FDA In Brief: FDA issues guidance on direct marking of certain reprocessed devices with a unique device identifier (UDI)
For Immediate Release: Nov. 16, 2017
"Direct marking of medical devices with a unique device identifier – or UDI -- is vital for certain reprocessed devices like duodenoscopes. Devices like these that are reused multiple times and go through sterilization or high-level disinfection between uses have been associated with life-threatening infection transmission; there can be serious public health consequences if reprocessing directions are not properly followed. Direct marking can help identify and locate devices during urgent public health situations,” said Linda Sigg, associate director of the informatics staff at the FDA’s Center for Devices and Radiological Health. “But not all reprocessed devices carry the same risks. For example, a stethoscope does not carry the same risks as a duodenoscope. Thus, our guidance makes it clear that direct marking is not required for devices that are only intended to undergo cleaning or lower levels of disinfection between uses, like a reflex hammer or MRI machine."
Today, the FDA issued a final guidance outlining recommendations and clarifying requirements for direct marking of a unique device identifier (UDI) on medical devices. Federal regulation requires that devices intended to be used more than once and reprocessed before each use include a direct marking, subject to some exceptions. Certain medical devices are reused multiple times and are disinfected and/or sterilized between uses. In the final guidance, the FDA interprets “intended to be reprocessed” for UDI direct marking purposes to mean devices that are intended to undergo high-level disinfection and/or sterilization before each use or between uses. The guidance also explains that “intended to be used more than once” means intended for repeated uses on or by different patients.
While many medical devices now carry a UDI on their product labels and packages, direct marking requirements apply to devices that are intended to be used for months or even years, and are likely to be separated from their label.
The requirement is important in order to help identify and locate devices subject to reprocessing in case of problems with the reprocessing.
The FDA has taken many actions over the past few years to reduce the risks of infections associated with scopes, including duodenoscopes, that are reprocessed for use in multiple patients. Duodenoscopes are used in more than 500,000 procedures in the U.S. each year in the small intestine as a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions. While these devices play an important role in the treatment of patients, there is evidence that some have been associated with the transmission of infectious agents, including antibiotic-resistant infections.
For More Information:
- FDA: Guidance: Unique Device Identification: Direct Marking of Devices
- FDA: Unique Device Identification
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.