July 28, 2025 – This article by Lawrence F Muscarella, Ph.D. respectfully proposes that The Centers for Medicare & Medicaid Services (CMS) consider including endoscope-associated infections as a reportable clinical quality measure to incentivize improvements in safety and reduce the risk of healthcare-associated infections.
Note: Dr. Muscarella is accepting new clients seeking expert guidance in medical errors, the causes and prevention of healthcare-associated infections, disinfection, sterilization, and other related topics.
HIGHLIGHTS
- The prevention of healthcare-associated infections (“HAIs”), including endoscope-associated infections (“EAIs”), is one of public health’s essential cornerstones, understanding that millions of Medicare beneficiaries undergo an endoscopic procedure annually in the U.S.
- Many outbreak investigations in recent years have linked the ineffective cleaning of a flexible endoscope to HAIs of multidrug-resistant organisms, including carbapenem-resistant Enterobacterales (“CRE”), with associated morbidity and mortality.
- Several of these investigations reported the cross-infections despite the medical facility’s apparent adherence to manufacturer instructions (or published guidelines) for cleaning and disinfecting the flexible endoscope.
- In response, FDA has advised the public about the risk of bronchoscopes, certain gastrointestinal endoscopes and urological endoscopes remaining contaminated after reprocessing and infecting patients.
- Adding to the safety concerns are recent (voluntary) recalls related to the risk of endoscope contamination and patient infection.
- These recalls, outbreak investigations, and FDA alerts, along with the thousands of adverse event reports submitted to FDA in recent years discussing endoscope contamination (with and without infection), raise timely questions about quality, performance, and the effectiveness of today’s endoscope reprocessing practices.
- Based in part on these concerns, relevant precedents and today’s reporting to Medicare of certain other types of HAIs, this article respectfully proposes that CMS consider including EAIs as a reportable clinical measure to prioritize, and further incentivize, patient safety and infection prevention in the endoscopic setting.
July 28, 2025 (by: Lawrence F Muscarella, PhD) – The federal Centers for Medicare & Medicaid Services (“CMS”) provides health coverage for more than 150 million people through several U.S. government programs including Medicare and Medicaid.
As part of its effort to improve the quality, efficiency and affordability of patient care, CMS has developed several value-based programs that link Medicare reimbursement and incentive payments to performance in the inpatient hospital setting. These programs include the Hospital Value-Based Purchasing (VBP) Program and Hospital-Acquired Condition (HAC) Reduction Program.
CMS uses several different measures, depending on the value-based program, to gauge quality and evaluate hospital safety.
The Hospital VBP Program, for instance, scores hospitals based on measures that include mortality and complications, whereas the agency’s HAC Reduction Program evaluates performance using measures that include postoperative sepsis rates and pressure ulcer rates.
Both of these CMS programs use healthcare-associated infections, or HAIs, to evaluate and compare hospital quality.
Infection Case Reviews, Expert Guidance: LFM-Healthcare Solutions, LLC provides medical expertise for legal representatives, device manufacturers, and medical facilities specializing in healthcare-associated infections linked to contaminated reusable medical equipment.
Endoscope-associated infections, outbreaks
Endoscope-associated infections, or EAIs, remain a well-recognized public health concern. More healthcare–associated outbreaks have been linked to contaminated endoscopes than to any other medical device, according to the U.S. Centers for Disease Control and Prevention (CDC).
Many outbreak investigations in recent years have linked a contaminated flexible endoscope to infections of life-threatening multidrug-resistant organisms, including carbapenem-resistant Enterobacterales (“CRE”).
Several of these investigations, conducted both in the U.S. and overseas, reported the cross-infections despite the medical facility’s apparent adherence to manufacturer instructions (or published guidelines) for cleaning and disinfecting the endoscope. In some cases, the investigators reported the complexity of the flexible endoscope’s design as a primary contributor to ineffective reprocessing and disease transmission.
A primary objective of this proposal is to raise awareness about the importance of device safety and the risk of flexible endoscopes remaining contaminated after reprocessing and infecting patients with potentially deadly multidrug-resistant organisms. — Lawrence F. Muscarella, Ph.D.
Focusing on one type of complex gastrointestinal endoscope, Muscarella (2019) studied several investigations, including a formative report by Epstein et al. (2014), that linked contaminated duodenoscopes to outbreaks of multidrug-resistant organisms, with associated morbidity and mortality. Duodenoscopes are routinely used to perform an upper GI procedure called endoscopic retrograde cholangiopancreatography, or ERCP.
The next year, Mehta and Muscarella (2020) similarly reviewed several outbreak investigations that linked contaminated bronchoscopes to infections of multidrug-resistant organisms, also with associated morbidity and mortality. Bronchoscopes are routinely used to examine a patient’s respiratory tract.
The ineffective reprocessing of urological endoscopes, a third type of flexible endoscope, has also been linked to infections and patient deaths. These devices, which include cystoscopes, ureteroscopes and ureterorenoscopes, are routinely used to examine a patient’s urinary tract, including the bladder.
A continuing infection concern
The risk of EAIs remains a scourge.
Earlier this year, Haak et al. (2025) reported an outbreak of CRE in a tertiary care hospital, in Germany. Suggesting a GI endoscope may be responsible for the infections, these investigators detected the outbreak’s strain in 16 patients who had recently undergone a GI endoscopic procedure including gastroscopy and ERCP.
Like ERCP performed using a duodenoscope, gastroscopy is a type of upper GI procedure performed using a gastroscope.
And, even earlier today, a medical center in Oregon “confirmed a recent 11-day closure of the hospital’s endoscopy department” in response to an infection-control breach. Further supporting this article’s proposal herein, hospital officials wrote that this endoscopy department had been closed from June 27 to July 8 (2025) after it was discovered “that some quality-control steps and related processes in endoscopy cleaning were not completed in some cases,” according to a news report.
In response to the well-recognized risk of EAIs, FDA has advised the public about the risk of bronchoscopes (in 2021), duodenoscopes (in 2022) and urological endoscopes (also in 2021) remaining contaminated after reprocessing and infecting patients. The mortality rates of healthcare-associated infections, including EAIs, caused by CRE and related multidrug-resistant bacteria can be as high as 50%, or more.
Further highlighting the current risk, manufacturers have recently issued voluntary recalls related to the risk of a contaminated flexible endoscope infecting patients. One of the recalls, in 2023, involved a duodenoscope model, while another recall the same year related to the risk of infection due to water remaining in a small percentage of insufficiently dried bronchoscopes returned to customers after repair.
A third recall posted earlier this year, in January, was in response to complaints linking infections to the ineffective reprocessing of a reusable accessory used with certain urological endoscope models. According to the FDA’s alert, the agency “has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.”
Last month, FDA issued import alerts “to prevent future shipments of certain devices,” including some flexible endoscope models (i.e., flexible bronchoscopes, ureterorenoscopes), from entering the United States. According to the agency’s notice, the FDA “continues to have concerns” related to the manufacturer’s “outstanding Quality System regulation violations.”
These recalls, many outbreak investigations, published reviews, and FDA alerts, along with many adverse event reports submitted to FDA just in 2025 discussing endoscope contamination, raise timely questions about safety, performance and the effectiveness of today’s reprocessing practices for the prevention of cross-infection during a flexible endoscopic procedure.
Forensic Case Reviews, Outbreak Investigations: LFM-Healthcare Solutions, LLC provides medical expertise for legal representatives, device manufacturers, and medical facilities specializing in healthcare-associated infections linked to contaminated reusable medical equipment.
The Proposal
Designed to improve safety in the endoscopic setting and reduce the well-documented risk of flexible endoscopes cross-infecting patients with potentially deadly multidrug-resistant organisms, this article’s author (Dr. Muscarella) submitted a letter to CMS last year, in May 2024, proposing for the first time that the agency consider including EAIs as an additional reportable quality measure within, for example, Medicare’s value-based HAC Reduction Program.
In response, CMS wrote three months later that it thanks those who submitted “recommendations on potential future measures to include in the HAC Reduction Program and will consider them for future program years.”
Now, a year later, this updated article herein readdresses the continuing risk of EAIs and, with some new content, again respectfully proposes that CMS consider (if not at least evaluate the merit of) using EAIs as a trackable infection measure to further improve safety in the endoscopic setting.
According to the agency, CMS’s HAC Reduction Program incentivizes improvements in patient safety by reducing payments to hospitals based on their performance on measures of certain hospital-acquired conditions.
These measures include postoperative respiratory failure rates and postoperative sepsis rates — as well as certain HAI outcome measures such as central line-associated bloodstream infections (“CLABSIs”) and catheter-associated urinary tract infections (“CAUTIs”).
In addition to aligning with CMS’s outcome- and value-based goals and initiatives, the inclusion of EAIs as a clinical quality measure thus has some relevant precedents and would complement CMS’s use of these other reportable HAI measures to evaluate hospital performance and determine reimbursements.
More healthcare–associated outbreaks have been linked to contaminated endoscopes than to any other medical device. — Centers for Disease Control and Prevention (2008)
An “EAI” may be defined as a primary infection of a body site (e.g., the bloodstream, urinary tract, respiratory tract, biliary tract) caused by an exogenous organism (e.g., CRE, Pseudomonas aeruginosa) that is typically diagnosed within a few days (e.g., 1-2 days) following a patient’s exposure to a (reusable) flexible endoscope, with no more likely source or risk factor for the infection identified other than the patient’s endoscopic procedure.
Additional evidence, such as culturing the endoscope for the infection’s strain or identifying another endoscopy patient infected with the same organism, may be used to further link or substantiate a contaminated endoscope as the infection’s likely cause.
“Best practices”
CMS’s use of EAIs within the HAC Reduction Program — like the reporting of CLABSIs and CAUTIs (via the CDC’s National Healthcare Safety Network) — would reasonably further incentivize improvements in performance and safety particularly for “at risk” endoscopy patients (e.g., the elderly and immuno-suppressed patients).
Use of EAIs as a reportable quality measure might also help to standardize clinical practice in endoscopic settings, providing an additional impetus to ensure competency and compliance with “best practices” for endoscope reprocessing and the prevention of disease transmission.
Moreover, this article’s proposal is consistent with the general objective under the authority of the Center for Medicare and Medicaid Innovation (CMMI) to consider and test innovative models and approaches intended to improve patient care, transparency, and accountability.
Emphasizing well-documented concerns about the risk of a flexible endoscope cross-infecting patients, the FDA has issued several safety alerts, as well as overseen a number of recent endoscope recalls, focusing on the risk of bronchoscopes, duodenoscopes and urological endoscopes remaining contaminated with multidrug-resistant organisms despite the medical facility’s reported adherence to the manufacturer’s reprocessing instructions. — Lawrence F. Muscarella, Ph.D.
The prevention of HAIs, including EAIs, is one of public health’s essential cornerstones, understanding that in addition to millions of Medicare beneficiaries undergoing an endoscopic procedure annually, more than 2.8 million antimicrobial-resistant infections occur each year in the U.S.
Other recent posts by Dr. Muscarella include:
- “In Support of Patient Safety, Healthcare Access, and Medicare Payment for a Single-Use Bronchoscope Model” (2024)
- “Dr. Muscarella’s Recent Recommendations to Medicare to Prevent Hospital-Acquired Infections” (2024)
- “Esophageal Tissue Tears and Other Adverse Events Reported When Using Duodenoscopes with a Single-Use Endcap” (2023)
Discussion
In response to the many recently published outbreak investigations linking flexible endoscopes to infections of CRE and other multidrug-resistant organisms — as well as thousands of adverse event reports submitted to FDA in recent years detailing contamination of a reprocessed endoscope (with and without infection) — this updated article again respectfully proposes that CMS consider including EAIs as a reportable HAI measure (e.g., within Medicare’s HAC Reduction Program).
Highlighting the EAI risk, some reports have suggested improvements that include reclassifying flexible endoscopes (e.g., duodenoscopes) as “critical” devices (according to the Spaulding device scheme) requiring sterilization, instead of their current classification as “semi-critical” devices requiring at least high-level disinfection (after cleaning).
As much as to identify trends and allocate limited resources, however, the reclassification of a device based on its infection risk (and intended use) would seem to require a clearer, more precise understanding and estimation of the device’s actual infection rate.
Due in part to limited active surveillance and tracking to identify certain adverse events including EAIs, as well as the difficulty detecting post-endoscopic infections caused by antibiotic-susceptible organisms, accurate estimates of the true EAI rate is challenging to calculate and validate.
Published estimations notwithstanding, some studies, including an analysis by Wang et al. (2018), suggest that the actual rate of infections (e.g., the number of infections per 1000 endoscopic procedures performed) following colonoscopy, for example, may be significantly higher than the reported rate (e.g., in the ambulatory-surgery-center, or “ASC,” setting).
Wang et al. (2018) wrote that, consistent with this article’s proposal herein — and CMS’s published goals, patient-accessible public reporting of “facility-level procedure volumes and infection rates may be valuable to patients seeking quality of care information” — adding that “[q]uality reporting may prevent ASC-specific postendoscopic infections.”
Further underscoring the importance of accurate estimates of HAIs (including EAIs), a 2017 report by the Agency for Healthcare Research and Quality stressed that healthcare harms and conditions “can be effectively addressed and prevented through training, adherence to evidence-based treatment guidelines, and hospital best practices, but only if the HACs (hospital-acquired conditions) are first properly measured and understood.”
Cost analysis: This article did not attempt to study or estimate the potential financial impact on hospitals of tracking and reporting EAIs as a quality measure to Medicare (through the CDC’s National Healthcare Safety Network).
However, while it is likely that implementation of such a new quality improvement initiative would require additional, dedicated resources, the possibility cannot be ruled out that the initial expenses would be offset, at least in part, by the savings realized from improved safety and a likely (and expected) reduction in EAIs.
CMS wrote, in 2010, that “HAIs not only put the patient at risk, but also increase the days of hospitalization required for patients and add considerable health care costs.” Similarly, a CDC study estimated that “the overall annual direct medical costs of HAI to U.S. hospitals ranges from $28.4 to $33.8 billion.”
To be sure, estimates of the cost for a hospital to investigate, notify impacted patients of, and to treat EAIs and associated outbreaks provide an important impetus and financial incentive for healthcare providers and payers to consider new quality strategies, such as this updated article’s proposal vis-a-vis EAIs.
Zimlichman et al. (2013) concluded that, “While quality improvement initiatives have decreased HAI incidence and costs, much more remains to be done.” As hospitals realize savings from the prevention of various types of complications and patient harms under payment reforms, these authors note that hospitals “may be more likely to invest in such strategies.”
Endoscope types: This updated article’s proposal would apply to the reporting of EAIs linked to the use of several different types of flexible endoscopes, including bronchoscopes, duodenoscopes, gastroscopes, and urological endoscopes used in the hospital setting.
This article’s author performed an analysis, in 2022, of more than 10,000 adverse event reports, submitted to the FDA between 2014 and 2021, that describe actual or potential contamination of six (6) types of flexible endoscopes (with or without infection).
This 2022 analysis had several objectives, including identifying general trends in the reporting of endoscope contamination cases, evaluating the adequacy of today’s reprocessing practices, and assessing whether any of the six studied endoscope types might pose an under-appreciated infection risk.
Among other findings, the study found that the number of FDA reports describing confirmed or potential contamination in 2021, compared to 2014, increased significantly for each of the six endoscope types — with gastroscopes displaying the most pronounced increase.
The results of this 2022 analysis, consistent with this article’s proposal herein, further underscore concerns that current endoscope reprocessing practices may not always be sufficiently effective, and sometimes may require additional measures, to prevent a flexible endoscope from cross-infecting patients with multidrug-resistant microorganisms including CRE.
Other factors and considerations: Several other considerations associated with this article’s proposal also warrant discussion.
Feasibility: Performing one or more studies or trials focusing on certain human factor considerations may be advantageous to demonstrate the value and feasibility of the implementation of this updated article’s proposal.
A phased-in approach: Using an approach previously discussed by CMS in 2010 for CLABSIs, the agency might consider “phasing in” over time the adoption of EAIs as a reported HAI measure, based on assessed risks. A requirement to track and report EAIs might reasonably apply first to duodenoscopes, followed by bronchoscopes, cystoscopes, gastroscopes and other endoscope types.
The “EAI rate,” an SIR: The incidence of EAIs – which is specific to the flexible endoscope type (e.g., duodenoscope, bronchoscope) if also to the endoscopic setting (e.g., acute-care hospitals) – could be calculated by dividing the total number of EAIs (as defined above) during a defined timeframe for a specific endoscope type (the numerator) by the total number of procedures (e.g., 1,000 procedures) performed during the same timeframe using that same endoscope type (denominator).
The EAI quality measure might also be classified as unit-based or hospital-based, and be risk-adjusted using previously published methodologies.
For example, a Standardized Infection Ratio (SIR) could be determined to track and compare EAI rates by dividing the actual number of reported EAIs by the “predicted” number.
Designed to facilitate more accurate comparisons by adjusting for various risk factors (e.g., patient population, hospital type, ICU vs. ward) that contribute to HAI risk, SIRs are currently calculated in the CDC’s NHSN for other types of reportable HAIs (e.g., CLABSIs and CAUTIs). The NHSN is “the nation’s most widely used healthcare-associated infection tracking system.”
Data validation: Consideration of validation of the EAI data may be considered to ensure their integrity and uniformity. The applicable methods for EAI data validation might be adopted, for instance, from those currently used to validate other HAI data, such as CLABSIs.
Data sources: The sources of the EAI data would include electronic clinical data, claims data, and/or medical records.
Infection surveillance: Many U.S. hospitals do not perform active surveillance of patients for post-endoscopic infection (i.e., EAIs), which is a limitation that can prevent the prompt identification of a endoscope-related bacterial infection, cluster or outbreak as well as hinder accurate estimates and modelling of the true infection rate.
Some reports have suggested that review of blood cultures (e.g., after performing ERCP) or the adaption of surveillance methods used for surgical site infections might improve the detection of post-procedure EAIs.
Endoscope culture surveillance: In 2015, FDA recommended for the first time that, as one of four supplemental measures, healthcare facilities consider periodic microbiological surveillance culturing to evaluate the effectiveness of duodenoscope reprocessing and reduce the infection risk.
This recommended measure, like this updated article’s proposal herein, offers an innovative practice for hospitals to monitor quality, enhance the effectiveness of endoscope reprocessing and improve patient safety.
While it has certain practical limitations (e.g., endoscope sampling is not immune from false-negative results), the FDA and CDC published guidance in 2018 for microbiologically sampling duodenoscopes.
In addition to endoscope culture surveillance, Yang et al (2024) suggested “utilization of single use endoscopes on patients with or at risk for CRE colonization” as a risk mitigation strategy.
Case Reviews, Expert Infection Prevention Guidance: LFM-Healthcare Solutions, LLC provides medical expertise for legal representatives, device manufacturers, and medical facilities specializing in healthcare-associated infections linked to contaminated reusable medical equipment.
Summary
Many outbreak investigations in recent years have linked the contamination of a flexible endoscope to infections of multidrug-resistant organisms, including CRE, with associated morbidity and mortality. Several of these investigations documented the cross-infections despite the medical facility’s apparent adherence to manufacturer instructions (or published guidelines) for reprocessing the flexible endoscope.
In response, FDA has advised the public about the risk of bronchoscopes, duodenoscopes and urological endoscopes remaining contaminated after reprocessing and infecting patients. According to the CDC, more healthcare–associated outbreaks have been linked to contaminated endoscopes than to any other medical device.
Based on published data, this article’s author recently suggested that FDA similarly alert the public to the potential for gastroscopes to remain contaminated after reprocessing and expose patients to multidrug-resistant organisms, and to provide guidance to reduce this documented risk.
Adding to the potential safety concerns are recent device recalls related to the risk of endoscope contamination and patient infection.
These recalls, outbreak investigations, and FDA alerts, along with the thousands of adverse event reports submitted to FDA in recent years discussing endoscope contamination (with and without infection), raise timely questions about safety, performance and whether today’s reprocessing practices are sufficiently effective, in all clinical circumstances, to prevent a flexible endoscope from cross-infecting patients with CRE and other potentially deadly multidrug-resistant organisms.
Based in part on these concerns, relevant precedents, the importance of accurate estimates of the actual EAI rate, and today’s reporting to Medicare of certain other types of HAIs (e.g., CLABSIs), this updated article herein again respectfully proposes that CMS consider (if not at least evaluate the merit of) including EAIs as a reportable HAI measure (e.g., within Medicare’s HAC Reduction Program) to prioritize infection prevention in the endoscopic setting and incentivize adoption of “best practices.”
The prevention of HAIs, including EAIs, is one of public health’s essential cornerstones, understanding that millions of Medicare beneficiaries undergo an endoscopic procedure annually in the U.S.
Article by: Lawrence F Muscarella, PhD. LFM Healthcare Solutions, LLC. Dr. Muscarella is the president and founder of LFM Healthcare Solutions, LLC, an independent quality improvement company. Click here for a list of his quality improvement healthcare services. E: Larry@LFM-HCS.com. [LFM-ver-1.4]
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Acknowledgment: This article was sponsored, in part, by AMBU, a manufacturer of single-use flexible endoscopes.
Other disclosures: According to FDA, adverse event reports “are a valuable source of information” that may be used to monitor a device’s performance and to detect potential risks. These reports generally have not been peer-reviewed, however, and can include “incomplete, inaccurate, untimely, unverified, or biased data.”
Also, “linking” or ”associating“ an endoscope or other type of reusable device with an infection or an outbreak does not confirm the device transmitted or otherwise caused the infection, as one or more other factors could be, in part or solely, responsible. More data
would be typically required to conclude more definitively that a contaminated device was the cause of an infection.
Expert services: Details about the quality and expert services Dr. Muscarella provides healthcare facilities, patients, device manufacturers and legal representatives are available here.