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Quality Assursance of The Blood Cold Chain
Quality Assursance of The Blood Cold Chain
PERSONAL
Gilles RIES
Technical education in general engineering and cooling technology
Working for B Medical Systems since March 2000
AGENDA
B Medical Systems introduction
Blood cold chain storage temperatures the B Medical Systems cold chain offering
Blood Cold Chain traceability the 2BH-RFID solution
Offering
References
Q&A
B Medical Systems:
VIDEO
1979
WHO &
UNICEF launch
EPI
Electrolux
acquires
Camping
freeze
1980
1983
First Cold
Chain
product
Launch of
Medical
Line
1987
1992
Launch
of RCB
42 P
Launch
Gold
Line
1995
2000
Launch
of Silver
Line
Medical
Systems
Acquisition
of TUS &
Launch
MBF
Launch
of SDD
2015
MBO
with
Navis
Established
as Dometic
Launch of
Green Line
Fields of expertise
Leading manufacturer
and distributor of coldchain equipment for
large scale vaccination
programs in emerging
markets
Manufacturer of high
end medical
refrigerators for
hospitals, clinics, Blood
Transfusion Centers,
pharmaceutical
companies and
research centers in
developed markets
globally
RFID technology
solution for MedRef
Blood transfusion
sector
Temperature
Traceability
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The correct temperature during processing and stocking of blood products is essential and the basis for the
quality assurance.
Today, the problem in refrigeration is the risk of freezing products due to the lack of professional refrigeration
equipment.
Many blood banks around the globe are still using household refrigerators, where the risk of freezing and
overheating is extremely high and not documented.
Plasma must be frozen to -30C core temperature in less than 60min in order to reach a high concentration of
factors, however it is mostly frozen in standard freezers needing 24h and more.
FFPs have to be stocked in specific storage freezers, guaranteeing the right temperature even during defrosting
or door opening.
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Whole blood
Red cells
Platelets
White cells (leukocyte)
Plasma & cryoprecipitate*
Plasma & cryoprecipitate*
2C 6C
2C 6C OR < -60C
20C 24C agitated
2C 6C
-18C to -25C for 3 months
below -25C for 36 months
750L
110L
Refrigerators for the legally safe storage of blood bags / erythrocyte concentrates at +4C
The BR range comprises 5 Blood Refrigerators that are built in compliance with the requirements of :
- European Medical Device 93/42/EEC (ISO 13485)
- DIN 58371 (Germany, Blutkonserven-Khlgerte/ Blood Refrigerators)
- NORM K 2030 (Austria, Blutkonserven-Khlschrnke/ Blood Refrigerators)
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110L
750L
Deep Freezers for plasma storage according DIN 58375 & European Medical
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Transport boxes
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Even in the case where blood products are being kept in the correct refrigerators and freezers, there is
often no proof that this equipment has been delivering the correct temperature by monitoring.
If there is a proof of monitoring, still nobody knows if the blood product was effectively stocked in exactly
that equipment.
A traceability system must allow to verify at any point in time between donation and transfusion / industrial
processing, for all blood components : -> in what equipment the product was kept
-> for how long the product was stocked
-> what was the temperature of storage
-> who was the donor / receiver
-> what was the shelf life
-> at what moments was the product out of the refrigerator and for how long
-> who of the staff was handling the product
etc etc etc
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RFID introduction
What is RFID ?
RFID = Radio Frequency Identification
RFID is a technology, existing since 1948. The technology is using magnetic fields or high frequency radio waves,
to transmit data between a transponder, called the RFID tag and a reading device. This technology is used today
In :
Credit cards, ID cards, anti theft labels, as well as more and more to replace barcodes because the cost of the RFID
chips has come down drastically in the past few years. One of the latest developments is the use of RFID technology
in blood transfusing, by adhering an RFID chip located in an adhesive label to a blood bag.
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An RFID chip is integrated into the blood bag label, and is programmed automatically while the label is printed.
It can store all information contained on the label, and even more. It can also be reprogrammed should the blood
bag have to be reassigned to a new patient.
Using an RFID chip, guarantees the safety of data, avoids the problem with human interfacing, and ads a level of
safety to the transfusion system.
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Communication
software
1. Somebody there
2. Yes Im 12345
3. Give me your details 12345
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Complete process
Traceability
Donor
Monitoring
Monitor in real-time cooling equipment
Receive email / SMS alarms
Record all the temperature in the system
Transfusion
Cross Match
Bedside Cross Match
Hemovigilance
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Donor / Donation
Donor ID allows for donor identification using:
Fingerprint
Positive-ID
Other IDs
Donor Screening
Donor History
Questionnaire
Physical Examination
Donor Phlebotomy
O
R
Lab
Interface
Manual
Result Entry
Labeling
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Interfaces
2BH-RFID Interfacing Module is based on
standard communication protocols such as
HL7 and XML.
2BH-RFID can be easily integrated with other
Applications (Electronic Health Records, HIS,
LIS,
Inventory
Management
Systems,
Invoicing, and Accounting Software Packages).
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Offering
During the duration of a contract between B Medical Systems and a customer we include :
Everything is provided without initial investment for the customer, if a consumable based business model is applied.
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Return on Investment
Equipment
New refrigeration equipment provided with full warranty and after sales service
New IT equipment provided with full warranty and service
Software
All licenses included: no need to buy additional licenses
Staff
Process automation: saves working hours on phone calls, verifications, searches
Automatic stock management: no need to daily check the stock
Reduced shipping activity due to automated inventory
Interface to all lab devices: no need to enter the data manually
Data transported on tag: no need to recode all the data
Vital emergency
Services
Warranty and services are included during the whole contract length
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Thanks to no
initial
investment and
all the listed
benefits youll
have an instant
ROI
References
References
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