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Not only pharmaceutical products are subject to counterfeiting, also counterfeit medical devices are being sold world wide. Therefore the FDA has put in place regulations for the US market to ensure safety and to prevent counterfeiting of medical devices. The key of the new regulation is the unique identification of medical devices, namely by adding the unique device identifier (UDI) to the label of the medical device. The uniqueness is achieved by making the batch/lot, serial number or expiration date part of the UDI. In addition the manufacturer has to report certain parameters which are assigned to the specific device version or model into a central government database. By 09/2014 the regulation will become effective for the most strictly controlled class of medical devices, (Class III, e.g. implants, HIV diagnostic tests, …). Other classes follow until 2018.

UDI_Timeline.png

1. Establish a UDI

The UDI is a unique numeric or alphanumeric code that includes a device identifier (DIDevice / Product Identifier – GTIN) which is specific to a device model, and a production identifier (PI) which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.

2. Print UDI on Label

The UDI must appear on the label in a human readable format, as well as in a manner that can be read by automatic identification and data capture (AIDC) technology, such as a linear or 2D Data Matrix barcode. The label with the unique UDI must be applied to the “base package” and higher levels of packaging. In addition devices must bear the unique UDI as a permanent marking when the device is intended to be used more than once.

3. Submit device version data to a central government database

FDA Global UDI Database (GUDID) serves as the repository of key device identification infor-mation. The GUDID contains ONLY the DI, which serves as the primary key to obtain device information in the database. PIs are not submitted to or stored in the GUDID; the GUDID will contain only production identifier flags to indicate which PI attribute(s) are on the device label.

SAP’s proposal to approach this topic is via Master Data Governance. SAP’s MDG capabilities allow to

  • extend the data model according to the requirements of different regulatory bodies (e.g. US FDA, EU, China, …),
  • govern the creation and approval process for product data across different systems,
  • manage the submission processinto the GUDID,
  • maintain one version of the truth!
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2 Comments

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  1. Nagesh Ramesh

    Oliver – Very informative article. Thank you for sharing your knowledge! The purpose of UDI and GUDID database is less to do with preventing counterfeiting of medical devices and more to do with ensuring a single harmonized way of identifying a device across the entire supply chain. This will assist FDA during recalls and complaint reporting. When fully implemented, by performing a search with the UDI in the GUDID database, general public must be able to get information about the safety of a device (free of charge) helping improve safety of these devices. More information is available at the below link. http://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/globaludidatabasegudid/default.htm 

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  2. Dean Jackson

    Oliver – Thanks for outlining the requirements of UDI.  I agree with Negash that UDI is about patient safety.  This fact requires that the industry has some form of post market surveillance.  The issue with the ruling is that is does not ask nor require devices to be scanned, logged, tracked, identified anywhere throughout the supply chain.  It only requires manufacturers to included the, “device identifier” on the label and perform the GUDID submission.  No where does it talk about accountability across the supply chain so this is really an opportunity for us (including SAP) to work with the GS1, GTO and HTG to set standards using the SAP Master Data Governance model.

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