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Prior Authorization

One More Reason to Dislike Insurance Companies

No one has given me prior authorization to rail on prior authorization, but I’m going for it anyway. Oh, insurance companies, how I don’t love thee. Warning: in this letter I’m going to exhibit significant bias against insurance companies. If you’re into that, read on! However, if big insurance companies are your jam, you might want to skip this letter.

It’s not an understatement to say that I hate insurance companies. (My late father’s words are echoing in my ears now; I hear him saying, “Hate is a very strong word.” So let me weigh this memory before using the term … Okay, I weighed it and—sorry, Dad—I do indeed hate insurance companies). But there is no small irony in including my dad, since:

  1. I’m on a commercial flight (I’m headed to the Healthcare Sterile Processing Association conference) and my dad died on a commercial flight.
  2. If it weren’t for insurance companies being selfish cheapskates, my dad could very well still be alive.

In 2006, Dad died of a heart attack. He was 51. I was 25. The autopsy determined his problem would have been detected by a specific test that his insurance covers at age … 53. He had considered getting that test, but since he seemed to be in decent health, he didn’t want to incur the enormous out-of-pocket charge. Had he found out what was wrong he would have taken immediate and serious steps to reduce stress and eat even better. I know this to my very core. Another insurance irony here (and for me a tragedy, because it all led to losing Dad way too young) is that stress was a major contributor to his heart attack, and guess what his biggest stressor was? The fact that he was working two jobs because he needed insurance. He was in business for himself as a pressure washer, and he had a job on the side, driving for a nursing home.

My dad worked hard his entire life and lived frugally, yet the truth is impossible to ignore: He needed two jobs to secure insurance and make enough money to survive. We all know people in this position. Some of us may be in this position right now. And these days, people have it much harder than when Dad died in 2006, since the cost of living has gone up exponentially, while salaries haven’t kept pace. It sure isn’t getting any easier to be a middle-class person in the United States. One of the last things my dad ever said to me is, “The rich are gonna keep getting richer.” Boy, was he right.

The reason I initially chose this topic—before I got pretty damned sad and frustrated thinking about my dad—is that one of the many injustices of our modern national healthcare insurance cluster-mess is the concept of prior authorization. The American Medical Association released a great opinion article on this topic recently. It’s titled, “Don’t Fall for These Myths on Prior Authorization,” by Tanya Albert Henry. (See blue section below for article).

According to Henry, “Knowing the truth is important because prior authorization, a utilization-management tactic that in- surers once reserved for extremely expensive intervention, is now employed for even the simplest generic medication. And denials only seem to be becoming an even greater problem for physicians and patients’ health. A recent AMA survey shows that 61% of physicians fear payers’ unregulated use of AI tools will increase prior authorization denials. The payers’ automat- ed decision-making systems create systemic batch denials with little or no human review.”

I often wonder how big a headache the average endoscopy facility staff considers insurance to be. What’s your facility’s relationship with insurers? I imagine it’s not a one-size-fits-all situation—indeed, some insurers must be worse than others in what they’ll approve and in how they communicate. This is surely true of prior authorization as well.

Henry wrote, “Behemoth health insurers claim this time-wast- ing practice improves care and saves everyone money. Look beyond the myths and find out the facts. …Patients and phy- sicians beg to differ with the claims that insurers bandy about when discussing payers’ time-wasting, care-delaying tactics that are designed to control costs. And physicians have the research to back up their position.” AMA leaders aren’t sitting around complaining like I am; they’re taking action.

AMA is challenging insurance companies to eliminate care delays, reduce patient harm and decrease inconvenience to practices. “That includes setting the record straight on what the research shows about how prior authorization is used and how it affects American healthcare,” Henry wrote. A large section of her article is printed below, wherein Henry does a great job comparing fact and fiction with it comes to prior authorization.

Myth: Prior authorization lowers cost

Prior authorization, in fact, does not lower costs. Drug prior authorization costs $93.3 billion annually, according to a study published in Health Affairs. No one is immune. The study estimates that prior authorization costs payers

$6 billion, manufacturers $24.8 billion, physicians $26.7 billion and patients $35.8 billion annually.

Meanwhile, 88% of physicians surveyed by the AMA reported that prior authorization leads to higher healthcare utilization because of avoidable emergency department visits and patients being forced by payer policies to initially use ineffective treatments.

Fact: It’s expensive for doctors—and payers

Here’s what some researchers have discovered about how prior authorization translates in economic terms for physicians and payers.

For primary care physicians, prior authorization costs an individual doctor between $2,161 and $3,430 annually, according to a study published in the Journal of the American Board of Family Medicine.

At 11 dermatology clinics that researchers examined, completing a prior authorization for biologic drugs cost an average $15.80 per request—or about $3,454.15 for the month studied, according to research published in JAMA Dermatology.

Emergency visits and hospitalizations rose 1.7 percentage points when access to antidepressants was restricted, according to research published in Forum for Health Economics and Policy.

Formulary  restrictions  on  antipsychotics  increased hospitalization risk, inpatient costs and total medical costs, according to a study of 24 state Medicaid programs published in the American Journal of Managed Care. Restrictions increased the number of incarcerated people by 9,920 and upped the costs associated with incarceration by $362 million nationwide

Meanwhile, if a “gold carding” program—a system that allows approved physicians to forgo prior authorizations for certain medications or procedures—were implement- ed, it would save 5%–10% for payers and physicians, a McKinsey & Co. analysis found.

Fact: Prior authorization is wasteful

The AMA’s most recent annual survey of 1,000 physicians about prior authorization found that practices on average complete 39 prior authorization requests per physician, per week.

The AMA survey (PDF) also found that:

  • Physicians and their staff spend an average of 13 hours completing those requests each week.
  • 40% of physicians have staff who work exclusively on prior authorizations.

After jumping through all of those hoops, 98.5% of prior authorizations in pediatric oncology and hematology were eventually approved, according to a study in the Pediatric Blood & Cancer journal. Similarly, an AMA-funded cohort study published in Arthritis Care & Research found that 96% of all prior authorizations on rheumatoid disease treatments were ultimately approved.

Myth: Prior authorization improves care

The opposite is true. Prior authorization worsens patient outcomes.

Insurance companies’ overuse of prior authorization causes patients real harm — in some instances even resulting in death. Nearly 30% of the physicians who participated in the AMA prior authorization survey reported that the practice has led to a serious adverse event for a patient in their care, including 8% that said prior authorization led to a patient’s disability or permanent bodily damage, congenital anomaly or birth defect or death.

Fact: It delays necessary care

In addition to the agonizing anecdotes that every physician has, numerous peer-reviewed studies back up the fact that prior authorization results in patients not getting necessary care as quickly as they should be getting it. Here are a few examples.

Reduced access to novel anticoagulants because of prior authorization and step therapy led to higher risk for mortality,  stroke  and  transient  ischemic  attack, according to research published in The American Journal of Managed Care.

In an American Society for Radiation Oncology survey, 31% of radiation oncologists said that prior authorization had delayed a patient’s treatment by one week, alarming because other research has shown an association of “each week delay in starting cancer treatment with a 1.2% to 3.2% increased risk of death.”

Dermatology patients with approved prior authorization requests had a 71.1% likelihood of disease improvement; those who had requests denied had a 58% likelihood of improvement, says a study published in the Journal of the American Academy of Dermatology.

Fact: It blocks evidence-based care

Physicians spend many years in medical school, residency and fellowship training and continuing medical education to gain the knowledge and skills needed to provide the best care for patients.

Yet prior authorization decisions are frequently made by those who do not share those qualifications. When physicians have “peer-to-peer consults,” the person on the other end of the line may be a nurse or a physician in a completely different specialty with little to no knowledge of the disease or treatment in question.

In addition, research has shown that prior authorization has led to:

  • A nine-times increased likelihood that irritable bowel disorder patients will need surgery when medication has been denied through prior authorization, says a study published in the journal Inflammatory Bowel Diseases
  • Over 40% of commercial patients and 53% of Medicare patients not beginning the oncology treatment their physician prescribed after a prior authorization denial or step therapy requirement, according to a white paper published by IQVIA
  • Limited access to pre-exposure prophylaxis (PrEP) and increased rates of HIV diagnosis in regions with high rates of prior authorization for PrEP, which protects against contracting HIV, according to a JAMA Network Open study

If you’d like to learn more about what healthcare teams and patients can do to help reform efforts, or if you’d like to share personal experiences with prior authorization, contact FixPriorAuth.org. I’m going to take part in the reform, in honor of my dad. I’m still typing on a plane like I was at the beginning of this letter, and I’m still thinking of Mark Beaver in a way that, if I delve deeper, will make me cry. He took his final breaths in an airplane cabin just like I’m in right now. I’ve always wondered if I’d ever meet someone who was on that flight from Albany, New York to Sarasota, Florida. Who knows—maybe one of you were on that flight or knew someone who was. The plane emergency-landed in North Carolina, but it was too late. Dad left the plane in a body bag.

That’s not a flight anyone on board would ever forget, and I’ll never forget that had it not been for the penny-pinching, wildly rich misers at insurance companies, my father probably would have lived a lot longer. I can never condone that Luigi Mangione killed UnitedHealthcare CEO Brian Thompson—the murder was wrong; it was sick and cruel— but I can understand the rage he felt, and I suspect many of you may understand that rage as well. I’d love to ask my dad his thoughts on all this, but I can’t. He’s gone. And so, I’ll ask you, as a healthcare professional whose practice deals with insurance, for your thoughts instead. Please feel free to email me at [email protected].

Note: As we go to press the last week in May, 2025, our senior editor is still trying to get an urgent medication prescribed in late April by her doctor. Her insurance company kicked it back for—you guessed it—prior authorization.

Author

  • Michelle has worked as a journalist, editor in chief and communications professional for more than 20 years with 12 years specializing in healthcare, including as editor in chief for the EndoNurse media brand. She’s the editor, ghost author and co-author of several books.

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The Ups & Downs of Hydrotherapy

An Alternative Colonoscopy Prep

Hydrotherapy has been the butt of a lot of jokes.

Okay, thanks for letting me get that out of my system. So to speak.

We all know bowel prep is the critical factor in ensuring a successful colonoscopy. So much so, there’s a rating system for it: the Boston Bowel Preparation Scale (BPPS). (You have to wonder who drew the short straw to decide exactly how much fecal matter determined the “degree of soiling” level?) In the BPPS, the bowel is divided into three sections—right colon, transverse colon, and left colon—and then further segmented by degree of soiling. First published in 2009 by Edwin Lai and associates, the BPPS was part of a 2016 systematic review of colon-cleansing scales—including Ottawa Aronchick and Harefield, among others. Authors Robin Parmar and associates concluded that “The BBPS is the most thoroughly validated scale and should be used in a clinical setting.” The scale now is used and accepted worldwide.

But let’s face it: Scale or no scale, patients hate colonoscopy bowel prep. They just do. The uncomfortable, undignified process has become fodder for objectors and comedians alike. And who can blame them when side effects can include nausea, vomiting, bloating and, in some cases, increased hemorrhoidal flare and loss of sleep? But the success of a colonoscopy depends heavily on how well the patient follows prep instructions.

If the patient is indifferent, well—crap gets in the way of the exam. In a 2022 prospective observational study, Niels Teich and associates wrote, “Patients often consider [bowel prep] to be the most burdensome part of colonoscopy, which might be a main barrier to the procedure.” Some people simply refuse to schedule their colonoscopy—all because of what they’ve heard about the prep.

Hydrotherapy is a method of cleaning out the colon working from the bottom up, rather than the top down, by irrigating the colon with warm water. In some cases, massage is introduced to help loosen fecal matter. According to ColonicsDetox, based in the United Kingdom, the method has been in practice for thousands of years, with origins in Egypt, Greece and India. “It is an integral part of a modern naturopathic approach to health and was used in hospitals until the 1970s. The ultimate detox, it’s a very safe and gentle treatment,” the website states.

Teich, et al., wrote, “… bowel cleansing quality of colonic irrigation is considered comparable to oral purgative [regimens] but with less side effects and high patient satisfaction.” The study examined the efficacy of colonic irrigation as a method of bowel prep, using a new colon hydrotherapy device. They found the device to be “an effective and low-risk alternative to traditional oral preparation.”

Trouble in Paradise

The problem with bowel prep isn’t always with patient noncompliance. To put it indelicately, some patients are simply more full of crap. Some patients may have medical conditions that predispose them to problematic prep. And patients are always pressing for a more palatable regimen that includes lower volume.

Cristina Rutherford and Audrey Calderwood wrote in Current Treatment Options in Gastroenterology that between 10% and 25% of patients have “inadequate colon cleansing” on the day of their colonoscopy.

The big question is, why? Were patients noncompliant? Or was the prep inadequate? Practitioners can help facilitate answers to these questions, although this can be tricky: Will a patient hide the truth if she didn’t drink the whole prep? Or will she, like me, admit she had to stop about two-thirds of the way because she came close to vomiting and there was nothing coming out of her but bile, anyway? (Full disclosure: My gastroenterologist said my prep was fine and she had no trouble visualizing.) But I’m an average-sized woman of low weight. Should the same prep be used for me that’s prescribed for a 300-pound man who eats nothing but cheeseburgers?

Nabil Fayad and associates asked that same question in the journal Clinical Gastroenterology and Hepatology. In a 2013 retrospective study, they discovered that bowel prep was inadequate for 44.2% of patients who, it turned out, had “significantly higher mean BMIs” than those for whom prep was adequate. Their takeaway? “BMI is an independent factor associated with inadequate split bowel preparation for colonoscopy,” they wrote. But they also cited additional factors that might affect prep, including “diabetes, hypertension, dementia, and use of tobacco and narcotics. Patients with BMIs ≥ 30 kg/m2 should be considered for more intensive preparation regimens.”

Conversely, a 2019 observational study published in the Journal of Clinical Gastroenterology found no correlation between obesity and bowel prep; instead, the authors cited factors such as male gender, diabetes, liver cirrhosis, coronary artery disease, refractory constipation and current smoking as predictive of poor bowel preparation.

In a 2021 narrative review, Emanuele Sinagra and associates examined a low-volume polyethylene glycol/ascorbic acid solution (PEG-Asc) that might improve patient compliance. But they emphasized that a “one size fits all” prep is not feasible, and “a bowel preparation [regimen] must always be selected and tailored by the clinician for each patient, evaluating the best options on a case-by-case basis.”

Just Add Water

With hydrotherapy, poor prep is no longer a pressing problem. At GI Associates in Mississippi, patients are already enjoying the ease and benefits of hydrotherapy. The FDA-approved HygiPrep system allows the patient to be treated in a private room during the process. While seated in a sanitized basin, the patient inserts a sterile, disposable nozzle into the rectum, and a gentle stream of warm water is introduced, which loosens fecal matter and cleans the colon. Sanitary and odorless, the process takes less than an hour.

Possible side effects of the procedure can include cramping, dizziness, nausea and vomiting, as well as “clinically insignificant rectal abrasians,” according to the online brochure. Other practitioners cite bloating and perianal soreness, electrolyte imbalance, bowel perforation, liver toxicity, water intoxication, and infection. In an abstract published in the American Journal of Gastroenterology, Amulya Reddy and associates wrote, “It is thought that increased intraluminal pressure during colonic hydrotherapy results in bacterial translocation into the peritoneal cavity.” And the process isn’t for everyone: patients with congestive heart failure, renal insufficiency or intestinal perforation should not use HygiPrep.

That said, GI practitioners gave the process a 98% approval rating for cleanliness; nearly 2500 patients scored it even higher, with 99% saying the experience was “good” or “very good.”

One of the few controlled studies available on colonic hydrotherapy compared it with a polyethylene glycol electrolyte lavage (PEG-EL) solution. The findings were interesting: While the PEG-EL group had better colonic cleanliness, and fewer adverse effects, which went over well with practitioners, the hydrotherapy group boasted higher diverticulosis detection rates and higher patient satisfaction.

Community Feedback

While we might improve patient satisfaction by splitting the prep solution or going with hydrotherapy, one group that’s not happy with the whole “cleaning out the colon” thing is our microbiome.

The microbiome is a teeming collection of beneficial bacterial hordes that live quite happily in our gut. Without this tiny community, our gut could not function. These “good bugs” help digest our food, balance our immune system, and destroy bad bacteria that cause disease. Most of the beneficial stuff that happens in our small intestine, happens because of the good bacteria; they produce enzymes to break down indigestible carbohydrates, ferreting out the nutrients our body needs. And as you probably already suspect, what we eat has a big impact on our microbiome, with fruits, vegetables and whole grains getting a big thumbs up, but processed foods and those high in fat and sodium, not so much.

In Integrative Medicine: A Clinician’s Journal, Matthew Bull and Nigel Plummer wrote, “Imbalance of the normal gut microbiota have been linked with gastrointestinal conditions such as inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS), and wider systemic manifestations of disease such as obesity, type 2 diabetes, and atopy.” So not only is it important to possess a microbiome—it’s also important to keep the little guys happy and functioning properly.

Amit Gajera and associates noted that patients with IBD must endure frequent colonoscopies because of their higher risk for colorectal cancer. However, the prep often becomes burdensome. “Additionally, oral BP has been noted to possibly induce colon mucosal inflammatory changes in some patients, which may be misleading when assessing actual disease activity,” they wrote. Mucosa visualization is critical to IBD diagnosis, so the disruption of gut mucosa caused by oral purgative-based preps, “especially those containing sodium phosphate,” can skew the exam’s results.

In addition, they argued that mucosa can suffer injury from oral preps, especially those that contain sodium phosphate, “even to the point that it mimics CD.” One of the benefits of HygiPrep is that it does not use mucosa-affecting chemicals. “The prep induced peristalsis as the water gently flows in the gut lumen and naturally loosens the colon content, including that of the ascending (right) colon,” they wrote. “Therefore, this prep is likely to be less disruptive for the bowels of IBD patients and circumvents the disruptive nature of the oral purgative prep while providing a more accurate assessment of disease activity.”

While many practitioners argue that a nice colon cleanse is good for us, our bacteria family—if they could—would claim otherwise.

In a randomized controlled trial, Jonna Jalanka and associates examined two study groups who consumed prep in a single dose or two separated doses. The team examined fecal samples taken for a baseline, after bowel cleansing, and at 14 days and 28 days post-treatment. What they found was that although the patients’ bacterial communities were restored by 14 days, “the rate of recovery was dose dependent: consumption of the purgative in a single dose had a more severe effect on the microbiota composition than that of a double dose, and notably increased the levels of Proteobacteria, Fusobacteria and bacteria related to Dorea formicigenerans. The abundance of the latter also correlated with the amount of faecal serine proteases that were increased after purging.” Cleansing by using two separated doses turned out to be easier on the gut’s microbiota.

No one’s arguing that we should give up colonoscopies. But it’s good for practitioners to be aware of the prep’s impact on our microbiota, especially for patients with IBS, Crohn’s or other conditions that may be negatively affected.

As Gajera and associates wrote, “Using this BP for IBD patients can allow earlier interventions, significantly impacting disease management and future outcomes.” If the procedure increases compliance among IBD patients, it could also do the same among the general population.

The only thing hydrotherapy won’t change is the late-night comedy jokes.

Author

  • Lisa, a senior editor at EndoPro Magazine, has had a long career as an editor, writer and designer, with an emphasis on medical content.



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Advancing to Sterilization

Enhancing Patient Safety

The high infection rate associated with flexible endoscopes remains a significant challenge in healthcare globally despite advancements in reprocessing techniques. Endoscope-associated infections (EAIs) have been a persistent issue, with recent data indicating that infection rates following endoscopic procedures are higher than previously reported. The infection rate for certain endoscopic procedures can be as high as 1 in 1,000.1 Even with improvements in device design, reprocessing methods and equipment, and staff training and oversight, pathogen transmission from persistent contamination of flexible gastrointestinal endoscopes continues to occur.2

Human errors and variability are inevitable and can increase the risk of breaches in the reprocessing protocol. Staffing shortages, coupled with the complexity and length of reprocessing instructions, contribute to increasing time-constrained pressure on healthcare workers. It is imperative for healthcare organizations to use the most effective and robust reprocessing technology to reduce the chances of infection transmission and increase the margin of safety for patients.3

Infection Outbreaks

Inadequately cleaned endoscopes have been implicated in multiple drug-resistant organism (MDRO) infection outbreaks4 and continue to be reported to the FDA related to patient safety concerns. In cases of outbreaks related to MDROs, the failures in the processing or the equipment were not always identified even though the facilities followed the guidelines and manufacturers’ written instructions for use (IFU).4 “Flexible endoscopes are complex medical devices that require equally complex processes for effective cleaning and sterilization or HLD. Even the most rigorous processing methods can be undermined by the design of the device or contamination of the endoscope during handling, rinsing, drying, transport or storage.”5

Endoscope Design: A Reprocessing Challenge

The complexity of endoscope design, particularly in devices like reusable duodenoscopes, makes thorough cleaning and disinfection difficult, leading to residual contamination and subsequent infections.6 Reprocessing instructions can be very lengthy and describe more than 100 specific steps for personnel to execute. Current guidelines also do not specify a minimum amount of time required for manual cleaning, leading to wide variations in practice and potentially inadequate removal of bioburden.7

In recent years, most endoscope manufacturers have enhanced duodenoscope designs and brush models to improve cleaning and facilitate access to the intricately designed and hard-to-clean areas such as the distal end. Yet, the long lumens of these devices remain common sources of hidden microorganisms.7

Reprocessing: Increasing the Level of Assurance

The reprocessing of medical instruments is a critical component in ensuring patient safety in healthcare settings. Two primary methods used to decontaminate medical instruments are high-level disinfection (HLD) and sterilization, both of which aim to reduce the risk of infection transmission. These methods differ in their efficacy and procedures, as well as the level of safety they provide.

High-Level Disinfection vs. Sterilization: What’s the Difference?

HLD is a process designed to eliminate all microorganisms, except for bacterial spores, which are highly resistant to disinfection.8 HLD typically involves the use of chemical disinfectants and results in a lower margin of safety compared to sterilization. Sterilization, on the other hand, is the most thorough method for eliminating all microorganisms, including bacterial spores, viruses, fungi and bacteria. The process involves exposing instruments to high-pressure steam, gas or hydrogen peroxide vapor.8

The margin of safety decreases when processing flexible endoscopes, especially when using HLD instead of sterilization modalities.5 Evidence to support sterilizing all flexible endoscopes (semi-critical and critical) includes: high microbial load after patient procedure,4 complex design of flexible endoscopes, and risk for biofilm formation.4

Sterilization modalities also reduce the potential risks for an endoscope to become recontaminated post-disinfection. During HLD, the water, pipes and tubings used in automatic endoscope reprocessors (AERs) can potentially harbor harmful microorganisms if not monitored and disinfected routinely. Poor handling techniques post-HLD and during storage are also potential sources of transmission of microorganisms.9 Sterilized scopes are packaged and sealed prior to sterilization, reducing the risk of recontamination.

Sterilization: Elevating the Standard of Care

The goal of sterilization is to provide a higher level of assurance that all potential pathogens have been eliminated to minimize the risk of healthcare-associated infections (HAIs). As healthcare professionals strive to improve patient outcomes and reduce the incidence of EAIs, there is an increasing call to transition from HLD to sterilization.6 By adopting sterilization practices, healthcare facilities can better protect patients from the risks associated with endoscopic procedures, which contributes to safer and more effective healthcare delivery worldwide.

Sterilizing semi-critical devices enables compliance with Spaulding’s classification. Semi-critical endoscopes that enter a mucous membrane (non-sterile tissue), yet indirectly contact normally sterile tissue or enter the bloodstream, should be classified as critical devices.9 The Canadian Standards and Guidelines have classified bronchoscopes, laryngoscopes, cystoscopes and ureteroscopes as critical devices and have required their sterilization since 2018.10

High-risk endoscopes that have been associated with infectious outbreaks include bronchoscopes, cystoscopes, duodenoscopes, endobronchial ultrasound endoscopes, linear ultrasound endoscopes, and ureteroscopes. These scopes are difficult to process and pose an increased risk of incomplete cleaning of contaminating infectious organisms.4 According to AORN, “Sterilization provides the greatest margin of safety and assurance that the endoscope is safe for patient use. Correctly handled and sterilized items are rarely associated with patient infection.”5 Terminally sterilized endoscopes are rendered completely dry, packaged (which reduces the chance of contamination for longer periods of time), and are patient-ready. Packaged endoscopes have tamper-evident seals that clearly distinguish “used” endoscopes from “patient-ready endoscopes.”4

Culture of Safety

The Joint Commission has emphasized the importance of creating a culture of safety, notably in the context of medical instrument reprocessing. This culture focuses on reducing variations, reducing risk, and improving patient care with quality management systems.11

In the case of endoscopes, which are among the most used and complex instruments requiring reprocessing, the need for careful documentation and traceability is even more pronounced. With their high level of complexity, improperly reprocessed endoscopes can lead to significant patient harm. In the event of an endoscope-related infection outbreak, the ability to track each step of the reprocessing process is crucial to a rapid investigation and patient protection.12

Terminal sterilization offers a higher quality assurance over other modalities because the level of sterilization is accompanied by quality process monitors that verify the efficacy of the sterilization.13 By aligning the culture of safety, best practices and quality assurance, healthcare facilities can meet the highest standards of safety and quality of care.

Conclusion: Sterilization is the Gold Standard

Many people will become a patient receiving an endoscopy procedure as part of preventative or diagnostic healthcare in their lifetime. For healthcare providers and personnel who provide endoscopy procedures, there is great satisfaction in supporting patient care through these lifesaving procedures. Endoscopes play a vital role in the effective delivery of healthcare; however, risks associated with unintentional transmission of infectious organisms via endoscopes continue to be a significant concern. The complexity of endoscope design presents a challenge to achieving consistent and effective processing. Although risk-mitigation steps are detailed in manufacturers’ IFU, these steps fail to account for the high-risk design elements, such as long, internal lumens and recessed spaces that either cannot be visualized or are difficult to visualize.4

The process of improving patient safety in flexible endoscopy requires clear guidance on endoscope processing, effective training and competency verification of personnel, comprehensive quality-control systems, validated methods for ensuring adequate processing, and designing processes with margins of safety that account for the level of risk associated with use of these devices.14 As part of this process, the healthcare industry should support and encourage continued research and partnerships between endoscope, reprocessor and sterilizer manufacturers to elevate the standard of endoscope processing from high-level disinfection to sterilization.4

Current guidance from professional organizations recommends sterilization whenever possible for processing reusable flexible endoscopes that are manufacturer-validated for sterilization.4,5 Many endoscopy departments and facilities have successfully transitioned the processing of high-risk endoscopes to low-temperature sterilization.15 Through thoughtful planning and staff education, healthcare facilities can implement changes in endoscope processing practices and workflow with minimal disruption. Leaders can positively influence the success of these transitions by keeping their teams focused on the outcomes of preventing infection outbreaks and improving patient safety.

References

  1. Saleh N. Post-endoscopic infection rates are higher than ‘1 in a million’. MDLinx. Published July 12, 2018. https://www.mdlinx.com/article/post-endoscopic-infection-rates-are-higher-than-1-in-a-million/lfc-2029.
  2. Benowitz I, Moulton-Meissner HA, Epstein L, Arduino MJ. The Centers for Disease Control and Prevention Guidance on Flexible Gastrointestinal Endoscopes: Lessons Learned from Outbreaks, Infection Control. Gastrointest Endosc Clin N Am. 2020 Oct;30(4):723-733. doi: 10.1016/j.giec.2020.06.009. Epub 2020 Aug 1. PMID: 32891228; PMCID: PMC7962740.
  3. Ofstead, C. L., Buro, B. L., Hopkins, K. M., Eiland, J. E., Wetzler, H. P., & Lichtenstein, D. R. (2020). Duodenoscope-associated infection prevention: A call for evidence-based decision making. Endoscopy International Open, 08(12), E1769–E1781. https://doi.org/10.1055/a-1264-7173
  4. Association for the Advancement of Medical Instrumentation (AAMI). American National Standards Institute (ANSI). ANSI/AAMI ST91:2021. Flexible and semi-rigid endoscope processing in health care facilities. AAMI.
  5. Association of PeriOperative Registered Nurses. (2023). eGuidelines for Perioperative Practice: Flexible Endoscopes.
  6. Adler, D. G, Yu, A., & Barakat, M. T. (2024). Frontiers in endoscopy, Series #89 Disposable endoscopes: Current status and future directions. Practical Gastroenterology. https://practicalgastro.com/2024/03/19/disposable-endoscopes-current-status-and-future-directions/
  7. van der Ploeg, K., Vos, M. C., Erler, N. S., Bulkmans, A. J. C., Mason-Slingerland, B. C. G. C., Severin, J. A., & Bruno, M. J. (2024). Impact of duodenoscope reprocessing factors on duodenoscope contamination: a retrospective observational study. Journal of Hospital Infection, 154, 88–94. https://doi.org/10.1016/j.jhin.2024.09.018
  8. Centers for Disease Control (CDC) and Prevention. (2008;2024). Guideline for disinfection and sterilization in healthcare facilities. U.S Department of Health and Human Services. https://www.cdc.gov/infection-control/hcp/disinfection-and-sterilization/index.html
  9. Rutala, W.A., Weber D. J. (2023) Reprocessing semicritical items: An overview and an update on the shift from HLD to sterilization for endoscopes, p.98 American Journal of Infection Control https://doi.org/10.1016/j.ajic.2023.01.002
  10. Canadian Standards Association (CSA) Group, National Standard of Canada (2023). Canadian medical device reprocessing in all healthcare settings, Z314:23, 12.6.1, p.161
  11. The Joint Commission. (2025, January). Comprehensive Accreditation Manual for Nursing Care Centers ( CAMNCC) Update 2, 2025, Patient Safety Systems, number 4 CAMNURSINGCARECENTER_PS_Jan_2025.pdf, p.1
  12. Multidisciplinary and Multisociety Practice Guideline on Reprocessing Flexible Gastrointestinal Endoscopes and Endoscopic Accessories. (2020). Clinical Endoscopy, 53(3), 276–285. https://doi.org/10.5946/ce.2020.106
  13. Klacik, S.G., Transitioning from High-Level Disinfection to Sterilization for Semicritical Devices, AAMI/ARRAY, 2019, Transitioning from High-Level Disinfection to Sterilization for Semicritical Devices, https://array.aami.org/doi/epdf/10.2345/0899-8205-53.s2.23
  14. (2022). Infections Associated with Reprocessed Duodenoscopes. FDA. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes
  15. Nadeau, K. (2024, August 27). Key Considerations for Transitioning Scopes from HLD to Sterilization. Hpnonline.com; Healthcare Purchasing News. https://www.hpnonline.com/sterile-processing/article/55129311/key-considerations-for-transitioning-scopes-from-hld-to-sterilization

Authors

Breaking the Burnout Cycle

Cures for the Nursing Shortage

Burnout and a shortage in healthcare, particularly in nursing, have reached a critical point. Even before the pandemic, the nursing profession faced challenges such as an aging workforce and increasing demand for care. Today, the situation has escalated, with 42 out of 50 U.S. states projected to experience a critical nursing shortage by the year 2030. This shortfall makes it increasingly difficult to meet the patient-care standard of one nurse per four patients, leaving healthcare systems struggling to keep up.

Experts anticipated this crisis over a decade ago, citing the impending retirement of a significant portion of baby-boomer nurses. The global pandemic then pushed the already strained system to its near breaking point.

The impact of understaffing creates a vicious cycle. Fewer staffers means heavier workloads, leading to burnout and more resignations, which further exacerbates the problem. This results in higher patient loads, longer wait times, increased stress for healthcare workers, and a greater risk of errors—all contributing to poorer patient outcomes.

Having endured the strain of the pandemic and its impact on healthcare workers, the system now has an opportunity to change. By addressing the root causes of burnout and supporting nurses through better staffing and workplace improvements, we can break this cycle and ensure a stronger, more resilient healthcare system.

Leveraging Technology

Technology is transforming the way we train future nurses by enhancing practical learning and creating opportunities for students to navigate real-life ethical decisions. Nursing schools, such as the Arizona College of Nursing, now utilize advanced simulation labs that immerse students in realistic environments—from hospital rooms to home-care settings. These labs allow students to refine critical skills in scenarios that closely mimic real physiological responses.

Before entering clinical rotations, students gain hands-on experience in identifying heart and lung symptoms, assisting with childbirth, recognizing strokes and practicing other vital skills. They also lead their peers in active clinical decision-making, preparing them to handle complex situations with confidence.

In addition to improving training, technology can alleviate stress for healthcare workers by streamlining administrative tasks, scheduling and communication. Reducing these burdens helps create better outcomes for both healthcare teams and patients.

Flexibility and Accessibility in Nursing

There is a pressing need to expand opportunities for career changers and nontraditional students by offering flexible scheduling, especially for those balancing school with other responsibilities.

Working three consecutive 12-hour shifts—often stretching to 14 hours or more—is unsustainable and a direct path to burnout. Staff scheduling should prioritize manageable workloads to support long-term retention and well-being.

To meet the growing healthcare demands, the profession must be accessible to students from diverse backgrounds and life situations. Many students today juggle school, work and family obligations. By providing flexible options and resources to help them overcome potential barriers, we can support their success and build a stronger, more inclusive healthcare workforce.

Providing a Network of Support

Nursing is an incredibly challenging profession, both academically and in practice. Educators and clinical partners must work together to prepare nurses for the realities of the job, including how to handle loss, stress and tough decisions. Offering mentorship, individualized learning opportunities and mental health resources can significantly reduce burnout.

Partnerships between clinical organizations and educational institutions are vital. These collaborations help new nurses transition smoothly into the workforce, reducing “first-year burnout” and ensuring they are fully prepared to deliver quality care. Support roles across healthcare systems must also adapt to evolving needs, as they play a crucial role in sustaining a functional and healing environment.

By addressing these areas—technology, flexibility, and support—the healthcare industry can take meaningful steps toward breaking the cycle of burnout, addressing staffing shortages, and creating a sustainable future for nurses and their patients.

Author

AfterCare: Vacation on a Small Island

In Which I Embrace Prescribed ‘Down-Time’

“Little islands are all large prisons; one cannot look at the sea without wishing for the wings of a swallow.” — Sir Richard Francis Burton

A small island?

Well, the ‘bed’ I’ve been sleeping on in my living room during my first three weeks of recovery is scarcely a twin—it’s a chaise lounge on risers, dimensions 30 inches wide and 70 inches long, shared most nights with two frisky, two-year-old kits ‘of unusual size.’ However, it’s been an experience I wouldn’t trade for anything.

Why is that? When I was told that the plan post-op (left knee replacement, late January 2025) was six weeks of home physical therapy three times weekly, I reframed it as an opportunity.

“When life gives you lemons, sell them and buy a pineapple.” — Davin Turney

I don’t know about you, but after the COVID crisis waned, I had wondered what I might have chosen to accomplish if I had known going into the isolation just how long it would last. At least, I’d have done some ab work or yoga for increased flexibility (and who couldn’t benefit from some ab work?). Here I am, gifted with six weeks within my home, not allowed to descend my entry stairs until greenlighted by Carolyn, my amazeballs physical therapist.

“Small islands of coherence in a sea of chaos have the capacity to shift the whole system to a higher order.” — Ilya Prigogine, Nobel Prize-winning chemist

So, I made a list. Those who know me snort at this—my method of coping with anything is list making, strategizing and planning—and I am quite satisfied when I achieve between 50-75 percent of my goals. I make lists on the backs of junk mail envelopes, 3 x 5 cards, my bullet journal. For this project, I broke out the “Big Paper.” What is this, you may ask? It’s a pad of 2 x 3-foot Post-It note paper that I use when facing a long project with many facets over time. Yes, the paper is similar in width to my cot.

What are the highlighted plans for my six weeks on a small island? By the way, my small island includes the aforementioned cot, a bathroom with walk-in shower, shower chair and raised toilet seat, kitchen, living room with large-screen TV, and my desk and computer. Laundry and my expansive queen bed are just out of my reach upstairs. Hardly an average prison cell.

“Life is a mind game. Decide what game you’re going to play with your mind.” —Anonymous

For mental stimulation, I am reading my local book club assignments (last week, the club met at my home, and the ladies brought the healthy party food), continuing my daily dose of Duolingo (over one year of Italian lessons), watching selected documentaries (“Best of” lists for both Netflix and Amazon) and reading nonfiction for 30 minutes daily.

“You don’t get anything clean without getting something else dirty.” — Cecil Baxter

I started a TDAD project; standing for “Two Drawers A Day” in which I select drawers that matter to me in no other order for clean out/straightening. These include drawers in my nightstand, desk, kitchen, TV stand, pantry, storage areas … the only limit is that they are within reach of seated me. Go, me! I’m feeling so decluttered. I also cleared up some accounting issues requiring patience and my über-pleasant telephone voice for over a week, started organizing my taxes (as it would truly bite to still have those to do in March having been sequestered throughout February), and organizing my recipes (I have three bins of printed recipes that needed sorting and filing. I’m partway through; it’s not a fun task, but necessary).

“Don’t forget to drink water and get some sun. You’re basically a houseplant with more complicated emotions.” — Anonymous

I did well with twice-daily moisturizer (face soft as a baby’s bottom, with both moisturizer and being sequestered from the harsh weather of February), my home PT (twice a day), and making good food choices. I’ve enjoyed using my kitchen’s abundance of dried legumes. I also had the welcome support of friends, as they entertained me when invited for book club, Mexican Train dominoes and frozen margaritas, and twice-weekly lunches (I ordered, and they picked up). Not compliant with planned chair yoga, Pilates core work, and daily meditation. Ah, well.

“We talked of mice, the cat and I, and of the importance of napping.” ― Catherine Gilbert Murdock

In addition to frequent visitors, I leaned on my two-year-old sibling kits, Finley and Evie. When not napping, we’ve done well with daily play with wands and laser lights, and with treat/ clicker training. We are all three failing at kit dental hygiene.

“The monotony and solitude of a quiet life stimulates the creative mind.” — Albert Einstein

I’m enjoying plant care for my numerous houseplants (and the IKEA rolling cart makes an excellent functional watering and pruning walker), but haven’t had a hankering to do other creative outlets on my suggested list. Like crocheting scrub pads, doing Zentangle, or painting rocks. Meh—I guess I was thinking like a creaky lady when I made that Big Paper list. As a callback to the COVID days, I’ve embraced online shopping spending time and cash at ThredUp, a well-designed online clearing house for stylish thrifted clothing.

So, what’s next?

“Remember that life is an ADVENTURE, and cheer ‘Whee…’ all the way down the slippery razor-blade of life.”— Jonathan Lockwood Huie

I’m halfway through my six-week confinement and am still of sound mind and heart. I will plan to up my game with that missing core and flexibility work, a focus on feline oral hygiene, and get the tax prep completed by the last week of my incarceration. Additionally, I’ve just rented the adult son of a friend (in between his archeology master’s degree and his first dig, with time to spare) to work on household projects I cannot yet accomplish.

“Every island to a child is a treasure island.”— P. D. James

And when I’m done? A brand-new knee, and an experience I wouldn’t have traded for anything. I have indeed treasured this experience in time.

Author

  • Pat is a retired gastroenterologist and educator savoring the 3rd third of her life in coastal Virginia. She completed her gastroenterology fellowship at the Medical College of Virginia oh, so long ago, and after a 30-year gastro practice in south- eastern Virginia and thriving professional speaker and broadcast career, is a popular provider of second opinions in gastroenterology for 2nd MD, now educating people one by one. You will likely find her in her greenhouse or gardens, either propagating fig trees or growing much of her vegan diet organically with donated rabbit poo.

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TechTalk: The Ultimate Litmus Test

Are We Ready to Sterilize Endoscopes?

The effectiveness of a sterilization process is contingent upon a successful preparation phase, the proper operation of equipment, and the expertise of the reprocessing technician. Currently, most flexible endoscopes are subjected to high-level disinfection (HLD), with only a limited number validated for sterilization, despite a growing number of infections and outbreaks reported by the Food and Drug Administration.

Earlier this year, the FDA announced it is investigating the source of 450 infections associated with patients who underwent procedures involving urological endoscopes. These cases, which occurred between January 2017 and February 2021, are documented in Medical Device Reports submitted to the FDA. According to the FDA, inadequate reprocessing of the scopes used in these procedures could cause infections.

In an April letter regarding these investigations, the agency recommended high-level disinfection or low-temperature sterilization to mitigate infection risks. These incidents and subsequent investigations have sparked a debate among experts about the most effective reprocessing method for these delicate instruments to ensure patient safety.

Keeping It Clean

Sterilizing flexible endoscopes is important. While most flexible endoscopes typically undergo high-level disinfection, sterilization remains a crucial part of their reprocessing, along with their accessories. However, a common misconception is that if items are placed in a sterilizer and the cycle is completed, those items are automatically considered sterile.

This is far from the truth.

In reality, the device cannot be deemed sterile if the steps leading up to sterilization are not meticulously performed. For sterilization to succeed, proper cleaning, testing, inspection, assembly, positioning, packaging and loading must be done correctly.

Cleaning an endoscope is recognized as the most vital step in its reprocessing. Inadequate cleaning can leave residual debris that obstructs effective disinfection, significantly increasing the risk of infection transmission to patients. This concern is amplified by the sensitive nature of the internal channels and the likelihood of significant bacterial contamination from bodily fluids encountered during procedures. Ultimately, the guiding principle remains: “You can’t disinfect what isn’t clean.”

Cleaning is imperative because any delay in the process allows organic material to stay on the endoscope, forming a biofilm. This biofilm effectively shields bacteria, making them far more challenging to eliminate. Strong disinfectants or sterilants often fail to penetrate through residual debris, leaving pathogens viable and posing a risk of transmission to other patients. Due to the critical infection risk, healthcare facilities are obligated to follow stringent guidelines for endoscope reprocessing to ensure the prevention of infection transmission.

According to Cori Ofstead, MSPH, founder and CEO of the medical research firm Ofstead & Associates, the sterilization process is “more rigorous than high-level disinfection and provides a much larger margin of safety.”

Sterilization offers much greater assurance of eliminating microbes and provides a substantial safety buffer against potential patient infections. This is due to the more thorough kill rate achieved during sterilization. Sterilization is often characterized by a significantly more significant “log reduction” than disinfection, typically reaching a higher log10 reduction of microbes. This underscores the critical importance of sterilization in ensuring patient safety in healthcare settings.

The Best Agent for the Job

There are a few methods for sterilizing endoscopes today: ethylene oxide (EtO), vaporized hydrogen peroxide (VH2O2), paracetic acid, and plasma. EO is not commonly used but still exists in some areas. EtO is a colorless, flammable gas used mainly as a sterilizing agent for medical equipment and certain food products like spices, as it can effectively kill bacteria even on materials that cannot be sterilized with heat; however, due to its potential to cause cancer with prolonged exposure, it is considered a hazardous air pollutant, and its use is strictly regulated by environmental agencies like the EPA.

Vaporized Hydrogen Peroxide

VH2O2 is a form of hydrogen peroxide that exists as a vapor. It is harnessed primarily for its antimicrobial properties in various sterile environments. This versatile agent decontaminates enclosed spaces such as hospital rooms, laboratory workstations and aircraft interiors, playing a critical role in infection control and bio-decontamination processes. One of the standout features of VH2O2 is its effectiveness in sterilizing heat-sensitive medical devices. Traditional sterilization methods, such as autoclaving, rely on high temperatures that could damage delicate instruments.

In contrast, vaporized hydrogen peroxide can effectively eliminate many pathogenic microorganisms, including bacteria, viruses, and fungi, without requiring elevated temperatures. This property makes it particularly valuable in hospitals and other healthcare settings where maintaining the integrity of medical instruments is crucial.

When exposed to air, VH2O2 breaks down into harmless byproducts: water and oxygen. This transformation underscores its reputation as an environmentally friendly disinfectant. Moreover, when vaporized, hydrogen peroxide molecules can penetrate various surfaces effectively. This penetrative ability enhances its capacity to kill microorganisms in hard-to-reach areas, making it an efficient choice for thorough disinfection.

Low-temperature sterilization is perfect for applications involving materials that are sensitive to heat. Certain plastics, electronic components, and other fragile materials that cannot withstand traditional sterilization techniques can be safely treated with vaporized hydrogen peroxide. Some endoscopes on the market today, such as bronchoscopes, cystoscopes and rhinolaryngoscopes, are validated for VH2O2 sterilization.

However, while VH2O2 is recognized for its antimicrobial efficacy and safety in many applications, it has some drawbacks. High concentrations of vaporized hydrogen peroxide can lead to potential skin irritation or respiratory discomfort if inhaled, emphasizing the need for adequate ventilation during application. Proper monitoring protocols are essential to maintain a safe working environment while using this agent. Additionally, VH2O2 can be corrosive to certain materials, limiting its use in specific contexts or requiring careful selection of compatible materials.

Overall, vaporized hydrogen peroxide is a powerful and effective solution for sterilization and decontamination. It combines high efficacy against various microbes with a relatively safe and environmentally benign profile.

Peracetic

Peracetic acid is a powerful liquid sterilant (LCS) utilized with a specialized liquid chemical sterilization system to disinfect heat-sensitive medical devices effectively. In this process, the device is fully immersed in the sterilant, ensuring thorough exposure to eliminate pathogens, and subsequently rinsed to eliminate residual sterilant.

During the rinsing phase, the water is meticulously treated to eradicate or neutralize harmful microorganisms, including bacteria, viruses, protozoa and fungi. This makes the system adept at processing various flexible endoscopes commonly used in multiple medical procedures.

Although this system is classified as a point-of-use sterilizer, it is essential to note that if the disinfected devices are not immediately used and are instead stored after the sterilization cycle, their status changes from sterile to high-level disinfection, which may not ensure complete safety against microbial contamination. The entire sterilization cycle is precisely timed at 30 minutes, utilizing a neutral pH use dilution specially formulated to protect delicate instruments from potential damage. Given the chemicals involved, personnel handling the sterilization must don appropriate personal protective equipment to ensure their safety and minimize exposure risks.

Gas Plasma

Plasma sterilization is an innovative and efficient process designed to eliminate microorganisms from surfaces using the unique properties of gas plasma. This method operates at low temperatures, making it exceptionally suitable for items that are sensitive to heat, such as delicate medical devices, advanced electronics and various agricultural products. The process begins by injecting hydrogen peroxide into a specially designed vacuum chamber. Inside this chamber, the hydrogen peroxide is vaporized, transforming into a gas that thoroughly permeates the enclosed space. Radio-frequency or microwave energy is then applied to create the plasma, causing the hydrogen peroxide gas to ionize and form a reactive plasma state. This plasma is rich in free radicals, which are highly energetic particles capable of damaging the cellular structure of microorganisms, disrupting their vital functions.

As the sterilization process unfolds, the plasma undergoes a transformation and ultimately breaks down into harmless by-products: water and oxygen molecules, both nontoxic and environmentally friendly.

One of the standout features of plasma sterilization is its effectiveness against various microorganisms, including resilient bacteria, stubborn fungi and harmful viruses. Moreover, this method can significantly reduce cycle times compared to traditional sterilization techniques, enhancing efficiency in settings that require rapid turnaround. Plasma sterilization proves invaluable for sanitizing medical instruments, especially those prone to corrosion. This allows for safe, reliable use in critical healthcare applications. Plasma sterilization is a cutting-edge solution for maintaining hygiene and safety in numerous sensitive environments.

Mission Critical

The growing momentum to adopt sterilization protocols for endoscopes is primarily driven by the substantial risk posed by patient-to-patient transmission of infections linked to inadequately disinfected instruments. This concern is particularly acute for endoscopes interacting with mucosal surfaces, such as gastrointestinal scopes that are directly exposed to internal bodily environments. Sterilization techniques provide a markedly enhanced level of decontamination, eliminating nearly all types of microorganisms, including highly resistant spores that can survive standard disinfection processes. These spores can potentially initiate severe infection outbreaks that can have dire consequences for patient health if not addressed through rigorous decontamination practices.

Moreover, the intricate and often sophisticated design of endoscopes— including their narrow lumens, complex moving parts, and multiple channels—presents significant challenges for thorough cleaning and adequate disinfection. This complexity increases the likelihood of residual contamination and emphasizes the necessity for reliable sterilization methods to ensure patient safety and prevent the risk of infection. The shift toward a sterilization approach is essential in addressing these critical concerns and protecting patient well-being.

High-level disinfection (HLD) is widely recognized as the gold standard for reprocessing semi-critical flexible endoscopes. This classification stems from the Spaulding Classification system, which categorizes medical devices based on their risk of infection; according to this system, most flexible endoscopes are designated as semi-critical devices. During diagnostic and therapeutic procedures, these devices make close contact with intact mucous membranes. Still, they typically do not penetrate sterile tissues within the human body, and this factor influences the appropriate level of disinfection required.

Disinfection is a critical process defined as “the method to inactivate viable microorganisms to a level that is considered safe for a specific purpose” (ISO 15883-4:2018). HLD is particularly important in this context, as it ensures that the endoscopes are sufficiently disinfected to prevent infection while maintaining their functionality and integrity.

Despite ongoing discussions surrounding sterilization techniques, there is a lack of substantial evidence demonstrating that sterilization yields significantly better clinical outcomes compared to high-level disinfection. As a result, HLD continues to be the preferred and most widely accepted method for processing flexible endoscopes, balancing efficacy in infection control with practical considerations of device handling and patient safety.

In policy, the Centers for Disease Control and Prevention aligns with the Food and Drug Administration: if a medical device can be sterilized, it should be sterilized. The FDA actively encourages manufacturers to sterilize any device, as proper sterilization is crucial for preventing patient infections and is considered a standard practice for medical devices that come into contact with sterile body tissues or fluids. If the margin of safety is higher with sterilization, the facility should use the method with the highest level of validated reprocessing methods.

The ultimate litmus test is what is best for the patient.

Author

  • Roberta is the president and CEO of RLH Consultants, LLC, located in southern New Jersey. The company was founded in 2021 and provides SPD and GI consultations, quality assurance assessments, competency assessments, design of sterile processing areas (in hospitals, surgery centers, dental practices, FQHC healthcare facilities, and endoscopy processing areas), on-site training, virtual training, and certification-preparation education and training.



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Reaching New Heights

The Summit Medical Group Ambulatory Surgery Center

At Summit Medical Group Ambulatory Surgery Center in Berkeley Heights, New Jersey, one factor that makes the team excellent is “the working relationship and the trust that the physicians and the staff have for one another,” said Kimberly Bujnowski, director of nursing.

The Summit facility is a multi-specialty center with six rooms, three of which are dedicated to endoscopy procedures. “We perform colonoscopies, upper endoscopies and endoscopic ultrasounds,” Bujnowski said. The staff includes seven gastroenterology technicians and eight RNs.

As a part of VillageMD, Summit Health is dedicated to envisioning a world where people “live longer, healthier lives in stronger communities.” The group’s focus is advancing healthcare by providing high-quality, compassionate care that keeps patients’ needs and best interests firmly front and center. “Our team is patient-focused, and the physicians, nurses and technicians work cohesively to ensure the best patient care possible,” Bujnowski said.

As with most top-notch endoscopy centers, excellence doesn’t just happen. At Summit Medical, it starts with education— specifically, the Certified Endoscope Reprocessor certification available  through  the  Healthcare  Sterile  Processing Association. “The department made the decision to require CER certification for our employees in 2024,” Bujnowski said. “Despite the challenging period, the vast majority have obtained certification as required. By doing this, the staff will be kept up to date on evolving regulatory standards.”

Before an applicant can even be considered for testing, they must first complete three months of hands-on work experience. The hours can be completed on a professional or volunteer basis, but they must include reprocessing endoscopes in a medical center, hospital, surgery center, or independent endoscope center, according to the HSPA. They wrote, “firsthand experience is essential to supplement an individual’s understanding of the necessary knowledge and concepts of reprocessing, and to illustrate their practical use. This experience must include the pre-cleaning, testing, decontaminating, inspecting, disinfecting and/or sterilizing, transporting, and storing of endoscopes.”

The subsequent exam was developed “to measure the un- derstanding of endoscope care and handling and infection prevention,” according to the HSPA. Study materials recom- mended include:

  • HSPA’s Endoscope Reprocessing Manual (2nd ed.)
  • ANSI/AAMI ST91 (2022 ed.)
  • CDC’s Essential Elements of a Reprocessing Program for Flexible Endoscopes (2017 ed.)
  • Articles by the Society of Gastroenterology Nurses and Associates (SGNA): Standard of Infection Prevention in the Gastroenterology Setting (2019), and Standards for Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes (2018)
  • SGNA’s Guidelines for Use of High-Level Disinfectants & Sterilants in the Gastroenterology Setting (2017 ed.)

Certification doesn’t stop there. Certificate holders must recertify every year by taking continuing education.

And the dedication pays off. Roger Klein, M.D., observed, “The team is so proficient that they are able to anticipate patient and physician needs which helps make the day run smoothly and efficiently.”

The team works hard, but they also take time to recharge by hosting potluck lunches. According to Bujowski, the staff has an off-site dinner on a quarterly basis, and they end the year “with a huge holiday party as we celebrate the conclusion of a fantastic year and the start of an even better one. The staff really enjoys the events and contribute by choosing themes, location and—most importantly—food.”

Hazar Michael, M.D., said, “What makes the team special is that the staff is diligent about their work, and they take pride in and enjoy their work.”

Water Works

Is Hydrotherapy a Good Colonoscopy Prep?

Any medical professional who works at a gastroenterology office knows the importance of a good colonoscopy prep for patients. A poor prep equals poor pictures. Done deal. It’s that simple. But also simple: Everyone hates the standard prep process. Our cover story this month focuses on colon hydrotherapy and whether it makes for a good prep alternative.

In the precursor to this publication, EndoNurse Magazine, we long ago did a cover story that asked whether colon hydrotherapy should be more widely used as a prep. I was intrigued by the article and the very topic of hydrotherapy, because as we all know, the compliance rating for standard colonoscopy prep is too low. I was open to potential solutions. Colon hydrotherapy sounded like a decent alternative, but the method was far from mainstream. That was about 15 years ago, and not a lot has changed in this regard.

When I was searching recently for a gastroenterologist I tried to find one who would allow hydrotherapy as a prep, since I have all the same fears of a traditional prep that most people have. My tract is already troubled enough, thank you. I don’t want to throw violent diarrhea and potential vomiting into the mix. I live in a large metropolitan area (okay, it’s urban sprawl: Phoenix, Arizona) with a huge number of gastroenterology practices and yet I couldn’t find any that accept hydrotherapy as a prep (and that accept my insurance).

Could I have tried harder? Probably. But it’s still safe to say that the average gastroen- terologist wants the standard prep, the whole prep, and nothing but the prep. That was certainly true for my gastroenterologist. Our conversation on the topic went as follows:

Me: Do you have an opinion on colon hydrotherapy as a prep? Her: Not happening. Don’t ask.

Me: So it’s not an option?

Her: Never. Next question. But not about hydrotherapy.

Not the best conversation I’ve had! She ended up retiring a month later, anyway, and my insurance won’t cover the procedure until July, so I’m waiting. I’d still like to be able to try the alternative, or at least find a gastroenterologist who will discuss it.

Do you have any opinion on hydrotherapy as a prep alternative? If so, I’d love to hear it! Please email me at [email protected]. For the cover story, “The Ups and Downs of Hydrotherapy: An Alternative Colonoscopy Prep,” visit p. 16.

Author

  • Michelle has worked as a journalist, editor in chief and communications professional for more than 20 years with 12 years specializing in healthcare, including as editor in chief for the EndoNurse media brand. She’s the editor, ghost author and co-author of several books.



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Robotics in Pulmonary Endoscopy

Leading Change Through Collaboration and Growth

Traditionally, endoscopy departments focus on procedures of the gastrointestinal system. When I joined this field at the end of 2023, that focus was evident in the expertise and training of my team. Many of my colleagues are experienced endoscopy professionals with strong backgrounds in gastrointestinal procedures.

In recent years, however, interventional pulmonary services grew, and a few team members learned these procedures, adapting as new technologies emerged. In early 2024, a switch in robotics providers impacted some of these procedures, and we decided to transition them from the operating room to an endoscopy suite.

As a newly appointed leader to the department, my motivation to focus on growing pulmonary procedures was driven by the combination of both the lure of untapped potential and the support of an exceptional team. With my background in cardiac and pulmonary nursing, I was naturally drawn to this area of care.

Beyond personal interest, I saw the hidden promise both in the geographic area and in the organization. Southern New Jersey, despite its proximity to Philadelphia and Manhattan, is densely populated enough to warrant its own local, expanded healthcare services. Our location is near several casinos (a known source of respiratory exposures) which further highlighted the need for specialized, accessible pulmonary care.

Our endoscopy team is engaged, intelligent and motivated to provide excellent care. The providers within interventional pulmonology possess all those qualities, along with a willingness to be flexible, teach and grow with the team.

Another key factor in success is that the program had executive support and aligned with organizational strategic goals. I embraced my role as both an advocate for the program’s growth and a facilitator of its operational success.

Assembling the Team

Knowing how few team members were specialized in robotic pulmonary care, we addressed this gap by focusing the initial deployment on team members who were engaged with the previous robotic implementation. The recipe to develop this pulmonary care team was a simple one, and we already had all the ingredients. With support from our partners at Intuitive Surgical, we facilitated on-site training in Atlanta.

We continue to fine-tune our processes, focus on cross-training more team members, and find ways to streamline turnover methods— which ultimately have increased procedural capacity. The more procedures we can do, the more diagnoses we reach—leading to prompt treatment, faster responses and better outcomes for our patients and communities.

This has been both deeply impactful and inspiring work, but translating progress into the day-to-day operations can be daunting. One significant challenge was ensuring this growth of pulmonary procedures did not feel like a burden for the team, but instead an opportunity for improved patient care, personal impact and professional growth.

Staffing presented another layer of complexity to consider. Balancing a steady volume of patients along with organizational and unit-ba- sed changes impacting team morale required thoughtful navigation.

Additionally, the operational shuffle of pulling team members offline for training in an intricate new process required strategic planning to maintain team cohesion and patient coverage.

Overcoming Obstacles

Our department, together with the operating room, previously utilized a different robotic system for navigational bronchoscopies. Although this was effective, it posed significant operational challenges. It required extensive setup and takedown, necessitating patient transport and at least an hour of preparation time.

Previously, all of these cases had occurred in the operating room, demanding the movement of equipment—such as protective lead aprons, specimen containers, medications, etc.—as well as staff across multiple areas of the hospital. This logistical burden decreased the amount of time our team could spend with direct patient care.

To address these inefficiencies, we held many discussions about how to more seamlessly integrate the program into the endoscopy unit. Clear communication was a priority, so I spoke with each team member involved to be sure they understood the rationale behind these changes. We talked through what was needed in an effective handoff.

I gathered their input on what an ideal implementation would look like. With their feedback as a guide, I worked to remove obstacles and secure whatever resources they needed to succeed. Strong representative presence helped the team in realtime. When I encountered challenges beyond my expertise, I sought advice from colleagues. I asked a lot of questions.

We collaborated closely with radiology, IT, IT security, and Intuitive’s team to ensure seamless integration with the PACS system. (A PACS, or picture archiving and communication system, stores medical images and reports).

We collaborated with sterile processing. Additionally, we engaged with colleagues from other disciplines to enhance the patient ex- perience, ensuring it was efficient and patient-centered. The dedication and investment of the pulmonary team to their patients and exceptional care delivery was evident throughout.

Milestones and Achievements

In just four months, our team achieved a remarkable milestone, completing over 50 cases and increasing our daily procedural volume from two navigational bronchoscopies per day to five. This was a testament to the team’s collective efforts and dedication.

We celebrated this together, with our providers emphasizing the difference prompt, accurate diagnoses can make in the life of a patient. In one instance, the pulmonary team was able to sample from a lymph node that would have previously required a sternotomy to reach. This was a significant clinical milestone for the endoscopy team to participate in and witness.

We learned to adapt as we saw issues arise. We adapted the scheduling models to ensure patient care coverage was more than adequate.

The outcome? Proficiency grew.

In five months, the percentage of the endoscopy nurses proficient in these cases grew by 250% and technicians showed a 100% growth, doubling their team’s proficiency! Team members were engaged and satisfied. To ensure efficiency and reduce fatigue, we implemented a buddy system for cases and room breakdown. This ensured refreshed perspectives and maintained high standards of care throughout the day.

Lessons Learned

The most important lesson learned throughout this process was that partnership and collaboration are tantamount to success.

Endoscopy teams already handle a complex workflow, managing high-level disinfection, and partnering with procurement for inventory management. The team routinely performs POUT (Peri-Operative chemotherapy versus surveillance in upper-tract urothelial cancer), manual cleaning, automated disinfection, forced air drying, protein-testing and storage management. In this case, a key partnership with the hospitals’ sterile processing department was essential for parts that cannot be immersed and needed sterilization.

The new robotic system introduced new challenges, such as parts with defined case-lives. This required reconfiguration of how the inventory for each of these parts were managed. The team devised a couple strategies to manage stock electronically, pivoting when necessary and partnering with our buyers.

Delicate Nature

Given the delicate nature of robotic parts—with sensors and small components—case setup and room turnover became more intricate. These and other processing challenges were met with training, repetition, troubleshooting support, more training, and ongoing collaboration to ensure the team was equipped to adapt effectively.

Procedural space constraints added another layer of complexity.

Geographic changes to the procedural room and on the unit are ongoing and prove critical to optimize turnover time and workflow efficiency. Even small adjustments, such as the direction a door swings, can significantly impact procedural flow. By working with facilities and construction management we explored new layouts for the equipment and procedural personnel. Regular check-ins with the team allowed their feedback to be incorporated in decisions about space utilization, workflow and room layout.

We made changes gradually to facilitate adaptation and align with budget constraints. We empowered the team members by involving them in decisions. This approach fostered a sense of shared ownership.

This implementation taught me a few things as well, such as that I work with some incredibly talented people. I also learned that over- communication is unlikely (but forgivable) when undertaking a process change.

Questions are essential.

My main summary after this process is that I’m so proud of my team and I’m inspired by their successes. They are truly phenomenal.

Author

  • Nicole is a clinical leader focused on delivering results, both in excellent patient care and in providing support to her teams. She currently oversees endoscopy services in two New Jersey hospital campuses. Her clinical background also includes telemetry and medicalsurgical unit leadership, clinical supervision in cardiac/progressive care and oncology acute care, and direct patient care. Nicole enjoys traveling, eating good food, spending time with her loved ones and dogs, and having fun—both in and outside of work!



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Digestive Enzymes for FODMAPs

How FODZYME Educates Providers

Research has shown that a diet that is low in fermentable oligo-, di-, monosaccharides and polyols (FODMAPs) helps manage abdominal pain, bloating, and other digestive symptoms in 70-75% of patients with irritable bowel syndrome (IBS). However, the low-FODMAP enzyme supplements can be challenging and access to registered dietitians (RDs) and other healthcare providers trained in the low-FODMAP diet is limited.

I would know.

I’m an RD with a specialty in gastrointestinal (GI) nutrition, and I provide education and resources on FODMAP intolerances to gastroenterologists (GIs), nurses, RDs and other providers.

I’m also part of the team at Kiwi Biosciences, the biotechnology company behind FODZYME. FODZYME is a novel digestive enzyme blend specifically designed to break down the most common FODMAP triggers: fructan, galacto-oligosaccharides (galactans/GOS) and lactose.

FODZYME’s Founding Story

FODZYME was developed based on personal experience. When Anjie, our cofounder and CEO, was forced to restrict herself from enjoying her favorite foods on an effective (yet frustrating) low-FODMAP enzyme supplements, she rallied a group of world-class experts in research, medicine and nutrition to create a scientific approach to break down FODMAPs before they cause digestive distress. This novel approach to managing FODMAP intolerance led to the creation of FODZYME and enabled her to put foods like garlic, onion, wheat, chickpeas and more back in her life.

Some patients find the low-FODMAP diet too hard to follow. They may experience cravings, increased food stress and anxiety, development of disordered eating behaviors, nutrient deficiencies and troubling alterations in gut microbiota.

Since day one, our mission with FODZYME has been to provide digestive relief and improve the quality of life for patients with FODMAP digestive enzymes issues. We’ve very much valued our partnerships with professional gastroenterology organizations, research institutions, hospitals, clinics and our world-class advisors, including Dr. Bill Chey, chief of the division of gastroenterology and hepatology at Michigan Medicine. Digestive enzymes are increasingly recognized as a highly effective tool for those with FODMAP intolerances to ensure nutritional adequacy, dietary flexibility, symptom relief and quality of life.

The Power of Digestive Enzymes

Broadly speaking, enzymes are specialized proteins (chains of amino acids) folded in particular ways. FODMAP-targeting digestive enzymes are designed to break down FODMAPs in foods before they can trigger symptoms.

There’s a mature body of research supporting the efficacy of digestive enzymes for FODMAPs intolerance, and their long-term safety is well-recognized. However, I’ve found many healthcare providers rarely utilize this science with patients until they learn about FODZYME.

In fact, guidelines published in the Journal of Neurogastroenterology and Motility on how to implement the low-FODMAP diet into gastroenterological and nutrition practice recommend the use of digestive enzymes for symptom management and to allow for more dietary flexibility during the third personalization phase of the low-FODMAP diet.

Monash University, the leading research institution on FODMAPs and the low-FODMAP diet, also recommends use of digestive enzymes to enable a less restrictive diet long-term while managing symptoms. For example, digestive enzymes allow for increased intake of tofu, peas, legumes, nuts, soy, whole grains, dairy and many other nutrient-rich, high-fiber foods to avoid nutritional deficiencies and their consequences.

FODMAP Digestive enzymes are also recommended prior to or in lieu of a traditional low-FODMAP diet in patients with bloating, gas and other lower-GI symptoms who are not good candidates for the three-phased diet. Those who already identify high-FODMAP foods as triggers (such as garlic, onion, wheat and beans) can benefit from digestive enzymes right away. Patients at increased risk for disordered eating or with other contraindications for a restrictive diet (e.g., children and the elderly) can use enzymes alongside their existing diet.

A Scientific Approach

FODZYME represents two layers of innovation: a highly efficacious powder format and a proprietary Fructan hydrolase supplement. Let’s dive into both.

The importance of a powder format

It’s crucial to maximize FODMAP-enzyme homogenization as soon as a meal is consumed, which is why FODZYME is a powder. FODMAP digestive enzymes begin work as soon as they come into contact with FODMAPs and are most effective when they can freely homogenize with food. A powder facilitates greater contact between the enzymes and their target FODMAPs at the post-prandial gastric pH most favorable to FODMAP breakdown, which leads to greater efficacy than a pill or capsule.

In fact, Fodmap digestive enzymes in capsules or pills are a less efficacious method for delivering carbohydrate-targeting enzymes, as they isolate enzymes from their intended target and may be deactivated in the stomach before coming into contact with FODMAPs. (Note: this is not the case for prescription enzymes; these enzymes are generally encapsulated to delay release until arrival in the small intestine.)

FODZYME’s Novel Fructan Hydrolase Supplement

FODZYME is a blend of natural enzymes featuring fructan hydrolase, lactase and alpha-galactosidase. FODZYME’s fructan hydrolase supplement adds to the scientific and clinical field with its novel ability to break down the broad spectrum of fructans, including levan, inulin and fructooligosaccharides, which each vary in their chain length and linkages.

Fructans are widely recognized as the most common FODMAP trigger in IBS.

Furthermore, fructans and galactans/GOS provide particular benefits for digestive health by supporting short-chain fatty acid production (SCFA). These fibers are also in many high FODMAP foods that patients may have trouble tolerating. We’ve conducted extensive peer-reviewed research, published in the journal Gastro Hep Advances, to confirm that FODZYME administration with prebiotic fiber reduces but does not deplete SCFA production, suggesting that use of digestive enzymes with prebiotic-rich foods is favorable to overall colonic health than avoiding FODMAPs altogether.

In other words, with digestive enzymes, patients can more readily follow a high-fiber diet and benefit from fiber’s protective role against many gastrointestinal diseases, such as colon cancer.

Ongoing Research

Our team and research partners are regulars at the top nutrition and GI conferences, where we frequently exhibit and present. In 2022, we presented our findings at Digestive Disease Week (DDW) on FODZYME’s in-vitro efficacy.

We recently presented three abstracts on our clinical work at conferences including the Food & Nutrition Conference & Expo (FNCE), the American College of Gastroenterology (ACG) and North American Society for Pediatric Gastroenterology and Nutrition (NASPGHAN). Findings from these studies showed that after four weeks of FODZYME use, patients reported significantly less bloating, diarrhea, constipation and abdominal pain. While I cannot reveal too much here, we anticipate having additional publications on our clinical research to share in 2025.

Furthermore, our R&D on additional ways to develop products that support those with digestive issues continues. In our pipeline are novel approaches to tackle additional FODMAPs groups, like polyols such as mannitol and sorbitol.

Supporting Providers

Standard training for healthcare providers rarely covers in any depth how to integrate digestive enzymes into patient care. The educational programming I run aims to change that.

Our resources for healthcare providers include training on how to manage FODMAP intolerances while minimizing the impact of dietary restriction. We offer dozens of free trainings and materials for the clinicians, such as:

  • Webinars: Presented by expert GI clinicians, our free continuing-education webinars cover a wide-range of GI nutrition topics.
  • Educational handouts: Our free handouts for patients provide accessible, practical education on FODMAPs and how to effectively use digestive enzymes. The library also includes time-saving resources for providers to reference in their practice.
  • Clinic trainings: As an RD with deep expertise in Fodmap enzyme supplements, I often present on clinical application of enzymes and how to integrate them into the patient-care process.
  • 1:1 Calls: Providers come to me with specific questions on complex cases, counseling approaches and our research, and I welcome the opportunity to share my knowledge with them.

It’s a privilege to support the diverse community of healthcare providers in our network. All these resources are available on demand on our website, fodzyme.com/partners.

Beyond background on FODMAPs, the benefits and potential cons of a low-FODMAP diet and the science of Fodmap digestive enzymes, points I emphasize are:

How to identify FODMAP intolerances?

FODMAPs tend to cause trouble 4-8 hours after a meal, which is when they generally reach the colon and trigger gas, bloating, diarrhea, constipation and abdominal pain. This can be a very helpful clue to watch for when helping patients get to the root of what may be driving symptoms. This also means that when using FODMAP-targeting enzymes, patients should expect to see a benefit roughly 4-8 hours after a high-FODMAP meal.

The pathogenesis of FODMAP intolerance

Except for lactase, the body does not produce enzymes for FODMAPs. Rather, FODMAP intolerances arise from alterations in the gut microbiota (dysbiosis), increased sensitivity to digestive processes (visceral hypersensitivity), their osmotic effect, and other miscommunications between the gut-brain-axis, although research remains ongoing.

Contraindications for the low-FODMAP diet

Restrictive diets must be implemented with extreme sensitivity in many groups, such as children, the elderly, pregnant women and other populations with additional energy and nutrient needs or challenges meeting them. Patients with low interest or ability to implement a low FODMAP enzyme supplements are also less likely to find symptom relief if they do try to follow one. These patients are better suited to a simplified FODMAP approach or alternative interventions.

Safety profile of digestive enzymes

Over-the-counter digestive enzymes for Fodmaps work on food (not the body). The enzymes will be metabolized like any other dietary protein if they do not break down in contact with FODMAPs, and their byproducts are excreted. They can be safely used as frequently as, and for as long as, FODMAP intolerances persist.

FODMAP Freedom

I’m passionate about educating on how FODMAP digestive enzymes provide benefits beyond symptomatic relief by enabling a more nutrient- dense, diverse diet. The many providers using FODZYME with their patients support us in our mission, as well. The most rewarding moments are when I hear success stories about how their patients are enjoying the foods they love without worry or pain.

“The best compliment I get from my patients is when they finally have freedom to eat what they love. FODZYME is so small [and] easy to use and now my patients can go out to their favorite restaurants. My patients have been enjoying high-fiber meals that are painless and make them feel good.”

— Dr. Kumkum Patel, M.D., board-certified gastroenterologist specializing in IBS

Dietary freedom also means patients can enjoy the integral cultural and social role food plays. From feeling free to join a communal family meal, to having the confidence to enjoy a catered meal at a friend’s wedding, patients who have been reluctant to expand their diet due to food fears or anxiety gain invaluable psychological benefits from digestive enzymes for Fodmaps.

“This has been life-changing. I’m able to dine out without worry. I no longer have excessive bloat after those meals.”

— Jennifer, FODZYME user of three years

Conclusion

For those with IBS, digestive enzymes allow for a tailored, nutritionally robust diet. Dietary flexibility and inclusion of delicious, high- FODMAP foods is possible with digestive enzymes for Fodmaps, even among the most FODMAP sensitive.

Our commitment at FODZYME is to educate healthcare providers on dietary and non-dietary lifestyle strategies to manage digestive symptoms. We all know IBS is a chronic condition that requires lifelong management. This makes it especially vital that providers can ensure their patients achieve adequate nutritional intake and can enjoy the many psychosocial pleasures of food with a plan that is sustainable on the long-term.

 

Foods FODZYME Helps Patients Tolerate:

Author

  • Jocelyn is a registered dietitian with a master’s degree in clinical nutrition. She specializes in gastrointestinal nutrition and leads educational programming for clinicians, nutrition communications and industry partnerships at FODZYME. Jocelyn holds a BA from Duke University, a Masters Degree in Clinical Nutrition from New York University and is a Registered Dietitian Nutritionist.



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