New Identification Standard for Medical Devices
GS1 Healthcare (Brussels, Belgium) has published a new voluntary standard for the Automatic Identification and Data Capture (AIDC) of medical products. The standard provides a common set of data and data carriers for medical products at every packaging level, including specific guidance on selection and use of:
- Appropriate product identification keys, such as any current GS1 key: GTIN, GRAI, or GIAI, etc.
- Additional product and production data, such as lot number, expiration date, and/or serial number (where applicable).
- Data carriers including linear bar codes, two-dimensional bar codes, and Radio Frequency Identification (RFID) tags.
“Sector-wide implementation of AIDC systems will improve patient safety, including reducing medication errors, fighting counterfeiting and enabling effective product recalls, and adverse event reporting,” said Mike Wallace, Director Global Standards and Serialization, Abbott, and Co-Chair of GS1 Healthcare, in a press release issued by GS1. “It will also help remove inefficiencies throughout the Healthcare supply chain, allowing stakeholders to improve and integrate their processes.”
“Implementing this standard will ensure that medical products can be unambiguously identified by anyone in the Healthcare supply chain,” said Joe Pleasant, Chief Information Officer, Premier, Inc. and member of the Global Leadership Team of GS1 Healthcare, in the press release. “The Healthcare sector must now leverage technology advances to create a more efficient and effective supply chain, bringing us one step closer to an efficient supply chain like those seen in other industries.”
“We need a global vision: Healthcare is a global business where supply chain partners exchange goods and information. Country-specific non-standard requirements have a major impact on product assortment and on supply chain management,” added Volker Zeinar, Global Coordination Auto-ID Affairs, B Braun and member of the Global Leadership Team of GS1 Healthcare, “Global standards are key success factors for process improvements for suppliers.”
The standard recognizes the potential of two-dimensional bar codes, such as GS1 DataMatrix, for meeting specific of healthcare supply chain requirements, such as including more fixed and variable information while maintaining a small size bar code (e.g., bar code at the unit of use level) and the need for direct part marking (e.g., surgical instruments).
GS1 notes that the 14-digit Global Trade Item Number (GTIN) will be used in nonretail applications.
The product ID key referred to in the press release is any current GS1 key, such as GTIN, GRAI or GIAI, etc. GS1 used the general term 'product identification key' because in some limited situations in the standard, identification keys other than the GTIN may be used--but this is a minor point and an exception in the real world (for example, it is possible that a hospital might decide to use a GIAI to mark a reusable surgical instrument instead of a GTIN, but this is limited to certain partners and certain packaging levels under certain situations).
All additional production data would be added as Application Identifiers, same as for any other sector.
Regulatory agency representatives, including FDA, participated in the actual standards work and were made aware of this work through several communications mechanisms. The workgroup sought to develop a standard that would meet the diverse needs of the overall industry, which of course includes the needs of the regulatory agencies. Since UDI and other regulations are still in a draft phase, we hope that these jointly-developed, global standards will be taken into consideration as the final rules are developed.
The new standard provides a global framework taking all specific requirements for medical products into account, explains Ulrike Kreysa, Director Healthcare, GS1 Global Office. “Many countries have regulated product identification systems for medical product registration and reimbursement purposes. However, using these numbers for supply chain management purposes is sub-optimal. A GS1 Identification Key can be mapped to a national number in a national database by the brand owner. Over 65 countries already accept GS1 Identification Keys for medical products.”
Industry collaboration was behind standard development. “Over the last 3 years, more than 100 experts from every region of the world and representing every segment of the healthcare supply chain contributed to the development of this standard,” reported Grant Hodgkins, Alcon Laboratories Inc., Co-Chair of the AIDC Application Standards work group and member of the GS1 Healthcare Global Leadership Team. “In over 150 meetings, or more than 4500 contact hours, our teams carefully compiled the industry’s business requirements, then designed and delivered global solutions to meet these challenging requirements. The healthcare industry can now begin adoption efforts to realise the benefits already demonstrated in other sectors that use the GS1 System of Standards.”
For more information, see the position statements at www.gs1.org/healthcare/library.
GS1 Healthcare is a global, voluntary healthcare user group developing global standards for the healthcare supply chain and advancing global harmonisation. GS1 Healthcare consists of participants from all stakeholders of the healthcare supply chain manufacturers, wholesalers, and distributors, as well as hospitals and pharmacy retailers. GS1 Healthcare also maintains close contacts with regulatory agencies and trade organizations worldwide. For more information, visit www.gs1.org/healthcare.