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Customer Letter

Dear LSI Customers,

On September 23, 2013, the Food and Drug Administration (FDA) in the US released their Unique Device Identification (UDI) Final Rule which specifies the use of standardized barcode information for all medical device products. In accordance with this mandate, LSI SOLUTIONS® is in the process of changing the labelling on all product packaging to include a GS1 Healthcare Standard 2D Data Matrix barcode.

The GS1 system is the most widely used supply chain standards system in the world with utilization across numerous industries. It utilizes a Global Trade Item Number (GTIN) that uniquely identifies devices that are distributed throughout the supply chain. LSI barcodes will display the GTIN, along with the lot number and expiration date of the product to make up the Unique Device Identifier (UDI) number. An example of the LSI barcode information is provided below and will appear for all newly manufactured items required to comply in a similar format as shown. Please note, for your convenience, we have tried to place the barcodes on our packaging in the same location where customers have become accustomed to finding the lot and expiration information today.

As you may already be aware, the changes required by the UDI Rule, aspire to:

• Help to reduce medical errors caused by the incorrect identification of products.
• Simplify integration of device usage information into computer data systems.
• Facilitate quicker identification of medical devices associated with adverse events.
• Enable more efficient solutions to reported problems and resolution of device recalls.
• Provide an easily-accessible source of definitive device identification information.
• Help in detecting counterfeit devices.
• Improve Inventory Management and Supply Chain efficiencies.
• Facilitate development of electronic patient records.
• Help identify similar or replacement devices in case of a shortage.

This is a complex project that will be phased in over the next several years. Based on current inventories, the first LSI products to contain the UDI and barcodes will begin shipping towards the beginning of November 2015.

If you have a barcode scanning system or are planning on implementing barcode scanning to accommodate this new rule, please ensure that your systems are capable of reading GTINs and GS1 two-dimensional (2D) Data Matrix barcodes. As we phase in certain products required to comply, it is important to note that until existing inventory is depleted, there will be LSI SOLUTIONS® products in the field with the new GS1 barcode format, as well as items manufactured prior to compliance dates which will not currently contain the UDI nor a barcode. It is not necessary to return product that does not contain the UDI and/or barcode. Any LSI product that is returned is subject to the applicable restocking fees. Please also continue to use product part numbers when placing new orders.

To obtain a cross-referenced list of LSI SOLUTIONS® products that have started transitioning to the new labelling, please refer to the GTIN Reference List. This tool provides a current list to assist in updating existing scanning systems to reflect the new unique label identifiers as they become readily available.

We are committed to helping you with this change and encourage you to contact your LSI SOLUTIONS ® Sales Consultant with questions or requests for support. In addition, our Customer Service team can be reached at 866-575-3493 or emailed to customerservice@lsisolutions.com.

We thank you in advance for sharing this information with the appropriate individuals in your healthcare facility.


Kevin Bentley
Executive Director of Regulatory Affairs and Quality


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