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FDA Introducing New Medical Device Tracking System

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Jarod Cassidy4 years ago

According to a press release by the U.S. Food and Drug Administration, manufacturers of high-risk medical devices will now be required to put a unique identifying number on their products to aid in early-warning for devices that pose safety hazards to patients.

FDA Requiring Unique Identification Numbers for Medical Devices

  • As part of an effort to enhance patient notification in the case of possible defects or hazards found in a medical device, the FDA is instating a unique device identification system (UDI).
  • Mananufacturers of medical devices will be required to mark all their products with a unique identification number providing information on the device’s lot number and expiration date.
  • This code will be placed on the product or on the product packaging in both plain text and a machine readable format (i.e. barcode).

FDA Global Unique Device Identification Database (GUDID)

“UDI (Unique Device Identification) represents a landmark step in improving patient safety, modernizing our post-market surveillance system for medical devices, and facilitating medical device innovation.” – Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health in a FDA press release

  • The unique identification numbers will be entered into a publicly accessible data base in which patients, doctors and companies will be able to track malfunction and determine what patients are at risk.
  • The FDA hopes this will lead to more effective monitoring of medical device malfunctions as well as create a more efficient method of patient notification, reducing the risk of patient injury and death.
  • None of a patient’s personal information (phone number, address, social security number) will be made public on the database, but patients will have the choice to opt in or opt out of making such information available to the healthcare system.
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