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 different 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 disinfect or sterilize them. When the labeling instructions for reprocessing are completely and correctly followed, reprocessing results in a medical device that can be safely used for more than one patient.
Adequate reprocessing of reusable medical devices is vital to protecting patient safety.
Inadequate reprocessing between patients 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 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 the FDA; health care facilities responsible for cleaning, sterilizing or disinfecting the devices; manufacturers, responsible for providing adequate 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.
FDA evaluation of safety reports and other information indicate 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.
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 identify device designs that facilitate proper reprocessing, to evaluate the clarity and effectiveness of manufacturer reprocessing instructions, and to promote collaboration among all stakeholders.
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.
Draft Guidance for Industry and FDA Staff - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Public Workshop - Reprocessing of Reusable Medical Devices, June 8-9, 2011
- Press Release - FDA looks to improve design and cleaning instructions for reusable medical devices