Quality assurance of the blood cold chain

Mexico City, 15th of August 2016

Gilles RIES CTO B Medical Systems

PERSONAL
Gilles RIES
Technical education in general engineering and cooling technology
Working for B Medical Systems since March 2000

B Medical Systems - CTO (Chief Technical Officer)

In charge of R&D, product development and -management & training

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

- at the heart of Europe

The Grand Duchy of Luxembourg is located at the heart of Western Europe
between Belgium, France and Germany.
Territory: 2586 km2
2015 total population: 563.000
Caracteristics:
Multicultural
Highly cosmopolitant capital
Governmental economic focus: FinTech, BioTech, Big Data
Founding member of EU

- at the heart of Europe

B Medical Systems S. r.l. factory located in Luxembourg / Europe

Luxembourg: +200 employees
Worldwide: network of 120 agents
Certifications:
ISO 9001 (Quality on high Level)
ISO 14001 (ECO managment)
ISO 13485 (Medical Device)
FDA

+ 35 years of experience & expertise in Cold Chain

Meeting
in
London:
start of
Cold
Chain
1974

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

2001 2005 2010 2013

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

Critical areas in the blood cold chain

The safety of the blood cold chain defines the safety of blood and blood components from donation to
transfusion or industrial processing.
Since all blood components have to be processed and stocked with very specific and tight temperature
profiles, the key of safety and success is located in 2 main areas :

Temperature
Traceability
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Critical areas in the blood cold chain

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Critical areas in the blood cold chain

-TEMPERATURE

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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Blood components and their storage requirements

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

Blood bank refrigerators

QUICK SPECS
Ambient temperature : 10C -> 43C
Setpoint : 4C fixed
Variance : +/- 1,5C
100mm insulation
FOC monitoring system
Alarms by email / SMS
Up to 8h of autonomy
Automatic door closing
Forced air circulation

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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Plasma contact shock freezers

Contact shock freezers are used to quickly reduce the temperature of plasma.
The target core temperature for the plasma bags is - 30C which is reached in 35 to 55 minutes
depending on ambient temperature and content of bag.
Incraeses factor VIII concentration by up to 150%
MBF12 : 12 bags of 450ml

MBF21 : 21 bags of 450ml

MBF42 : 42 bags of 450ml

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Plasma storage freezers

QUICK SPECS
Ambient temperature : 10C -> 32C
Setpoint : -35C to -41C
Variance : +/- 2C
100mm insulation
FOC monitoring system
Alarms by email / SMS
Automatic door closing
Intelligent hot gas defrosting system
Forced air circulation

110L

750L

Deep Freezers for plasma storage according DIN 58375 & European Medical

Device 93/42/EEC for model FR & MF. Storage of plasma at -41C.

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Transport boxes

Can be used to transport blood components at temperatures of -32C, +4C, +22C,

+37C, using PCM (phase change material) or standard ice packs.
100mm of insulation and WHO standards guarantee autonomy times of up to
1 week.

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Critical areas in the blood cold chain

-TRACEABILITY

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 in blood cold chain:

product VIDEO

18

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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RFID in blood transfusion

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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How RFID works

RFID Tag (chip + antenna)
Electromagnetic field signal

Communication
software

1. Somebody there
2. Yes Im 12345
3. Give me your details 12345

4. Here are my details:

MY UID: 12345
Group: A+
Donation number: 12345
Type: Red cells
Donated: 11/03/2015 16:00
Expiry: 12/04/2015 16h00
Weigth: 300g
Phenotype: D+C+E+c+e+
Status: Valid
Owner: Blood Bank
Cross Matched for Patient: no
Patient

Simple RFID Process

Simplified RFID process

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Complete process

Traceability

Donor

Labeling products with an RFID Tag

Trace products through RFID Tag
Intelligent equipment (Fridges, Freezers,
Agitators)
Transport temperature monitoring

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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Mobile collection units

Donor management and recruiting
Phlebotomy
Processing & Testing
Instrument interface

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

Labeling & labeling verification

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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

Cost: Pay by Tag

During the duration of a contract between B Medical Systems and a customer we include :

Refrigerators, Freezers, contact shock freezers transport units

Server, backup, workstations, data loggers

ALL 2BH-RFID related software packages and licenses

Full warranty & local support

Everything is provided without initial investment for the customer, if a consumable based business model is applied.

A price per TAG(label) will be calculated for each project based on

All necessary hardware (refrigeration and IT equipment) & services

Number of years of commitment

Number of tags consumed per year

Equipment will be owned by end customer at the end of the contract

Instant ROI because of no initial investment

37

Return on Investment

Financial savings are made on:

Components (Red cells, Plasma, Platelets)

Reduce number of expired products because of better product management (FIFO)
Re-use of components due to component traceability & possible return to blood bank

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

La Providence hospital in Switzerland

La Chaux-de-Fond Blood centre in Switzerland
EFS France
LFB France
CETS Centro Estatal de Transfusin Sanguinea de Veracruz
Hospital Regional de Alta Especialidad de Veracruz
Centro de Especialidades Medicas del estado de Veracruz " Dr. Rafael Lucio"
Instituto Nacional de Cancerologa "Dr. Miguel Dorantes Mesa"
Hospital Regional "Dr. Luis Gomez Nachn"
Hospital Regional de Rio Blanco
Hospital Comunitario "Dr. Valentin Gomez Farias"
Hospital Regional de Poza Rica
Appollo Hospital Group India
Red Cross Luxembourg

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Thank you for your attention