WO2009034448A1 - Process and system for controlling transfusions of blood components - Google Patents

Process and system for controlling transfusions of blood components Download PDF

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Publication number
WO2009034448A1
WO2009034448A1 PCT/IB2008/002362 IB2008002362W WO2009034448A1 WO 2009034448 A1 WO2009034448 A1 WO 2009034448A1 IB 2008002362 W IB2008002362 W IB 2008002362W WO 2009034448 A1 WO2009034448 A1 WO 2009034448A1
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WO
WIPO (PCT)
Prior art keywords
transponder
patient
bag
memory area
detecting
Prior art date
Application number
PCT/IB2008/002362
Other languages
French (fr)
Inventor
Pier Maria Fornasari
Carlos Alberto Baigorria
Original Assignee
Istituto Ortopedico Rizzoli
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Istituto Ortopedico Rizzoli filed Critical Istituto Ortopedico Rizzoli
Publication of WO2009034448A1 publication Critical patent/WO2009034448A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02Blood transfusion apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6009General characteristics of the apparatus with identification means for matching patient with his treatment, e.g. to improve transfusion security

Abstract

A process for controlling transfusions of blood components, comprising: associating a first transponder (10) with a patient; providing a bag (30) for containing a blood component intended for that patient, said bag (30) comprising a second transponder (40); detecting the UID code of the first transponder (10) and storing it into a predetermined memory area (41a) of the second transponder (40); before giving said patient the transfusion of that blood component, performing the following steps: carrying out a first detection for detecting the UID code of the first transponder (10), carrying out a second detection for detecting the contents of the predetermined memory area (41a) of the second transponder (40), checking whether the results of said first and second comparisons are identical. Also described is a system (1) for putting said method into practice.

Description

PROCESS AND SYSTEM FOR CONTROLLING TRANSFUSIONS OF BLOOD COMPONENTS
D e s c r i p t i o n
The present invention relates to a process and a system for controlling transfusions of blood components.
In particular, these blood components can consist of blood, plasma, etc. that are transfused into a patient, after being drawn from the patient himself/herself or from another individual whose blood has characteristics compatible with those of the patient's blood.
It is known that transfusions of blood components can substantially be of two types .
First of all there are the autologous transfusions in which the blood (or more generally the blood component of interest) is drawn from an individual for the purpose of subsequently giving the same individual a transfusion, if necessary. These types of transfusions are particularly used in case of surgical operations, during or after which the patient may need to restore the blood lost exactly during the operation.
There are then the homologous transfusions in which the patient- receives blood (or other blood component) from another individual .
In both cases, the blood to be supplied to the patient is preserved in suitable bags kept in a collection and storage place; said bags are then to be picked up at the moment the transfusion is to be given. In this context, associating the patient in a correct manner, without any possibility of mistake, with the bag to be used for transfusion appears to be crucial; in fact it is known that when transfusions are given with blood or blood components having different characteristics from those of the patient (which characteristics therefore are not compatible with those of the patient himself/herself ) , very serious damages can occur to the addressee of the transfusion, and the patient may even die.
The present invention aims at providing a process and a system for controlling transfusions of blood components capable of ensuring a high reliability in associating the patient with the bag to be used in the transfusion.
In particular, it is an aim of the present invention to make available a process and a system that are very reliable both in case of autologous transfusions and in case of homologous transfusions.
It is a further aim of the invention to provide a control process and system capable of ensuring correctness in the performed operations while maintaining the necessary privacy as regards the personal data of the treated patients .
The technical features of the invention, based on the above mentioned aims, can be clearly found in the contents of the appended claims, and the advantages of same will become more apparent from the following detailed description, "taken with reference to the accompanying drawings, representing an embodiment thereof and given by way of non-limiting example, in which: - Fig. 1 diagrammatically shows the components of the system in accordance with the invention, through which the process of the invention is carried out;
- Fig. 2 diagrammatically shows a detail of the system in Fig. 1;
- Fig. 3 diagrammatically shows a section, taken along line III- III, of the detail seen in Fig. 2 ;
- Fig. 4 diagrammatically shows the storage' structure used in the system in Fig. 1.
According to the drawings, the system in accordance with the invention has been generally identified by reference numeral 1.
As mentioned above, system 1 is used for putting into practice the process of the invention.
The process first of all comprises a step of associating a first transponder 10 with a patient.
The first transponder 10 comprises at least one memory 11 and an antenna 12, through which a signal incorporating the contents of said memory 11 is transmitted.
Preferably, the first transponder 10 is not provided with a powering unit; the required power for generation of said signal is received via ether, through antenna 12.
In other words, when the contents of the transponder memory 11 are to be read, said transponder is impinged on by an electromagnetic radiation at a predetermined frequency, so that it can be power supplied and can generate said signal. Preferably, the first transponder 10 is mounted on a bracelet 20 that is applied to the patient.
Generally bracelet 20 is applied to the patient in such a manner that it cannot be disengaged from the patient without the first transponder 10 being damaged; in case of an attempt to remove the bracelet from the patient, the damaged part could be antenna 12.
Figs. 2 and 3 diagrammaticalIy show how bracelet 20 can be made .
Bracelet 20 preferably comprises an elongated element 21, in particular a strip of flexible material such as paper or plastic material, for example. The elongated element 21 has at least one through hole 23 at one end, and preferably a plurality of through holes, to enable adaptation of same to the patients ' wrists that are of different sizes. At the opposite end 24 the elongated element 21 has an expansion 25 transverse to the longitudinal extension X of the elongated element 21; the transverse expansion 25 has a first portion 26 the shape of which matches that of said through hole 23, and a second tapering portion 27 adapted to be inserted into the through hole 23 and to keep a condition of mutual engagement between the ends 22, 24 of the elongated element 21.
The elongated element 21 carries the first transponder 10 in such a manner that antenna 12 of same extends along the longitudinal extension X of the elongated element 21 at least from the through hole 23 to the transverse expansion 25.
In this manner, should bracelet 20 be broken, breaking of antenna 12 would occur and the first transponder 10 would become useless.
In other words, as better clarified in the following, as a result of breaking of bracelet 20, the patient would no longer be recognised as "associated" with any bag of blood components and would no longer be able to receive any transfusion (except following a reinitialisation of the association procedure, to be described herebelow) , following a logic according to which, in order to prevent mistakes in transfusions, if a patient is> not correctly and uniquely associated with a bag, he/she cannot receive the blood component contained in said bag.
The process according to the invention further comprises a step of providing a bag 30 for containing a blood component intended for the patient .
In 'case of autologous transfusions, bag 30 contains blood material drawn from the patient himself/herself ; in case of homologous transfusions, bag 30 contains blood material drawn from another individual .
Bag 30 comprises a second transponder 40 provided with a respective memory 41 and a respective antenna (not shown) ; the second transponder 40 can be incorporated into the bag structure or can be applied externally of- bag 30 through suitable fastening techniques.
At the moment the patient (i.e. the first transponder 10) is to be associated with bag 30, the UID (unique identification) code of the first' transponder 10 is detected and it is stored in memory 41 of the second transponder 40. In fact, it is to be noted that each transponder device is identified by a unique -code that is unmodifiable; this code, consisting of 8 ASCII characters, is stored in a reserved area of the transponder memory at the moment it is produced. This reserved memory area is then irreversibly marked as "available for reading only" so that the UID code cannot be changed or erased.
The UID code of the first transponder 10 is stored into a predetermined area 41a, preferably defined by the available two first lines of memory 41 of the second transponder 40 that are marked as "read only memory", so that contents of same cannot be varied and correct association between the first transponder 10 and second transponder 40 is not impaired.
For detection of the UID code of the first transponder 10 detecting means 100 can be used which substantially consists of a device capable of feeding the first transponder 10 and receiving the signal generated thereby .
For storage of the UID code of the first transponder 10 in memory 41 of the second transponder 40, first writing means 110 can be used which is operatively associated with said detecting means 100 and advantageously consists of a device capable of acceding to memory 41 of the second transponder 40 to write the UID code of the. first transponder 10 therein.
As mentioned above, in case of autologous transfusions, the blood is directly transferred from the patient to bag 30; preferably the step of storing 'the UID of the first transponder 10 into memory 41 of the second transponder 40 is exactly performed while the blood component is being drawn from the patient and transferred into bag 30, so that mistakes cannot occur when association between patient and bag takes place.
Advantageously, the detecting means 100 and the first writing means 110 can consist of a single device, adapted to perform reading/writing operations on the transponder memories ;
In case of homologous transfusions, on the contrary, association between patient and bag 30 does not take place while bag 30 is being filled; bag 30 in fact has already been filled previously, from a blood donor for example;, through evaluation of the characteristics of the patient's blood and the donor's blood, bag 30 is first selected and afterwards associated with a patient in view of the transfusion to be given.
In more detail, an auxiliary container 50 is filled with a predetermined amount of the patient's blood or blood component; preferably the auxiliary container 50 is a test tube, as diagrammatically shown in Fig. 1.
The auxiliary container 50 is provided with a third transponder 60 equipped with a respective memory 61 and a respective antenna (not shown) .
The UID code of the first transponder 10 is stored in a predetermined area 61a of memory 61 of the third transponder 60; preferably, this storage operation is carried out while a predetermined amount of blood component is being transferred from the patient to the auxiliary container 50.
Preferably, the predetermined memory area 61a is defined by the, two first lines that are available in memory 61 of the third transponder 60.
Preferably, said lines of the predetermined memory area 61a are marked as "read, only memory", so that the data contained therein cannot be erased or overwritten.
For storage of the UID code of the first transponder 10 in memory 61 of the third transponder 60, suitable second writing means 120 can be used which is operatively associated with the detecting means 100.
Advantageously, the detecting means 100 and second writing means 120 can consist of . a single device adapted to " perform reading/writing operations on the transponder ' s memories .
This device can be exactly identical with the above mentioned one with reference to the autologous transfusions; distinction between the first writing means 110 and second writing means 120 has been made only for better clarifying the functional characters of the system in the two cases.
The contents of the auxiliary container 50 are used for selecting bag 30 among all the available bags, based on the characteristics of the patient's blood.
When bag 30 has been selected, the contents of the predetermined memory area 61a of the third transponder
60 is stored in the predetermined memory area 41a of the second transponder 40. In other words, the UID code stored in a predetermined memory area 61a associated with the auxiliary container 50 is copied in memory 41 associated with bag 30; in this manner, the first transponder 10 is uniquely and correctly associated with the bag 30 selected for the transfusion to be given.
In more detail, auxiliary reading means 130 allow the contents of the predetermined memory area 61a of the third transponder 60 to be detected; the auxiliary reading means 130 is operatively associated with the first writing means 110 to allow the latter to store the UID code of the first transponder 10 in memory 41 of the second transponder 40.
Advantageously, the auxiliary reading means 130 and first writing means 110 can be formed with a single device adapted to perform the reading/writing operations on the transponder memories.
In addition, this device" can be quite analogous to the above mentioned ones with reference to autologous transfusions and to insertion of the UID code of the first transponder 10 in the memory of the third transponder 60 in homologous transfusions; distinction between the different means 100, 110, 120, 130 has been done only for the sake of clarity.
The description hitherto made relates to how the first transponder 10 suitably applied to the patient is combined with bag 30 from which the patient will be able to receive the blood component during a transfusion.
Before giving this transfusion, a control is carried out on the correctness ' of the bag 30 that has been brought close to the patient; control is made in the same manner both in case of an autologous transfusion and of a homologous transfusion.
Said control comprises a step of carrying out a first detection to detect the UID code of the first transponder 10; this step can be accomplished through suitable first reading means 140.
Then, preferably through suitable second reading means 150, a second detection is carried out in order to detect the contents of the predetermined memory area 41a of the second transponder 40.
Then the results of the two detecting operations are compared, preferably by means of a processing unit 160 operatively associated with the first and second reading means 140, 150; if they are identical, the transfusion is authorised; on the contrary, if in the predetermined memory area 41a of the second transponder 40 there are data different from those of the UID code of the first transponder 10, the transfusion is not authorised, since it is apparent that bag 30 is not the one to be combined with the patient.
Authorisation or "non-authorisation" to transfusion are practically given through a suitable visual and/or audio signal addressed to the operator who at that moment is responsible for the transfusion.
It is to be noted that the first reading means 140, second reading means 150 and processing unit 160 can be made as a single electronic device adapted to perform the above mentioned functions .
In case of autologous transfusions, the same device suitably set, can be used both for reading the UID code of the first transponder 10 and writing it in the memory of the second transponder 40, and for carrying out a comparison between the UID code of the first transponder 10 and the contents of the predetermined memory area 41a of the second transponder 40.
In case of homologous transfusions, the same device, suitably set, can be used both for reading the UID code of the first transponder 10 and writing the same in the memory of the third transponder 60, and for reading the contents of the predetermined memory area 61a of the third transponder 60 and copying it in memory 41 of the second transponder 40, and also for carrying out a comparison between the UID code of the first transponder 10 and the contents of the predetermined memory area 41a of the second transponder 40.
For the sake of clarity, Fig. 4 diagrammatically shows the structure of a transponder memory, as it can be used in the first transponder , 10, in the second transponder 40 and also in the third transponder 60.
Memory 90 is provided with a reserved area 91, in which the UID code of the device is stored; this reserved area 91 is not accessible and not rewritable, so that the UID code cannot be modified.
Following a sequential order, there are lines 92a, 92b constituting said predetermined memory areas 41a, 41b of the second and third transponders 40, 60, respectively. Each line of memory 90 is associated with a suitable flag 93 that can be marked, following writing of a line, for indicating that this line is exclusively made available in the "read only" mode, and the contents of this line therefore cannot be erased, modified or overwritten.
Flag 93 is the one that is marked, in the second and. third transponders 40, 60, relatively to the predetermined areas 41a, 61a, after the expected data have been inserted in said areas .
The invention achieves important advantages .
First of all, the process and system of the invention allow a patient to be associated in a very simple and reliable manner to the bag of blood material that is to be used for a transfusion.
In particular, the advantages in terms of simplicity and reliability are obtained with reference both to autologous transfusions and to homologous transfusions.
In addition, the correct combination between patient and bag, due to use of the UID code of the first transponder 10, allows the operations to be carried out in a quite sure manner without use of the patient ' s personal data, so that an absolute privacy is maintained on said data.

Claims

C L A I M S
1. ■ A process for controlling transfusions of blood components, comprising: - associating a first transponder (10) with a patient;
- providing a bag (30) for containing a blood component intended for that patient, said bag (30) comprising a second transponder (40) ;
- detecting the UID code of the first transponder (10) and storing it into a predetermined memory area (41a) of the second transponder (40) ;
- before giving said patient the transfusion of that blood component : carrying out a first detection for detecting the UID code of the first transponder (10) ; carrying out a second detection for detecting the contents of the predetermined memory area (41a) of the second transponder (40) , checking whether the results of said first and second comparisons are identical.
2. A process as claimed in the preceding claim, characterised in that the step of associating the first transponder (10) with said patient comprises: - providing a bracelet (20) on which said first transponder (10) is mounted;
- applying said bracelet (20) to said patient.
3. A process as claimed in the preceding claim, characterised in that said bracelet' (20) is applied to said patient in such a manner that it cannot be disengaged from the patient without said first . transponder (10) being damaged.
4. A process as claimed in the preceding claim, characterised in that the step of providing said bracelet (20) comprises the step of preparing an elongated element (21) having at least one through hole
(23) at one end and an expansion transverse to the longitudinal extension (X) of said elongated element
(21) at the. opposite end, said elongated element (21) carrying said first transponder (10) in such a manner that an antenna (12) of the latter extends along said longitudinal extension (X) at least from said through hole (23) to said transverse expansion (25) .
5. A process as claimed in anyone of the preceding claims, characterised in that the step of storing the UID code of the first transponder (10) in the memory (41) of the second transponder (40) is performed while said blood component is being drawn from said patient and transferred into said bag (30) .
6. A process as claimed in anyone of the preceding claims 1 to 5, characterised in that it further comprises the steps of :
- providing an auxiliary container (50) for holding a predetermined amount of blood component of said patient, said auxiliary container (50) being equipped Vvrith a third transponder (60) ;
- storing the UID code of said first transponder (10) in the memory (61) of said third transponder (60) , preferably while said predetermined amount of blood component is being transferred from the patient to said auxiliary container (50) ;
- selecting said bag (30) ;
- detecting the contents of the predetermined memory area (61a) of said third transponder (61) and storing them into the predetermined area (41a) of said second transponder (41) .
7. A system for controlling transfusions of blood material, comprising:
- a first transponder (10) associated with a patient;
- a bag (30) for holding a blood component intended for said patient, said bag comprising a second transponder
(40) ;
- first detecting means (100) for detecting the UID code of the first transponder (10) ,-
- first writing means (110) for storing the UID code of said first transponder (10) in a predetermined memory area (41a) of the second transponder (40) ;
- first reading means (140) for carrying out a first detection to detect the UID code of the first transponder; - second reading means (150) for carrying out a second detection to detect the -contents' of the predetermined memory area (41a) of the second transponder (40) ;
- a processing unit (160) operatively associated with said first and second reading means (140, 150) for checking whether the results of said first and second comparison are identical .
8. A system as claimed in the preceding claim, characterised in that said first transponder (10) is mounted on a bracelet (20) applicable to said patient.
9. A system as claimed in the preceding claim, characterised in that said bracelet (20) is applicable to said patient in such a manner that it . cannot be disengaged from the patient without said first transponder (10) being damaged.
10. A system as . claimed in the preceding claim, characterised in that said bracelet (20) comprises an elongated element (21) having at least one through hole >
(23) at one end (22), and an expansion (25) transverse to the longitudinal extension (x) of said elongated element (21) at the opposite end (24) , said elongated element (21) carrying said first transponder (10) in such a manner that an antenna (12) of the , latter extends along said longitudinal extension (X) at least from said through hole ' (23) to said transverse expansion (25) .
11. A system as claimed in anyone of claims 7 to 10, characterised in that it further comprises: an auxiliary container (50) for holding a predetermined amount of blood component of said patient, said auxiliary container (50) being equipped with a third transponder (60) ;
- second writing means (120) for storing the UID code of said first transponder (10) in a predetermined memory area (61a) of said third transponder (60) ; auxiliary reading means (130) for detecting the contents of the predetermined memory area (61a) of said third transponder (60) , said auxiliary reading means (130) - being operatively associated with said first writing means (110) to allow the latter to store the contents of the predetermined memory area (61a) of said third transponder (60) in the predetermined memory area (41a) of said second transponder (40) .
PCT/IB2008/002362 2007-09-10 2008-09-08 Process and system for controlling transfusions of blood components WO2009034448A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT001741A ITMI20071741A1 (en) 2007-09-10 2007-09-10 PROCEDURE AND SYSTEM FOR THE CONTROL OF TRANSFUSION OF HEMOCOMPONENTS
ITMI2007A001741 2007-09-10

Publications (1)

Publication Number Publication Date
WO2009034448A1 true WO2009034448A1 (en) 2009-03-19

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2008/002362 WO2009034448A1 (en) 2007-09-10 2008-09-08 Process and system for controlling transfusions of blood components

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WO (1) WO2009034448A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004042677A1 (en) * 2002-11-05 2004-05-21 Rubertelli, Luca Positive identification device, particularly for hospital health technology
US20040189470A1 (en) * 2003-03-26 2004-09-30 Girvin Joshua M. Non-reusable identification device
GB2420893A (en) * 2004-12-02 2006-06-07 Newcastle Upon Tyne Hospitals Blood transfusion checking system

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004042677A1 (en) * 2002-11-05 2004-05-21 Rubertelli, Luca Positive identification device, particularly for hospital health technology
US20040189470A1 (en) * 2003-03-26 2004-09-30 Girvin Joshua M. Non-reusable identification device
GB2420893A (en) * 2004-12-02 2006-06-07 Newcastle Upon Tyne Hospitals Blood transfusion checking system

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Publication number Publication date
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