The coronavirus pandemic has altered social norms and daily routines, influenced consumer spending and upended the global economy. It also may be changing the way medical professionals examine and operate inside your body.
Reusable medical scopes have long been the standard in patient care settings, despite isolated reports of contamination, infection and even death emerging from hospitals alleged to have failed to fully sanitize the devices. The U.S. Food and Drug Administration says that the risk associated with reusable scopes is “relatively low,” provided that cleaning and reprocessing guidelines are strictly followed.
But more than a year into the public health crisis, a Maryland company that specializes in single-use endoscopy technology said COVID-19 has seen that calculus change to its advantage, especially as consumers resume in-person clinician visits and sign up for the elective procedures they put off early in the pandemic.
“COVID has really accelerated this conversion,” said Jens Kemp, vice president for marketing at Ambu, a Danish developer and producer of medical devices whose U.S. headquarters is in Columbia. “There is heightened awareness around contamination, and it’s gotten more hospitals to take a closer look at infection control practices.”
Generally, during an endoscopy, a doctor snakes a scope into a patient’s body, often through the mouth or anus, to examine their stomach, lungs or colon. The long, thin scopes often have been inside several other human bodies before, perhaps even earlier that day, though all equipment is to be cleaned after each use.
Ambu, one of a handful of companies that sells disposable endoscopy products, saw it revenue grow 26% last fiscal year and 33% in its first quarter even as demand for some of its other medical devices dropped off.
The firm sold more than a million disposable endoscopes last year, Kemp said. Demand surged particularly for the company’s single use bronchoscopes after the American Association for Bronchology and Interventional Pulmonology released a statement in March 2020, saying disposable bronchoscopes “should be used first line when available” given the COVID-19 contamination risk.
Bronchoscopes, used in the lungs and airways, received increased attention in 2020 as the number of patients placed on mechanical ventilators to help them breathe skyrocketed. The company’s other scopes are used for procedures and visual examinations in the bladder, airways, lungs, small intestine, ear, nose and throat.
This month, the FDA sent a warning to health care providers specifically about the potential risk of infection associated with reprocessed urological endoscopes, and previously issued a recommendation for gastroenterologists to transition to single-use duodenoscopes for procedures involving the small intestine and bile duct.
The agency received more than 450 medical device reports describing post-procedure patient infections or other possible contamination issues associated with reprocessed urological devices from 2017 to 2021, according to the agency’s website. It says the devices themselves are not faulty, but the strict reprocessing guidelines must be followed.
Hospitals currently are not required to track which patients receive which scopes, which could pose problems in controlling a potential contamination event, said Madris Kinard, a former FDA official and the CEO of Device Events, a company that tracks adverse events and equipment recalls in medical settings.
She said patients may not be aware of the life span of the instruments used to examine their insides.
“I look at it as a systemic issue, that these devices can’t be cleaned,” Kinard said. “If the FDA could identify a better way to clean them, they would’ve tried, and manufacturers are trying too.”
Kinard said there have been 2,600 contamination reports filed to the FDA in the last decade, a figure that may be vastly underreported. Contamination reports decreased in 2020, which Kinard said is likely due either to the introduction of scopes with disposable parts or the number of elective procedures decreasing during the pandemic.
Reusable scopes and the FDA itself came under scrutiny in 2015 after an incident involving a contaminated medical scope that infected dozens of patients at Cedars-Sinai Medical Center in Los Angeles. The Los Angeles Times reported that the federal agency downplayed warnings about the risks associated with using such devices, and allowed the providers to keep using them to prevent an equipment shortage.
“They care and are trying, but they don’t have any way to force manufacturers to innovate,” Kinard said of the FDA.
Instead, the agency called on companies to create fully disposable scopes, or scopes with disposable parts.
Though the coronavirus may have helped boost Ambu’s sales of its four types of endoscopes, Kemp said single-use devices also can lower health care costs, improve productivity and help treat more patients. The company also uses the latest, high-definition camera technology and its scopes are evolving faster than its reusable rivals, Kemp said.
“Initially there was some concerns — can you develop a product that can perform clinically, as well as be single use?” Kemp said. “Ten years in, there is more and more confidence that single use is a viable alternative, and in many cases, has features that are preferable to reusable [endoscopes].”
Several studies have shown disposable scopes to be superior in convenience and quality than their reusable competitors. Some who use them call them “game changers.”
“You’re sticking a scope down someone’s throat, then you stick it down someone else’s throat. Are they really completely disinfected? The answer was ‘yes, maybe,’ " said Dr. Blaine Kristo, medical director of urology at Mercy Medical Center in Baltimore, who started using the Ambu scopes within the last year.
“COVID has raised an issue that there are potential contaminants we don’t know about, so why take that risk?”
Kristo also said the single-use scopes are lighter to transport, making them easier to treat patients where they are.
“You can go anywhere in the hospital to use them,” he said. “Before, you had to bring [the patients] into the operating room.”
Sure enough, Ambu, which has its global headquarters in Denmark, got its name from the Latin word “ambulare,” which means “to go,” “to move,” or “to travel.” Its hand-held manual resuscitator, or “Ambu bag,” was considered a breakthrough in emergency medicine, giving providers the ability to treat patients outside of hospitals and doctors’ offices.
Kemp said there’s evidence of cost savings for those who use the disposable scopes. The unit price can be hefty, running as high as $1,700 apiece for the duodenoscopes alone.
But reusable scopes may carry more long-term costs, Ambu’s team contends.
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Health care workers using reusable scopes must spend time and resources on meticulously cleaning and reprocessing the devices, which still may fall prey to human error. Back-to-back or same-day procedures might be difficult for providers. And when damage happens, the scopes can be expensive to repair.
Detractors of disposable medical products contend that they create even more medical waste, which is either landfilled or burned in waste-to-energy incinerators, contributing significantly to greenhouse gas emissions.
Dr. Jason Marx, senior vice president of physician integration and value-based care at the University of Maryland Medical System, said hospitals generally conduct a “rigorous” cost-benefit analysis when deciding to use new instruments and medical equipment. Safety, patient outcomes and quality of care tend to win out over sustainability concerns, he said.
“Our primary concern always remains safety and quality of care of our patients,” Marx said. “All health care providers will do what’s best for the patients.”
Meanwhile, at the University of Maryland Medical Center, trials for single-use scopes, and scopes featuring disposable parts, are underway.
Dr. Eric Goldberg, director of endoscopy at the medical center, said disposable scopes will make up a critical piece of medicine’s future, even post-pandemic. For now, he and other providers will have to gradually shift to new methods and let go of the reusable devices they have come to know well.
“Anytime there’s new technology, it takes a while to get used to,” Goldberg said. “It’s like garden work. You could use a bunch of different types of hoes and rakes, but there’s always going to be one that works best.”
This story has been updated to reflect that Ambu is a Danish company whose U.S. headquarters is located in Columbia.