Instruction manual of implantable medical device

Abstract

The invention relates to a description manual (1) for an implantable medical device, comprising at least one first page (10) having a front side (10a) and a back side (10b), where the first page (10) comprises an integrated patient implant (20) card releasably connected (e.g. Through an elongated perforation (21) or by adhesive) to an adjacent portion (10c) of the first page (10). A fold line (23) is provided. The slit (22) may be a part of the perforated portion. The first page may be a cover of the book.

Description

Technical Field

[0001] The invention relates to an instruction manual for an implantable medical device. Furthermore, the invention relates to a method for processing a patient implant card (PIC). Background Art

[0002] The so-called Medical Device Regulation (MDR) of the EU requires every VI implant product in the corresponding national language of the EU to have such a PIC.

[0003] The current design of such a PIC therefore consists of 24 separate PICs, each written in one of these languages ​​and fixed to an instruction manual (also denoted IFU, Instructions for Use).

[0004] A large number of individual PICs results in a relatively high cost and weight of the PICs for 24 languages. In addition, due to the large number of PICs, their handling is also difficult.

[0005] Based on the above, the problem to be solved by the present invention is to provide an instruction manual and a corresponding method for handling a patient implant card, which are improved with respect to the above difficulties. Summary of the invention

[0006] This problem is solved by an instruction manual for an implantable medical device comprising the features of claim 1. Furthermore, the problem underlying the invention is solved by a method having the features of claim 14. Preferred embodiments of these aspects of the invention are claimed in the respective dependent claims and are described below.

[0007] According to claim 1, an instruction manual for an implantable medical device is disclosed, comprising at least a first page having a front side and a back side, wherein the first page comprises an integrated patient implant card releasably connected to an adjacent portion of the first page.

[0008] In particular, the design provides the possibility of using an effective multilingual patient implant card (PIC) integrated in the first page of the instruction manual (IFU). And can be easily separated from the instruction manual, which is currently impossible due to the large number of individual patient implant cards for each language. In particular, the patient implant card according to the invention covers all national languages ​​using instructions / explanations based on symbols that can be understood independently of the language. Having only a single patient implant card (or a relatively small number of such cards) allows a significant improvement in the handling of such cards. In addition, the production costs are significantly reduced. In addition, advantageously, the weight of the instruction manual is reduced, and in particular, less paper is required to produce the instruction manual.

[0009] According to a preferred embodiment of the present invention, the adjacent part surrounds the patient implant card. This allows the patient implant card to be securely connected to the instruction manual, which also allows reducing the risk of damaging the patient implant card.

[0010] In a preferred embodiment of the invention, the patient implant card is connected to the adjacent part via an elongated perforated portion, which extends along and in particular around the patient implant card.

[0011] Preferably, in an embodiment of the invention, said elongated perforated portion comprises two opposite ends, preferably on one side of the patient implant card. According to another preferred embodiment of the invention, at least one first page comprises an elongated slit extending between said opposite ends. This allows easier manual separation of the patient implant card from the adjacent portion of the first page, since, for example, a finger of a person handling the instruction manual can be inserted into said slit, which allows pulling the patient implant card in a convenient manner in order to separate the patient implant card from the surrounding adjacent portion by tearing the first page along said elongated perforated line, which releases the patient implant card from the adjacent portion of the first page of the instruction manual.

[0012] According to preferred alternative embodiment, the patient implant card is releasably connected to the adjacent part of the first page by adhesive.Here, in particular, the adjacent part forms the backing of the patient implant card.

[0013] According to another preferred embodiment of the invention, the patient implant card comprises a marking area for applying a sticker to the patient implant card, wherein preferably the sticker comprises an identifier identifying the implantable medical device (in particular the model and the manufacturer) implanted in the person to which the patient implant card is assigned. In particular, the sticker is removable from the packaging of the implantable medical device.

[0014] In addition to the identifier, the patient implant card is configured to contain one, several or all of the following information: patient name, hospital, doctor name, implant date, location of the implantable medical device (eg, stent).

[0015] According to an embodiment of the present invention, the patient implant card includes a dedicated area for receiving the patient's name.

[0016] Furthermore, according to an embodiment of the present invention, the patient implant card includes a dedicated area for receiving the name of the hospital.

[0017] Furthermore, according to an embodiment of the present invention, the patient implant card includes a dedicated area for receiving the name of the physician.

[0018] Furthermore, according to an embodiment of the present invention, the patient implant card comprises a dedicated area for receiving the implant date.

[0019] Furthermore, according to an embodiment of the present invention, the patient implant card includes a dedicated area for receiving the location of an implantable medical device, such as a stent.

[0020] According to a further embodiment of the invention, the patient implant card comprises a fold line marking indicating a fold line for folding two integrally connected parts of the patient implant card onto each other. Thus, once the patient implant card is separated from the first page of the instruction manual, the patient implant card can be conveniently folded, in particular in order to reduce its size, which in particular allows the patient to store the patient implant card in a folded state in a wallet. In particular, the patient implant card may comprise the size of an ordinary credit card.

[0021] Furthermore, according to an embodiment of the present invention, the patient implant card comprises two opposing recesses arranged opposite to each other, the fold line marking extending between the recesses.

[0022] Preferably, in an embodiment of the present invention, the instruction manual includes a last page having a front and a back, wherein the last page includes a redundant or spare integrated patient implant card releasably connected to an adjacent portion of the last page. Current IFU / PIC solutions do not provide a spare PIC. In the event that the PIC is damaged, whether by manufacturing defects or improper handling by the operator, the doctor basically has three options: (i) fix the damaged PIC with an adhesive (tape) or any other fixing means, (iii) remove the complete IFU / PIC from another (unopened) device in the required language, or (iii) use the complete IFU / PIC in a language other than the patient's native or preferred language. All three options have disadvantages: for option (i), the damaged, temporarily fixed PIC is still susceptible to further damage. In the case of option (ii), the operator needs to reorder a new IFU / PIC from the device manufacturer or distributor, and in the case of (iii), the patient is discharged with a PIC that is not written in the patient's native or preferred language.

[0023] Furthermore, according to a preferred embodiment of the invention, the instruction manual comprises a plurality of intermediate pages arranged between the at least one first page and the last page, wherein in particular the intermediate pages contain technical information about the implantable medical device, in particular in different languages.

[0024] In addition, according to a preferred embodiment of the present invention, the middle pages each include a grammage lower than the grammage of at least one first page and / or last page. In particular, since the middle pages do not include a patient implant card, they can include a significantly lower grammage, thereby further reducing the weight and size of the instruction manual.

[0025] Furthermore, according to a preferred embodiment of the present invention, the at least one first page is formed by a sheet of flexible material. According to another embodiment, the last page is formed by a sheet of flexible material. According to yet another embodiment, the intermediate pages are each formed by a sheet of flexible material.

[0026] Preferably, in one embodiment, at least one of the first page and / or the last page and / or the patient implant card comprises a sheet of 25 to 350 g / m 2 In the range of 80 to 240 g / m 2 In the range of 120 to 200 g / m 2 The weight (also called basic weight or area density) is within the range of 160 g / m2. 2 .

[0027] Furthermore, according to a preferred embodiment of the present invention, at least one of the first page and / or the last page, and / or the intermediate pages, and / or the patient implant card comprises or is formed from one of the following materials: paper, such as cellulose-based paper, parchment, straw paper or recycled paper, polymer film or foil, metal film or foil, or any other suitable printable material.

[0028] According to another aspect of the present invention, a method for processing a patient implant card is disclosed, the method comprising the following steps:

[0029] - providing an instruction manual for an implantable medical device according to the invention,

[0030] - separating said patient implant card from the instruction manual,

[0031] - adhering a sticker removed from a packaging of an implantable medical device, the sticker comprising an identifier identifying the implantable medical device to be implanted in a patient, and

[0032] -Give the patient implant card to the patient.

[0033] In particular, further information such as described above may be provided on the patient implant card before the patient is handed over to the patient. In particular, the method according to the invention may be further specified by the features described in conjunction with the instruction manual according to the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In the following, embodiments of the present invention as well as other features and advantages of the present invention are described with reference to the accompanying drawings, in which:

[0035] Figure 1 shows the front side of a first page of an embodiment of an instruction manual according to the invention with an integrated patient implant card;

[0036] Figure 2 Shows Figure 1The back of the first page shown in ;

[0037] Figure 3 showing the front of the last page of an embodiment of an instruction manual having an integrated redundant or backup patient implant card; and

[0038] Figure 4 Shows Figure 3 The back of the last page shown in . DETAILED DESCRIPTION

[0039] Typically, with regard to implantable medical devices, it occurs that a product will be marketed on the CE market in 25 different languages. Currently, for each language, a separate PIC is integrated into the cover of the instructions for use, i.e. 12 additional pages of thick paper. Only one of these is used for the patient at a time. In the case of the 25th language required by the MDR, another 4 pages of thick paper will be added.

[0040] In comparison, Figures 1 to 4 An embodiment of an instruction manual 1 according to the invention is shown, which provides at least one integrated patient implant card (PIC) 20, wherein Figure 1 As shown, the PIC 20 may be integrated into the first page 10 of the instruction manual 1. Another redundant or backup PIC 40 may be integrated into the last page 30 of the instruction manual 1. Note that for simplicity, the figure does not show intermediate pages that may be provided between the first page 10 and the last page 30. In particular, the redundant or backup PIC 40 integrated into the last page serves as a backup. The first and last pages 10, 30 each include a front side 10a, 30a and a back side 10b, 30b, the back side 10b, 30b of the respective page 10, 30 facing away from the front side 10a, 30a.

[0041] Thanks to the invention, about 12 to 16 pages which are usually required can be saved. Preferably, only the front (ie the first page 10) and the back (ie the last page 30) of the instruction booklet 1 are made of thick paper.

[0042] The patient implant card 20 is provided with an elongated perforated portion 21 extending along the outer edge of the PIC 20, which allows the PIC 20 to be easily removed from the adjacent portion 10c of the first page 10 of the instruction manual 1. The perforated portion includes a breaking or holding point along the length of the PIC on either side of the fold line 23, 43. The breaking or holding points are provided on the left and right sides of the fold line 23, 43 along the width of the PIC. At the marked point, the elongated perforated portion 21 is replaced by a slit (e.g., a cut) 22, which makes the elongated perforated portion 21 easier to break. Therefore, the slit / cut 22 extends between the opposite ends 21a, 21b of the perforated portion 21.

[0043] In the same manner, the adjacent portion 30c surrounds the spare patient implant card 40 of the last page 30 (see Figure 3 and Figure 4 ), wherein here also a redundant or spare patient implant card 40 is connected to the adjacent part 30c via an elongated perforated portion 41, which includes two opposite ends 41a, 41b, and a slit (e.g., a cutout) 42 extends between the two opposite ends 41a, 41b (see above).

[0044] In addition, if Figure 2 As shown, the patient implant card 20 preferably includes a marking area 20c for applying a sticker 2 to the patient implant card 20, the sticker 2 including an identifier identifying the implantable medical device implanted in the human body. If present, it may be suitable for a spare PIC 40, which may also include a marking area 40c for such a sticker 2. The spare / redundant PIC 40 may be used in the event that the PIC 20 is damaged or has been handled incorrectly.

[0045] Furthermore, specifically, the respective PIC 20, 40 may comprise a fold line marking 23, 43 indicating a fold line for folding two integral connecting parts 201, 202 or 401, 402 of the respective patient implant card 20, 40 onto each other. Furthermore, the respective patient implant card 20, 40 may comprise two opposite recesses 24, 25 or 44, 45 arranged opposite each other, wherein the respective fold line marking 23, 43 extends between said recesses 24, 25 or 44, 45. Due to these recesses, the respective PIC 20, 40 comprises rounded corners on both sides of the fold line in the folded state. Furthermore, the other corners of the PIC 20, 40 opposite to the fold line 23, 43 are preferably rounded. The rounded corners facilitate the perforation process.

[0046] On the first page 10 (such as Figure 1 and Figure 2 As shown) and the last page 30 (as shown Figure 3 and Figure 4 The instruction manual 1 may include a plurality of intermediate pages, which may contain technical information about the implantable medical device, in particular in different languages. The intermediate pages may each include a thickness less than the thickness of the first page 10 and / or the last page 30, to save weight and space.

[0047] Preferably, the PIC 20, 40 uses standard symbols. The symbols and instructions for handling the respective PIC 20, 40 are preferably explained in the instruction manual 1 in a multilingual manner, i.e., without using a specific language, by using said symbols which may correspond to the pictograms and which may be understood by the respective health care institution. Thus, additional new languages ​​may be covered without increasing the paper volume of the PIC 20, 40 or the manual 1. The symbols / instructions for handling the respective PIC 20, 40 may be provided on the second side 10b (e.g., on the adjacent portion 10c) of the first page 10 of the instruction manual, e.g., above the PIC 20, as Figure 2 As indicated in .

[0048] In particular, the Patient Implant Card (PIC) 20 should be gently removed from the first page 10 (or last page 30) of the instruction manual 1. Then, peel off the sticker 2 of the inner or outer label of the implantable medical device and place it onto the corresponding blank field / label area 20c on the PIC 20. In case of implanting devices from the same family, and if there is space on the PIC 20, the same PIC 20 can be used for more than one implant.

[0049] After the sticker 2 has been provided on the PIC 20, the following information is typically filled in on the corresponding marking areas: patient (eg, name and surname); hospital and physician; date of implantation; location (implantation site) of the medical device (eg, stent).

[0050] Finally, PIC 20 was handed over to the patient.

[0051] To detach or remove the PIC 20 and / or 40 from the instruction manual 1, other mechanisms may also be used, such as, for example, adhesive labels or solutions using other adhesive techniques.

[0052] The invention includes advantages according to which the respective customer does not have to choose his language from 24 different PICs. Moreover, due to the specific design of the PIC according to the invention, significant cost savings in production and transport are achieved due to the reduced weight. Finally, due to the lower weight of each product, more products can be transported per transport trip.

Claims

1. An instruction manual (1) for an implantable medical device, comprising at least one first page (10) having a front side (10a) and a back side (10b), in, The first page (10) includes an integrated patient implant card (20) releasably connected to an adjacent portion (10c) of the first page (10).

2. The instruction manual according to claim 1, wherein: The adjacent portion (10c) surrounds the patient implant card (20).

3. The instruction manual according to claim 1 or 2, wherein: The patient implant card (20) is connected to the adjacent portion (10c) via an elongated perforated portion (21).

4. The instruction manual according to claim 3, wherein: The elongated perforated portion (21) includes two opposite end portions (21a, 21b).

5. The instruction manual according to claim 4, wherein: The at least one first page (10) comprises an elongated slit (22) extending between the opposite ends (21a, 21b).

6. The instruction manual according to claim 1, wherein: The patient implant card (20) is releasably connected to an adjacent portion (10c) of the first page by an adhesive.

7. An instruction manual according to any one of the preceding claims, wherein: The patient implant card (20) comprises a marking area (20c) for applying a sticker (2) to the patient implant card (20).

8. An instruction manual according to any one of the preceding claims, wherein: The patient implant card (20) includes a fold line marking (23) indicating a fold line for folding two integrally connected parts (201, 202) of the patient implant card (20) onto each other.

9. The instruction manual according to claim 8, wherein: The patient implant card (20) comprises two opposite recesses (24, 25) arranged opposite each other, the fold line marking (23) extending between the recesses (24, 25).

10. An instruction manual according to any one of the preceding claims, wherein: The instruction manual (1) comprises a last page (30) having a front side (30a) and a back side (30b), wherein the last page (30) comprises a redundant or spare integrated patient implant card (40) releasably connected to an adjacent portion (30c) of the last page (30).

11. The instruction manual according to claim 10, wherein: The instruction manual (1) comprises a plurality of intermediate pages arranged between the at least one first page (10) and the last page (30).

12. The instruction manual according to claim 11, wherein: The intermediate pages each comprise a grammage lower than the grammage of the at least one first page (10) and / or the last page (30).

13. An instruction manual according to any one of the preceding claims, wherein: The at least one first page (10) and / or the last page (30) and / or the patient implant card (20) comprises 25 to 350 g / m 2 Weight.

14. A method for processing a patient implant card (20), the method comprising the steps of: - providing an instruction manual (1) for an implantable medical device according to any one of the preceding claims, - separating the patient implant card (20) from the instruction manual (1), - adhering a sticker (2) removed from the packaging of the implantable medical device, the sticker (2) comprising an identifier identifying the implantable medical device implanted in a patient, and - Handing over the patient implant card (20) to the patient.

15. Use of the instruction manual (1) according to any one of claims 1 to 13 for an implantable medical device.

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