg and President, Endoscopy, at Boston Scientific, about the new bronchoscope.
Conn Hastings, Medgadget: Congratulations on receiving FDA clearance for the EXALT Model 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. In designing the device, we prioritized high-quality imaging and superior suction performance – a critical factor in bedside procedures where strong suction is required. The scope is designed to provide a sense of familiarity in a single-use platform, which eliminates the need for reprocessing and scope repairs. From talking with physicians, we know that having single-use scopes stocked is important for ensuring that a new, sterile bronchoscope is available and ready for use when needed at the point of care. The simple set up of EXALT Model B can also be completed quickly by nurses or technicians who don’t require special training.
Medgadget: What types of procedures can the device perform? How does the system cope with different patient anatomies?
Dave Pierce: The EXALT Model B Bronchoscope can be used for a wide variety of bronchoscopy procedures including secretion management, airway intubation, percutaneous tracheostomy, double lumen endotracheal tube placement and biopsies. The three sizes – slim, regular and large – allow physicians to use the device in a variety of procedures, care settings and patient anatomies. For instance, the superior suction of the EXALT Model B large scope may be beneficial for patients requiring aspiration of blood clots and management of challenging secretions, the suction capabilities of the regular size scope were designed to support most bedside ICU procedures, and when placing a double lumen tube, the slim size scope can provide suction that other tested single use and reusable scopes did not.
Medgadget: What inspired you to develop a single-use bronchoscope?
Dave Pierce: Our product pipeline is largely influenced by what we see and hear from physicians with regard to the greatest unmet needs in the industry, and we listen closely to physicians to ensure we’re addressing those needs as we develop our products. With the EXALT Model B Bronchoscope, what we understood from physicians was the importance of suction and visualization functionality in a single-use device. Suction is one of the main reasons physicians do bronchoscopy in the ICU, so suction capability was critical for Model B.
We were pleased that internal bench testing showed the EXALT Model B has superior suction power when compared to tested 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 water compared to other 5.0mm scopes.*
Medgadget: Given that the device is single-use, does it offer value for the money?
Dave Pierce: In addition to the benefit of eliminating the risk of infection due to ineffective reprocessing, single-use devices provide value associated with on the spot availability. The intense cleaning and sanitization process for a reusable scope is time-consuming, meaning that scopes undergoing reprocessing are unavailable for extended periods of time. That being the case, a hospital can only complete a finite number of procedures in a given timeframe with its reusable device inventory. Procedures may be delayed or spaced further apart due to a lack of available, sterile scopes, so there’s an inherent value in having a new, unused device ready to go at any given time. Reusable scopes also create an operational burden for hospitals, as device reprocessing ties up staff for extended periods of time, and requires significant financial and time-intensive investments to adequately train and credential these employees on the process.
Medgadget: In the age of COVID-19, how does the device help to protect patients and healthcare staff from infection?
Dave Pierce: The EXALT Model B Bronchoscope doesn’t require reprocessing, which eliminates the risk of potential infection caused by ineffective reprocessing – as well as challenges associated with the transportation and maintenance of reusable scopes. While the device was in active development before COVID-19, the pandemic accelerated its need. Especially in the ICU where there is already a heightened risk of infection and a dire 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 the confidence by eliminating the risk of infection due to ineffective reprocessing, from COVID-19 or otherwise, at a time when these conversations are at an all-time high.
The FDA has gone on record to recommend healthcare providers utilize single-use bronchoscopes when there is a heightened risk of spreading infection, especially when a patient is immunocompromised, or if immediate reprocessing of a bronchoscope isn’t possible. For patients with COVID-19, the American Association for Bronchology and Interventional Pulmonology issued a similar statement encouraging the use of single-use bronchoscopes if they are available.
*Data on file – Boston Scientific benchtop study testing 15 units each of 9 single-use scope models, and 1 each 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 suctioned via 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