FDA launches initiative to improve reusable medical device cleaning

May 12, 2011

The FDA has announced steps to help reduce the risk of exposure to improperly reprocessed medical devices, including endoscopes, that can lead to the transmission of disease.

The FDA has announced steps to help reduce the risk of exposure to improperly reprocessed medical devices, including endoscopes, that can lead to the transmission of disease.

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," said William Maisel, MD, MPH, of the FDA’s Center for Devices and Radiological Health. "The FDA, industry, and health care facilities share the responsibility of making sure that reprocessing procedures work and are properly implemented."

Endoscopes are used in more than 10 million medical procedures per year, the FDA said. In a review of adverse event reports on endoscopes filed with the agency from Jan. 1, 2007 to May 11, 2010, the FDA identified 80 reports of inadequate reprocessing and 28 reports of infection that may have occurred from inadequate reprocessing.

The FDA said it believes that the risk of acquiring an infection from a reprocessed device is relatively low and that the benefits of these important devices outweigh their risks. The agency does not recommend that patients cancel or delay procedures that involve such devices.

To help manufacturers produce safer reusable devices, the FDA is issuing a draft guidance that, when final, will provide greater clarity on how to scientifically validate the reprocessing instructions that are part of the device labeling.