Definition GS1 - Healthcare Barcoding Organization

Marc

Fully vaccinated are you?
Leader
GS1 is an international non-profit organization. Until 2004 it was known as European Article Numbering-Uniform Code Council.

It has headquarters in Brussels (Belgium) and Princeton, New Jersey (US).

GS1 standard barcoding is increasingly used in health systems around the world. It was mandated in the 2014 NHS e-Procurement Strategy and is being pioneered in 2016 in six demonstrator sites: Derby Teaching Hospitals NHS Foundation Trust, Leeds Teaching Hospitals NHS Trust, North Tees and Hartlepool NHS Foundation Trust, Plymouth Hospitals NHS Trust, Royal Cornwall Hospitals NHS Trust and Salisbury NHS Foundation Trust. A GS1 UK healthcare advisory board has been established. Not only equipment and supplies but also staff and patients are barcoded.

The South Australia Department of Health decided to implement a GS1 procurement in 2007 linked to a tender for a master data management solution, which was implemented in 2016.

Source: Wikipedia reference-linkGS1

More information: GS1
 

Ronen E

Problem Solver
Moderator
GS1 is also one of the three code issuing agencies currently accredited by the FDA for implementation of the UDI (Unique Device Identification) rule.

GS1 has branches all over the world. GS1 US seems to be leading the way with everything UDI, however, manufacturers not based in the US can't directly register with GS1 US (they need to register with their local/regional branch if they choose to work with GS1).
 

MDRexpert

Involved In Discussions
GS1 is also one of the three code issuing agencies currently accredited by the FDA for implementation of the UDI (Unique Device Identification) rule.

GS1 has branches all over the world. GS1 US seems to be leading the way with everything UDI, however, manufacturers not based in the US can't directly register with GS1 US (they need to register with their local/regional branch if they choose to work with GS1).
Hi Ronan,

Can you throw some light from a supplier point of view? Since GS1 is a non profit organization they do not provide us enough information to access risk and have them added to our vendor list. We decided to create a memo and have them as exception in our system. In such cases what are other organizations doing? Can you suggest/advise what should be added in the memo to access risk specifically in terms of GS1.
 
Thread starter Similar threads Forum Replies Date
C GTIN & GS1 - what does the law say ? CE Marking (Conformité Européene) / CB Scheme 5
R GS1 DataMatrix code does not meet GS1 Specification EU Medical Device Regulations 0
N UDI: GS1 or HIBC ??? EU Medical Device Regulations 2
M DI format for UDI after we have registered it with GS1 Other US Medical Device Regulations 0
Sam Lazzara GS1 introduces Global Model Numbers for Medical Devices Other Medical Device Regulations World-Wide 2
Edward Reesor UDI (Unique Device Identification): HIBCC or GS1? ISO 13485:2016 - Medical Device Quality Management Systems 39
Pmarszal Two Questions on UDI Product Description (GS1 US and GTIN aspects) Other US Medical Device Regulations 2
S Dates on Labels acceptable to the USA - GS1 General Specification 3.4.4 Other US Medical Device Regulations 3
S GS1 (Barcode) Adoption for suppliers to the NHS Other Medical Device and Orthopedic Related Topics 11
P GS1 NHRN AIs - Creating Barcodes for Human Product Other ISO and International Standards and European Regulations 4
C UDI: HIBCC vs. GS1 - Recommendations regarding which one to select Other US Medical Device Regulations 2
Sam Lazzara Medical Device Barcode Pros and Cons: GS1 versus HIBC Other Medical Device Related Standards 18
K Barcode Traceability System - GS1 Food Safety - ISO 22000, HACCP (21 CFR 120) 1
bio_subbu MoHFW of India mandates GS1 Barcodes on Medical Devices other medical supplies Other Medical Device and Orthopedic Related Topics 3
W Strategy for determining which components from a system should be "ME EQUIPMENT" -- home healthcare environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
D Digital Healthcare - QMS requirements Other US Medical Device Regulations 3
K ISO 9001 Auditing in a Healthcare setting Process Audits and Layered Process Audits 15
Ed Panek GDPR in Urgent Healthcare Setting Other ISO and International Standards and European Regulations 1
L IEC60601-1-11 Home Healthcare + IEC60601-1-2 EMC (Functional Earth allowed?) IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M Informational Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2018 to 2019 Medical Device and FDA Regulations and Standards News 0
M Informational EU MDR and IVDR Factsheet for healthcare professionals and health institutions Medical Device and FDA Regulations and Standards News 0
B Practical ideas for information labelling in healthcare environment IEC 27001 - Information Security Management Systems (ISMS) 2
Jen Kirley Moving on - I accepted an offer to be a Supplier Quality Engineer at GE Healthcare Coffee Break and Water Cooler Discussions 42
shrutisancheti Upgrading medical device at healthcare establishments (user facility) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Marc US Healthcare under Siege Other Medical Device and Orthopedic Related Topics 0
S Does anyone know what a healthcare GDSN data pool actually looks like? Hospitals, Clinics & other Health Care Providers 2
JoCam Incident Reporting MHRA (Medical & healthcare regulatory agency) EU Medical Device Regulations 3
S Pharmaceutical and Healthcare Sciences Society ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 5
A IEC60601-1 - Battery Charger Requirement - Home Healthcare Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Are ISO 13485 & ISO 14971 applicable to Healthcare IT software? ISO 13485:2016 - Medical Device Quality Management Systems 3
Y Siemens Healthcare - FDA Warning Letter Analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Sidney Vianna European Norm 15224 - A Certifiable Standard for Healthcare Organizations Hospitals, Clinics & other Health Care Providers 0
A Donabedian Model in Healthcare Setup Hospitals, Clinics & other Health Care Providers 2
M MHRA (Medical & Healthcare Regulatory Agency) Design Dossier Review Delays EU Medical Device Regulations 2
R Could IEC 60950 Compliant Adaptor be used in Home Healthcare Environment? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S Healthcare Time and Motion Study Hospitals, Clinics & other Health Care Providers 13
S ISO 14001 for Mental Healthcare Facilities ISO 14001:2015 Specific Discussions 3
S Writing Good Documentation - Healthcare Sector Document Control Systems, Procedures, Forms and Templates 4
AnaMariaVR2 Shocking Warning Letter - Baxter Healthcare Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
H ISO 13485 & 21 CFR 820. Healthcare Plant Readiness Checklist ISO 13485:2016 - Medical Device Quality Management Systems 5
I Quality Manual for Healthcare/Medical Center Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
AnaMariaVR2 Healthcare Focused Error Proofing Hospitals, Clinics & other Health Care Providers 3
M IEC 60601-1-11 MEE used in Home Healthcare Environment Published IEC 60601 - Medical Electrical Equipment Safety Standards Series 21
Wes Bucey Leave automotive for healthcare? Career and Occupation Discussions 15
M Do any ISO standards related to healthcare and infotechnology require FMEA/FTA? FMEA and Control Plans 2
J Need Book Recommendation: Lean Six Sigma for Healthcare Lean in Manufacturing and Service Industries 4
chris1price ISO 80369 Part 3 Status - Small-Bore Connectors for Liquids and Gases in Healthcare ISO 13485:2016 - Medical Device Quality Management Systems 17
Colin Lean in Healthcare - Presentation ideas wanted Lean in Manufacturing and Service Industries 3
J Healthcare Canada vs. FDA - Differences in obtaining approval to sell product Canada Medical Device Regulations 2
M Proposed subforum: Quality Systems for Hospitals & Healthcare Providers Hospitals, Clinics & other Health Care Providers 11

Similar threads

Top Bottom