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FDA to Publish Final Rule – Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
Recently, the FDA published the final rule to update Code of Federal Regulations (CFR) that govern regulations for blood and blood components. The new rule suggests a more flexible framework to more closely align with current FDA recommendations, to better address new or emerging infectious agents, and to accommodate advancing technology. Amongst several changes, the rule requires that blood centers and transfusion services have procedures to control the risk of bacterial contamination of platelets. According to the rule, “Section 606.145 requires establishments to assure that the risks of bacterial contamination of platelets are adequately controlled using FDA approved or cleared devices or other adequate and appropriate methods found acceptable for this purpose by FDA, and explicitly addresses the responsibility of transfusion services to comply with this current good manufacturing practice.” The FDA rule is anticipated to go into effect in May 2016.
For more information, please click here.
To link to the FDA Code of Federal Regulations, please click here.
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Speakers: Richard J. Benjamin, MD, PhD, FRCPath (Chairman), James P. AuBuchon, MD, and Joanne Becker, MD
The 2014 FDA approval of the INTERCEPT Blood System for Platelets and Plasma, coupled with the expressed need for the mitigation of transfusion-transmitted infections is shifting the landscape of blood safety and transfusion medicine. This symposium will examine the role pathogen reduction can play in meeting the needs of blood centers and hospitals who strive to deliver timely, safe, and efficacious products to meet patient needs. During this interactive program speakers and panelists will discuss the INTERCEPT Blood System, including potential operational efficiencies gained, and the value that INTERCEPT-treated components may provide to patients. The symposium will be followed by a networking reception.
To learn more about this program, and to pre-register today, please visit www.intercept-usa.com/aabb15
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Blood Bank of Delmarva (BBD) Produces INTERCEPT Pathogen Reduced Platelet Units
BBD announced today the production of pathogen reduced platelets. BBD was the first blood center to sign an agreement with Cerus Corporation following the FDA approval received for the INTERCEPT Blood System for platelets and plasma in December 2014. BBD provides blood transfusion products and services to hospitals and patients in the Delmarva region which includes the State of Delaware, Maryland, as well as portions of the Eastern Shores of Maryland and Virginia. BBD supplies approximately 13,000 platelet and 21,000 plasma units per year. “I am pleased that BBD is able to offer pathogen reduced platelets to our hospitals and their patients. This product provides a greater level of safety by lowering the risk for transfusion-transmitted infections,” says Chris Nare, Lead Executive of Laboratory Services and Distribution at BBD.
To learn more about BBD, please click here.
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PIPER Surveillance Study Open and Recruiting Hospital Participants
Cerus is executing a post-marketing active surveillance study, or the Phase IV INTERCEPT Platelets Entering Routine use (PIPER) Study. PIPER is a prospective, open-label study designed to evaluate the transfusion of conventional and INTERCEPT treated platelets in hematology/oncology patients, including those undergoing hematopoietic stem cell transplant, who are expected to require one or more platelet component transfusions.
To learn more about PIPER, please contact piper@cerus.com or click here.
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SCIENCE SECTION: WHAT WE'RE READING
Chagas’ Disease
Bern, C. N Engl J Med 2015;373:456-66. DOI: 10.1056/NEJMra141050
Read the full article here (subscription required for full access).
Comparative effectiveness of plasma prepared with amotosalen-UVA pathogen inactivation and conventional plasma for support of liver transplantation
Cinqualbre, J., et al. (2015). Transfusion. 55:1710–1720. doi: 10.1111/trf.13100
Read the full article here (open access).
Bitten by a bug or a bag? Transfusion-transmitted dengue: a rare complication in the bleeding surgical patient
Oh, HB., et al. (2015). Transfusion. 55:1655–1661. doi: 10.1111/trf.13054
Read the full article here (subscription required for full access).
Inactivation of Zika virus in plasma with amotosalen and ultraviolet A illumination
Aubry, M., et al. (2015). Transfusion. doi: 10.1111/trf.13271
Read the full article here (subscription required for full access).
Making thawed universal donor plasma available rapidly for massively bleeding trauma patients: experience from the Pragmatic, Randomized Optimal Platelets and Plasma Ratios (PROPPR) trial
Novak, DJ., et al. (2015). Transfusion.55:1331–1339.doi: 10.1111/trf.13098
Read the full article here (subscription required for full access).
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There is no pathogen inactivation process that has been shown to eliminate all pathogens. Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process.
CONTRAINDICATIONS: Contraindicated for preparation of plasma and platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of platelet and plasma 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 <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 and plasma are approved for use with the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet and plasma components. No other source of UVA light may be used. Please refer to the Operator's Manual for the INT100 Illuminator. Discard any platelet or plasma 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.
PLATELETS: INTERCEPT processed platelets may cause the following adverse reaction: Acute Respiratory Distress Syndrome (ARDS). An increased incidence of ARDS was reported in a randomized trial for recipients of INTERCEPT processed platelets, 5/318 (1.6%), compared to recipients of conventional platelet components (0/327). Monitor patients for signs and symptoms of ARDS.
PLASMA: Amotosalen-treated plasma may cause the following adverse reaction Cardiac Events. In a randomized controlled trial of therapeutic plasma exchange (TPE) for TTP, five patients treated with INTERCEPT Blood System processed plasma and none with conventional plasma had adverse events in the cardiac system organ class (SOC) reported. These events included angina pectoris (n=3), cardiac arrest (n=1), bradycardia (n=1), tachycardia (n=1) and sinus arrhythmia (n=1). None of these events resulted in documented myocardial infarction or death. Monitor patients for signs and symptoms of cardiac events during TPE for TTP.
Rx only. For full prescribing information, please see package insert.
MAN-EN-00165-03
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