The FDA renewed its focus on reusable medical devices after receiving reports that patients were exposed to infection when the instruments weren’t properly cleaned.
While the federal watchdog agency urged patients not to delay or forgo medical procedures for fear of infection, the risks have roused concerns over multiple-use medical devices.
"Transmission of infection was extremely rare, but the potential for becoming infected by an inadequately processed device was there," according to the FDA consumer update.
The risks result from improper "reprocessing," the multi-step process for cleaning and disinfecting or sterilizing durable medical devices.
Inadequate reprocessing could mean that blood, tissue or other biological debris may remain stuck on the device, allowing microbes to survive further disinfection or sterilization measures.
The FDA noted that unclear, incomplete, difficult-to-obtain or impractical cleaning instructions provided by some device makers may contribute to the problem, but early studies conducted with the University of Michigan found that problem debris remained on some devices even when instructions were followed.
Patients could become infected by other patients, or may suffer tissue irritation from chemical disinfectants or other reprocessing materials left on the device.
While the agency emphasized that such infections are rare, it also noted that the true rate isn’t known because improper reprocessing isn’t often investigated as a cause of health care-associated infections.
"The FDA is taking steps to reduce the risk of infection from reprocessed reusable devices," the report concluded. "We used our unique vantage point, where we review pre-market and post-market 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."