by Jay Crowley
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Unique device identifiers (UDIs) on individual devices support traceability over their lifetime, and the direct marking of the UDI on a device can facilitate the identification and tracking of an instrument used on a patient with a contagious disease.

Though the iatrogenic transmission of Creutzfeldt-Jakob disease (CJD) has been reported in less than 1% of patients, exposure has been linked to the use of contaminated neurosurgical instruments. This concern, among others, led the U.S. Food and Drug Administration (FDA) to require that reusable surgical instruments, and other similar devices, be directly marked with a UDI to facilitate instrument tracking in operating rooms.
 
The foundation of the UDI System is the requirement for a UDI to be placed on the label of every device in order to identify the device throughout distribution and use.
 
Download the complete white paper, The Direct Marking of Medical Devices in the U.S. and Europe​, to read more about:

  • Direct marking requirements
  • Devices subject to the direct marking requirement
  • How to implement the requirements
  • UDI direct marking technologies
  • Direct marking exceptions
  • Non-sterile orthopedic implants
Jay Crowley
Jay Crowley

Vice President of Medical Device Solutions and Services Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.

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