In October 2011, more than 275 participants convened at the FDA headquarters in Silver Spring, Md., for a multidisciplinary AAMI/FDA Medical Device Reprocessing Summit. The summit built on an FDA public workshop on reprocessing in June 2011. For all participants, the summit proved to be an opportunity for a renewed emphasis on performing all the necessary steps in reprocessing reusable medical devices to ensure clean and disinfected or sterilized devices—not just in the universe of regulations, standards, and best practices, but also in the harried clinical environments and diverse sterile processing centers that are ground zero for reprocessing.
The summit crystallized a compendium of challenges and priority actions for delivering on patients’ basic expectation of cleanliness for reusable medical devices. Indeed, this “patient safety first” focus—with the ideal of ensuring that reprocessing is done correctly every time— was a recurring message from summit participants. So, too, was the overarching challenge for all stakeholders to deepen knowledge and eliminate confusion about reprocessing requirements, to increase communication and collaboration, and to pay closer attention to human and environmental challenges.
The clarion themes that emerged from the summit should serve as a call to action for all stakeholders with roles to play in improving patient safety in reprocessing reusable medical devices. The seven clarion themes 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 greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.
The entire post-summit publication may be accessed by clicking HERE.