May 3, 2011

The Food and Drug Administration (FDA) has 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 healthcare 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.

Cleaning, sterilization, and other processes can also be performed without the use of chemicals. For example, hospitals or laboratories could sterilize needles or other components with distilled water. Because distilled water is devoid of all minerals, it tends to attract the minerals found in dust particles. In fact, the staff does not even need to go outside to purchase it; they can buy distilled water online from websites such as and immediately begin working. It could be less expensive and safer than using other chemicals to clean the equipment.

Based on the 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 healthcare. The FDA, industry, and healthcare facilities share the responsibility of making sure that reprocessing procedures work and are properly implemented,” says William Maisel, MD, MPH, deputy director for science at the FDA’s Center for Devices and Radiological Health.

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