Compliance with UDI Labeling Mandates:
A Proven Methodology

There has never been a better or more urgent time for manufacturers of healthcare products to make a close examination of their product labeling systems. Why? Because in most cases, existing solutions were developed over time, usually organically and often departmentally, individually and separately by each manufacturing entity to a labeling standard of their own choice. This approach has mostly worked, albeit at great expense, with much inefficiency, and at the tremendous risk of error, manufacturing interruptions, counterfeit labels and a host of other problems. But in addition to these well-known limitations, there is one additional major reason why now is a good time to explore labeling solution alternatives. New labeling mandates from the FDA – now expected to be imposed no later than September, 2013 – are going to require all healthcare products manufacturers in the United States to adhere to a uniform set of Unique Device Identification (UDI) labeling standards. This means that proprietary labels and any labels that are not part of a universally-accessible database for common use by all other manufacturers and at all checkpoints in any supply chain will, virtually overnight, be a thing of the past in the United States. In fact, it is likely the FDA initiative will further drive the global effort occurring at this time to effect this same kind of UDI solution worldwide.

Continued on White Paper >>

Healthcare and Compliance Label Concerns

If you are responsible for business labeling at any medical device or diagnostic firm, whether in a familyof 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 2009. 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.

Do you need controlled labeling? GS1 compliance?

Loftware’s products integrate directly into your existing ERP and electronic Content Management [eCM] system to provide a controlled, compliant system for label output management. Combining the approval and validation workflow features of your existing eCM with the powerful label automation features of our ERP Connectors and Print Server (LPS) ensures you have the approved content on the right label at the right printer at the right time, every time.

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.

 

 

GS1® Link:
Healthcare

FDA Links:
Draft Guidance for Industry on Standards for Securing the Drug Supply Chain

FDA Docket Info

Further reading on GS1: LoftwareBlog

We are very familiar with the emergent labeling requirements from GS1 in its US-national and international dimensions. We have a popular blog on the topic which you can visit from here to find out about all things GS1 label related – and how Loftware views, addresses and solves GS1 label issues. We provide these pages and our on-going blog as a convenient, single-stop place to get up to speed on this global standard that will effect every supplier of medical device and related materials in the world.

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