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CBER Issues Guidance Agenda for 2017
The Center for Biologics Evaluation and Research (CBER), the center within the FDA that regulates biological products for human use under applicable federal laws, released the 2017 guidance agenda which lists planned guidance documents for the upcoming year. Included in this agenda is the final guidance that would follow the "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion-Draft Guidance for Industry" released in March 2016. This draft guidance provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of platelets, and includes pathogen reduction. The guidance agenda also includes a new draft guidance titled "Implementation of Pathogen-Reduction Measures to Reduce the Risks of Transfusion-Transmissible Infections in Transfused Platelets and Plasma; Draft Guidance for Industry."
Read the CBER Guidance Agenda
Read the FDA Bacterial Risk Control Strategy Draft Guidance
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Efficacy, Safety Assessed for Pathogen Reduced Platelets in Pediatric, Hematology/Oncology, Cardiac Surgery Patients, in Routine Practice
A recent study (Amato et al.) evaluated the efficacy and safety of pathogen reduced platelets via active hemovigilance surveillance at the University Hospital, Innsbruck Austria (UHI). Platelet, red blood cell and plasma component utilization indirectly measured platelet efficacy before and after the adoption of pathogen reduction; the safety profile was assessed by monitoring transfusion-related adverse events in both conventional and pathogen reduced platelets. Approximately 1,700 patients each, in the control and test periods, were evaluated, and included cardiac surgery (~40%), hematology-oncology (~27%) and pediatric/neonate (~9%) patient subgroups. The authors concluded that pathogen reduced platelets were equivalent to conventional platelets for prophylaxis and to prevent active hemorrhage, as demonstrated in hematology-oncology and cardiac surgery patients, respectively. Platelet, red blood cell and plasma component utilization, and the occurrence of transfusion-related adverse events were comparable between control and test periods.
Amato et al. Vox Sanguins. 7 Sept 2016. DOI:10.1111/vox.12456
Read the Article
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AABB US Hemovigilance Symposium, February 13-14, 2017
Cerus is pleased to announce the AABB Hemovigilance Symposium in Atlanta, Georgia on February 13-14, 2017. The AABB US Hemovigilance Symposium is the first of what is intended to become an annual event to bring experts from around the United States and around the world to discuss US hemovigilance. Experts will address the state of US hemovigilance, recognizing the successes of the past 10 years, identify the challenges such as perceived barriers to participation and share recommendations for future improvement and harmonization. Click here to register and to see more information about keynote speakers.
Register Here
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Science Section: What We’re Reading
Prevention of Transfusion-Transmitted Zika virus in French Polynesia, Nucleic Acid Testing Versus Pathogen Reduction
Musso et al. ISBT Science Series. 14December2016. DOI: 10.1111/voxs.12335
Read the Article Here
Zika Virus in the Blood Supply
Richard J Benjamin. Blood. 12 January 2017. Volume 129 2. DOI 10.1182/blood-2016-11-753160
Read the Article Here
Is Platelet Transfusion Associated with Hospital-Acquired Infections in Critically Ill Patients
Aubron et al. Critical Care. (2017) 21:2. DOI 10.1186/s13054-016-1593-x
Read the Article Here
Infectious Zika Virus in Vaginal Secretions from an HIV-Infected Woman, France, August 2016
P. Penot et al. Eurosurveillance. 19 January 2017. Volume 22 Issue 3. DOI: http://dx.doi.org/10.2807/1560-7917.ES.2017.22.3.30444
Read the Article Here
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Calendar of Events
AABB US Hemovigilance Symposium
February 13-14, 2017 | Atlanta, GA
Additional Information
BMT Tandem Meetings (Center for International Blood & Marrow Transplant Research & American Society for Blood and Marrow Transplantation)
February 22-27, 2017 | Orlando, FL
Additional Information
ABC (America's Blood Centers) Spring Meeting
March 24-29, 2017 | Washington DC
Additional Information
CSTM (Canadian Society for Transfusion Medicine)
April 20-23, 2017 | Ottowa, Canada
Additional Information
SCA (Society of Cardiovascular Anesthesiologists)
April 22-26, 2017 | Orlando, FL
Additional Information
ASPHO (The American Society of Pediatric Hematology/Oncology)
April 26-29, 2017 | Montreal, Canada
Additional Information
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Data for pathogen reduction of the Zika virus by the INTERCEPT Blood System, pathogen reduction system, have not been submitted for FDA review.
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.
INTERCEPT Blood System for Red Blood Cells is in development and not available for sale.
Rx only. For full prescribing information, please see package insert.
MKT-EN 00165-19
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