EP1748401A2 - Labels and their application to the historical tracking of patients - Google Patents

Abstract

The method involves fixing fixation sheets (24) of a label to a single usage medical product which is destined to a medical treatment. Removable self-adhesive labels (26) of an article are separated from the fixation sheets of the label and are stuck on a file, where the self-adhesive labels of the article contain information related to properties of the medical product. An independent claim is also included for a label for a medical product.

Description

The present invention relates to a new application of self-adhesive labels to the historical monitoring of patients undergoing repetitive treatment, and a label useful for this purpose.

The use of self-adhesive labels is already known in a number of applications in which it is desirable that information carried by a removable label can be transmitted from one medium to another.

So the utility certificate German DE-84 25 059 describes the bonding of two labels, having identical coded information, to test tubes used for laboratory analyzes. When a sample has been introduced into a test tube, one of the two labels is removed and is attached to an accompanying form. So we already know the realization of a connection between a test tube and a form by moving the self-adhesive label of the test tube form.

The document FR-2 703 156 discloses a method and an identification medium implementing key labels comprising a plurality of removable tags. The body of a main label is stuck on a test tube containing a sample, and the removable labels, which carry the same information as the main label, are attached successively to other test tubes used for different analyzes. on the same sample.

The document EP-1 452 194 relates to a bag system used for the collection of biological fluids, in which there are already several receptacles in the form of test tubes, each provided with a label which was fixed to it initially, and information of the labels of the test tubes correspond to those of a main tag carried by the fluid collection bag.

The document US-6,599,481 also describes the use, on a test tube, of a main label associated with a removable label, the removable label being separable from the main label; information under barcodes are formed straddling the boundary between the two labels, so that each label carries the same information. The removable portion is intended to be placed on a support other than the test tube.

All the aforementioned documents implement a removable label that keeps an identification link between two elements: a sample tube and a form.

The German utility model DE-20 2004 004 504 describes a system in which data relating to a product, a manufacturer, an origin, a composition, an expiry date, etc. concerning a food product, are placed on a removable label placed on a packaging of this food product. According to this document, removable labels can be retained to eventually determine the link between intestinal diseases that consumers would present and the nature or quality of food products consumed.

All the aforementioned documents thus allow a certain traceability, thanks to the creation of a link between a product or a sample and a form. The invention relates to an extension of this type of traceability to repetitive medical treatments, in which the state of a patient can evolve in a way that must be connected not to a single event, but to a whole series of events. .

One can for example consider the case of dialysis. It is known that some patients must undergo dialysis, for example every three days, and that each dialysis session is performed with a dialyzer which is a single-use medical device, membrane-based or fiber-based, capable of provide filtration instead of a kidney. A single dialysis session provides significant wellness to the patient, but the beneficial effect of each session can change over time, from one session to another, and sometimes it is necessary to change the nature of the dialyzer (by example its filtration capacity or its maximum capacity) according to the evolution of the results obtained.

It is therefore desirable that information relating to each dialysis session, including each dialyzer, can be recorded and juxtaposed to allow a useful comparison to determine the evolution of the patient's condition. It is therefore desirable to have removable labels carrying information representative of each session in the form of a series of tags allowing a comparison of the information relating to each dialysis session, including the parameters used.

More specifically, the invention relates to a label for a medical product, which comprises, on the one hand, a fixing sheet having, on one side, a strong adhesive for a substantially permanent fixation to a medical product, or the fixing sheet , or the strong adhesive does not present a risk of reducing the functionality of the medical device, and on the other side, a product with non-stick properties, and, secondly, a removable label disposed on the face having anti-adherent properties so that it can be easily separated from the other side of the attachment sheet.

Preferably, it also comprises a non-removable label, the removable label and the non-removable label are formed by the same adhesive sheet and are separated by a substantially continuous line of perforations, and the removable label and the non-removable label. both have information, at least some of which is common.

Preferably, the removable label covers only a portion of the other side of the attachment sheet, and at least a portion of the remainder of the attachment sheet carries a non-removable label.

It is advantageous that the removable label and the non-removable label both have information of which at least a part is common. Preferably, the information has at least one machine-readable portion.

In one embodiment, the removable label and the non-removable label are formed by a single sheet self-adhesive and are separated by a virtually continuous line of perforations.

Preferably, the removable label comprises a gripping device designed to facilitate its mobility. The gripping device may be a tongue, or a corner defined by the line of perforations.

The invention also relates to an application of medical product labels according to the preceding paragraphs, to the historical follow-up of patients subjected to a medical treatment referenced in a file, the application comprising the fixing of the attachment sheet to a medical product for use single device for medical treatment, the removable adhesive label carrying at least information relating to the properties of the medical product, and, in combination with a processing step, separating the self-adhesive removable label from the attachment sheet, and its collage on the folder.

When the treatment is repetitive, the separation and gluing steps being performed several times, the application comprises gluing the successive removable labels in the form of a series according to the order of the treatments, in a manner allowing the comparison of the labels. successive removable.

Preferably, the application further comprises the provision, at least on the removable label, information of which at least a portion is readable by man.

In the present specification, the term "removable label" indicates that the label can be removed from its support without causing any deterioration of its support or the medical device which carries it.

• la figure 1 est une vue en plan d'une étiquette autocollante qui peut être utilisée dans un système mettant en oeuvre l'application selon l'invention ;
• la figure 2 est une vue en plan d'une autre étiquette autocollante plus élaborée qui peut être utilisée dans l'application selon l'invention ; et
• la figure 3 représente un autre mode de réalisation d'étiquette autocollante utile selon l'invention.

Other characteristics and advantages of the invention will become more apparent from the description which follows, given with reference to the appended drawing, in which:

• Figure 1 is a plan view of a self-adhesive label that can be used in a system implementing the application according to the invention;
• Fig. 2 is a plan view of another more elaborate adhesive label which may be used in the application according to the invention; and
• Figure 3 shows another embodiment of self-adhesive label useful according to the invention.

Figure 1 shows a label that can be used in the application according to the invention to the historical monitoring of a patient to undergo regular dialysis sessions.

The label 10 includes a fixing sheet 12 which carries, at a first face disposed on the back side in FIG. 1, a layer of a strong adhesive for attaching the sheet to a disposable medical device. This can be a dialyzer in this case. An example of a dialyzer comprises a fiber bundle of a poly-α-sulfone, disposed in a transparent cylindrical body closed by caps at the ends for the delimitation of a circulation chamber.

The other face of the fixing sheet 12 carries a layer having anti-adhesive properties, that is to say not allowing the bonding of a non-adhesive material, but allowing a temporary retention of adhesive labels.

A self-adhesive removable label 14 is glued to the visible face of the fixing sheet 12 and can be separated therefrom, as indicated by the raised corner 16.

It will be noted in FIG. 1 that the removable label 14 carries information indicated on the one hand in the form of machine-readable information 18, for example a barcode reader, and human-readable information, represented in a simple digital form.

In the dialyzer manufacturing plant, a label 10 is adhered to each dialyzer, carrying information 18, 20 which corresponds to its properties, for example its filtration rate, its capacity, etc., as well as to its nature. chemical, etc.

At each dialysis session, an operator of a dialysis machine, at the moment when a patient lies down in order to session, has a record that includes various patient and dialysis-related features that must be performed. He can thus ensure that the dialyzer to be used corresponds to that which is stipulated, by observing the information carried by the dialyzer. When he has made sure of this conformity, he removes the self-adhesive removable label 14 and glues it on the patient's back, in the place provided for this purpose, that is to say, preferably close to a label stuck to the previous dialysis session.

FIG. 2 represents an improvement in which the label 22 fixed to the single-use medical device, a dialyzer in this case, comprises a first removable label 26 placed on a fixing sheet 24, and a second label 28, the two labels. having identical information.

Although, in the example shown, the information of the two labels are identical, it is possible that only part of the information is common. Indeed, it may be advantageous to keep, on the label 28 that remains on the medical device, fragmentary information or readable only by the machine, while the other label 26 carries more human readable information, to facilitate the understanding of the historical follow-up of the patient by the medical staff.

Figure 3 shows a variant in which two labels, one of which is removable and the other 34 is intended to remain on the medical device, are nested. More specifically, the removable label 32 is delimited by a line of perforations which forms a continuous or substantially continuous loop allowing easy separation of the removable label 32 when its corner 36 has been raised.

Although there have been described labels in which the removable label is removed by lifting a corner, the capture can also be facilitated by forming a tab provided for this purpose.

With the various embodiments of labels described above, the medical staff has a folder in which the series of removable labels is firmly fixed and allows, by simple reading, to determine the evolution of certain treatment characteristics. Of course, the file may be supplemented by analysis results or measurements of various parameters, which are preferably juxtaposed with the labels corresponding to the specific dialysis sessions concerned.

Although the invention has been described in its application to renal dialysis, it is suitable for other repetitive treatments, whenever the evolution of a patient's condition is to be followed over an extended period.

Claims (7)

Label for a medical product, characterized in that it comprises
a fixing sheet (12, 24) having, on one side, a strong adhesive for a substantially permanent fixation to a medical product, neither the fixing sheet (12, 24), nor the strong adhesive presenting any risk of reducing the functionality of the medical device, and on the other side, a product with anti-adherent properties, and
a removable label (14, 26, 32) disposed on the face having release properties so that it can be easily separated from the other side of the attachment sheet (12, 24). Label according to claim 1, characterized in that: it further comprises a non-removable label (28, 32), the removable label (26, 32) and the non-removable label (28, 32) are formed by the same self-adhesive sheet and are separated by a substantially continuous line of perforations, and the removable label (26, 32) and the non-removable label (28, 32) both carry information of which at least a part is common. Label according to one of claims 1 and 2, characterized in that the removable label (14, 26, 32) comprises a gripping device to facilitate its mobility. Label according to claim 3, characterized in that the gripping device is selected from a tongue and a corner (16, 36) delimited by the line of perforations. Application of labels for a medical product according to any one of the preceding claims, to the historical monitoring of patients subjected to a medical treatment referenced in a file,
the application being characterized in that it comprises: attaching the attachment sheet (12,24) to a medical disposable product for medical treatment, the removable adhesive label (14,26,32) carrying at least information relating to properties of the medical product, and , in combination with a processing step, separating the self-adhesive removable label (14, 26, 32) from the fastening sheet (12, 24), and bonding it to the backrest. Application according to claim 5 to be used for a repetitive treatment in which the separation and gluing steps are performed several times, characterized in that the application comprises gluing the successive removable labels in the form of a series following the order of the treatments, in a manner allowing the comparison of the successive removable labels. Application according to one of claims 5 and 6, characterized in that further comprises the provision, at least on the removable label, information of which at least a portion is readable by the man.

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