1.
E X P LO R I N G T H E P O S S I B L E U S E
O F R F I D T E C H N O LO G Y I N T R A N S F U S I O N M E D I C I N E
F. Bidet, M. Behague
MacoPharma, Tourcoing, France
BACK GROU ND
For more than 30 years, MacoPharma has developed and manufacture blood bags systems for transfusion therapy. The traceability improvement was always a priority for securing the
blood chain processes. Today, this traceability is insured through printed barcodes and codes printed or embossed on sub-elements of blood bags. New technologies could increase
the reliability and facility of the traceability data collection and transfer.
Radio Frequency Identification (RFID) is a technology which is able to register and transfer a considerable amount of data along the whole shelf life of an item. RFID tags are now used
in many different industries. According to IDTechEX, 650 billions of RFID tags will be used worldwide in 2018.
RFID can be applied to improve patient safety by matching caregiver, patient and blood components to ensure the 5 “rights”: right patient, right medication, right time, right dose and
right route.
AIMS
Traceability manufacturer
- Lot Number
Considering the possible benefits of this new technology,
- Product reference
MacoPharma wanted to validate an appropriate RFID tag for blood bags and explore - Expiry Date Traceability Blood banks
all possible uses of the RFID technology in Transfusion Medicine. - Sub-elements - Blood group
- Donation Data
RFID could be used for: - Process Data
- Temperature
•ensuring a complete traceability of blood bags from manufacturer to patient,
Traceability Hospitals
•securing a specific process (like viral inactivation or bedside blood cross-match)
- Data Storage
•speeding up data exchange in the different processes of blood transfusion - Blood Type
•avoiding misusing of blood components (counterfeit, illegal traffic). - Temperature
Possible Targets of RFID in Transfusion Traceability
M E T H O D S & R E S U LT S
RFID systems consist in the combination of a chip with an antenna, a reader linked to a computer, dedicated
MacoTrace
software (“middleware”) and a database.
We selected different passive RFID tags from different suppliers (Omron®, Infineon®...).
Data
We used a stand alone RFID reader/writer from Feig Electonic and embedded readers in MacoPharma equipment
Signal
(MacoPharma ABC®, Docon® and MacoTronic®).
We developed specific software “MacoTrace” for RFID feasibility study.
Antenna We evaluated the integration of these tags in the manufacturing of blood packs for transfusion.
MacoPharma Internal Validation
Before starting pilot studies in hospitals, we proceed to internal validation on
Data chip
more than 1000 RFID labels in order to select an appropriate RFID tag for
blood bags.
We tested all chips after all the following processes:
– Industrial labelling
– Sterilization (Steam, EO or Irradiation)
Antenna
– Pasteurization
Reader
– Centrifugation (up to 5000g)
– Freezing (-30°C & -80°C) & defrosting
RFID principle : Transmit data over Radio Frequency range
– Storage & stability (up to 3 years)
RFID Tag Validation
This test has shown that the position of the tag is very important in order to resist to the multiple stresses during the blood bag lifetime (especially centrifugation and freezing).
In our experience, RFID labels with cooper antennae were more reliable that the one with aluminium.
Existing RFID tags are resistant to steam sterilisation but they are not resistant to Beta sterilisation.
We have chosen the Omron Cooper RFID chip (I-code2 conform to ISO 15693) with a 128 bytes memory capacity. Other RFID tags will be validated as they are becoming available.
This RFID tag operates at High Frequency (13.56MHz).
The RFID label is placed under the base label of a blood bag (see picture).
In order to evaluate integrated RFID solutions, we have defined a mapping for the use in Transfusion Medicine. This mapping includes Smart Label
Unique Identification, an application code, MacoPharma reference number, lot number, space for donation number and blood product code.
We are planning to use an ISBT Standard mapping when it will be approved.
External Transfusion Pilots studies
Pilot studies have been run within blood transfusion centres and hospitals in Europe.
The aim of these different pilot studies were to:
•Trace and secure a process: pathogen inactivation of plasma using the TheraFlex-MB PlasmaTM system.
•Demonstrate the RFID technology input for optimising vein to vein transfusion traceability from donor to patient.
•Secure autologuous transfusion (routine use)
•Evaluate the use of an active RFID for the temperature monitoring of red blood cells concentrates. RFID bag
Securing the process of plasma inactivation
Theraflex MB Plasma is a process for reducing pathogen in blood plasma using Methylene blue and light.
Light exposure stage is critical to the activation of Methylene blue and it must be a GMP compliant controlled process. It is not possible to use light sensitive indicators to confirm
illumination.
Plasma kits are equipped with RFID tags. The MacoTronic illuminator is equipped with individual RFID reader/writer. Tags are automatically detected by the machine and data are
transferred to the computer. During the whole process of illumination, the reader is controlling that the plasma with Methylene blue is correctly illuminated. Using such a control during
the process guarantees the pathogen inactivation.
T h e r a f l e x Pa c k P l a s m a Pa c k M a c o Tr o n i c User
Manufacture User Illumination Status Check
Product Ref Donation No Serial No / User Name / Energy on successful
Lot No Prod Code Illumination duration / Maximum temperature illumination
Vein to vein traceability
120 kits were equipped with 2 RFID labels on empty bags.
During the donor examination, the doctor transfer data to the chip (donation number, donor number, ABOrh group and the volume to collect).
As the nurse put the collection pack on the MacoPharma ABC, the automate set up automatically the volume to collect. The nurse is therefore able to concentrate only on the relation
with the donor and the venipuncture. The automate writes on the chip all donation datas.
The packs are sent back to the blood processing centre and could be register in bulk.
Bags are centrifuged and blood components are separated. Red blood cells concentrates are stored at +4°C and plasmas are treated with Theraflex MB plasma system.
³
Plasmas are connected to treatment kit. Data are transferred from the RFID chip on plasmas to the RFID chip on the illumination kit in less than 2 seconds.
Donation Bag Blood Donation
Before collection
Reading:
Automatic recognition
of the bag & data
After collection:
Writing:
Writing
Donation Number
Limitator SN
Donor Number
Volume collected
Volume to collect
Duration
ABO Rh
Flow errors
³
Sheet
Blood Processing Labelling & Storage
Centrifugation/Separation/leucodepletion
Storage at +4°C
Freezing
Storage -40°C
Reading:
Reading/writing
Reading/writing:
Data transfer at blood
Check and final labelling
Control of processes & operators
processing centre
Bag in process
Plasma Pathogen Inactivation
Illumination on MacoTronic
Reading/writing Reading/writing
Transfer of data to Illumination status
new processing kit MacoTronic SN
Sterile Connection Illumination Data Reading/writing:
& operators
Release of PI Plasma
None of the RFID labels were reported to be damaged or unreadable after the whole process.
Cost consideration
The cost of blood bags equipped with RFID labels is higher than standard bags. The return over investment should be calculated not only with the improvement of the traceability.
Real financial benefits are coming from the time-saving in reading, writing and transferring data from RFID chips to/from Blood Banks and Hospitals Information Systems. It could be done
in bulk and with no need of sign alignement. Our experiment shows than a blood centre could save more than 100 hours of processing time per 1000 blood packs processed.
To have a complete benefit RFID labels should be integrated to all blood packs.
CO NC LU S I O N
Our validation studies show that RFID tags could be easily included to blood bags.
RFID tags are useful to ensure optimal traceability (especially between non compatible IT systems), to secure transfusion processes (pathogen inactivation, bed-side electronic
cross-matching), to improve data acquisition (time-saving and safer), to simplify blood components storage (random storage) and avoid illegal use of blood components.
A large scale use should confirm the return over investment for passive and active RFID tags in Transfusion Medicine.
Acknowledgements to Graz Blood Centre (Austria), Valencia Blood Centre (Spain) and National Blood Services (England) for their collaboration to these pilot studies.