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.
1. Establish a UDI
The UDI is a unique numeric or alphanumeric code that includes a device identifier (DI – Device / 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!