GS1 Global Approves Global Traceability Standard for Health Care
April 1, 2009 // Published as a news service by IHS
The GS1 Global Health Care User Group approved the Global Traceability Standard for Health Care (GTSH), which helps provide a framework for describing the traceability process and defining interoperability requirements between traceability systems across the health care supply chain.
Security, traceability and efficiency in health care are at the forefront of government regulations and industry concerns around the world, according to GS1. Some related issues include counterfeiting, product recalls, adverse event reporting, medication errors and efficient logistics management.
Many proprietary and incompatible solutions were proposed to national and international supply chain stakeholders, according to GS1. As a global open standard, GTSH was defined and adopted to help counter inefficient non-standard solutions.
The GS1 Global Traceability Standard for Health Care includes:
- Identification of parties, items and events.
- Labeling and/or marking and/or tagging of traceable items.
- The nature and type of data to be captured and collected.
- Recordkeeping, including archiving/data storage.
- Communication and sharing of information (information can be shown at the physical level of packaging labels and printed barcodes or captured and recorded at a data management level and communicated using e-business messaging).
- Links identification and management.
- Retrieval/search of information (the ability to track and trace a traceable item from creation to the point of sale, dispensing, use or destruction).
All pharmaceutical products and all risk categories of medical device products are in scope, for example:
- Units, such as hip prosthesis, batches/lots of pills.
- Trade items, such as a box of surgical gloves.
- Logistic units, such as a pallet.
- Packed and bulk products, such as medical gases.
- Branded goods, private labels and generic unbranded products.
Since GTSH was approved via the GS1 Global Standards Management Process, the work team is developing implementation guidelines to assist users in the implementation of traceability across health care supply chains.
Source: GS1.