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Stryker’s GS1 standards adoption journey

Stryker’s GS1 standards adoption journey


Stryker is one of the world’s leading medical technology companies and offers a diverse array of innovative products and services in orthopaedics, medical, surgical, neurotechnology, and spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.

What was the problem?

The advent of the US FDA’s Unique Device Identification (UDI) Final Rule and the NHS eProcurement strategy meant that Stryker, as with all other medical suppliers, needed to update their product labelling to comply with these new regulations.

How was the problem solved?

Stryker saw this problem as an opportunity to standardise all of their product identifiers and barcodes. This approach makes life easier for their customers and increases efficiencies in the healthcare supply chain. Stryker recognised GS1 as the preferred standard for their customers and began implementation of GS1 standards across all 72,000+ Stryker products globally. This was a complex process, requiring hundreds of people, in multiple functions across all product and selling divisions.

The organisation first needed to identify the product data owners within the company, which was a vital step to ensure accuracy and consistency. Collaboration and consolidation of the information was required from:

  • Regulatory (GMDN, authorized representative)
  • Marketing (brand)
  • Product development (dimensions, storage conditions)
  • Supply chain (packaging level, unit of measure)

The Stryker teams developed sustainable business processes to harvest and consolidate these disparate product attributes into a new product master data system. This approach created one source of truth for Stryker product data.

Prior to the adoption of GS1 standards, the majority of Stryker products were labelled in production with HIBCC identifiers. An additional benefit of transitioning to GS1 standards, specifically GS1-128 linear or GS1 DataMatrix barcodes wherever possible, was to support a single scan on a product label.

A phased approach was developed to introduce GS1 standards globally, making the transition more manageable. The first GS1 labelled products started shipping in September 2014 and the rest will be phased in over the next four years.

What are the benefits?

By adopting the GS1 standard, Stryker anticipates there will be many benefits both internally and to their end customers, including:

  • Help reduce medical errors caused by the incorrect identification of products
  • Simplify integration of device usage information into computer data systems
  • Facilitate faster 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 detect 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
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