EP2080132A2

EP2080132A2 - Method and system for tracking medical products

Info

Publication number: EP2080132A2
Application number: EP07858437A
Authority: EP
Inventors: Erick Cloix
Original assignee: Implanet SA
Current assignee: Global Healthcare Exchange LLC
Priority date: 2006-10-12
Filing date: 2007-10-12
Publication date: 2009-07-22
Also published as: US20100096454A1; FR2907241B1; US8042738B2; AU2007306266A1; KR20090085054A; WO2008043921A2; KR101475535B1; MX2009003744A; FR2907241A1; WO2008043921A3; ZA200902416B; CA2666247A1; CA2666247C; JP5886516B2; JP2010506321A; AU2007306266B2

Abstract

The present invention relates to a method and a system for tracking medical products in which the product (11, 12) and/or the conditioning (16) thereof is marked with a first reference (18) stored in a first file (20), and the conditioned product is delivered (7) to the client and stored for further use by a patient registered in a second file (31). The method further comprises automatically and remotely detecting (27) the product references upon delivery and storing them in a third file (28) for the management of the client's stock upon an operation. The method further involves automatically detecting (30) the removal of the product from the stock, inserting the product references into the second file (31) corresponding to the client's patient for whom it is used or will be used, creating a fourth file (36) containing partial references from the patient's file and the determined references of the product for tracking, and automatically or semi-automatically transmitting (5) said fourth file to the product provider (4).

Description

METHOD AND SYSTEM FOR MONITORING MEDICAL PRODUCTS

The present invention relates to a method and system for monitoring medical products continuously and continuously, allowing perfect traceability thereof, especially for purposes of insurance and after-sales service, while ensuring respect for medical confidentiality. It finds a particularly important application, although not exclusive, in the field of internal prostheses such as knees, hips etc., likely to wear and / or change over time, resulting in the need for a replacement or a new intervention.

It is particularly interesting in the case of using innovative surgical implants or become standard or generic.

By minimizing costs, it contributes to the gains made imperative by the evolution of the market linked to the aging of the population and the need for ever greater medical coverage.

It also finds an important application in the field of drug monitoring, allowing in particular to access almost instantaneously at risk products that have been marketed to individuals and that would require to be stopped and / or recalled suddenly.

Methods and devices for memorizing information are already known which allow an automatic reassortment of the products sold to from inputs / outputs of products in a warehouse. Such systems (which generally use barcodes) do not allow for tracing products beyond warehouses, especially at the end-user level.

There is also known systems for global management of data concerning a patient, in particular to enable his hospital follow-up.

Such a system does not take into account the intervention of external services not subject to professional secrets and belonging to more traditional industrial circuits.

Also known (WO 2004/008387) a drug control system or prescriptions using chips or tags transmitting and receiving radio frequencies.

Such a system does not make it possible to ensure unambiguous and reliable monitoring of information. The present invention aims to provide a method and a system for monitoring medical products such as in particular surgical implants better than those previously known to the requirements of the practice, in particular in that it allows a traceability and monitoring products so reliable and uninterrupted, from the manufacturer to the patient, by automating and greatly simplifying their logistics. The product is intended to be used and / or to be implanted in an identified patient but for which the medical secret is kept, and this in accordance with the regulatory standards of traceability so far not respected, lack of method satisfactory to implement it while minimizing costs.

The invention therefore allows professionals to comply with a legal requirement whose commissioning has been sought for many years without success.

In addition, with the invention, the hospital, paramedical and / or medical personnel have practically no manual intervention to perform, which increases safety by minimizing the risk of human errors, while being present, if as a filter to respect medical confidentiality.

Immediate identification of affected patients for a problem or potential problem with a type of implant or medication is also possible, which is a considerable advantage, possibly saving lives.

Also with the invention, the management for both medical organizations such as hospitals, pharmacies or medical practices, as for the suppliers of drugs and / or implants, as for doctors, becomes very easy, and this thanks to permanent and immediate access by any means of sorting or analysis of data, to all and / or some of the databases concerning the products concerned.

For this purpose, the invention essentially proposes a method for monitoring medical products in which the product supplier is identified and identified with the product and / or its packaging with a first reference which is stored in a first file and delivers said conditioned product to client for storage for use or subsequent implantation in a patient listed in a second file at the client, characterized in that it automatically detects and remotely the references of the product during its delivery that is stored in a third file customer's inventory management system, the output of the product of said stock is automatically detected, the product references are inserted into the second file corresponding to the patient of the client for which it is or will be used, and a fourth file containing partial references is constituted from the patient's file and the determined references of the product for tracing and this fourth file is automatically or semi automatically transmitted to the supplier of the product. In advantageous embodiments, one and / or the other of the following provisions is also used:

- the product is a surgical implant;

- the product is a medicine; the simultaneous or substantially simultaneous output of the references of at least two products is automatically detected and the references of the product used for the patient are automatically inserted into the second file by automatic detection and then subtraction of the product (s) returned after use, with the products released;

the products and / or their packaging are marked and detected by optical recognition means; the products and / or their packaging are marked and detected by means of radio-electric recognition; the product corresponding to the fourth file is automatically recommended for the customer concerned;

- An Intranet or Internet computer network is used to interrogate and communicate with the provider's remote data storage server to control and transmit the fourth file and to update, if necessary, the first product file;

- The various files are sorted and analyzed to identify and identify automatically or semi-automatically the products and / or patients concerned by a potential problem or problem related to said product and / or types of patients.

The invention also proposes a system implementing the method as described above. It also proposes a system for monitoring medical products comprising means for marking and identifying the products and / or their packaging with a first reference, means for storing said references in a first file, storage means after transporting the data. at least one of said products packaged in a client for subsequent use in a patient listed in a second file at said client, characterized in that it further comprises means for automatically and remotely detecting the product references when its delivery, means for storing said references in a third client's inventory management file, means for automatically detecting the output and / or input of one or more products of said stock, means for inserting the product references in the second file corresponding to the patient of the client in which he is or will be implanted, means for forming a fourth file comprising partial references from the patient's file and the determined references of the product used for tracing and means of transmission automatic or semi automatic from this fourth remote file at the product supplier.

Advantageously, it comprises means for marking and detecting the products and / or their packaging by optical recognition.

Also advantageously, the product being placed in a package comprising a transparent face or a transparent box, the marking means are glued or fixed on the inner face of said transparent face of the package containing the product.

If such a label is more difficult to place, it has the particular advantage of better protection.

In an advantageous embodiment, it comprises means for marking and detecting the products and / or their packaging by radio-electric recognition.

Advantageously, a label called RFId (Radio Frequency Identification) is used for this purpose, and is fixed in particular inside the package. For example, a blank surface of any information (inner face of the package and / or a flap of the latter) is used, which makes it possible to select for each box size the RFId chip of maximum size and therefore of optimize the reading of the chip (transmission-reception distance).

A better protection of the RFId chip against any aggression resulting from the various manipulations due to the operations of handling, transport and storage is also obtained.

Coexistence with the external labeling of the box, which would lead to the obligation to reduce the size of the RFId chip (or that of the labeling), to the detriment of the optical and radio readability, or to the choice of a RFId chip also acting as a label (paper side with legal information such as: designation, size, reference, etc. ..) is avoided.

In another advantageous embodiment, the label is glued so that its lower right corner is closer to the lower right corner of the package and / or its flap.

Such a positioning of the RFId chip optimizes its detection and its reading by any portable means of transmitting-receiving radio waves. Indeed, it has been observed that hospital personnel naturally tend to align the reading means on the right side of the boxes.

In another advantageous embodiment, it comprises means arranged to automatically recommend the product corresponding to the fourth file for the client concerned. Also advantageously, it comprises means arranged to use an Intranet or Internet computer network for interrogating and interacting with the provider's remote data storage server to control and transmit the fourth file and to update, if necessary, the first product file.

Advantageously, it includes means for sorting and analyzing the different files to identify and identify automatically or semi-automatically the products and / or patients concerned by a potential problem or problem related to said product and / or the types of patients.

In an advantageous embodiment, the means for marking and identifying the product also comprise at least one card integral with an RFID tag contained in the product packaging.

This card, in credit card format, initially has no identifier and the RFId chip embedded therein contains only the product information contained in the package.

Following the intervention, the card will include the partial identity of the patient, the date and the type of intervention performed.

It then receives, by radio transmission, all the data concerning the implants used.

(designations, references, batch numbers) that are stored in the RFId chip. The card can then be delivered to the patient.

Thus, during postoperative follow-up consultations, it allows to store information supplementary information on acts performed after the operation.

During consultations for potential re-intervention, it allows however to retrieve all patient information / products immediately by simply reading the chip.

Otherwise it has an individual serial number, and in the case of planning a new intervention in the same hospital, it then allows to recover all the data of the previous intervention automatically, either directly by reading a file contained in the chip, either by automatic recall of the patient's file. In one embodiment, the individual serial number of the card allows access, via the website of the manufacturer of the device, partial file of the patient. This feature is used when the hospital where the consultation is being held is not (or no longer) equipped with the system.

Advantageously, the patient card may be equipped, in addition, with a detachable portion (electronic chip) that can be inserted into a memory card reader for viewing patient information.

Advantageously, the partial files mentioned above are created automatically when the information of the RFId chip of the implant is entered in the patient file property of the hospital.

Partial files that allow the manufacturer to obtain a large amount of information from which personal information relating to to the patient, thus preserve the medical confidentiality in an absolute way.

In addition, the partial files of the different implants can be crossed which allows to know precisely the number of implants of each category having been implanted with the actual implantation dates as well as the pathologies for which they were used.

These data also allow the automatic establishment of implant survival curves and thus to permanently have a photograph of the real life of each type of implants.

Finally, the patient card described above is useful here for monitoring the implants of the company because it allows to decrease the number of implants each time a revision (removal of a prosthesis) is performed.

This is an exceptional result because, unless conducting extremely expensive studies, no implant manufacturer is currently capable of such a level of traceability in the context of materiovigilance while preserving medical confidentiality.

The advantage of using partial files and patient cards for post-marketing monitoring required by international quality standards is also understandable.

Thus, although the company can not know the identity of the patients, an immediate correspondence can be made, by the hospital, between the partial files, contained in the information system of the company, and the patient files contained in his own database. This makes it possible to almost instantly find the patients to contact as part of a materiovigilance process (product recall). The invention will be better understood on reading the following description of embodiments given as non-limiting examples. The description refers to the accompanying drawings in which:

FIG. 1 is a general diagram illustrating the principle of the method according to the invention.

- Figure 2 shows schematically a system and its operation according to the embodiment of the invention more particularly described here applied to surgical implants. FIG. 3 is a block diagram showing the sequence of steps of the steps implemented in the method of the invention more particularly described here.

FIG. 1 schematically shows a diagram 1 illustrating the principle of the method implemented according to the invention.

The products manufactured in an industrial 2 are delivered (arrow 3) to the supplier of products 4, where they are packaged and marked with a first reference stored in a first file.

Through the Internet 5, by phone, or by any other means, the products are then ordered by the customer (a hospital center, a pharmacy, a doctor, ...) 6, then delivered (arrow 7) . On arrival, they are detected automatically, and their references are stored in a third file. In use, they are out (arrow 8), transmitted for use in 9 where they are detected automatically.

The chosen product is then taken by the patient or implanted in the patient, the unused products being returned (arrow 10) being redetected.

The information corresponding to the patients and the implants are taken into account to form the fourth file which is then retransmitted by the Internet network 5, for information of the follow-up / tracing of the product necessary for the respect of the legal provisions .., and / or for restocking by the supplier 4.

In the following, we will use the same numbers to identify the same references or identical or similar references.

Figure 2 illustrates more precisely the embodiment of the invention more particularly described here. From implants 11, 12 manufactured at a first manufacturer 13, and controlled by the supplier 4, (arrow 14) it carries out the packaging of these implants, for example by putting them in sachets 15, 16. These sachets are here marked with numbers 17, color codes, chips (not shown) and / or bar codes 18 in a manner known per se, to form first references establishing a bionivocal relationship between an identifier and an implant. The references of the implants and / or their sealed packages are then introduced into a computer 19 to form a file 20 called "FILE N ° 1" implants available and listed at the supplier.

"FILE N ⁰ I"

* Internal supplier code

When ordering via the Internet 5 and / or other means 21, such as the telephone 22, a surgical clinic 23 performs a command (arrow 24); this is introduced into the computer 19 which comprises means of calculation, analysis, printing, etc. of data corresponding to the command and types of implants ordered. This command allows the output of the implants which are automatically taken into account by reading their bar code (device 25) or by other means (not shown) such as remote reading of a chip integrated in packaging and / or at the same time. 'implant.

The data concerning the implants ordered and released for deliveries are for example also transmitted for confirmation via the Internet to the computer 26 of the clinic 23.

The ordered products are then delivered (truck 7) to the clinic.

On arrival, they are detected automatically and remotely by the means 27 located at the customer to constitute a file 28 called "FILE No. 3", for example of the type below.

"FILE N ° 3"

* Internal supplier code ** Internal code at the hospital

When a surgeon must intervene in operating room 9, by means of a similarly programmed means, namely a computer or a PDA 29 and a barcode reader and / or smart card reader, the references 18 of the implants are detected. priori necessary. In general, there are several implants of different sizes, the choice of effective size is often made at the last moment by the surgeon.

Simultaneously, and from the file 31 called "FILE No. 2", including the records 32 of the patients of the service, it appears from the computer 29 for example, the card 33 of the patient 34 to operate. FILE N ° 2 »

** Internal code at the hospital

The surgeon then operates and returns the unused implants which are automatically detected remotely by the device 30, giving by reference the references of the implant 35 'that has been used.

The barcode or identifier of the latter can also be read live rather than obtained by difference. A mixed card 33 'is then constituted, and serves firstly to update the patient's card 33 (whose history will now contain the operation), and to the preparation of the card 36 says " FILE No. 4 "containing partial references 37 to preserve the medical secret on the patient concerned by the operation and the specific references of the implant 35 '.

"FILE N ° 4"

** Hospital Code

The fourth file is then transmitted automatically or semi automatically, for example for validation by a key from the medical staff, via the computer 26 network, to the provider 4 via the Internet 5.

The information received is then processed at 19 by computer means to enable trace tracking of the implant in accordance with legal requirements and other operations such as a reassortment command for example.

The operations of the invention are described below in the embodiment more particularly described here with reference to the functional flowchart of FIG. 3.

After manufacture at 40 at the manufacturer of the implants concerned, a control step by the supplier (step 41) is performed. Then the product having been delivered, it is stored at the supplier (step 42) which identifies it and marks it in a manner known per se (step 43).

Simultaneously, the supplier constitutes the FILE No. 1, as described above. A control step 44 by the hospital center 46 is then performed, followed by delivery (step 45). At the end of the delivery, the

FILE N ° 3 by remote reading and recording

(Step 46) implants introduced into the storage area of the hospital center, for example by reading a barcode and / or a remote smart card reader.

When implementing an implant following a request from a surgeon, a step 47 for extracting the implants required for the operation is performed with automatic detection at 48 of said implants by means of identical means.

In 49 the operation is performed by the surgeon, knowing that previously was issued the card of the patient concerned from a FILE No. 2 belonging to the files of the hospital.

After the operation is carried out in 50 the automatic detection of implants that have not been used and are therefore re-entered in the storage system of the hospital center. Then a step 51 of constitution of the FILE 4 expurgated so as to preserve the medical secret of the patient operated is performed.

In other words, FILE # 4 includes non-confidential information about the patient and information about the implant that has been implanted.

A step 52 of transmission to the supplier of the elements of FILE No. 4 will allow complete tracing of the implant through the operation of the patient.

Followed a step 53 of verification and storage and files, then update (step 54) of the FILE No. 1 implants at the supplier, possibly followed by a step 55 allowing the automatic control of the restocking of the new implants following the one that will be used during the operation, and a last possible step 56 of elaboration of analysis and statistics related to the implants and / or to types of operations related to a certain type of patient.

As is obvious and as also follows from the above, the present invention is not limited to the embodiments more particularly described. On the contrary, it embraces all the variants and in particular those in which the product is a drug, or a series of medicaments intended for complex and / or vital treatments such as, for example, against AIDS, or neurodegenerative diseases, such as diabetic diseases. Alzheimer's or Parkinson's.

Claims

1. A method of monitoring medical products in which the product supplier is identified and identified (43) with the product and / or its packaging with a first reference that is stored in a first file (20) and delivered ( 45) said product conditioned to the client for storage for subsequent use by a patient listed in a second file at the customer, characterized in that it detects (46) automatically and remotely the product references upon delivery that the stored in a third inventory management file of the customer, the product output is automatically detected (48), the product references are inserted in the second file corresponding to the patient of the client for whom he is or will be used a fourth file is created (51) comprising partial references from the patient's file and the determined references of the product for tracing and transmits (52) to tomatically or semi automatically this fourth file to the product supplier.

2. Method according to claim 1, characterized in that the medical product is a surgical implant.

3. Method according to claim 1, characterized in that the medical product is a drug.

4. Method according to any one of the preceding claims, characterized in that the simultaneous or substantially simultaneous output of the references of at least two products is automatically detected and the references of the product used for the patient in the second file are automatically inserted. by automatic detection (50) and subtraction of the product (s) returned after operation, with the products released.

5. Method according to any one of the preceding claims, characterized in that the products and / or their packaging are marked and detected by optical recognition means.

6. Method according to any one of the preceding claims, characterized in that the products and / or their packaging are marked and detected by radio-recognition means.

7. Method according to any one of the preceding claims, characterized in that the product corresponding to the fourth file for the customer concerned is automatically recommended (55).

8. Method according to any one of the preceding claims, characterized in that an Intranet or Internet computer network is used to interrogate and communicate with the provider's remote data storage server to control and transmit the fourth file and update it. if applicable, the first product file.

9. Process according to any one of the preceding claims, characterized in that sorts and analyzes (56) the different files to identify and identify automatically or semi-automatically the products and / or patients concerned by a potential problem or problem related to the product and / or the type of patients.

10. A medical product tracking system comprising means for marking and identifying the products (11, 12) and / or their packaging (15, 16) with a first reference (18), storage means (19). said references in a first file (20), storage means after transport of at least one of said packaged products to a client for subsequent use by a patient listed in a second file (31) at said client, characterized in it further comprises means (27) for automatically detecting and remotely referencing the product when it is delivered, means (26) for storing said references in a third file (28) for managing the customer's inventory, means (30) for automatically detecting the output and / or input of one or more products of said stock, means (29) for inserting the product references in the second file (31) corresponding to the client's patient dan s of which it is or will be implanted, means for forming a fourth file (36) comprising partial references from the patient's file and the determined references of the implanted product for tracing and means (26) for automatic or semi automatic transmission of this fourth remote file to the supplier of the product.

11. System according to claim 10, characterized in that it comprises means (18, 25) for marking and detecting the products and / or their packaging by optical recognition.

12. System according to any one of claims 10 and 11, characterized in that it comprises means for marking and detecting the products and / or their packaging by radio-electric recognition.

13. The system of claim 12, characterized in that the packaging of the product comprises a package comprising an at least partially transparent face and in that the marking means comprise a label stuck on the inner face of said transparent face.

14. System according to claim 13, characterized in that the label is glued in the right angle of said transparent face of the box.

15. System according to any one of claims 10 to 14, characterized in that the marking and identification means comprises a smart card arranged to store the first and fourth files.

16. System according to any one of claims 10 to 15, characterized in that it comprises means (26) arranged to automatically recommend the product corresponding to the fourth file for the client concerned.

17. System according to any one of claims 10 to 16, characterized in that comprises means arranged to use an Intranet or Internet computer network (5) for interrogating and communicating with the provider's remote data storage server for controlling and transmitting the fourth file and updating, if necessary, the first product file.

18. System according to any one of claims 10 to 17, characterized in that it comprises means (19) for sorting and analyzing the various files to identify and identify automatically or semi-automatically the products and / or patients concerned by a potential problem or problem related to these products and / or types of patients.

19. System according to any one of claims 10 to 18, characterized in that the medical products are surgical implants.

20. System according to any one of claims 10 to 19, characterized in that the medical products are drugs.