“I went to get a routine colonoscopy and because of that I am going to be in turmoil mentally,” said one patient. “It’s sleepless nights, near panic attacks at times….” For healthcare administrators, this reads like a stake to the heart. Due to suspected lapses in endoscopy procedures at one Eastern U.S. facility, someone did find themselves facing these heartbreaking comments after routine colonoscopies went wrong.

There might be a few questions that come from reading reports like these:

• “Could I have been involved in one of these events as a patient, provider, or as a loved one?”
• “How many events aren’t being reported?”
• “How many other people might have been affected?”
• “What did we do wrong here?”
• “What’s going to get this to change?”

Rising Adverse Events as Reported by the FDA

It’s shocking but true that adverse events within gastroenterology continue to be reported at all-time highs. The United States Food and Drug Administration considers an adverse event as any undesirable experience associated with the use of a medical product in a patient, or when there is concern about a product’s quality, authenticity, performance or safety.

A 2022 report released by Lawrence Muscarella, PhD and President of LFM Healthcare Solutions reported more than 10,000 adverse events related to contaminated flexible endoscopes between 2014 and 2021. As of Q4 2024, the FDA posted 8,903 adverse events in just three months, a 14% increase over the same time period from 2023 (you can find frequent updates from Cori Ofstead on quarterly findings like these in social posts, here).

The reason for each adverse event seems to be limitless. Reasons range from distal endcaps falling off in patients, balloon catheters being stuck inside biopsy channels, or clogged channels from insufficient reprocessing. Lapses often occur during manual processes, such as point-of-use cleaning, flushing, brushing, or visual inspection. Even the most well-trained reprocessing departments are likely to have lapses; tools can be insufficient, processes can be rushed, or nurses and technicians can get interrupted in their work. Regardless of the why, the trend in rising adverse reported events to the FDA is alarming.

The hardest part of this equation to define are the costs associated with adverse events. Adverse events are broad and cover a large array of issues, and studies to get firm financial data associated with these events are rare. As adverse events continue to climb, it’s likely that their financial impact will come into clearer focus as well.

Rising Demand – the Future of Colonoscopies

If adverse events are not addressed, the issue will grow. By evaluating colonoscopy procedures alone, the United States can expect to see growing surgical volume. It is estimated that roughly 15 million people receive a routine colonoscopy procedure each year. By the American Cancer Society’s estimate, over 1 in 3 adults over the age of 45 are not receiving regular colonoscopies. This indicates that nearly 30 million people are routinely skipping colonoscopy screening. Imagine the burden of an estimated 45 million annual colonoscopy procedures on the United States healthcare system!

The Weldon Cooper Center for Public Service, a part of the University of Virgina, published expected population projects for the United States through 2050. While the United States’ population growth rate is slowing, it is quickly aging. This can be expected to further add demand and strain on routine colonoscopies over the next 30 years. It is expected that by 2030, more than 20% of the population will be over the age of 65 and nearly half the United States’ population will be in their 40s or older.

Can the gastroenterology industry solve two problems at once: a rising trend of adverse, negative events, and an influx of demand on its hospitals and ambulatory surgery centers, all within the next 5 years?

Image credit belongs to the University of Virginia Weldon Cooper Center for Public Services, 2024. The direct use of this graph can be found, here. 

Shifting Sands – How Endoscope Reprocessing is Changing

Among rising adverse events and patient demand, the sand under many GI professionals’ feet is shifting. New endoscope technologies are popping up faster than can be adapted to. The discussion between reusable and single-use gets more complex during each round of discussion. Further, staffing shortages, exacerbated by COVID-19, continue to impact productivity.

According to the 2024 GI Reprocessing Landscape Report, over 28.42% of participants cited that the most important area to focus efforts on in 2024 was IFU compliance. Together with Training & Certification and Cleaning Verification, over 67% of reported responses indicated a focus on improving competencies with reprocessing, quality assurance, and efforts to overachieve IFU requirements were most important. When asked what the most important problem to solve was, Processes led responses with 19.88%, shortly followed by compliance at 19.30%. It’s clear these challenges led GI and sterile processing professionals to seek improved processes that provide guardrails and security around quality.

The endoscope reprocessing environment will continue to evolve in many exciting, positive ways. It’s fun to speculate on what’s on the horizon for gastroenterology, and some developments are sure to surprise! When participants were asked what they see when they look ahead, 33.29% in the 2024 survey cited compliance, guidelines, and IFU requirements to be one of the most challenging opportunities moving forward for the industry. With what the industry has reported, it’s easy to understand why this is top of mind.

Endoscope processing is at the heart of debate, conversation, and change. What’s most important to keep in mind is that endoscopy procedures generally result in positive outcomes and are a routine, safe practice that catch early signs of cancer. However, any lapse in patient safety requires thorough investigation; what can be done more effectively for a patient’s safety, should be.

Following adverse events in endoscope reprocessing is not pessimism, it is awareness. Identifying areas for improvement by seeing where lapses occur can help sterile processing and gastroenterology professionals take control over their own quality outcomes. Awareness is the start to identifying, and ultimately, making lasting change.

Looking for more information about endoscopy reprocessing outcomes? Download our free, GI Landscape Report, where hundreds of gastroenterology professionals share their insights from the floor of the patient room, and we turn them into actionable insights!

Works Cited

1. Vanderbilt endoscopy patients at risk of contracting HIV or hepatitis after reported issue
2. Product Problems | FDA
3. https://www.ormanagement.net/Infection-Control/Article/09-22/Reports-of-Endoscope-Contamination-Rose-Significantly-Since-2014-New-Analysis-Says/68366
4. https://www.linkedin.com/posts/activity-7282446227445559296-IyMC?utm_source=share&utm_medium=member_desktop
5. How well do colonoscopies prevent colorectal cancer? What you need to know – Harvard Health
6. Data and Progress – American Cancer Society National Colorectal Cancer Roundtable
7. National 50-state population projections: 2030, 2040, 2050 | Cooper Center
8. US hospitals pass on most of the costs of errors – PMC