The introduction of two single-use duodenoscopes and other partially disposable models for use in endoscopic retrograde cholangiopancreatography (ERCP) in the last 18 months has sparked an abundance of new research and debate.

This was especially clear during the 2021 Digestive Disease Week, held virtually for the second consecutive year because of the COVID-19 pandemic.

So, is new technology the best way to address risks of patient cross-contamination in ERCP?

“It’s an amazing advance that single-use duodenoscopes have been developed,” Dr. Brennan Spiegel, editor-in-chief of the American Journal of Gastroenterology, said during the event. “This is a terrific advance.”

New research presented during the virtual conference centered on the performance of single-use duodenoscopes, the potential environmental impact, the cost, and other ways to reduce risk of infection in ERCP, such as improving surveillance and quality assurance after reprocessing.     

“Gone are the days when we are doing ERCPs without any thought or regard to the infection risk,” Dr. Mark Gromski of the Indiana University School of Medicine, said during a panel discussion on the adoption of single-use duodenoscopes. “We need a careful, well thought out strategy.”

Does Single-Use Stand Up?

ERCP is one of the most complex endoscopic procedures to perform. Clinical research presented at DDW indicates that single-use technology can stand up to the challenge.

Numerous peer-reviewed studies, posters, and abstracts presented at the conference reported high success rates for ERCP procedures of all grades of difficulty, performed by endoscopists with varying levels of experience.

In fact, new research from the University of Pittsburgh revealed a 96 percent success rate with single-use duodenoscopes over the period of one year. Success rates showed little variance despite reported difficulty of the ERCP procedure or the experience level of the endoscopist. Researchers also reported similar cannulation rates for all endoscopists using the single-use duodenoscopes.

Environmental Impact

All endoscopic procedures generate waste, from disposable accessories used to the personal protective equipment (PPE) needed for handling and reprocessing.

“We should remember that our current endoscope reprocessing generates a large amount of waste,” Dr. V. Raman Muthusamy, a professor at UCLA, said while making the case for institutional adoption of single-use duodenoscopes. Muthusamy pointed to reprocessing chemicals and the PPE technicians are required to wear to clean and disinfect duodenoscopes.

Muthusamy also said that recycling programs for single-use duodenoscopes should be developed and adopted.

One abstract from the University of Michigan presented during the conference suggested that the production of single-use duodenoscopes would contribute most to greenhouse gas emissions. Given that, the abstract concluded single-use duodenoscopes may harm the environment more than legacy duodenoscopes, but more research is required.

Is the Price Right?

Per-procedure costs for ERCP differ widely by institution based on procedural volume, reprocessing methods, repair costs, and manufacturer maintenance contracts.

One abstract presented at DDW 2021 estimated per procedure costs would be significantly higher at a high-volume center — 930 annual ERCPs — with a single-use duodenoscope priced at $1,900. The research, however, did not account for potential bulk purchase pricing of single-use duodenoscopes, TPT codes, or the cost of treating device-related infection.

“Prior studies have found that duodenoscope-related infections can significantly increase the cost per procedure of reusable duodenoscopes, thus select usage for cases with high risk of infection-related complications may be reasonable,” the abstract from the University of California concluded.

During a debate about whether institutions should fully adopt single-use duodenoscopes, Spiegel based his argument against the adoption of single-use duodenoscopes on the price being too high at $3,050 per device. He argued that, from a healthcare system perspective, the risk of infection and death by device-related cross-contamination in ERCP was too low to justify that kind of spend for every procedure.

But, if the amount of each duodenoscope were to come down, he said, “there will, really to me, be no debate that disposable duodenoscopes are the way to go.”