International Society for Blood Transfusion Guidelines for Traceability of Medical Products of Human Origin

Affiliations

¹ Roper Management Consultants Ltd, Kent, UK.
² Department of Pathology, Michigan Medicine, Ann Arbor, Michigan, USA.
³ Omar Freelance Quality and Accreditation Consultant, Rochester, Minnesota, USA.
⁴ Australian Red Cross Lifeblood, Information, and Communications Technology, Adelaide, South Australia, Australia.
⁵ Swiss SCWeb AG, Lugano, Switzerland.
⁶ Department of Clinical Immunology, Odense University Hospital, Odense, Denmark.
⁷ Cell Manipulation Core Facility, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
⁸ ICCBBA, San Bernardino, California, USA.

Paul Ashford et al. Vox Sang. 2023 Jul.

. 2023 Jul;118(7):587-597.

doi: 10.1111/vox.13473. Epub 2023 May 25.

¹ Roper Management Consultants Ltd, Kent, UK.
² Department of Pathology, Michigan Medicine, Ann Arbor, Michigan, USA.
³ Omar Freelance Quality and Accreditation Consultant, Rochester, Minnesota, USA.
⁴ Australian Red Cross Lifeblood, Information, and Communications Technology, Adelaide, South Australia, Australia.
⁵ Swiss SCWeb AG, Lugano, Switzerland.
⁶ Department of Clinical Immunology, Odense University Hospital, Odense, Denmark.
⁷ Cell Manipulation Core Facility, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
⁸ ICCBBA, San Bernardino, California, USA.

No abstract available

Keywords: biovigilance; haemovigilance; patient safety; traceability.

References

1. 21 CFR Part 606 Current Good Manufacturing Practices for Blood and Blood Products. Department of Health and Human Services-Food and Drug Administration. 2022. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606. Accessed 16 Jan 2023.
1. EU: EC Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Directive 2001/83/EC.
1. Tugwell BD, Patel PR, Williams IT, Hedberg K, Chai F, Nainan OV, et al. Transmission of hepatitis C virus to several organ and tissue recipients from an antibody-negative donor. Ann Intern Med. 2005;143:648-54.
1. World Health Organization (WHO). World Health Organization (WHO): guide to establishing a National Haemovigilance System. Geneva: WHO; 2017.
1. ISO 1497:2019. Medical devices. Application of risk management to medical devices. International Organisation for Standardization.