U.S. Food and Drug Administration Finalizes Rule on Codes that Will Track Medical Devices

Monday, October 21, 2013
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On September 20, 2013, the U.S. Food and Drug Administration (FDA) announced that companies will have to include unique device identification (UDI) codes on medical devices. These codes will provide a consistent way to identify medical devices, and therefore, should improve patient safety, according to the FDA. The codes allow regulators to track products, monitor them for safety and expedite recalls. The UDIs will be entered into a public database that the FDA will maintain.

Click here to read the press release from the FDA.

To fully realize the system’s benefits, hospitals, health plans and physicians must integrate these codes into patients’ health records and insurance billing transactions.


The Two Parts of the UDI System.

The UDI system consists of two parts: (1) a device identifier and (2) a publically searchable database, according to the FDA. The device identifier is a unique number assigned by the device manufacturer to the version or model of a device. The identifier will include production-specific information such as the product’s lot or batch number, expiration date and manufacturing date.

The second component is a publically searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID). The GUDID will serve as a reference catalogue for every device with an identifier. It is important to note that no patient information will be stored in this device information center.


Implementing UDI System.

The FDA plans to gradually phase in the UDI system, focusing first on high-risk medical devices (Class III). These devices will be required to carry unique device identifiers on their label and packaging, and submit corresponding information to the database within one year, according to the FDA.

Manufacturers will have three years to act for most moderate risk (Class II) devices. Class I device manufacturers that are not exempt from UDI requirements will have five years to act.


Implementation Issues.

According to a Reuters article, implementing the UDI system will be costly and challenging. Companies will be required to integrate the UDI into existing information systems, test barcode printing software and train employees. They will also have to redesign device labels to include a barcode and install equipment needed to print and verify the UDIs.

To read the Reuters article, click here
.


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Comments?

What affect do you think the identifier codes have on the medical device industry? How will it affect health care professionals and providers? Do you think it will help improve patient safety? Please leave any thoughtful comments below.


Sources:

Clarke, Toni. “U.S. FDA Issues Final Rule on Medical Device Identifier Codes.” Reuters. (September 20, 2013). From: http://www.reuters.com/article/2013/09/20/us-medicaldevices-fda-idUSBRE98J0J520130920

Rivers, Synim. “FDA Finalizes New System to Identify Medical Devices.” U.S. Food and Drug Administration. (September 20, 2013). From: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369276.htm


About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.


Tag Words: U.S. Food and Drug Administration, FDA, unique device identification system, UDI, medical devices, identifying medical devices, medical device manufacturer, unique device identifier, requirements for medica devices, Global Unique Device Identification Database, GUDID, FDA Final Rule, Health Law Firm, The Health Law Firm


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10/21/2013

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