Patients and healthcare organizations alike are playing catchup for nonemergent care procedures that were put off during the COVID-19 pandemic, and providing patients with safe, affordable and accessible care is top of mind for providers.
Ambu A/S, headquartered in Ballerup, Denmark, created the world’s first disposable video endoscope in 2009, and now offers a wide spectrum of single-use endoscopes for hospital-based procedures in the operating room, emergency room, intensive care units and at the bedside. Their products have been used for millions of endoscopy procedures performed in office and outpatient clinic care settings, as well.
“We give [healthcare organizations] the ability to grow an endoscopy department and become more efficient without hurting the balance sheet,” said Ambu CFO Michael Bavonese.
Today, Ambu’s complete line of single-use endoscopes includes 2021 Red Dot Award-winning duodenoscopes and cystoscopes as well as rhinolaryngoscopes and fourth-generation bronchoscopes. Ambu also replaces a traditional video endoscopy tower’s size and expense with a compact, portable platform that is significantly less expensive.
Benefits of single-use devices
“We have a health economics team that works closely with healthcare organizations,” Bavonese said. “What their analyses show is that when all the benefits of single-use are considered — including streamlining operations, improving workflow and efficiency, and reducing cross-contamination and patient infection risk — single-use is cost neutral or even saves money for many facilities.”
There also is a cost for the time, personnel and materials used to clean reusable devices. In addition to these maintenance expenses, staff and devices are unavailable for other procedures during the cleaning process.
“It’s become more and more evident how difficult it is to clean reusable devices,” said Jens Kemp, Ambu’s vice president of marketing. “There is no way to guarantee that scopes are 100% clean.”a
Reprocessing endoscopes can take up to two hours to complete and includes up to 100 steps, which must be strictly adhered to for adequate disinfection. The U.S. Food and Drug Administration has acknowledged in several safety communications that reprocessed endoscopes pose a risk for cross-contamination and patient infection.
In the latest communication from the agency to address reprocessed bronchoscopes, single-use bronchoscopes were recommended for use on patients at high risk for transmitting infection or when reprocessing is not immediately available. The FDA also encouraged providers to consult COVID-19-related recommendations from the American Association for Bronchology and Interventional Pulmonology on the use of single-use bronchoscopes in coronavirus cases.
FDA safety communications about reprocessed duodenoscopes and urological endoscopes have also included information about outbreaks traced back to contaminated scopes.
In addition to the patient impact, an outbreak related to a contaminated endoscope could be financially and reputationally devastating. With single-use devices, healthcare facilities are able to remove cross-contamination and infection risks.
Kemp also pointed out that older technology, like a fiber scope that an ear, nose and throat doctor (ENT) may use, would put the doctor in close proximity to each patient. Maintaining safe distance, particularly after the pandemic, is a priority for doctors and patients.
“Our video technology allows more distance [between the clinician and] the patient,” he said.
In the wake of the pandemic, the distance, cleanliness and accessibility of single-use endoscopes are especially significant.
“COVID has shown that sometimes external factors happen that influence demand for services to the hospital,” Kemp said, referring to an almost complete stop of revenue-generating services during the pandemic. “Reusable equipment is sitting on a balance sheet incurring costs even with no activity.”
“Because reusable equipment costs are generally fixed — depreciating capital investments, reprocessing operations and repair contracts — if procedures slow or stop, those costs don’t decline to match the loss in income,” he said.
By contrast, single-use endoscopes are considered supplies, and costs therefore vary by procedure volume, creating predictable margins. Because they’re supplies, they do not depreciate and stay on a balance sheet for years like reusables.
“There is a real cost to maintenance agreements that you have to pay out,” Bavonese said, pointing out that single-use scopes relieve that financial burden because you only pay for a scope when you have a procedure.
Facing the backlog of procedures
Now, as medical providers face more than a year’s worth of backlogged procedures, they need resources efficient enough to make up for lost time without the long-term financial commitment of reusable items.
“How can you expand capacity for a temporary period of time without investing in capital you might not need 12 months from now?” Kemp asked.
Single use is the answer. Single-use flexible endoscopes are sterile and patient-ready out of the package. They offer a system that is always ready when needed, without the risk of cross-contamination and without the delayed clinical workflow from cleaning and reprocessing.
“The ability to do procedures efficiently is really important,” Bavonese said. “Our product is about as efficient as you can get.”
Healthcare organizations can start a program with Ambu efficiently and with low capital investment.
In fact, Ambu hosts a team of clinical training specialists who provide continued support for customer training and education. This team also collects client feedback to guide new developments that meet market needs.
The long lifespan of reusable devices also leads to slower adoption of new technologies — a hurdle not faced with single-use products.
Ambu’s track record of innovation
“A key feature for healthcare organizations to know is our track record of innovation in the medical device industry,” said Kemp. “That includes our ability to rapidly accelerate the introduction of new technologies with shorter product life cycles.”
Ambu has been around for more than 80 years and is widely known for the self-inflating resuscitator bag developed by founder Holger Hesse and anesthesiologist Henning Ruben in 1956. The Ambu ventilation bag is widely used for emergency medicine and hospital care.
Now, they’re Frost & Sullivan’s 2021 Global New Product Innovation Award winner thanks to their work on single-use endoscopy.
They take advantage of rapid technology advancements with image sensors, materials, artificial intelligence and image enhancement. By pairing innovation with high-scale, low-cost manufacturing, Ambu is always improving.
“Our short product life cycles are unique,” said Kemp. “As soon as a product has launched, in most cases, we’ve already started developing the next generation.”
Ambu is on contract with the United States’ four major group purchasing organizations (GPOs), with recent contract expansions giving 90% of the country’s hospitals access to the complete line of single-use endoscopes and giving 98% of the hospitals access to their rhinolaryngoscopes, bronchoscopes and cytoscopes.
“If a hospital goes to a single-use model, they need to be confident there’s not going to be a supply issue,” Kemp said. “They want to make sure manufacturers are able to meet the demand.”
Ambu has that advantage, he said, noting they sold nearly 1.1 million endoscopes last year. Their closest competitor sold about one-fifth of that.
Since the pandemic, they’ve doubled their manufacturing capacity to meet the significant spike in demand.
“All of our products are single use. That’s all we do. That’s what gives us this advantage, this manufacturing scale,” Bavonese said. “This ability to manufacture and sell at a fair price is very important.”
To learn more about Ambu products, visit www.ambuusa.com
To access some of their latest insights, as well as flexible endoscopy news and analysis, visit Ambu’s learning centers:
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety, and performance of our single-use endoscopy, anesthesia, and patient monitoring & diagnostics solutions. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America, and the Asia Pacific. For more information, please visit www.AmbuUSA.com.
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a. Devices for which a 510(k) should contain validation data (Reprocessing Final Guidance Appendix E.), U.S. Food & Drug Administration, March 23, 2018.