ShockWatch Blood Temp Minimizing loss & mitigating risk with ShockWatch Blood Temp.

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ShockWatch Blood Temp Minimizing loss & mitigating risk with ShockWatch Blood Temp

Transcript of ShockWatch Blood Temp Minimizing loss & mitigating risk with ShockWatch Blood Temp.

Page 1: ShockWatch Blood Temp Minimizing loss & mitigating risk with ShockWatch Blood Temp.

ShockWatch Blood TempMinimizing loss & mitigating risk with ShockWatch Blood Temp

Page 2: ShockWatch Blood Temp Minimizing loss & mitigating risk with ShockWatch Blood Temp.

ShockWatch Solutions

TrekView

Multi-use recorder

Per

form

ance

Data Recorders

Chemical Indicators

ColdMark2

WarmMark2

Single use Low cost

Go – No/Go

Price

Increasing Value to Customer

ColdMarkWarmMarkColdMarkWarmMark

Intelligent Monitoring System

Real-time Monitoring

Page 3: ShockWatch Blood Temp Minimizing loss & mitigating risk with ShockWatch Blood Temp.

Red Blood Cell Regulatory Requirements

• Blood must be stored between 1°C to 6°C

• Blood cannot exceed 10°C when transported

• Generally accepted 30-minute rule• Blood components may be held at

ambient temperature for no longer than 30 minutes

Page 4: ShockWatch Blood Temp Minimizing loss & mitigating risk with ShockWatch Blood Temp.

Blood Life Cycle

After donation, blood is stored in a refrigerator

Unused blood is discarded if it cannot be determined that the cold chain was maintained properly.

Blood is moved from a refrigerator to the operating room or emergency room

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Blood Bag Temperatures

As a filled blood bag is warmed from refrigerated temperature to room temperature, the temperature inside the bag will vary by location

Johnson, Langeberg, Makuria and Sandler 2006

Temperature recordings by a thermographic camera of a blood bag removed from refrigerated storage (2°C-6°C) and placed at room temperature (25°C) for 33 minutes (Courtesy of Jakob Woisetschläger, PhD, Graz University of Technology, Graz, Austria).

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Blood Bag Temperature Study Details• Digital thermometer temperature

measurements were made of the contents of 5 units of red blood cells.

• Temperatures were measured during refrigerated storage (1°C-6°C) at 5 locations inside the blood bags: a top corner, core/center surface, bottom midline, and a bottom corner.

• Temperature measurements were repeated at the same locations after the bags had been removed from refrigerated storage and maintained at ambient room temperature (23.2°C-23.5°C) for 15 and 30 minutes.

• After 15 min at room temp, differences could be detected in peripheral locations compared with core locations

• After 30 min at room temperature none of the temperatures in the peripheral locations were consistent with the core temp

• The center of the bag cools slower than the peripherals

Johnson, Langeberg, Makuria and Sandler 2006

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Design Considerations• Temperature indicator must:

• Be easy to arm• Be easy to interpret (regardless of language)• Be easy to apply / handle

• Suitable for mounting directly onto a blood bag

• Monitor core blood temp (not air temp)• Display breach when blood core temp rises above 10°C• Be small and discreet

• Solution – ShockWatch Blood Temp

Page 8: ShockWatch Blood Temp Minimizing loss & mitigating risk with ShockWatch Blood Temp.

ShockWatch Blood Temp

• Application specific member of the WarmMark2 product family• Single-use temperature indicator• Field-armable• Easy to read with a definitive color

change when armed and activated• Accurate

• Identifies when blood bag core temperature reaches 10°C

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Layout of Blood Temp

Breach WindowTurns blue after temperature breach

Indication of ArmingTurns green when product is active

Unique Serial NumberOn every product

Activation BlisterProduct is inert prior to activation

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Blood Temp Construction

MembraneDye travels through micro pores

Aluminum BackingDerives greater core blood temp accuracy

Blister Housing

Dye SolutionBlister awaiting activation

Mask / DesignDetermines breach window layout

Page 11: ShockWatch Blood Temp Minimizing loss & mitigating risk with ShockWatch Blood Temp.

How Blood Temp Works

Activated: blister squeezed,yellow to green color change inthe arming window confirmsproduct is armed.

Inert: liquid in blister beforearming

Breach: liquid moves into thebreach window (blue colorappears) when blood bag coretemperature reaches 10°C

Page 12: ShockWatch Blood Temp Minimizing loss & mitigating risk with ShockWatch Blood Temp.

Applying Blood Temp to the bag

• Blood bag must be pre-chilled to refrigeration temperature (2°C/36°F – 6°C/43°F) before applying the Blood Temp indicator

• Ensure that the blood bag is clean, oil free and moisture free before applying

• Blood Temp should be applied on the lower 1/3 of the blood bag since this is where the greatest volume of blood is held

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Using the Blood Temp• Indicators must in an environment above 10°C/50°F

• Firmly squeeze the blister located on the top of the indicator

• Confirm that the Blood Temp has been activated appropriately by verifying that the arming window has changed from yellow to green

• Re-squeeze the blister firmly if immediate color change does not occur

• Immediately remove the adhesive liner and adhere the indicator to the prepared location on the blood bag

• Apply constant pressure for 3-5 seconds to maximize adhesion quality

• Blood bag is now ready for use!

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Easy to Interpret

Yellow window indicates product has not been

armed.

Green window indicates the device has been armed.

Blue window indicates the blood bag core temperature

has reached or exceeded 10°C

White window indicates temperature control has been maintained.

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Estimated Return on Investment

• Reducing your loss rate by 8% pays for total investment. • A conservative 25% reduction more than triples your return.• Not captured in current costs (that may be reduced with monitoring program):

• Administration fees• Biohazard waste disposal fees• Audits / Regulatory Fines• Potential Litigation

Est. total Blood Bags (Per Year)

X Est. loss rate = Lost Bags(Per Year)

20,000 5% 1,000

Number of lost bags X Avg. cost per bag

= Current yearly costs for lost bags

1,000 $300 $ 300,000

Est. total Blood Bags (Per Year)

X Blood Temp unit cost = Total ShockWatch investment

20,000 $ 1.20 $ 24,000

Current yearly costs for lost bags

x Conservative loss reduction rate using a Blood Temp

= 25% decrease in loss equates to savings of

$300,000 25% $75,000

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Benefits

Reduce blood waste

Increase patient safety

Ensure regulatory compliance

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Reduce Blood Waste

Blood Temp allows you to determine if it is safe to return blood bags to refrigerator for reissue or if blood must be discarded

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Increase Patient Safety• “Bacterial contamination of blood components is the

most frequently reported cause of transfusion-related fatalities reported to the FDA” – Lab Medicine

• “The blood bank or transfusion service shall have methods to limit and detect bacterial contamination in all platelet components” - AABB

Sources: http://labmed.ascpjournals.org/content/35/10/616.full.pdfhttp://asheducationbook.hematologylibrary.org/content/2003/1/575.full?sid=6490eff7-b721-4045-acb3-c35b7f367383

Blood Temp ensures that bacteria growth due to elevated temperatures has not compromised blood during storage, transportation and distribution

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Ensure Regulatory Compliance

Blood Temp provides auditable proof that your blood has been stored, transported and reissued properly and according to relevant regulatory standards.

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Blood Life Cycle with Blood Temp

After donation, blood is stored in a refrigerator

Blood is moved from a refrigerator to the operating room or emergency room

Blood is discarded if the cold chain was not maintained properly

Blood Temp indicates if blood is safe to return to refrigeration for reissue

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Blood Temp Benefits

Accuracy• Temperature accuracy of +1°C• Aluminum backing acts as a

conductive surface for greater accuracy in monitoring core blood temperature

• No false activations from human handling

Easy to Read and Use• Field-armable• Clear indication when armed

(yellow to green)• Clear indication when breach

(white to blue)

Quality

• Certificate of conformance with every shipment

• Heat-sealed to prevent bleeding• Tamperproof• Splash / moisture-resistant

Traceability

• Unique identifiers assist tracking• Product is lot-traceable

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Key Specifications

Monitored temperature (blood bag core)

10°C/50°F

Temperature accuracy +1°C/2°F

Storage conditionsStore in a cool, dark location22°C/72°F at 20-80% RH

Shelf life 2 years from date of manufacture

Display Irreversible

Size 30 X 19 X 0.5 mm

Blister height 2.5 mm

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How Blood Temp WorksActivated Not Activated

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For additional informationemail [email protected]

or visit www.shockwatch.com