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Health Canada Approves INTERCEPT Blood System for Plasma Texas Department of State Health Services Confirms the First Locally Acquired Case of Chikungunya | Study Evaluates Optimal Conditions for the Pathogen Reduction of Bacteria in Platelet Components | Science Section: What We're Reading | Calendar of Events
Health Canada Approves INTERCEPT Blood System for Plasma
Health Canada has approved the INTERCEPT Blood System for plasma. The INTERCEPT Blood System for plasma is intended to be used for the ex vivo preparation of pathogen-reduced, whole blood derived or apheresis plasma in order to reduce the risk of transfusion-transmitted infection (TTI). Approval of the INTERCEPT Blood System for plasma also helps move forward Health Canada’s review of the INTERCEPT Blood System for platelets, which will be considered an amendment to the core license.

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Texas Department of State Health Services Confirms the First Locally Acquired Case of Chikungunya
A Texas resident who became sick with chikungunya in November 2015 was diagnosed with a lab test in January 2016. However, the case was not reported to the local health department until April 2016. The investigation performed by the Cameron County Department of Health and Human Services determined the patient had not traveled, and the case was confirmed in May 2016 by testing at the US Centers for Disease Control and Prevention. Currently, there are no commercially available screening tests to detect chikungunya that may be present in blood components. The INTERCEPT Blood System has been shown to reduce 5.7 logs of chikungunya virus in platelets and plasma.

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Study Evaluates Optimal Conditions for the Pathogen Reduction of Bacteria in Platelet Components
Residual risk by passive reporting of bacterial sepsis from transfusion of platelet components remains, despite the successful introduction of several risk reduction measures. Estimates of residual risks of sepsis for apheresis platelets measured by passive hemovigilance may be as much as 10-fold below actual risk due to under-recognition and under-reporting. In a recent in vitro study, the INTERCEPT Blood System for platelets was evaluated for its ability to inactivate relevant levels of 5 transfusion-related organisms to sterility as a function of time between bacterial inoculation and inactivation, at 24 and 30 hour time points.

"Investigation of bacterial inactivation in apheresis platelets with 24 or 30 hours between inoculation and inactivation." Wagner, S. J., et al. Vox Sanguinis. 2016 doi: 10.1111/vox.12410. epub ahead of print.

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Science Section: What We’re Reading

Zika virus: A new threat to the safety of the blood supply with worldwide impact and implications
Lanteri et al, Transfusion, published online 9 June 2016.
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Global distribution and environmental suitability for chikungunya virus, 1952 to 2015,
EO Nsoesie et al, Eurosurveillance, Volume 21, Issue 20, 19 May 2016.
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Dengue and other Aedes-borne viruses: a threat to Europe?
G Rezza, Eurosurveillance, Volume 21, Issue 21, 26 May 2016.
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Autochthonous dengue outbreak in Nîmes, South of France, July to September 2015
T Succo et al, Eurosurveillance, Volume 21, Issue 21, 26 May 2016.
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Calendar of Events

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

 
SABM Annual Meeting (Society for the Advancement of Blood Management)
September 29 - October 1, 2016 | Grand Rapids, Michigan
Additional Information


AABB (American Association of Blood Banks) Annual Meeting
October 22-25, 2016 | Orlando, FL
Additional Information


ASA Annual Meeting (American Society of Anesthesiologists)
October 22-25, 2016 | Chicago, IL

Additional Information
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 00165-12
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