US FDA Pushes for Safer Reusable Medical Devices

In an effort to reduce the risk of disease transmission associated with reusable medical devices, the US Food and Drug Administration (FDA, Silver Spring, MD, USA) is collaborating with the University of Michigan (Ann Arbor, MI, USA) on new standards and guidelines that highlight improved design features and cleaning techniques.

To that end, the FDA are using their access to pre- and post-market data on reprocessed devices from all manufacturers and device types to identify designs that facilitate proper reprocessing, evaluate the clarity and effectiveness of reprocessing instructions, and promote collaboration among all stakeholders. In addition to finalizing draft guidelines for manufacturers on how to produce safer devices, the FDA will continue to work with standards-setting groups on developing new cleaning protocols. They also have plans to hold a public workshop to discuss their findings and collaborate on solutions.

The FDA has identified design features that facilitate cleaning, disinfection and sterilization and reduce the likelihood of retaining debris. These features consist of smooth surfaces, including smooth inner surfaces lumens in endoscopes; easy disassembly of devices with multiple components; noninterchangeable connectors for critical connections; clear identification of connecting accessories, such as drainage tubing; clear indication and identification of components that must be discarded after patient use and cannot be reprocessed or reused; disposable components for the hardest to clean areas; designs that address how fluid flows through the device, and designs that address areas of debris build-up within devices.

"Reprocessed devices play an integral role in health care,” said William Maisel, MD, MPH, deputy director for science at the FDA's Center for Devices and Radiological Health. "The FDA, industry, and health care facilities share the responsibility of making sure that reprocessing procedures work and are properly implemented.”

Inadequate reprocessing of reusable medical devices between patients can result in the retention of blood, tissue, and other biological debris. This debris can allow microbes to survive the disinfection or sterilization process, which could then lead to healthcare-associated infections (HAIs). Inadequate reprocessing can also result in other adverse patient outcomes, such as tissue irritation from residual reprocessing materials, for example chemical disinfectants.

Related Links:
US Food and Drug Administration
University of Michigan