SILVER SPRING, Md., April 29, 2011 /PRNewswire-USNewswire/ —
The U.S. Food and Drug Administration today announced steps to help
reduce the risk of exposure to improperly reprocessed devices that
can lead to the transmission of disease.
Medical devices intended for repeated use are commonplace in
health care settings. They are typically made of durable substances
that can withstand reprocessing, a multistep process which includes
cleaning, disinfecting, or sterilization to remove debris and
biologic materials that may transmit infection between patients.
While successful reprocessing of reusable devices occurs routinely
in health care settings, there are some devices which present
particular challenges to reprocessing.
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.
On June 8-9, 2011, the FDA will sponsor a public workshop to
discuss these findings and collaborate with representatives from
other government agencies, manufacturers, health care providers,
and other stakeholders on future device design and scientific
advances in reprocessing.
“Reprocessed devices play an integral role in health care. The
FDA, industry, and health care facilities share the responsibility
of making sure that reprocessing procedures work and are properly
implemented,” said William Maisel, M.D., M.P.H., deputy director
for science at the FDA’s Center for Devices and Radiological
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