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Widespread implementation of pathogen reduction technology recommended for maintaining a safe blood supply in an era of emerging pathogens Estimates of the potential Zika virus risk for 50 U.S. cities AABB’s revised standards includes use of pathogen reduction technology for reducing the risk of transfusion-associated graft versus host disease | U.S. blood centers continue to make the move to pathogen reduction technology | Science Section: What We're Reading | Calendar of Events
Widespread implementation of pathogen reduction technology recommended for maintaining a safe blood supply in an era of emerging pathogens
A recent publication by Marks et al. calls for a more universal approach to protecting the blood supply in light of rapidly emerging threats.  The emergence of such pathogens can cause an initial disruption to the blood supply via deferrals, the need to import blood products, and the time and cost related to test development. This paper published for Infectious Diseases Society of America 2016 highlights how widespread or universal implementation of robust pathogen-reduction technology for all blood components could remarkably change our reactive blood safety paradigm.

Read the paper
The National Center for Atmospheric Research estimates the potential Zika virus risk for 50 U.S. cities
Several locations spanning the south-central and eastern regions of the US are considered vulnerable to local Zika virus transmission based on the observed population of the Aedes aegypti mosquito, a known carrier for Zika, according to the National Center for Atmospheric Research (NCAR). Summertime weather conditions are favorable for populations of the mosquito along the East Coast as far north as New York and across the southern tier of the country as far west as Phoenix and Los Angeles, according to computer simulations conceived and run by researchers at NCAR and the NASA Marshall Space Flight Center. Cities in southern Florida and impoverished areas in southern Texas may be particularly vulnerable to local virus transmission. Long-range forecasts for this summer also point to a 40–45% chance of warmer-than-average temperatures over most of the continental United States.

View the estimated cities at risk and projected timelines
AABB’s revised Standards for Blood Banks and Transfusion Services includes use of pathogen reduction technology for reducing the risk of transfusion-associated graft versus host disease
The 30th edition of the AABB’s Standards for Blood Banks and Transfusion Services finalized language to Standard 5.19.3 - Prevention of Transfusion-Associated Graft-vs-Host Disease to include the use of pathogen reduction technology.  The BBTS Standards Program Unit reviewed the effectiveness of pathogen reduction technology of platelet units and determined it would be as effective as traditional irradiation to satisfy their requirement to reduce the risk of transfusion-associated graft versus host disease (TA-GvHD).

View the bulletin
U.S. blood centers continue to make the move to pathogen reduction technology
A growing number of centers continue to initiate production with the INTERCEPT Blood System and others continue to sign agreements for future adoption. The Community Blood Center of the Carolinas, which previously signed an agreement for the use of INTERCEPT platelets and plasma, became the fifth U.S. blood center to begin production of pathogen-reduced platelets using the INTERCEPT System. “The proactive approach that the Community Blood Center of the Carolinas has taken will allow our blood center to continue collecting and preparing platelets and plasma if there happened to be an active Zika virus transmission in our community,” said Martin Grable, CEO of the Community Blood Center of the Carolinas.

Blood Centers of America (BCA) members Gulf Coast Regional Blood Center and LifeSouth Community Blood Centers also recently signed agreements for use of the INTERCEPT Blood System for platelets and plasma, joining several other BCA members that have already chosen to adopt INTERCEPT. BCA is a member-owned organization comprised of nearly 50 independent blood centers throughout North America that account for more than 30% of the US blood supply. Cerus is a BCA preferred provider for pathogen reduction technology.
Science Section: What We’re Reading

Fatal transfusion-transmitted infection due to Citrobacter koseri
Hauser, L et al. Transfusion, published online 4 April 2016.
Read the abstract

Severe sepsis and septic shock associated with chikungunya virus infection, Guadeloupe, 2014
Rollé A, et al. Emerg Infect Dis. 2016 May.
Read the article
 
Leishmania infantum infection in blood donors, northeastern Brazil [letter]
Monteiro DCS, et al. Emerg Infect Dis. 2016 Apr.
Read the letter
 
The role of hemovigilance and postmarketing studies when introducing innovation into transfusion medicine practice: the amotosalen-ultraviolet A pathogen reduction treatment model.
Corash, L. and Benjamin, R. J. Transfusion, 2016, 56: S29–S38.
Read the abstract

Platelets regulate vascular endothelial stability: assessing the storage lesion and donor variability of apheresis platelets.
Baimukanova, G., et al. Transfusion, 2016, 56: S65–S75.
Read the abstract
Calendar of Events

ILABB (Illinois Association of Blood Banks)
April 15, 2016 | Chicago, IL

Additional Information

ASCLS – CNE (American Society for Clinical Laboratory Science - Central New England)
Apr 26-28, 2016 | Providence, RI
Additional Information

ASFA (American Society for Apheresis) Annual Meeting
May 4-7, 2016 | Rancho Mirage, CA
Additional Information

ASPHO Annual Meeting
May 11-14 | Minneapolis, MN

Additional Information

CSTM (Canadian Society of Transfusion Medicine) Annual Meeting
May 11-15, 2016 | Vancouver, BC
Additional Information


TABB (Tennessee Association of Blood Banks)
May 12-13 | Chattanooga, TN
Additional Information

NJABBP (New Jersey Association of Blood Bank Professionals)
May 17 | New Brunswick, NJ
Additional Information

SCABB (South Central Association of Blood Banks)
June 2-6, 2016 | Houston, TX
Additional Information


BBANYS (Blood Bank Association of New York State) Annual Meeting
June 9-10 | Albany, NY
Additional Information

ABC Summer Meeting
August 2-4, 2016 | Honolulu, HI
Additional Information

AABB (American Association of Blood Banks) Annual Meeting
October 22-25, 2016 | Orlando, FL
Additional Information
Data for pathogen reduction of ZIKA by the INTERCEPT Blood System, pathogen reduction system, has 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.

Rx only. For full prescribing information, please see package insert.
MKT-EN 00165-10
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