The FDA is taking steps to help reduce the risk of exposure to improperly reprocessed devices that can lead to disease transmission.
Reprocessing is a multi-step process that includes cleaning, disinfecting or sterilization to remove debris and biologic materials that may transmit infection between patients. In a release, the agency points out that certain devices are intended for repeated use and are common in healthcare settings. However, there are some devices that present particular challenges to reprocessing.
The FDA has investigated pre- and post-market data on these devices and identified design features that reduce the likelihood of retaining debris, thus facilitating 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 agency singles out the endoscope, which is used in more than 10 million medical procedures annually. Endoscopes are long thin tubes with a camera or a light that are threaded into the lungs, the blood vessels or other cavities to visualize areas within the body. However, in a review of adverse event reports on endoscopes filed between Jan. 1, 2007 and May 11, 2010, the FDA identified 80 reports of inadequate reprocessing and 28 reports of infection that may have occurred from inadequate reprocessing.
Still, 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 says. Furthermore, it doesn't recommend that patients cancel or delay procedures that involve such devices.
Now the agency has issued a draft guidance that, when final, will provide greater clarity on how to scientifically validate the reprocessing instructions that are part of the device labeling. In addition, the agency will sponsor a public workshop June 8 and 9 to discuss these findings and collaborate with stakeholders on future device design and scientific advances in reprocessing.
- get more from the FDA release
- read the draft guidance