For 26 years, laryngologists used the Laser-Shield II, a laser-safe endotracheal tube that seemed to check all the boxes. They loved its smooth surface—perfect, it seemed, for passage along the delicate tissues of the vocal folds. They loved its flexibility—perfect, it seemed, for procedures that required ease of movement. And they loved its feel—perfect, it seemed, for a quality experience for both the surgeon and the patient.
Explore This IssueOctober 2021
Then, to their surprise, manufacturer Medtronic stopped making it. There were other approved tubes for the purpose of endotracheal laser procedures, but many felt that none of them came close to the Laser-Shield II. When otolaryngologists found out it was off the market, they reached out to the company but were unable to convince Medtronic to bring back the beloved tube.
Discontinuations of otolaryngology tools and technologies can come about for a variety of reasons, manufacturers say. They sometimes happen when a component of a product becomes unavailable, with no adequate replacement. Sometimes, the revenue generated isn’t sufficient for a company to justify making it anymore. And sometimes, corporate representatives say, companies just decide that a product isn’t innovative enough any longer or isn’t worth the hassle of making it.
But when discontinuations do happen, they often take otolaryngologists by surprise, leaving them with unsatisfactory alternatives and forcing them to adjust to a tool they feel isn’t as well designed for the best outcomes. As they describe it, it’s sometimes an experience that, far from propelling them to new efficiencies with the powers of innovation, seems like going back in time, forcing them to scramble to find new sources for the instrumentation.
“We don’t have a lot of say; it just happens,” said Michael Johns, MD, director of the University of Southern California Voice Center in Los Angeles. “It seems sort of shocking when we’ve seen great advances in some of the ways we give patients care, and then economic forces lead to it going away.”
Complicated Decision Making
On the plus side, new needs can result in a replacement that’s superior to the old product, as happened with the endotracheal tube after a gap of about four years without the well-regarded version. But, originally, one of the go-to replacements for the Laser-Shield II was a metal corrugated tube that, otolaryngologists say, was stiffer and, with its ridges, could be abrasive to the tissues of the vocal folds.
“The balloon on this metal tube also was very large and not tight-to-shaft. It actually made it difficult to intubate patients who have glottic stenosis or other reasons for their larynx to be constricted,” said Jonathan Bock, MD, professor of otolaryngology–head and neck surgery at the Medical College of Wisconsin in Milwaukee. “It also obscured the view as you passed it through the vocal cords. I’ve definitely had a handful of patients whom we could easily have intubated with the old tubes. And then you had to figure out how that would affect your care for the patient. Sometimes, that can have a significant negative impact.”
Amy Van Sach, Medtronic’s vice president of marketing for otolaryngology products, said the company understands that the transition to a new product can be difficult. “It was a popular product, and it’s always difficult to adjust to a different technology,” she said. “At the end of the day, it’s about making sure that patients can get the care that they need. In some cases, we’re going to be the one that can provide existing and new tools and solutions; in other cases, there might be another product in the marketplace.”
Van Sach said decisions to discontinue medical products aren’t simple. “It’s a complicated decision-making process, especially when you’re talking about medical devices, because it isn’t like discontinuing a consumer product. These are tools that physicians do rely on,” she said. “We want to make sure that we understand if there’s still an innovative nature to the product offering. I think that’s a question that a company has to continually ask itself when it’s in the business of providing innovative solutions in the healthcare space.”