FDA addresses consumer infection concerns

January 12th, 2015

Addressing rising patient concerns about the infection risk of outpatient procedures like endoscopy, the Food and Drug Administration is urging patients to ask questions while providing a general tone of reassurance of safety. The agency has created a new website with information about these medical tools. To report a problem, the site also provides a link to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

The FDA has received reports of patients being exposed to microscopic amounts of blood, body fluids and tissue from other patients that may have occurred because the reusable devices were inadequately reprocessed and these contaminants were not removed. “Transmission of infection was extremely rare, but the potential for becoming infected by an inadequately processed device was there," the FDA states.

Some medical devices are reused many times in common surgical and diagnostic procedures, and have been for years. They include instruments used in surgery (like clamps and forceps), and endoscopes (like bronchoscopes and colonoscopes) used to visualize areas inside the body. The FDA is working with healthcare providers, manufacturers, organizations that set standards, and other government agencies to reduce the risk of infection from the inadequate “reprocessing” of these durable devices designed for repeated use. Reprocessing means cleaning and high-level disinfection or sterilization, the agency clarified.

So if you’re scheduled to have a medical procedure, how worried should you be about this? Not worried enough to cancel or delay your plans, says the FDA. That said, there are questions you can ask your healthcare providers, including: What precautions are in place to ensure that the procedure will be done safely?

The FDA states that it is working with manufacturers and healthcare providers to: • Make sure that the makers of these devices are providing reprocessing instructions that are clear and scientifically validated. • Make sure that staff at hospitals and other healthcare facilities understand and are following the manufacturers’ instructions. • Identify device designs that facilitate optimal cleaning, disinfecting and sterilization.