FDA looks to cut down infections from improperly cleaned endoscopes

April 29, 2011 by MassDevice staff

The FDA releases guidance documents aimed at cutting down on infections from reusable medical devices.


The FDA launched an effort to cut down on the number of infections that occur from improperly cleaned endoscopes, which the federal watchdog agency says were responsible for more than 28 reports of infections from Jan. 2007 to May 2010.

The FDA said it received more than 80 reports of improperly reprocessed endoscopes during the three-year period. Endoscopes are long, thin tubes fitted with a camera or light that are threaded into the lungs, blood vessels or other cavities to visualize areas within the body.

Agency reviewers said they have also uncovered several other devices that are more likely to carry infections if not cleaned properly, by reviewing several years of 510(k) and PMA applications. Those devices have features that 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 FDA added that 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."

The agency released draft documents on properly cleaning and labeling reprocessed medical devices and is planning a public workshop this summer to help educate health care providers, slated for June 8-9.

A copy of the draft documentscan be found on the FDA's website.