June 10, 2011

Workshop on Reprocessing Re-usable Medical Devices

On June 9-8, 2011, the FDA hosted a workshop to discuss issues involved in the re-processing of re-usable medical devices, such as endoscopes and orthoscopic shavers. The purpose of the workshop was to establish what guidance documents should be established to ensure that reusable devices are being properly cleaned and disinfected/sterilized to ensure patient safety. Representatives from hospitals, regulatory, reprocessors, OEMs, and testing labs discussed the state of instructions for use, cleaning testing and validation, and the risks associated with poor cleaning.

Cambridge Polymer Group presented the most recent work performed at ASTM on standards targeted towards improving medical device cleanliness, and participated in a panel discussion of what future standards will be required.

The archived webcast of the conference can be found on the FDA website. A summary of the discussion can be found here.

CPG presentation on ASTM activities in Medical Device Reprocessing