7 Day Platelet Dating

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7 Day Platelet Dating with Safety Measure Testing…

Improves Safety

• Reduces the risk of bacterial contamination

Improves platelet availability

• Helps ensure a consistent supply
• Simplifies inventory management during weekends and holidays
• Provides inventory flexibility for managing rare HLA matched units

Provides Cost savings

• Reduces outdates and discards
• Can fully fund Safety Measure testing and provide additional savings

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FDA Clearance

FDA clearances now make 7 Day platelet dating possible:

Recent FDA clearances of 7 Day platelet storage containers from Fenwal and Terumo allow extension of dating of Apheresis platelets in plasma to 7 days when tested with a “Safety Measure”

• https://www.businesswire.com/news/home/20150803005109/en/Fresenius-Kabi-receives-FDA-clearance-7-day-platelet
• https://www.terumobct.com/Pages/News/Press%20Releases/FDA-Clears-Seven-Day-Platelet-Storage-and-Wireless-Capability-for-the-Trima-Accel-System-from-Terumo-BCT.aspx

The Platelet PGD Test is the only rapid test FDA cleared as a “Safety Measure” for platelet testing

• https://www.businesswire.com/news/home/20110922005202/en/FDA-Clears-Verax-Platelet-PGD-Test-%E2%80%9CSafety

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7 Day Platelets Are Safe

7 Day Platelets are Safe, Effective and Comparable to 5 Day platelets
A recently published major study in the UK comparing the clinical effectiveness of 7 day 5 day platelets in a Hematology patient population reported that:

• “Analysis using logistic regression…showed no significant difference in the proportion of patients with successful transfusions after administration of 2- to 5- versus 6- or 7-day PLTs”
• “In hematology patients, there was no evidence that 6- or 7-day PLTs were inferior to 2- to 5-day PLTs, as measured by proportion of patients with successful transfusions, bleeding events, or interval to next transfusion.”

Source: http://onlinelibrary.wiley.com/doi/10.1111/trf.13038/abstract

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• DHHS blood utilization data reports that 12% of SDPs outdate annually in the US
• Testing on Day of transfusion on Day 6 or 7 with a Safety Measure offers the opportunity to virtually eliminate outdating
• Cost savings can fund testing and provide additional savings as a fundamental element of a blood conservation program
• Case Study Examples of what 7 Days Can mean to you
  • • A 1,000 dose per year hospital with a 12% outdate rate
    • A 3,500 dose per year hospital with a 10% outdate rate
    • A 6,000 dose per year hospital with a 9% outdate rate

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Write an SOP for testing and determine how you will label the bags

Test the platelets in storage containers cleared for 7 Days within 24 hours of transfusion on Day 6 or 7 with a Safety Measure like the Platelet PGD test

Update your FDA Registration by simply notifying the FDA

Click here for a simple how to guide.