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The Rationale for Pathogen Reduction: Blood Center and Transfusion Services Perspectives

Part 3 of 3 – AABB Science and Innovation Forum: Assessing FDA Bacterial Guidance Strategies: Perspectives from Canadian Blood Services, the American Red Cross, and OneBlood

OneBlood provides its approach to complying with the FDA guidance, including the rationale for pathogen reducing the majority of OneBlood’s platelet inventory; blood safety, availability, and operational aspects are discussed from both the blood center and transfusion service perspectives.

Rita A. Reik, MD, FCAP
Chief Medical Officer
OneBlood

As Chief Medical Officer for OneBlood, Inc., Dr. Reik oversees OneBlood’s team of board-certified Transfusion Medicine physicians, and the operational areas of Therapeutic Apheresis, Cellular Therapy, Education, Transfusion Medicine Specialists Clinic and Research. She is board-certified in Anatomic and Clinical Pathology, Blood Banking/Transfusion Medicine, and Forensic Pathology. Dr. Reik’s past experience includes serving as Senior Medical Officer for the American Red Cross (ARC) Biomedical Services. She was also ARC’s Director of National Operations for the Center for Cell Therapy and Chief Medical Officer of the Pacific Northwest Region. Dr. Reik is a graduate of the University of Miami School of Medicine, and received her post-graduate training at University of Miami/Jackson Memorial Medical Center. Her areas of interest include Regenerative Medicine and Cellular Therapy, and new emerging diseases. She is a regional Principal Investigator for the NIH/NHLBI Transfusion-Transmissible Infections Monitoring System and served on task forces for Zika Virus. She serves on multiple national and international committees in the field of transfusion medicine and had authored research papers on new emerging diseases and their significance to the blood supply.

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Runtime: 19 min

INTERCEPT® Blood System for Platelets Pathogen Reduction System

INTENDED USE

The INTERCEPT Blood System for Platelets is intended to be used for ex vivo preparation of pathogen-reduced Amicus apheresis platelet components suspended in 65% PAS-3/35% plasma, and Trima apheresis platelet components suspended in 100% plasma in order to reduce the risk of transfusion-transmitted infection (TTI), including sepsis, and as an alternative to gamma irradiation for prevention of transfusion-associated graft versus host disease (TA-GVHD).

CONTRAINDICATIONS

Contraindicated for preparation of platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of platelet components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth less than 375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

WARNINGS AND PRECAUTIONS

Only INTERCEPT Processing Sets for platelets are approved for use in the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet components. No other source of UVA light may be used. Please refer to the Operator’s Manual for the INT100 Illuminator. Discard any platelet components not exposed to the complete INT100 illumination process. Tubing components and container ports of the INTERCEPT Blood System contain polyvinyl chloride (PVC). Di(2-ethylhexyl)phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released into the blood components must be weighed against the benefits of therapeutic transfusion.

INTERCEPT® Blood System for Cryoprecipitation for the manufacturing of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT® Fibrinogen Complex, IFC)

INDICATIONS FOR USE

PATHOGEN REDUCED CRYOPRECIPITATED FIBRINOGEN COMPLEX

Treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency.
Control of bleeding when recombinant and/or specific virally inactivated preparations of factor XIII or von Willebrand factor (vWF)
are not available.
Second-line therapy for von Willebrand disease (vWD).
Control of uremic bleeding after other treatment modalities have failed.

Limitations of Use: Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used for replacement of factor VIII.

CONTRAINDICATIONS

Contraindicated for preparation of blood components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of blood components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth less than 375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

WARNINGS AND PRECAUTIONS

Only the INTERCEPT Blood System for Cryoprecipitation is approved for use to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex. For management of patients with vWD or factor XIII deficiency, Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used if recombinant or specific virally-inactivated factor preparations are available. In emergent situations, if recombinant or specific virally-inactivated factor preparations are not available, Pathogen Reduced Cryoprecipitated Fibrinogen Complex may be administered.