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Candida Disrupts the Gut's Harmony

Every time I hear the term “candida,” I flash back to the 1970s, hearing Tony Orlando and Dawn singing. But I doubt it was an ode to these invasive yeasts.

The genus candida are regular denizens of our microbiome, operating in a happy symbiosis with us and our other gut bugs. Any fungal overgrowth is generally held in check by our immunological response. But as with all things in our digestive tract, it doesn’t take much to get the community balance out of whack; if we experience a change in diet, an uptick in stress, a new medical condition, or our immune system goes sideways for any one of a host of reasons, then our healthy bacteria’s numbers can take a precipitous slide. Candida takes advantage of this loss with all the enthusiasm of a four-year-old offered unlimited chocolate cake, proliferating like rabbits on Viagra.

S. A. Syed wrote how “alterations in gut flora and gene regulation raise the risk of opportunistic fungal infections in cases of immune system weakness or following antibiotic usage. Due to its ability to stick to tissues and create enzymes that dissolve barriers, candida thrives. Low immunity, improper use of antibiotics, chemotherapy, and endocrine or  nutritional  problems  are some  of  the  contributing causes to candida’s growth.”

Although  Candida  albicans gets all the press, Chung and associates wrote in the journal

Oncotarget that at least 15 others also colonize our bodies. According to Syed, “the five most prevalent pathogens— Candida albicans, Candida glabrata, Candida tropicalis, Candida parapsilosis, and Candida krusei—account for more than 90% of invasive diseases.”

It’s candida’s adaptability to its host that allows it to catch fire with immunocompromised patients, and it’s not picky about its incubator. Chung and associates wrote, “CI frequently involves the mouth, vagina, glans penis, esophagus, liver, gastrointestinal tract, respiratory tract, and skin.”

In the vagina, candida causes vaginal candidiasis; in the mouth, it’s known as thrush. The overgrowth can appear in the bowel movements of sufferers as white, yellow or brown mucus; a white, yellow or brown string-like substance; froth or foam; or diarrhea. Candida granuloma—severe and chronic— can appear on the skin, scalp, mouth or fingernails, while cutaneous candidiasis manifests as an itchy, raised red patch of pustules on folds of skin under the arms and breasts or in the groin area. Symptoms can also include white patches in the mouth, swelling, a burning sensation and cottage cheese– like vaginal discharge.

When candidiasis is at its worst, it becomes systemic: Invasive candidiasis is a serious infection of the blood or on the membranes that line the heart or brain, affecting some 25,000 U.S. patients per year.

And everyone’s a candidate. No one is immune to the possibility of overgrowth, but some folks make better hosts: pregnant people (thanks to the fluctuating hormones), diabetics, babies, hospitalized patients, and those with dentures and catheters are all at higher risk of candidiasis. In a patient with immune deficiency, candida can bloom like a wildfire out of control.

For most of us, an overgrowth of candida is mostly annoying, causing itching and discomfort. Systemic symptoms can include headache, fatigue, stomachache, flatulence, itchy skin and craving for sweets. If a patient who is receiving treatment for candidiasis develops a fever and chills, they should immediately call a doctor.

No one should shrug off these symptoms; untreated, candida can turn invasive and can even cause precancerous conditions that slide into cancer. Chung and associates wrote, “CI is not an infrequent complication of cancer and cancer-related therapy, and it may also play an active role in cancer development. The relationship between microbial infection and cancer is of great concern.”

They  argued  that  “several plausible mechanisms” support this  premise.  “First, Candida can produce compounds such as nitrosamines, which are identified carcinogens that play a role in oral cancer initiation,” they wrote. “Second, a previous study suggested that C. albicans promotes cancer through a proinflammatory response, mediated by an increase in cytokine production and adhesion-molecule expression. It is increasingly clear that the tumor microenvironment, which is largely orchestrated by inflammatory cells, is an indispensable participant in the neoplastic process. Other hypotheses, such as the induction of Th17 response and molecular mimicry, have also been proposed to explain the mechanism by which C. albicans might promote cancer progression.”

The First Date

For many women, our first experience with candidiasis showed up when we started taking oral contraceptives. For others, symptoms developed as side effects of various other medications: antibiotics, steroids, proton pump inhibitors, or medicines that cause dry mouth or “turn off” healthy bacteria. Additional triggers include a diet high in refined carbohydrates and sugar; uncontrolled diabetes, HIV, smoking, cancer, or anything that compromises the immune system; hormonal changes; and stress.

Candida isn’t contagious, exactly, but it can be spread by physical contact. Breastfeeding mothers can pick it up from babies who have thrush, and spouses can transfer it back and forth through sexual contact, including via oral sex. The disease seems to have no affiliation for gender or age; while the average age of infected patients is 57.4 years, other factors can influence its proliferation.

Practitioners diagnose candidiasis via tests and examination, including a physical exam and culture test. Average folks can chase off an outbreak with over-the-counter meds and a little time. Other at-home remedies include keeping the skin dry; limiti ng the use of anti bioti cs and hormone-disrupti ng birth-control methods; limiti ng sugary foods and keeping blood sugar in check; quitti ng smoking; and avoiding stress and heavy alcohol consumpti on. Oft en, this is enough to keep the proliferati on in check.

But for those with a compromised immune system, candidiasis is a whole other story.

Open Up Wide

The innate immune barrier in the esophagus is where the defense against candida begins, with the nonkeratinized strati fi ed squamous epithelium. If a pati ent has a candida overgrowth in the esophagus, it will show up as yellow-white patches, or plaques that cannot be removed, oft en in combination with oral thrush. Although herpes simplex virus and cytomegalovirus are among the other nasties that can cause infectious esophagitis, the most common type is esophageal candidiasis. While the oropharynx has the dubious distinction of being the most susceptible part of the GI tract to candida infection, the esophagus is second in line. And plaques can be found throughout the esophagus, or localized in the upper, middle, or distal areas.

Symptoms can include pain or difficulty swallowing, nausea, pain in the sternum area, heartburn, vomiting, weight loss, diarrhea, and melena, depending on the extent of esophageal damage. Abdimajid Ahmed Mohamed and associates wrote in the Canadian Journal of Gastroenterology and Hepatology that diagnosis may indicate

“(1) acute infection: extremely weak immunosuppression patients often die of acute fungal infection; (2) subacute infection: subacute infection may result in esophageal stricture or pseudodiverticulum; (3) chronic infection: usually from childhood, chronic infection is often associated with submucosal fungal infection and immunodeficiency.”

After confirming candida via endoscopic examination and subsequent biopsy, practitioners can contain the overgrowth with systemic oral antifungal drugs. However, “It is important to differentiate esophageal candidiasis from other forms of infectious esophagitis such as cytomegalovirus, herpes simplex virus, gastroesophageal reflux disease, medication-induced esophagitis, radiation-induced esophageal injury, and inflammatory conditions such as eosinophilic esophagitis,” Mohamed wrote. Complications can include necrotizing esophageal candidiasis, fistula and sepsis.

Further along in the gut, candida can cause gas, abdominal pain, diarrhea, nausea, bloating and cramps, among other symptoms. Patients who have some manner of compromise in the digestive tract—for example, Crohn’s disease, ulcerative colitis, gastric ulcers, duodenal ulcers and perforated ulcers—are more likely to present with candidiasis.

Syed wrote, “The three main risk factors for GI candidiasis are radiation, intestinal inflammation, and recurrent GI surgery.” But anything that compromises the immune system, including leukemia and lymphoma, or the use of cytotoxic drugs, corticosteroids or antibiotics, can cause a flare.

And candida’s toxic effects are increasing morbidity and mortality worldwide. According to Zhe Feng and associates in Frontiers in Cellular and Infection Microbiology, “When the human immune system is compromised, C. albicans can rapidly transition from nonpathogenic to pathogenic fungi, resulting in superficial or deep candidiasis, including thrush and candidemia.” Severe candidiasis kills approximately a million people worldwide every year—no small source of concern to healthcare practitioners.

Testing, 1, 2, 3

Diagnosing an overgrowth can be tricky; histological evidence can’t be determined from sputum or stool specimens, simply because candida is a normal part of the GI tract’s normal flora. An endoscopic biopsy sample “may exhibit pathological characteristics, including multiple abscesses and an acute inflammatory response. Pseudohyphae and fungal spores are typically observed, with neutrophils predominating,” Syed wrote.

Generally, a combination of clinical symptoms and notable growth is enough for a diagnosis. And if therapy helps, you know you’re on the right track. “The alleviation of dysphagia and substernal pain that occurs after systemic anticandidal therapy is indicative of candidal esophagitis,” Syed wrote. “Because dysphagic individuals run the danger of developing strictures, esophagoscopy is advised.”

Clinicians have three popular weapons in their arsenal against candidiasis: the small-molecule antifungal medications polyenes, azoles and echinocandins. However, each has limitations.

While polyenes like amphotericin B and nystatin have been around since the 1950s, they “can induce significant adverse effects as a result of the structural resemblance between the intended target, ergosterol, and cholesterol, a sterol found in mammalian cell membranes,” Zhe Feng and associates wrote. However, as Darius Armstrong-James wrote in Parasite Immunology, “antifungal resistance to this class of drugs has not significantly emerged during this time, although there are some fungal species with intrinsic resistance, such as Aspergillus terreus and Candida lusitaneae.”

Echinocandins (caspofungin, anidulafungin and micafungin) boast a commendable safety profile and are efficient fungicides, but cost, IV administration and narrow antifungal range inhibit their practical use. Armstrong James wrote, “They target beta-1,3-D glucan synthase, inhibiting the production of beta-1,3-D glucan, an essential fungal cell wall component.”

Azoles, with their low toxicity and broad antifungal efficacy, are a popular choice. They “have the advantage of a better toxicity profile and, importantly, are available orally. Fluconazole has specific utility for Candida albicans and Cryptococcus neoformans but no activity for Aspergillus species and patchy utility across dermatophytes and endemic mycoses,” Armstrong-Hames wrote.

In addition, according to Feng, “their fungistatic effects in certain species have led to the emergence of azole-resistant isolates.” Also, the effectiveness of these treatments decreases in patients who are immunocompromised.

Other options include terbinafine, “an ergosterol inhibitor with good oral bioavailability and activity against dermatophytes and dematiaceous (black) moulds,” Armstrong-Hames wrote, and flucytosine, a flurouracil pro-drug that suffered a rapidly emerging resistance that has limited it to adjunctive use.

A recent study in the journal Microbiology Research investigated the antifungal efficacy of vitamin D₃ (VD₃) against candida. The authors, Junwen Lei and associates, concluded that VD₃ may have “multitarget effects,” reducing the fungal burden in the liver, kidneys and small intestine. They wrote, “these findings suggest a new antifungal mechanism for VD₃ and indicate that VD₃ could be an effective therapeutic agent for use in [intra-abdominal candidiasis] treatment.”

While other antifungals are in the research pipeline, there’s just no magic bullet. And the need to find one is growing.

A New Attitude

One possible therapy addresses the patient’s immune system itself. Generally, the immune system will target the fungal invader, producing inflammatory factors and activating phagocytes to attack the infection. Feng, et al., wrote, “[In] addition to playing a crucial role in initiating early defense against fungal infections, the innate immune system also triggers various responses promoted by the adaptive immune system through [dendritic cells].” Two types of adaptive immunity—cell-mediated immunity and humoral immunity— combine to build a powerful immune defense against candida… when the immune system is working properly.

When it isn’t, Feng wrote, “immunotherapeutic approaches exhibit potential as a novel strategy for treating candidiasis, owing to the significant involvement of the human immune system in managing this condition. Immunotherapies encompass therapeutic approaches aimed at targeting and impacting the immune system of the body, thereby enhancing the host’s ability to combat infections (Qadri et al., 2023). These methodologies encompass various strategies, such as augmenting the population of phagocytes, activating innate defense pathways in phagocytes and DCs, and stimulating antigen-specific immunity through means like vaccines and monoclonal antibodies.”

Antibody-based medications, Feng wrote, have exhibited positive outcomes; compared to small molecule drugs, antifungal antibodies “present a diminished occurrence of adverse reactions and a broader array of choices.” And combining antifungal medications with monoclonal antibodies provides a one-two punch against the drug resistance seen in candida.

This also “enhances specificity,” potentially becoming an asset to better patient outcomes. Novel immunomodulatory techniques integrating the regulation of recombinant cytokines with monoclonal antibodies may enhance those antibodies’ therapeutic efficacy, according to Feng. “Moreover,” they write, “emerging technologies offer promising avenues for the treatment of life-threatening invasive fungal infections.”

This immunotherapeutic approach must always take into account the immunocompromised condition of the patient, as it’s necessary to customize the therapeutic intervention. Candida-generated proteins can be effectively targeted by antibody-based medications; a side benefit is fewer adverse reactions and a “broader array” of choices, according to Feng. When combined with antifungal medications, the monoclonal antibodies can help combat rising drug resistance in candida. And because the monoclonal antibodies are patient-specific, they hold the potential for improved clinical outcomes.

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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If You Process Scopes, You Must Stay Updated

As a nurse and patient advocate, I feel very uncomfortable when I visit a facility and discover their practices do not meet the current guidelines or national standards for endoscope processing. Today, there are so many opportunities to easily get up-to-date information, so why isn’t everyone in our field getting that information?

For many years in my profession I have been told, “If we have been doing it this way all this time and we have no infections, why change?” I’ve also been told, “I’m too busy.”

We all know that the past five years have been challenging, with COVID-19 and the aftermath, and all the mental and economic challenges that come with constant changes to healthcare. Many of us are still struggling and have excuses, but are any of the excuses acceptable? Whose responsibility it is to ensure current information and standards are readily available so that devices can be correctly processed? Who is ensuring there is adequate staffing to comply with the manufacturer’s instructions for use for processing endoscopes?

How often do we hear about a facility breach in protocol that required letters to be sent to patients? The patients usually need to have bloodwork to see if an exposure occurred. Sometimes the alert comes from the Food and Drug Administration—or from the manufacturer itself—regarding a problem identified with a product or device. Who is designated at your facility to receive such alerts and ensure the information is given to management for follow-up?

As professionals, we all fear the word “litigation.” To avoid litigation, healthcare providers must comply with established

standards of care. Standards of care arise from regulations based on state and federal legislation or statutes. Regardless of the term used, they are the law. So to keep our endoscopes patient-ready and safe, it’s our duty to keep abreast of the most current information.

Practice guidelines, such as from AAMI, CDC, AORN and SGNA, are all applicable. Guidelines are developed by professional organizations and their members with expertise. Input can be solicited from the members before the guideline is published. However, when AAMI publishes a national standard (represented as ANSI/AAMI National Standard) it is a very different process.

“Standards are consensus documents that provide requirements,  specifications,  guidelines  or  characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. AAMI develops standards documents aimed at enhancing the safety, efficacy, safe use and management of medical devices and health technologies. A standard may recommend to a manufacturer the information that should be included with a product, basic safety and performance criteria, and conformance measures that can be used to assess compliance. The inclusion of design specifications in a standard is permitted when circumstances warrant, but design specifications usually are avoided as they can hinder the advancement of technology. A standard may provide clinical users with guidelines for the use, care, evaluation or processing of medical devices.” ~ AAMI standards webpage

All AAMI documents are peer-reviewed by committee members and then sent out for public comments. AAMI committee members include product users as well as manufacturers. Once a document is completed it must be approved by a majority of the voting committee members. After approval, the document goes to the AAMI board for review and approval. If the document is to be a national standard, then the AAMI board refers the document to the American National Standards Institute (ANSI) for designation as a national standard.

When surveyors visit facilities, they will sometimes ask on what references the facility bases its processes. Some facilities use a combination of AAMI and a professional organization’s guidelines (e.g., SGNA or AORN).

In 2015, AAMI published ANSI/AAMI ST-91, “Flexible and Semi-Rigid Endoscope Processing in Healthcare Facilities.” This should be the bible for endoscope processing activities. Guidelines from other organizations are also applicable if the material is not covered in ST-91. A revised and updated version of ST-91 was published in 2021.

Practice guidelines and facility policies/ procedures are often introduced as standards of care by a prosecuting attorney trying to prove that negligence has  occurred,  meaning you  either complied with them or did not. On the other hand, a defense attorney can use the same guidelines and policies/ procedures as evidence that standards of care were met. Therefore, having policies and procedures to direct safe practice is critical to patient safety. To do this, you should reference your processing policies to the standards and guidelines used.

To  comply with  standards  and  guidelines  also  means compliance with all device processing equipment (e.g., AER) and chemical manufacturers’ instructions for use (IFU). Do you have the staffing, recommended cleaning implements,  testing  equipment,  chemicals,  processing equipment, etc., to ensure a device is safe when used on the patient?

Keeping informed is vital. Keeping processing staff updated on all matters pertaining to endoscope processing is the primary responsibility of the department or nurse manager. There are several ways to keep staff updated.

Join the Professional Association for Your Practice Area

The Society for Gastroenterology Nurses & Associates (SGNA), for instance, is a vital resource. All professional organizations have annual meetings as well as local (state) meetings that include educational programs. Seminars are also a good way to meet new colleagues. In addition, seminars often have vendor exhibits where you can see new products that can improve your practices. Join the AAMI, or at least purchase their national standard, ANSI/AAMI ST-91, to use as the baseline for endoscope processing practices.

The Joint Commission, the nation’s oldest and largest standards-setting and accrediting body in healthcare, was established in 1951 as an independent, not-for-profit organization. Its 21-member Board of Commissioners includes physicians, administrators, nurses, employers, quality experts, a consumer advocate and educators. Its offerings include accreditations and certifications, and it influences public policy through its advocacy office in Washington,

D.C. The Joint Commission expects facilities to reference its policies or specific national standards or guidelines used for its policies.

Most professional organizations have online help for questions and access to their guidelines. These same organizations offer memberships that often include regular meetings to provide education and updates on products and endoscopic procedures. Their guidelines may be offered at no cost to their members. Their websites usually have a list of all their member resources.

Sign Up for FDA Alerts

On  the  FDA  webpage,  you  can subscribe to the Center for Devices and Radiological Health (CDRH) mailing list based on your area of specialty. This will potentially alert you via email regarding pertinent information about medical device issues. While the CDRH was hit with layoffs in April of this year, the organization has not shut down. You can find them here: https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health

Attend Seminars and Webinars

Since the COVID-19 pandemic, with social distancing recommended and restrictions being placed on travel, virtually all organizations have relied on virtual education. Since then, it has become the norm for most of us, and today, it’s easier than ever.

Many companies that produce products used in endoscopy offer free educational programs. Contact these companies to sign up for alerts when they offer a program. Most of these programs offer continuing education credits as well. Some companies record their educational programs so you can still partake in the education on-demand when you are available. Many of these programs directly relate to endoscope processing.

Subscribe to Practice-Related Magazines

Practice-related  magazines  offer  new  information  and educational articles. For example, EndoPro Magazine and Healthcare Purchasing News, to name two. These magazines also have vendor ads where you can learn about new products or services. Make these magazines available to staff.

Documentation

Documentation is important because records can be subpoenaed in a court of law and can be used in court proceedings. Documents may also verify that staff members were properly trained. One of the most important pieces of documentation is employee training records for endoscope processing. The documentation should include details on the training used for all processing equipment, including automated dosing units (to dispense detergents), automated flushing devices, leak testers, automated endoscope reprocessors, equipment to test the accuracy of the leak tester, cleaning effectiveness testing products, and so on.

Documentation should include at a minimum the following information:

  • training instructors
  • annual competency assessments for all aspects of endoscope processing
  • dates of training and tasks/practices covered
  • the requirement to comply with manufacturer’s IFU for all equipment and products used
  • donning and doffing PPE needed for processing endoscopes
  • training provided on all makes and models of endoscopes
  • transport of used endoscopes
  • leak-testing procedures and verifying the accuracy of the leak tester
  • manual-cleaning protocols
  • inspection of endoscopes for all phases of endoscope processing
  • borescope use (if applicable) to inspect channels of endoscopes
  • quality-assurance testing of endoscopes after cleaning and before high-level disinfection  (e.g., cleaning effectiveness testing)
  • transport of used scopes, transport of processed scopes, storage of scopes
  • drying of scopes
  • transport and storage of processed endoscopes
  • transport of HLD endoscopes to the procedure room

Documentation should also include the results of a return demonstration for each task. In addition, the action taken if any return demonstration failed (e.g., whether the employee was retrained, dates of retraining, by whom, when the second return demonstration was performed, and the results.) Another piece of documentation that is critical is the employee’s annual competency verification for processing activities.

According to ANSI/AAMI ST-91, annual competency verification is “an activity designed to substantiate or confirm the ability of an individual to complete a particular skill, task, complex series of tasks, or behavior necessary to perform effectively.”

Competency assessments should include the following:

  • competencies for every make and model of endoscope
  • transport of used scopes (including documentation of when point-of-use treatment was performed)
  • use of PPE when handling used scopes (including donning and doffing)
  • compliance with manufacturer’s IFU for cleaning
  • use of specific cleaning brushes/equipment recommended in the IFU
  • leak testing/documentation of test results
  • verification of leak tester’s accuracy/documentation of results
  • selection and use of detergents
  • manual cleaning/inspection
  • automated flushing devices (if used)
  • drying/inspection of scopes
  • use of the high-level disinfectant, including MEC testing of the solution before use (if applicable)
  • manual HLD (if applicable)
  • use of the automated endoscope reprocessor (AER) including interpretation of printout
  • use of cleaning effectiveness testing tool with documentation of test results
  • transport of disinfected scopes
  • storage of scopes
  • transport of HLD scopes to the procedure room

Compliance with Stated Policies

It’s one thing to have policies referenced to current standards and guidelines, but are staff members always following those policies? There is no excuse for noncompliance with an endoscope reprocessing policy. Each step in the IFU must be followed to ensure a safe device for the patient. To ensure staff compliance, random audits should be performed, including verification of compliance with the manufacturer’s instructions. This can be done via observation and questioning.

Also, audits can be performed to verify compliance with stated policies. For example, monitor transport of used scopes, documentation records for accuracy, etc. AAMI, as well as other professional organizations, recommend that annual risk assessments be performed to determine needed areas of improvement.

Summary

Endoscope processing personnel need to be kept updated. Encourage your processing staff to achieve certification in flexible endoscope reprocessing and to keep updated in new practices and standards. Encourage competence by supporting their attendance at seminars/webinars. All staff members who attend conferences or webinars should be required to provide

a summary of the information disseminated at the educational program, so the remainder of the staff benefits as well. Virtually all continuing-education programs offer CE credits which support recertification efforts for processing staff.

We have a moral obligation to patients to provide the best care based on the most current national standards and guidelines. It is your responsibility. Get involved! Develop policies and procedures based on these standards and guidelines. Provide in-service opportunities for staff regarding policies and procedures that have been developed or updated. Review your processing policies on a routine basis.

Perform audits to ensure staff compliance with your policies. It’s important to remember that when you don’t comply with a stated policy, you can be found negligent. So, who is processing your endoscopes? What is their competency level? Were they given the tools to provide a patient-safe scope? As W. Edwards Deming said, “Learning is not compulsory; it’s voluntary. Improvement is not compulsory; it’s voluntary. But to survive, we must learn.”

 

Author

  • Nancy Chobin, RN, AAS, ACSP, CSPM, CFER, is the president and CEO of Sterile Processing University, LLC, an online education and continuing education website.

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The Difference Between Standards and Guidelines

As a sterile-processing professional, I’m often asked, “Which standards or guidelines should I follow in endoscopy?”

It’s no wonder people get confused when there are so many healthcare organizations that develop guidelines for endoscopy, such as the Association for the Advancement of Medical Instrumentation (AAMI), the Association of peri-Operative Registered Nurses (AORN), the Society of Gastroenterology Nurses and Associates (SGNA), the Association for the Practitioners in Infection Control (APIC) and multi-society guidelines, among others.

People often want to know which to follow in their practice setting. It has been my experience that most facilities follow guidelines developed by the professional organization to which they belong. In a hospital setting, the operating-room staff most likely will follow AORN’s guidelines for processing  flexible  endoscopes,  while  the  endoscopy department will follow SGNA. Much of the content of various guidelines have similar recommendations, but there can be practices not covered in the guidelines or that are in contrast to guidelines from another organization.

According to the National Institute of Health (NIH), “U.S. Standards  are  authoritative  statements  that  articulate minimal, acceptable or excellent levels of performance or that describe expected outcomes in health care delivery, biomedical  research  and  development,  [healthcare] technology,  or  professional  [healthcare].  Guidelines are  statements  of  principles  or  procedures  that  assist professionals in ensuring quality in such areas as clinical practice, biomedical research, and health services. Practice guidelines assist the [healthcare] practitioner with patient care decisions about appropriate diagnostic, therapeutic, or other clinical procedures for specific clinical circumstances.”

Healthcare professionals utilize the guidelines from their respective organizations to guide their practice. Often these practices relate to clinical matters. However, there is a difference between the two.

Standards

According to the Association for the Advancement of Medical  Instrumentation,  requirements,  specifications, guidelines or characteristics can be used consistently to ensure that materials, products, processes and services are fit for their purpose. AAMI develops standards documents

aimed at enhancing the safety, efficacy, safe use and management of medical devices and health technologies (www.AAMI.org).

AAMI  is  not  a  regulatory  agency  and  its  standards are  voluntary.  AAMI  committees  that  develop  these standards consist of representation from both industry (manufacturers) and users (healthcare professionals from agencies such as HSPA, APIC, AORN and SGNA). Each committee is cochaired by a manufacturer representative and a user representative. In addition, the Food and Drug Administration (FDA) has representation on every AAMI committee to provide additional guidance when documents are being developed.

There is an opportunity for members to communicate their concerns to manufacturers and to learn the science behind the products and processes. For example, for a very long time, users asked for ultrasonic cleaners with greater capacity. It took a while, but now most ultrasonic manufacturers offer multilevel sonic machines.

When a document is developed, a proposal for a new document must be submitted by a member in good standing. Then the need for the new document is distributed to the members to determine if there is a need for this document. If the majority feel the document is needed, a call for committee members is made.

The committee members develop the document over a period of time (depending on the topic, this can take two years or more). A new document might take longer to develop. At each committee meeting (regular meetings are held each spring and fall) the progress on the document is discussed and reviewed by all members. Comments regarding content are submitted in writing and designated as technical or editorial.

However, all comments are discussed and either accepted, accepted with modification, or not accepted. This review process continues until the document is completed and all comments have been resolved. Then the document is placed out for ballot by the committee members. A majority of votes are needed to pass. If passed, the document is then reviewed by the public for comments. Following the successful comments/approval process for the public review, the document is sent to the AAMI board of directors for its review/approval. Since the document is a standard, it also needs approval from the American National Standards Institute (ANSI).

Then the document is known as ANSI/ AAMI [title of the document]. Standards always have a ST designation and a number as part of the document’s title (e.g., “Flexible and semi-rigid endoscope processing in health care facilities,” ST-91 2021). All standards are reviewed every five years and either reaffirmed (document still needed but no changes are needed); discontinued (no longer relevant), or needs updating (with changes).

Of Note …

Like  standards  and  recommended practices, an AAMI technical information report (TIR) addresses a particular aspect of medical technology. However, a TIR differs markedly from a standard or recommended practice in terms of the process followed leading up to publication. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the ANSI. A TIR is not subject to the same formal approval process and reflects primarily a technical committee opinion rather than a national standard.

Summary

I believe there should be standardization of practices for endoscopy regardless of the clinical setting. For clinical issues, clinical guidelines excel, as they are specialty-specific. However, when it comes to processing, that is where the confusion comes in, and confusion has no place in healthcare. If a national standard carries more weight than a clinical guideline, then how can we justify not following it?

According to an American Journal of Law article, “What we are learning, however, is that, in addition to varying in scope and quality, many CPGs [clinical practice guidelines] (such as those created for utilization review by payors or those promulgated by specialty societies, which may conflict with other specialty societies’ standards) are designed to meet the needs of the drafting organization, rather than defining a specific, applicable standard of care for every case.

“This has complicated the adoption of CPGs in establishing the standard of care in particular cases.”

In my opinion, when developing policies relating to care, handling and testing of endoscopes, AAMI ST-91 should be the reference for the reprocessing protocols since it is a national standard. Having more than one reference in a policy is acceptable and, in this case, recommended.

Author

  • Nancy Chobin, RN, AAS, ACSP, CSPM, CFER, is the president and CEO of Sterile Processing University, LLC, an online education and continuing education website.

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Dr. Ravi Prakash Keeps Patients Front and Center

At Advocate Good Samaritan Hospital in Downers Grove, Illinois, endoscopy All Star Dr. Ravi Prakash creates a trusting and supportive environment by understanding and prioritizing patients’ individual needs. Beyond his clinical expertise, he is a champion for the adoption of advanced medical  technology  and  understands  that  traditional methods alone are outdated, given the rapid evolution of modern healthcare.

The hospital offers roughly 30 endoscopy bays for prep and recovery and four procedure rooms, and Dr. Prakash and his team offer a comprehensive range of endoscopic procedures, including EGDs, colonoscopy, ERCP, and EMR/ESD, among many other procedures.

Dr. Prakash is supported by a team of four technicians and roughly 10 procedural nursing staff members. He fosters team cohesion through dedicated initiatives focused on the comprehensive education and training of his collaborating staff.

His patient-centric philosophy means Dr. Prakash has a strong commitment to staying at the forefront of medical technology, and leverages tools like confocal laser endomicroscopy (CLE) as an invaluable adjunct to enable more accurate diagnosis and treatment of esophageal and gastric disorders.

One area where his expertise greatly excels is in radiofrequency ablation (RFA) for Barrett’s esophagus. By combining RFA and CLE with his thoroughness and attention to detail in the proceeding follow-up, he ensures earlier intervention and more optimal outcomes for his patients across their entire treatment journey.

Even amid high-intensity situations, Dr. Prakash says he tries to consistently maintain a calm attitude and composed manner, thereby cultivating a notably positive and stable environment for his staff.

Carmen Covarrubias, GI technician, said Dr. Prakash actively involves his staff during cases. “He goes above and beyond with his patients and staff, and he is very well respected amongst his colleagues,” Covarrubias said. “Dr. Prakash is a resource for many of his staff members, providing information and perspective on various different topics.”

Dr. Prakash is certified by the American Board of Internal Medicine, Gastroenterology. He completed his residency at MetroHealth Medical Center. Dr. Prakash has expertise in treating colonoscopy, upper GI endoscopy, gastroenteritis, among various other conditions, which makes him highly recommended by patients, one of whom wrote, “Dr. Prakash is a kind and trusted practitioner and I appreciate the thorough, thoughtful dialogue we had during my appointment.”

Over its nearly 40-year history, Advocate Good Samaritan has evolved into a recognized national leader in healthcare. The hospital earned a Crystal Award from Truven Health Analytics in 2014 for being named to the 100 Top Hospitals list five times. It also is the only healthcare organization in the state to earn the prestigious Malcolm Baldrige National Quality Award, achieving the honor in 2010.

Awards are just part of what makes working for Advocate Good Samaritan Hospital’s endoscopy team an interesting experience. According to Covarrubias, “There is never a dull moment when working in Dr. Prakash’s procedural rooms.”

Join Us for the SGNA Virtual Symposium

On behalf of the Society of Gastroenterology Nurses and Associates (SGNA), I am thrilled to share exciting news about an educational opportunity launching this summer: the SGNA Virtual Symposium, taking place August 8–9, 2025.

Previously known as the Annual Course Virtual Component, this event has been rebranded as the SGNA Virtual Symposium, better reflecting its identity as a distinct, stand- alone educational offering. The change underscores SGNA’s ongoing commitment to providing unique education that meets the evolving needs of our members and the broader GI nursing community.

While the name is new, the format and purpose of the event  remain  the  same—delivering  high-quality,  stand-alone content that complements, but never overlaps with, the in-person annual course. This rebranding highlights SGNA’s commitment to offering timely, relevant education throughout the year that meets the diverse needs of our community.

Over two impactful days, attendees will have access to 10 dynamic sessions focused on some of the most pressing and trending topics in GI care. You’ll hear from leading gastroenterologists and subject-matter experts as they share the latest insights on:

  • GLP-1 medications and their implications for GI practice
  • Colon-cancer screening and prevention
  • Liver diseases and advancements in care
  • Sedation best practices
  • Extracorporeal shock wave lithotripsy (ESWL) and endoscopic retrograde cholangiopancreatography (ERCP)
  • Celiac disease
  • Pelvic floor dysfunction
  • ATP testing and clinical applications

Whether you’re looking to deepen your knowledge, earn accredited continuing-education credits, or stay on the cutting edge of GI care, the SGNA Virtual Symposium offers 10 contact hours and unmatched educational value—all from the convenience of your home or workplace.

Registration will open in early June, so stay tuned for updates and mark your calendars. I look forward to seeing many of you online this August as we come together to learn, connect

and advance the specialty of gastroenterology nursing.

Author

A Quest for Our Personal and Professional Lives

“Now and then it’s good to pause in our pursuit of happiness and just be happy.” ~ Guillaume Apollinaire

Over the course of my gastrointestinal career, I have been honored to speak at roughly 20 SGNA conferences on various topics, either keynoting or as a breakout. Thirteen years ago (that was 2012; good heavens!), I presented “Happy People Don’t Get Sick: The Link Between Joy and Health.”1 As I’ve recently had free time on my hands with surgical recovery,2 I have gained unstructured time to delve back into that topic.

Coincidentally, a group at my alma mater, the William & Mary Society of 1918, sponsored a Zoom conference on “The Science of Happiness” last week. The stars had aligned, and I was delighted to virtually attend. The keynote speaker was the amazing Alexis Franzese, associate professor of sociology and chair of the department of sociology and anthropology at Elon University, who achieved the daunting task of distilling a 15-week/one-semester course into a one-hour Zoom—the whirlwind data dump was fabulous!

“My message to women: Do what makes you feel good, because there’ll always be someone who thinks you should do it differently. Whether your choices are hits or misses, at least they’re your own.” ~ Michelle Obama

Franzese led an interactive session with superior skill in post-COVID Zoomland, asking the retirement-age, alumni women participants to define “happiness.” Our definitions ranged  from  “contentment”  to  “pleasure,”  with  “life satisfaction,” “joy,” and “subjective well-being” also making the list. On defining what we considered to be “the good life,” participants differed.

The answers included:

  • Friends/connection/family
  • Love/pleasure
  • Physical wellness/lack of limitations
  • Exposure to sunshine/nature
  • Laughing out loud

What is your good life? Take a moment to contemplate. It works better if you choose a lane.

“When people feel insecure about something, they look around for validation. Show them that other people trust you.” ~ Francisco Rosales

Franzese described the differences on a spectrum between hedonic happiness (all of one’s time spent in the pursuit of self-pleasure) to eudaimonic happiness (gaining happiness via virtuous actions). And yes, I believe that most in healthcare are driven by eudaimonia—caring for others to validate and support our own happiness and self-worth. Franzese noted how our current society and our nation’s youth have been aggressively marketed into believing in hedonic happiness, the pursuit of newer and cooler stuff that marketers promise will allow us to finally purchase and achieve happiness. We are now extensively trained by marketers and a culture whose purpose is to show us what we should want to achieve fulfillment.

Have you become lost in today’s hedonic marketing trap?

“I didn’t have any accurate numbers so I just made up this one. Studies have shown that accurate numbers aren’t any more useful than the ones you make up.”

“How many studies showed that?” “Eighty-seven.” ~ Dilbert, by Scott Adams

Being  100%  happy  is  a  pathological  state;  Franzese suggests a more reasonable target is 70%, with occasional highs and lows. Of your own baseline happiness, 50% is based on genetics, 40% is your own governance by choice or behavior, and 10% is due to life circumstances. The final 10% tends to be transient; even in illness or trauma, that 10% resets to baseline, as has been seen in studies of folks who’ve suffered a traumatic hemiplegia. That means that even in times of scary current affairs with the locus of control seemingly out of our reach, that 40% remains under our own control.

“For once, I’d like to spiral into control.” ~ Unknown 

So what infringes on your personal mellow and interferes with your happiness and control of that 40%? Is it not enough free time and “me time”? Would you like to simply feel “whelmed” occasionally, neither over nor under?

We each need to choose to be happy in the now—not waiting for the stars to align to an excellent intimate relationship, a 20-pound weight loss, good health, sanity in government, and/or a new car or house.

We  get  stuck  in  indecision,  believing  that  focusing, correcting or obtaining one new thing will cause our happiness  (that  hedonic  happiness  from  earlier),  or  a decision-paralysis cycle, akin to going to a restaurant with a multipage menu—“Please just tell me your three best-reviewed dishes and I’ll choose one of those.”

“You have chosen…wisely.” ~ Indiana Jones and the Last Crusade

What can you choose to do, today, to increase your happiness? Several simple and free actions have been found to bolster that personal 40%.

First, please don’t get trapped in decision paralysis here, just choose one action that you can implement. Two, perhaps, if you’re an overachiever.

  • Schedule unstructured time for yourself.
  • Give to others, even simple thanks and gratitude.
  • Do 20 minutes of cardio exercise three times a week, preferably in nature.
  • Identify your happy place to visit daily. Your happy place can be real or imagined, it could be by water or a beach, in a garden, listening to a joyous mix tape, a cozy nook in which to read, a memorable smell that returns you to a moment of childhood bliss. Be authentic to yourself with your happy place; it need not compare with others’.

“There’s never enough time to do all the nothing you want.” ~ Calvin & Hobbes, by Bill Watterson

All too quickly, the one-hour whirlwind was over, followed by concurrent sessions on happiness through mindfulness or through art therapy. In the art-therapy session, we learned to register and then artistically recreate “glimmers” we had experienced that day; the opposite of a traumatic trigger, a “glimmer” is something that brings fleeting happiness and joy. We learned to capture our glimmers through decidedly imperfect art, and to reinforce and to seek glimmers daily.

“Cherish the glimmering moments, for they are the ones that will light up your memories.” ~ Unknown

Notes:

  1. The non-animated version of my 2012 happiness presentation, done on a software called Prezi, remains available at https://prezi.com/view/JFyvPqf4Eb5H2UfBSnhN/. The data is still accurate.
  2. I’m doing great now after left total-knee replacement January 24, 2025; I was recently released from six weeks of homebound/home physical therapy. Now starting outpatient PT for at least an additional six weeks. (If you’ve been on the knee fence, just do it!)

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.

    View all posts

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 michelle.beaver@endopromag.com.

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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