FDA: ‘Extremely Rare’ Infection Risk Exists With Reused Medical Devices

The U.S. Food & Drug Administration on Wednesday responded to reports that the reuse of some medical devices like surgical instruments and endoscopes may expose patients to microscopic amounts of blood, body fluids, and tissue from other patients if the devices aren’t properly cleaned.

The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly. (Jason Reed/Reuters)

The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly. (Jason Reed/Reuters)

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“Transmission of infection was extremely rare, but the potential was there,” stated the FDA.

The agency noted it is working with manufacturers and healthcare providers to reduce the risk of infection from the inadequate "reprocessing" of durable devices designed for repeated use.

Specifically, the FDA is looking 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; and identify device designs that facilitate optimal cleaning, disinfecting and sterilization.

“The risk of acquiring an infection from a reprocessed medical device is low,” said William Maisel, MD, deputy director for science at the FDA's Center for Devices and Radiological Health. “The benefits of these procedures in diagnosing and treating medical conditions far outweigh any risk.”

Pamela D. Scott, a biomedical engineer who has been working on the issue at FDA, encourages patients to ask healthcare providers about the process used for cleaning and disinfecting reusable tools. She did so earlier this year when her mother was preparing for a colonoscopy.

“Just to know that they took steps, that they had procedures, that helped me,” said Scott.

The FDA has created a new website (www.fda.gov/reprocessingreusabledevices) with information about medical tools that are reused. To report a problem, the site also provides a link to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.