Another Endoscope Contamination Reported at Academic Medical Center Exposing Patients to Potential Harm-Here We Go Again.....

Another Endoscope Contamination Reported at Academic Medical Center Exposing Patients to Potential Harm-Here We Go Again.....

A recent incident at a Nashville hospital has once again underscored the importance of meticulous reprocessing practices for medical equipment such as reusable flexible endoscopes. According to the most recent news report, patients may have been exposed to HIV and hepatitis due to improper cleaning of flexible endoscopes, used in procedures at the hospital. Sadly, an elective and important screening colonoscopy has now turned into a patient's worst nightmare.

This situation reflects a persistent challenge in healthcare: ensuring that flexible endoscopes—used in procedures such as colonoscopies and bronchoscopies—are thoroughly cleaned to prevent cross-transmission of infections. As these high-risk devices are increasingly used in modern medicine, improving reprocessing practices is more urgent than ever. Without strict adherence to protocols, healthcare facilities risk exposing patients to life-threatening infections, eroding patient trust, and facing significant legal and reputational damage.

The Risks of Reprocessing Failures

Flexible endoscopes are vital diagnostic and treatment tools, but they are also among the most difficult medical devices to clean thoroughly. The narrow channels and complex design of these instruments can trap biological material, providing a potential breeding ground for pathogens if not reprocessed correctly

When contaminated devices are reused, even trace amounts of bioburden material can result in the transmission of serious infections.

The Nashville incident is not an anomaly—similar cases have been documented in the past, where improper endoscope cleaning protocols led to cross-contamination with bacteria, viruses, and drug-resistant organisms. Regulatory bodies, such as the FDA , have repeatedly stressed the need for rigorous cleaning practices, yet compliance across facilities is inconsistent, partly due to staffing pressures, equipment unreliability, cleaning and reprocessing failure, and inadequate training.


Challenges in Reprocessing Flexible Endoscopes

  1. Complexity of Design: The internal channels and delicate parts of flexible endoscopes are difficult to access, requiring meticulous manual and automated cleaning.
  2. High Volume of Procedures: Busy healthcare facilities may struggle to balance the demand for endoscopies with the time required for proper cleaning and sterilization.
  3. Staff Training and Turnover: Reprocessing requires highly trained personnel, but frequent turnover can lead to knowledge gaps and procedural errors.
  4. Evolving Manufacturer Guidelines: Healthcare providers must keep up with updated manufacturer instructions for the latest equipment, which can vary significantly between models
  5. Inadequate Commercially Available Cleaning Solutions: Many of the current cleaning and reprocessing solutions do not foster the highest levels of reprocessing efficacy and outputs, have verifiable outcome measures that demonstrate consistently reliable reductions in contamination across the healthcare continuum. It is critical that new devices be introduced to the market that improve operational efficiencies and reduce the risks to patients, while incorporating a human factors engineered design as recommended by the FDA .


Recommendations to Improve Reprocessing and Patient Safety

1. Invest in Automated Reprocessing Technologies

Automated cleaning systems can standardize the reprocessing process, reducing human error and ensuring consistency. These systems can also track compliance, ensuring that all steps are followed meticulously.

2. Provide Ongoing Staff Training and Certification

Healthcare facilities must offer regular, updated training for all personnel involved in reprocessing. Certification programs help ensure staff members stay current on protocols and maintain competence despite evolving guidelines. There are two national flexible endoscope reprocessing certifications available from HSPA and Certification Board for Sterile Processing & Distribution (CBSPD) assist with reprocessing professionals demonstrating cognitive competency in this essential skillset.

3. Consider Innovative New Technologies to Reduce the Risk of Endoscope Reprocessing Failure

In some cases, particularly with immunocompromised patients, the risk of infection from cross transmission of the endoscope can be a substantial patient safety threat. Healthcare facilities and leaders should consider and demand innovative technological approaches to improve both the cleaning and drying components of current reprocessing processes. The manual cleaning and drying stages of the process must be fully optimized with the right tools to ensure the lowest possible risk profile for the endoscope. The market desperately needs better technology to advance patient safety.

4. Enhance Auditing and Monitoring Systems

Facilities should implement robust auditing systems to ensure adherence to reprocessing protocols. Regular inspections and real-time data logging can help detect and address deviations before they lead to adverse events. Collecting data, however, is not enough. Data must be used to drive action to protect patients and decrease mortality and morbidity.

5. Collaborate Closely with Manufacturers

Healthcare providers must maintain open communication with manufacturers for updated cleaning instructions and recommendations. Following the latest guidance ensures that equipment functions properly and minimizes infection risks. The manufacturer's instructions for use must be easy to comprehend and follow. Healthcare facilities should review the Association of Healthcare Value Analysis Professionals (AHVAP) Position Statement on The Critical Need for Improved Instructions for Use for Medical Devices in Healthcare. This reference is available on the Association of Healthcare Value Analysis Professionals (AHVAP) website here.


A Call to Action for Safer Practices Associated with Flexible Endoscopy

The incident at the Nashville hospital serves as a wake-up call for healthcare facilities to review and improve their reprocessing practices. The stakes are high: patient safety, trust, and healthcare quality depend on meticulous cleaning protocols for reusable medical equipment, including flexible endoscopes. Healthcare leaders must invest in training, technology, and compliance monitoring to prevent future cross-contamination incidents and ensure patient well-being. Organizations such as the American Society for Gastrointestinal Endoscopy (ASGE) , American Gastroenterological Association (AGA) , American College of Gastroenterology , AORN , and Society of Gastroenterology Nurses and Associates have significantly advanced the conversation about flexible endoscope safety and published extensive evidence-based guidance on this critical patient safety topic.

By taking these proactive steps, healthcare organizations can reduce the risks associated with flexible endoscopes and restore public trust. It is only through continuous improvement, the addition of innovative and highly-reliable processes and product solutions, and adherence to best practices that we can prevent such incidents from recurring and protect patients from unnecessary harm. The time to develop highly reliable, commercially-available solutions to make endoscope reprocessing safer is now. Our patients cannot afford to wait!

Centers for Disease Control and Prevention FDA AORN Society of Gastroenterology Nurses and Associates Association of Healthcare Value Analysis Professionals (AHVAP) APIC

This article represents the author's personal views and is not representative of the views of any employer or affiliation.

Matt Knueven

Sales Manager @ One Direct Health Network | Business Development, Medical Device Sales

6 天前

Hudson, thanks for sharing!

回复
Brad Vargo

COO, Vyve Medical, Inc.

4 周

“Complexity of Design”. This is, or should be, the point of focus. It is no different with many medical instruments today. Our technological progress has not generally considered an instruments’ ease of reprocessing to eliminate cross-infection possibilities. Never has this been more true than with the reusable laryngoscope over the past 50 years. “Green” the OR’s will soon aligned with the reduction of HSI’s for patients.

Yesenia Khattak, BSPH, CIC

Infection Preventionist at PVHMC

1 个月

I didn’t realize that after the many outbreaks associated with duodenum scopes that any healthcare facility in the U.S. still has antiquated reprocessing practices. Thanks for this!

Teresita Foliacci, MSN-Ed, RN, CGRN

Endoscopy Nurse Manager, Cleveland Clinic Florida Weston

1 个月

Thank you for sharing this article. Continous conversation about this is essential to keeping g our patients safe. Ongoing Training and education of staff is critical. I am support having dedicated staff to reprocessing of endoscopes. Larger organizations are transitioning to SPD reprocessing all endoscopes as well as sterilizing bronchoscopes.

Ken Shaw

President - Americas

1 个月

Having spent a lot of time recently in Endo suites and SPD departments, I see an immense problem begging to be solved. Manual cleaning is really hard for all the reasons you listed and not to mention hard to remove biofiilm. I too believe it will only be solved with Automation. Great article and advice Dr. Garrett!

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