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Loftware, Inc
166 Corporate Drive
Portsmouth, NH 03801
P: +603.766.3630
F: +603.766.3631
www.loftware.com

Healthcare and Compliance Label Concerns

If you are responsible for business labeling at any medical device or diagnostic firm, whether in a family of manufacturing companies, distribution centers and regional franchises or a medium-sized business, you are facing some immediate GS1 and GTIN label compliance, regulatory, and global issues in 2008. How you respond to these legal and regulatory requirements will determine your business, your sales, and your operations..

Some of the impending labeling issues include the global transition to GS1:

  • Country and regional requirements:
    • The UK: UK National Health Service: demands GS1 (UCC / EAN 128) barcoded labels. The UK NHS is responsible for the vast majority of medical device and diagnostic business in the UK.
    • France: All University Hospitals and 30 non-University Hospitals mandate GS1 barcodes
    • Canada: looking to include serialized GTINs (GS1 component) in their country-wide electronic health record. Bid specifications from hospitals are demanding GS1 barcodes to support this effort.
    • China: all products manufactured in China must have GS1 barcoded labels. Imported products may have HIBCC barcodes for now, but will soon be mandated to the GS1 standard.

  • Information Technology requirements – Your SAP or Oracle instance may handle the front-office functions just fine but can you, for example, have a lot number and a serial number for an item because both have to go on the label?

  • Distribution – Regional distribution warehouses must support local government/customer labeling requirements. As the manufacturer of the product, you may have no idea of the final destination of the product since it is warehoused in a regional distribution center.

The Standard Healthcare Distribution Model:
The standard distribution model for medical products often goes as follows:

  1. The product is manufactured and labeled at manufacturing site
  2. The product is delivered to the Regional Distribution Center supporting a regional area – North America, Canada, Brazil (South America), Brussels (Europe), Australia (Pacific) plus smaller distribution centers supporting smaller markets
  3. The Regional Distribution Center assembles shippers made up of various company products and delivers the products to the customer

Business Problem

  1. The point of manufacture has no insight into the final destination of their product
  2. Each country has unique requirements for data on the label
    • Japan requires JAN number
    • China requires differing information for imports vs domestic goods
    • Turkey requires specific, unique data
    • European Union requires LOT/BATCH data
    • Canada requires SGTIN
    • Australia requires Global Location Numbers (GS1 Service)
  3. While each country follows GS1 Organization standards, data is not uniform by GS1. For example:
    • “GS1 Japan” is Government owned
    • “GS1 China” is Government owned
    • “GS1 Switzerland” is Government owned
  4. Different Countries require different package levels – each package level requires a unique GTIN
    • Many Asian Countries break open cartons and sell products as individual units
    • Individual units are not labeled by manufacturer

Business Solution
Loftware provides a solution available to each regional distribution center that:

  1. Generates labels for warehoused products in compliance with customer demands “Pulls” data from Manufacturer ERP solution for Batch /Lot information and Packaging Level GTIN components (Mfg ID Number)
  2. Adheres to any Corporate Marketing Standards – “Maintains Look & Feel”
  3. Easy to use – Distribution centers have limited IT, label design, or data standards expertise. This knowledge is resident at Manufacturing site.
  4. System is “compartmentalized” to mitigate the risks of a regulatory agency shutting down the entire distribution model due to one bad label.