October 11 - 12, 2011

AAMI/FDA Medical Devices Reprocessing Summit

2011 Reprocessing Summit

Every patient undergoing a medical procedure has a basic expectation that the environment and instruments of care will be clean and safe. In recent years, that expectation has been shaken by reports of patients put at risk of serious infection from reusable medical devices that were inadequately cleaned, sterilized, or disinfected—the domain known as reprocessing.

Building from an earlier FDA meeting on this subject,  leaders from industry, regulatory bodies, and associations; clinicians from health institutions; subject experts, patient safety officers; researchers; and other gathered to identify, discuss, and formulate strategic initiatives and priorities to improve the safe reprocessing of reusable medical devices.

The Clarion Themes, as detailed in a free PDF report on the summit, are:

  1. Gain consensus on “how clean is clean” and on adequate cleaning validation protocols for reprocessing reusable medical devices.
  2. Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.
  3. Pay early, iterative, and comprehensive attention to reprocessing requirements throughout the device design process.
  4. Make human factors and work environment factors priorities when developing reprocessing requirements.
  5. Improve information collection and sharing to broaden the use of best practices in reprocessing.
  6. Improve reprocessing competencies by strengthening training, education, and certification.
  7. Create a great sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.

Summit Resources

Supporting Organizations