Gut Check | Monday, December 16, 2019

SGNA and AORN on FDA and Duodenoscope Reprocessing

By Catherine Bauer, MSN MBA CGRN CFER

As nurses, we are responsible for ensuring that duodenoscopes are properly prepared for safe patient use by using validated reprocessing instructions provided by manufacturers. To this end, we depend on medical device manufacturers and the FDA to provide clear and effective reprocessing instructions. The FDA has stated that reports of contamination since 2015 have been verified due to increased culturing.  However, recent outbreaks in which no breaches in reprocessing were found cause us great concern.

Last month, several organizations were asked to speak at a public advisory committee meeting at the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. AORN’s Erin Kyle, DNP RN CNOR NEA-BC, and I represented the nursing perspective and discussed best ways to achieve effective solutions regarding the issues with duodenoscope-related transmission of pathogens.

With this in mind, Erin and I highlighted the following during our presentation to the FDA:

• Issue 1: Patient Access, Safety and Cost
  • Access: We believe that for any solution to be effective, it cannot impede patient access to care. This should never be an afterthought.
  • Safety: We believe that more research is needed on disposable endoscopes and endoscopes with disposable components. What research has been done to demonstrate the clinical effectiveness of disposable items? Is it possible that fully disposable duodenoscopes could be clinically inferior and result in failures during procedures?
  • Cost: Low temperature sterilization has been shown to be an effective option for processing, however, many organizations don’t have the resources to sterilize endoscopes. Many organizations would require major renovation and major capital expense to sterilize endoscopes. With ethylene oxide processing (EO), the turnaround time for sterilization could be up to 16 times longer than current high-level disinfection (HLD) processes.
• Issue 2: Improving Duodenoscope Design and Processing Instructions for Use  
  • We strongly believe that improvements should be made at the manufacturing level to make duodenoscopes more resistant to damage with routine use.
  • We urge the FDA and manufacturers to work together to perform an analysis of duodenoscope processing failures by analyzing deliberate, systematic methods. The results should be used to inform improvements to both product design and processing instructions. 
  • We believe that duodenoscope manufacturers should, at little to no cost, be supported in updating and validating processing instructions for use that keep up with the scientific literature. 
• Issue 3: Environmental Sustainability
  • We believe that changes related to duodenoscope processing should include a thorough environmental impact assessment – a lifecycle assessment (LCA).
  • This, at minimum, should include waste streams, toxic emissions and carbon footprint of manufacturing, transportation and processing practices.
  • Environmental sustainability factors should be on the table along with patient access, safety and cost concerns.
• Issue 4: Research and Data

We would like to see a synthesis of the scientific literature in these areas:

• Most recent studies from manufacturers on contamination rates and root causes of contamination for duodenoscopes that fail HLD
• Effectiveness of low temperature gas (EO, H₂O₂, ozone, etc.) sterilization and its effects on endoscope materials
• Clinical acceptability and cost analysis of disposable duodenoscopes
• Occupational hazards of HLD/sterilization methods to the people who are performing endoscope processing during each step of the process

By identifying and developing safe and effective solutions, we can eliminate the risk of infection transmission. This is our top priority. SGNA and AORN strongly believe that government, industry and medical professionals must collaborate to drive evidence-based, quality healthcare improvements. We can only achieve this by understanding the consequences of those changes. Being able to present these ideas and concerns to the FDA was a meaningful opportunity to comment and connect with one another on this important issue.

While some solutions lie in the future, we must collaborate now and discover sustainable solutions that can have an immediate impact. Our patients are central to our decisions, and they must remain central to all our decisions.

You can find the 24-hour summary that includes reactions and recommendations from the FDA advisory meeting FDA website here: https://www.fda.gov/media/132494/download.

SGNA will continue to monitor FDA activity on this topic and share any information we receive as appropriate.