FDA tackles device reprocessing
The Food and Drug Administration (FDA) will hold a public workshop to discuss its recent findings concerning the quality of reprocessing of reusable medical devices.
Based on its access to premarket and postmarket data on reprocessed devices, the FDA identified device design features that reduce the likelihood of retaining debris and that facilitate proper reprocessing. These features include smooth inner surfaces of devices with long, narrow interior channels, clear identification of components that must be discarded after patient use, and designs that take into account how fluid moves through reusable medical devices.
The purpose of the workshop is to discuss factors affecting reprocessing quality, device design as it relates to reprocessing reusable medical devices, reprocessing methodologies, validation methodologies and healthcare facility best practices.
The workshop will be held June 8-9 at the FDA’s White Oak Campus in Silver Spring, Md.
Based on its access to premarket and postmarket data on reprocessed devices, the FDA identified device design features that reduce the likelihood of retaining debris and that facilitate proper reprocessing. These features include smooth inner surfaces of devices with long, narrow interior channels, clear identification of components that must be discarded after patient use, and designs that take into account how fluid moves through reusable medical devices.
The purpose of the workshop is to discuss factors affecting reprocessing quality, device design as it relates to reprocessing reusable medical devices, reprocessing methodologies, validation methodologies and healthcare facility best practices.
The workshop will be held June 8-9 at the FDA’s White Oak Campus in Silver Spring, Md.