Reprocessing of Reusable Medical Devices
Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes and stethoscopes.
When used on patients, reusable devices become soiled and contaminated with microorganisms. To avoid any risk of infection by a contaminated device, reusable devices undergo "reprocessing," a detailed, multistep process to clean and then disinfect or sterilize them. When the labeling instructions for reprocessing are completely and correctly followed after each use of the device, reprocessing results in a medical device that can be safely used more than once in the same patient, or in more than one patient. Adequate reprocessing of reusable medical devices is vital to protecting patient safety.
Inadequate cleaning between patient uses can result in the retention of blood, tissue and other biological debris (soil) in certain types of reusable medical devices. This debris can allow microbes to survive the subsequent disinfection or sterilization process, which could then lead to Health care-Associated Infections (HAIs). Inadequate reprocessing can also result in other adverse patient outcomes such as tissue irritation from residual reprocessing materials, like chemical disinfectants.
Reducing the risk of exposure to improperly reprocessed medical devices is a shared responsibility among various stakeholders. This includes the FDA; health care facilities responsible for cleaning, sterilizing or disinfecting the devices; manufacturers responsible for providing adequate reprocessing instructions that are user-friendly and proven to work; and other organizations.
The risk of acquiring such an infection from an inadequately reprocessed medical device is relatively low given the large number of such devices in use, although the potential for outbreaks of infection associated with their use remains an important public health concern. In addition, infections from inadequately reprocessed devices are not often recognized or reported to the FDA. The number of HAIs that can be attributed to inadequate device reprocessing is unknown because it is not often investigated as a cause of HAI.
FDA’s evaluation of available information including reports from health care facilities indicates that there are ways to improve the reprocessing of reusable medical devices. For example, manufacturer instructions for cleaning and the high-level disinfection or sterilization of devices and their accessories are sometimes unclear, incomplete, difficult to obtain from the manufacturer, or impractical for the clinical environment; and in some cases debris was retained in devices despite following manufacturer instructions.
In addition, the FDA continues to collaborate with the University of Michigan on the effectiveness of manufacturer instructions. This early research showed that in some instances, despite following manufacturer instructions, debris was retained in a device.
The FDA is taking steps to reduce the risk of infection from reprocessed reusable devices. We used our unique vantage point, where we review premarket and postmarket information from all manufacturers and reprocessed device types, to communicate clear regulatory requirements, to promote good manufacturing requirements, and to work with manufacturers to address public health concerns that arise after a device has entered the market. As a public health agency, FDA raises awareness of public health concerns and promotes collaboration among all stakeholders, including manufacturers, health care facilities and staff, accrediting organizations, professional organizations, standards setting organizations, and government agencies. For more information, see the Working Together to Improve Reusable Medical Device Reprocessing page.
On this website you can learn more about reprocessing of reusable medical devices, the challenges of reprocessing and ways the FDA is helping address problems with today's reprocessed devices while facilitating improvements in innovative design of the next generation of these devices. In addition, you can learn how to report reprocessing problems to the FDA.
Note: This website does NOT include reprocessing of single-use-only medical devices.