GS1 standards in healthcare
GS1 standards are open, global, proven and simple.
Open, technology-independent standards permit full interoperability and compatibility. End users are not locked into proprietary solutions and R&D resources can be released up for other added value developments once standards have been adopted.
Healthcare is by nature a global sector, with supply chains that often cross borders. A global standardised system for traceability, from product manufacture to patient treatment, is imperative to comply with the increasing legal requirements for product traceability around the world. In cases of cross border trading, a global trade item number (GTIN) can be used to identify that product in any country without any restrictions or errors.
The GS1 system of standards is a system that has proven its robustness over the last 30+ years in different sectors worldwide.
Standards must be simple to be useable by all players in the supply chain and not give undue advantage to certain players through complexity.
Healthcare specific standards already ratified
Automatic Identification and Data Capture (AIDC)
Adoption and implementation of GS1 AIDC
Automatic identification systems (barcode or RFID) can have a very wide range of applications, including point-of-care scanning to match product data to patient data, verification of patient identity via a wristband, enabling the introduction of robotic dispensing systems, recording implant serial numbers in patient records and central registries, tracking and tracing of individual instruments through decontamination, stock control and supplies management, tracking assets throughout a network of facilities, … All these applications and systems enable the realisation of associated health and economic benefits: reducing medication errors, preventing counterfeiting, saving costs and increasing the Healthcare supply chain efficiency and transparency. Numerous studies have shown that automatic identification throughout the entire Healthcare supply chain, right to the point of delivery to the patient, is an extremely effective tool in preventing medication errors. However, global standards are needed for an effective and efficient roll-out of automatic identification systems in the healthcare sector.
Application standard, which provides a common set of data and data carriers for medical products at every packaging level, including specific guidance on selection and use of product identification keys, additional product and production data [for example; lot number, expiration date, and/or serial number (where applicable)], and data carriers
Automatic Identification and Data Capture (AIDC) Application Standard for Small Instruments, which specifically covers the marking of surgical instruments to enable traceability throughout the instrument reprocessing cycle, and in particular to and from the sterilisation department.
These standards are all an integral part of the GS1 General Specifications, the core standards document of the GS1 System, which can be obtained from your local GS1 Member Organisation.
Implementation Guidelines
GS1 AIDC Healthcare Implementation Guideline, providing guidance for using GS1 keys in a healthcare environment along with; procedures for recognising if additional data is required for types of products, needs for traceability, and marking requirements.
GLN in Healthcare Implementation Guide, a general guide for the implementation of GLNs in healthcare and as a guide this document: assists the reader in understanding; what is a GLN, how are GLNs applied/used, the GLN data structure, and steps for implementing GLNs.
Barcoding Plasma Derivatives Implementation Guide, to enable a safe and efficient delivery control process for plasma derivatives and traceability ‘from vein to vein’.
GS1 EDI Healthcare Guidelines outline a model for harmonised and streamlined business processes as well as EDI processes to be used by the participants in the healthcare supply chain.
GS1 Pharmaceutical Image Implementation Guideline provides a method of image naming; associated data, and transport methods needed to increase efficiencies and minimise costs.
GS1 Pharmaceutical Clinical Trial Electronic Messaging Standard Implementation Guideline details the best practice approach to implementation of GS1 standards for electronic messaging in the pharmaceutical clinical trial supply chain.