FDA Releases Final Guidance on Endoscope Cross-Contamination

December 9, 2016

Final guidance on reducing cross-contamination from irrigation valves and accessories for flexible gastrointestinal endoscopes adds a new section on testing for backflow prevention.

The guidance, released in draft form in January 2015, calls on makers of gastrointestinal endoscopes to consider risk-mitigation in device design or ensure their devices are reprocessed or discarded after each use to prevent cross-contamination during flexible gastrointestinal endoscopy procedures. The recommendations follow reports of backflow from irritation channels into water bottles and tubing when irrigation channels lacked a backflow-prevention mechanism.

The final guidance states that when testing the performance of a system incorporating backflow-prevention valves or other features for reducing the risk of cross-contamination, manufacturers should use worst-case scenarios for backpressure, pressure cycling, duration, concentration of chemical and microbiological markers, and other conditions.

The tests also should identify relevant factors that may influence fluid backflow, including pressures; fluid volumes; flow conditions; type and purpose of connections within the flow path; tubing lengths; and time of relevant procedures. Tests should include positive and negative controls and be adequately sensitive.

The guidance recommends that test reports describe the device system used, including the backflow-prevention valve function and its critical operational characteristics.

Other changes to the draft guidance were minor, including:

  • Additional definitions and clarification of terminology;
  • Inclusion of a diagram to illustrate the potential for contamination;
  • Consolidation of two tables on recommended labeling and actions for components of irrigation systems; and
  • Citation of new standards and FDA guidance documents.

ISO 13485:2016 – A Devicemaker’s Transition Guide interprets the four key areas in the 2016 version — risk management, design control, supplier management and corrective and preventive action  and explains what kind of changes the new standard will require.