METHOD FOR IDENTIFYING MEDICAL DEVICES
Patent Information
- Application Number
- DE602022028856
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-05-17
- Filing Date
- 2022-05-16
- Publication Date
- 2026-01-21
- Estimated Expiration
- 2042-05-16
AI Technical Summary
Healthcare professionals face challenges in accurately identifying medical instruments once they are implanted in patients, leading to potential misuse and complications due to confusion between similar devices like PICC and midline catheters, resulting in risks such as incorrect drug administration and infections.
A method involving image collection, training of an identification model, and assignment of identifiers to medical devices using a computer-based process, coupled with a computer program product, to facilitate accurate identification and provide usage recommendations and structural characteristics.
Reduces the risk of misidentification and misuse of medical instruments by providing healthcare professionals with precise device identification and usage guidelines, ensuring safe and compliant handling.
Description
[0001] The present invention relates to a method for identifying medical instruments. The present invention also relates to an associated computer program product.
[0002] Various medical instruments can be used to administer an infusion to a patient. Such devices generally include an internal part intended to be inserted into the patient, for example into a vein, an artery, the esophagus (or other part of the digestive system), the cerebrospinal fluid (epidural catheters) or into a subcutaneous device (e.g. implanted port), and an external part visible from the outside and intended to be manipulated by healthcare personnel, for example, for the injection of drug or nutritional solutions.
[0003] However, it is not always easy for healthcare professionals to identify the nature of a medical device once it is already implanted in the patient. Incorrect identification can lead to serious side effects for the patient, due to non-compliance with the instructions for use of the medical device or the injection of an inappropriate product.
[0004] In particular, the risk of confusion is increased with PICC (peripherally inserted central venous catheter) and midline catheters, since both emerge from the patient's arm. The risks of confusion are described in detail in the article by Letournel C. Management of the risk of confusion between PICC lines and midlines. J Pharm Clin 2018; 37(1): 19-26 doi: 10.1684 / jpc.2017.0374. Confusion between PICCs and midlines can lead to the risk of injecting venotoxic drugs through a midline catheter or to infection if the maximum duration of use is exceeded.
[0005] Furthermore, it appears that the specific usage guidelines and best practices (SF2H Recommendations: Prevention of infections related to peripheral vascular and subcutaneous catheters. May 2019, Hygiènes Vol XXVII - No. 2; Infusion Therapy Standards of Practice 8th Edition, Jan / Feb 2021, Journal of Infusion Nursing, Vol. 44, No. 51) for various medical devices, whether inserted into the body, in contact with the skin, or connected to devices inserted into the body or in contact with the skin, are not always well understood by healthcare personnel. This can also lead to complications for the patient due to the misuse of these devices.
[0006] US 2015 / 209114 A discloses an automated medical system capable of detecting clinical events or conditions using sensors integrated into medical instruments, and displaying contextual instructions in response on a visualization device.
[0007] There is therefore a need to put in place means to reduce the risks of misidentification by healthcare staff of medical instruments worn by a patient, and thereby reduce the risks of misuse or failure to comply with good practices for the use of such instruments.
[0008] For this purpose, the present description relates to a method for identifying medical devices, referred to as medical devices of interest, medical devices of interest being instruments intended to be introduced into the body of a patient or to be brought into contact with the body of a patient, or being instruments intended to be connected to instruments introduced into the body of a patient or in contact with the body of a patient, each medical device of interest having an external part outside the body of the patient, the method comprising the following steps: the collection of images of external parts of medical instruments of interest, each image being labeled with an identifier of the medical instrument of interest from among a set of predefined identifiers, the collected images forming a training image database, the collection step being implemented by computer, the training of an identification model from the training image database to obtain a trained identification model to assign an identifier, from among the set of predefined identifiers, to a medical instrument of interest to be identified based on an image of the external part of the medical instrument, the training step being implemented by computer, the reception of an image of the external part of a medical instrument of interest to be identified, the reception step being implemented by computer, the assignment, by the trained classification model, of an identifier to the medical instrument of interest imaged on the received image,the classification step being implemented by computer, and the characterization of the medical device of interest according to the assigned identifier, in which each identifier is associated with an internet link and / or a remote database through which visual support relating to the use of the medical device of interest is obtained, the characterization step including the display of the visual support corresponding to the internet link or database associated with the assigned identifier, the visual support being for example a video, an image or an article.
[0009] In specific embodiments, the process comprises one or more of the following characteristics, taken individually or in all technically possible combinations: The process includes a step of manipulating the medical device of interest based on the characterization performed. The training image database consists of images of medical devices of interest of at least two different types, the at least two types of medical devices in the training image database being chosen from the following types: medical tube, venous catheter, arterial catheter, enteral feeding catheter, parenteral feeding catheter, drainage catheter, epidural catheter, systemic catheter, peripherally inserted central venous catheter (PICC), peripherally inserted central venous catheter (midline), central venous catheter (CVC), umbilical catheter, Huber needle, medical tube skin fixation system, covering dressing, valve, closed system, and cap connected to a medical tube hub. Each identifier is associated with data relating to a type of medical device.The characterization step includes determining the nature of the medical device of interest imaged in the received image based on the assigned identifier. Each identifier is associated with recommendations for the use of the medical device of interest. The usage recommendations include one or more of the following: the route of entry to be used for introducing the medical device of interest; the maximum flow rate of fluid injected into the medical device of interest; the maximum fault pressure of the medical device of interest; the frequency of changing any dressing applied to the medical device of interest; and the compatibility of the medical device of interest with other types of medical devices.o the compatibility of the medical device of interest with drug solutions, and o the compatibility of the medical device of interest with predefined medical examinations, and where applicable, the conditions for performing the examinations. Each identifier is associated with at least one structural characteristic of the medical device of interest, the structural characteristic or characteristics being chosen from: the brand of the medical device of interest, the contact of the legal manufacturer of the medical device of interest, the material(s) from which the medical device of interest is made, the potentially allergenic material(s) from which the medical device of interest is made, the size of the medical device of interest and, when the medical device of interest is a catheter or a medical tube, the diameter and initial length of the catheter or medical tube, the number of lumens of the catheter or medical tube,The dead volume of each lumen of the catheter or medical tube, the flow rates, by gravity or by injection via a pump or injector of contrast agents, of the catheter or medical tube, the characterization step including the determination of the structural characteristic(s) of the medical device of interest imaged on the received image according to the assigned identifier. Each medical device of interest has an internal part connected to the external part, the internal part being a tube or needle introduced into the patient's body,The external part includes at least one tube and / or a tube connector. The identifier assigned to the medical device of interest is associated with a remote database from which information on the use of the medical device is obtained. The usage information includes data defined by the manufacturer and / or data defined by a healthcare professional during the use of the medical device on a patient. The process includes a step of updating the usage information of the medical device for a given patient and / or a given use, with the usage information being archived to ensure patient follow-up and / or traceability of the medical device. The identifier is associated with information relating to the environmental impact and / or eco-design of the medical device of interest.
[0010] This description also relates to a computer program product comprising program instructions recorded on a computer-readable medium, for the execution of a process as described above when the computer program is run on a computer.
[0011] This description also relates to a readable information medium on which a computer program product, as previously described, is stored.
[0012] Other features and advantages of the invention will become apparent from the following description of embodiments of the invention, given by way of example only and with reference to the drawings which are: [ Fig 1], Figure 1 , a schematic view of a sample computer enabling the implementation of a medical instrument identification process, [ Fig 2], Figure 2 , an organizational chart of an example of the implementation of a medical device identification process, [ Fig 3], Figure 3 , a schematic representation of an example of a catheter, [ fig 4], Figure 4 , a schematic representation of an example of a medical tube, [ Fig 5], Figure 5 , a schematic representation of an example of a secured Huber needle, [ Fig 6], Figure 6 , schematic representation of an example of a medical instrument in contact with a patient's skin (transparent dressing covering the skin insertion site of a catheter), [ Fig 7], Figure 7 , schematic representation of another example of a medical instrument in contact with a patient's skin (catheter fixation dressing), and [ Fig 8], Figure 8 , schematic representation of an example of a closed system connected to the base of a catheter.
[0013] A calculator 10 and a computer program product 12 are illustrated by the figure 1 .
[0014] Calculator 10 is preferably a computer.
[0015] More generally, calculator 10 is an electronic calculator designed to manipulate and / or transform data represented as electronic or physical quantities in calculator 10 registers and / or memories into other similar data corresponding to physical data in memories, registers or other types of display, transmission or storage devices.
[0016] Calculator 10 interacts with computer program product 12.
[0017] As illustrated by the figure 1 The calculator 10 comprises a processor 14 including a data processing unit 16, memories 18, and a data storage reader 20. In the example illustrated by the figure 1 , the calculator 10 includes a keyboard 22 and a display unit 24.
[0018] The computer program product 12 includes information storage 26.
[0019] The information support 26 is a support readable by the computer 10, usually by the data processing unit 16. The readable information support 26 is a medium suitable for storing electronic instructions and capable of being coupled to a bus of a computer system.
[0020] As an example, the information medium 26 is a floppy disk or flexible disk (from the English name " Floppy disc "), an optical disc, a CD-ROM, a magneto-optical disc, a ROM memory, a RAM memory, an EPROM memory, an EEPROM memory, a magnetic card or an optical card.
[0021] The computer program 12, including program instructions, is stored on the information support 26.
[0022] The computer program 12 is loadable onto the data processing unit 16 and is adapted to drive the implementation of a medical instrument identification process, when the computer program 12 is implemented on the processing unit 16 of the computer 10.
[0023] Although the figure 1 While the term "computer" illustrates a calculator in the form of a physical computer, this description is not limited to such a type of computer. It extends to any device integrating a calculator in connection with a computer program (computer application).
[0024] Thus, in one example of implementation, the calculator and the computer program product 12 are integrated into a smartphone (ordiphone), a touch tablet or any other connected object.
[0025] The operation of calculator 10 will now be described with reference to the example of the figure 2 , which illustrates a flowchart of a medical instrument identification process, and to figures 3 à 8 which illustrate examples of medical instruments considered within the framework of this process.
[0026] The medical devices considered in the context of this process are referred to as medical devices of interest 50.
[0027] Medical instruments of interest 50 include, for example, an internal part 52 and an external part 54 connected to the internal part 52.
[0028] The internal part 52 is intended to be inserted into the patient's body. Once the medical instrument 50 is already inside the patient's body, the internal part 52 is thus hidden from view by healthcare personnel. The internal part 52 is typically a tube or a needle.
[0029] The external part 54 is intended to remain outside the patient's body so that it can be handled by healthcare personnel, for example, for injecting medication. The external part 54 includes at least one tube and / or a tube connector.
[0030] Medical instruments of interest 50 considered having an internal part 52 connected to an external part 54 are, for example, catheters, tunneled or not (illustrated in figure 3 ), more broadly medical tubes (illustrated in figure 4 ), and / or Huber needles (illustrated in figure 5 ).
[0031] As illustrated by the figure 3 The external part 54 of a catheter comprises a tube 59, usually with a hub 60, a clamp 62, and a connector 64 (Luer lock). A valve (not shown) is generally inserted at the end of the connector 64. The hub 60 is usually covered with an adhesive or subcutaneous anchoring system and a transparent dressing.
[0032] Catheters include, for example, venous catheters, arterial catheters, enteral / parenteral feeding catheters, drainage catheters, epidural catheters, systemic catheters, and intravenous catheters. It is clearly established (see Tools for Securing and Self-Assessing Medication Administration, HAS, May 2013; ISO 80369-1:2018 standard) that for all these catheters and medical tubes, there is a problem of confusion between the different access routes: in particular, central vs. peripheral, enteral vs. parenteral, pulmonary vs. other routes, and intrathecal vs. intravenous. Multiple access routes, as well as failure to identify the catheter or medical tube, can lead to errors, sometimes serious ones. For example, the intrathecal injection of vinca alkaloids, which are highly neurotoxic, is potentially fatal for the patient. Furthermore, the injection of molecules classified as vesicants (S.Manrique-Rodriguez, Standardization and Chemical Characterization of Intravenous Therapy in Adult Patients: A Step Further in Medication Safety, Drugs in R&D, December 2020) in an inappropriate peripheral catheter can lead to risks of phlebitis, necrosis or even extravasation.
[0033] More specifically, catheters include, for example, peripherally inserted central venous catheters, known as PICCs, peripheral venous catheters, known as Midlines, and central venous catheters, known as CVCs, central umbilical catheters, or enteral nutrition catheters.
[0034] A PICC line is a venous catheter designed to be inserted above the elbow crease into a deep vein in the arm, extending to the cavo-atrial junction. Its distal end is therefore located at the entrance to the heart. A PICC line is used for various purposes, including chemotherapy, antibiotic therapy, parenteral nutrition, and transfusions. A PICC line can remain in place for up to six months in a patient.
[0035] A midline catheter is designed to be inserted above the elbow crease into a vein in the arm, extending to the axillary line. The distal end is therefore located below the clavicle. A midline catheter is particularly suitable for injecting non-irritating products (< 900 mOs / L, 5 <pH<9) en traitement prolongé (supérieur à 8 jours), tels que des antibiotiques, analgésiques ou produits d'hydratation. Un Midline peut rester implanté jusqu'à 30 jours dans un patient.
[0036] A central venous catheter (CVC) is a catheter designed to be inserted in the neck, chest, or femoral vein. The distal end of such a catheter is located at the entrance to the heart.
[0037] Another type of tube is illustrated by the figure 4 In the example illustrated by the figure 4 The medical instrument 50 is a tube 65, one end of which is intended to be inserted into the patient, thus forming the internal part 52, and the other end of which forms the external part 54. In the particular example of the figure 4 The tube is of the oxygen tubing type. However, medical device 50 is potentially any other type of tube.
[0038] A Huber needle is an instrument designed for use with an implantable port catheter, also known as an IPC. An IPC is a subcutaneous implantable device consisting of an injection chamber and a central catheter. The Huber needle allows for injections and blood sampling by puncturing the port under the skin. The Huber needle includes a needle (with a tangential bevel) designed to be inserted into the patient's skin at the port and a connector that remains external, allowing it to be connected to a tube, for example.
[0039] As illustrated by the figure 5 The internal part 52 of a Huber needle is a needle (with a tangential bevel) intended to be inserted into the patient's skin at the port. The external part 54 includes a connector 70 designed to remain external so as to be connected to a tube, for example.
[0040] In addition or alternative, the medical instrument(s) of interest 50 consist only of an external part 54 visible from outside the patient (no internal part introduced into the body).
[0041] In this case, the external part 54 is, for example, intended to be in contact with the patient's skin or to be connected to a medical instrument intended to be introduced into a patient's body or to be in contact with the patient's skin.
[0042] Medical instruments of interest 50 considered having only an external part 54 are, for example, cutaneous systems of the type: cutaneous fixation system for medical tubes (catheters, drains, etc.), cover dressing, valves, closed system and plugs connected to the base of a medical tube (base 60 of a catheter for example).
[0043] There figure 6 illustrates by way of example a medical instrument of interest 50 in contact with a patient's skin. In this example, the medical instrument 50 is a transparent dressing 71 covering the skin insertion site 72 of a catheter 73.
[0044] There figure 7 is another example of a medical device of interest 50 in contact with a patient's skin. In this example, the medical device 50 is a dressing 74 for securing a catheter 75.
[0045] There figure 8 is yet another example of a medical device of interest 50 connected to a medical device intended to be introduced into a patient's body or to come into contact with the patient's skin. In this example, the medical device 50 is a closed system 76 connected to the base 77 of a catheter.
[0046] The identification process includes a step 100 of collecting images of external parts of medical instruments of interest 50. The collected images thus form a training image database. Step 100 is implemented by the computer 10 in interaction with the product computer program 12; that is, it is computer-implemented.
[0047] The images in the database were, for example, acquired by a camera, for example, belonging to a smartphone.
[0048] Preferably, the images collected are images in which the medical devices of interest 50 are in their configuration for use; that is, when the devices 50 include an internal part 52, the internal part is inserted into the patient's body, and when the devices 50 include only an external part 54, the external part 54 is in contact with the patient's skin or connected to another medical device inserted into the body or in contact with the patient's skin. Only the external parts of the medical devices are thus visible in the images.
[0049] Alternatively, the collected images also include images of medical instruments of interest 50 that are not worn by the patient.
[0050] The training image database is typically formed from images of medical instruments of interest of at least two different kinds.
[0051] In one example, the at least two types of medical instruments 50 pictured on the images in the training image database are chosen from the following types: medical tube, venous catheter, arterial catheter, enteral feeding catheter, parenteral feeding catheter, drainage catheter, epidural catheter, systemic catheter, peripherally inserted central venous catheter, also known as PICC, peripherally inserted venous catheter, also known as Midline, central venous catheter, also known as CVC, umbilical catheter, Huber needle, skin fixation system for medical tubes (catheters, drains, etc.), cover dressing, valve, closed system and cap connected to a base of a medical tube.
[0052] In a specific example, at least one type of imaged instrument is a peripherally inserted central venous catheter, called a PICC, and at least one type of imaged instrument is a peripherally inserted venous catheter, called a Midline, so as to differentiate these two types of catheters.
[0053] Each image is labeled with an identifier of the medical instrument of interest 50 from a set of predefined identifiers. The identifier was, for example, determined by an operator.
[0054] Each predefined identifier corresponds to the same category of medical devices, or even to a specific model of medical device (same reference). Medical devices labeled with the same identifier therefore have common characteristics or correspond to the same devices.
[0055] Advantageously, each identifier is associated with data relating to a type of medical device. Types of medical devices are, for example, one or more of the following: medical tube, venous catheter, arterial catheter, enteral feeding catheter, parenteral feeding catheter, drainage catheter, epidural catheter, systemic catheter, peripherally inserted central venous catheter (PICC), peripherally inserted venous catheter (Midline), central venous catheter (CVC), umbilical catheter, Huber needle, skin fixation system for medical tubes (catheters, drains, etc.), covering dressing, valve, closed system and cap connected to a base of a medical tube.
[0056] In a specific example, at least one type of instrument is a peripherally inserted central venous catheter, called a PICC, and at least one type of instrument is a peripherally inserted venous catheter, called a Midline, so as to differentiate these two types of catheters.
[0057] Advantageously, each identifier is associated with recommendations for the use of the medical device of interest 50. The recommendations are intended to guide healthcare personnel in the proper use of the devices.
[0058] In one example, the usage recommendations include one or more of the following: a. the access route to be used (peripheral, central, enteral etc.), b. the maximum flow rate of liquid injection (by gravity and via a pump or contrast agent injector) into the medical device of interest 50, c. the maximum fault pressure of the medical device of interest 50, d. the frequency of changing any dressing applied to the medical device of interest 50, e. the compatibility of the medical device of interest 50 with other types of medical devices, f. the compatibility of the medical device of interest 50 with drug solutions, and g. the compatibility of the medical device of interest 50 with predefined medical examinations, and where applicable, the conditions for carrying out the examinations.
[0059] Advantageously, each identifier is associated with an internet link and / or a remote database through which visual support relating to the use of the medical device of interest 50 is obtained. The visual support is intended to be viewed or read by healthcare personnel to assist in the correct handling of the medical device of interest 50. The visual support is, for example, a video, an image, or an article.
[0060] Advantageously, each identifier is associated with structural characteristics of the medical device of interest 50. These structural characteristics include, for example, one or more of the following: the brand of the medical device of interest 50, the contact information for the legal manufacturer of the medical device of interest 50, the material(s) from which the medical device of interest 50 is made, any potentially allergenic material(s) from which the medical device of interest 50 is made, the size of the medical device of interest 50, and, where the medical device of interest 50 is a catheter or medical tube, the diameter and initial length of the catheter or medical tube, the number of lumens in the catheter or medical tube, the dead volume of each lumen (channel) of the catheter or medical tube, and the flow rates, by gravity or by injection via a pump or contrast agent injector, of the catheter or medical tube.
[0061] The identification process includes a step 110 of training an identification model from the training image database. Step 110 provides a trained identification model to assign an identifier, from the set of predefined identifiers, to a medical device of interest 50 to be identified based on an image of the external part 54 of the medical device of interest 50. Step 100 is implemented by the computer 10 in interaction with the product computer program 12, i.e., is implemented by computer.
[0062] In one example implementation, the identification model training is carried out using a learning technique applied to the database.
[0063] The identification model is, for example, a neural network. The learning technique allows the neural network to be configured as it learns from the database. In one example, part of the database is used to configure the neural network and the other part to validate the configuration.
[0064] Typically, the trained model is designed to first recognize the specific (reference) model of the medical device, corresponding to an identifier, through physical characteristics unique to that device model. These physical characteristics include, for example, the color, shape, or accessories of the medical device. Other characteristics of the device are then retrieved based on the identifier (e.g., the type of device, usage recommendations, etc.).
[0065] The identification process includes a step 120 of receiving an image of the external part 54 of a medical instrument of interest 50 to be identified. The reception step 120 is implemented by the computer 10 in interaction with the computer program 12; that is, it is implemented by computer.
[0066] The medical device of interest 50 shown in the image is, for example, in a condition of use on the patient. Alternatively, the medical device of interest 50 shown in the image is not being worn by the patient.
[0067] The image received was, for example, acquired by a smartphone camera. The acquisition was, for example, triggered by healthcare personnel in order to identify a medical device of interest 50, for example, one or more medical devices of interest 50 introduced into a patient's body or in contact with their skin.
[0068] The identification process includes a step 130 in which the trained classification model assigns an identifier to the medical instrument of interest 50 pictured in the received image. The classification step is implemented by the computer 10 in interaction with the computer program 12; that is, it is computer-implemented.
[0069] Advantageously, a probability representative of a confidence level in the identifier assigned to the medical device of interest is also determined. This allows healthcare personnel to be alerted to a potential error in the identification performed. For example, in cases where the probability is below a predetermined threshold (e.g., 85%), the identification is considered potentially erroneous.
[0070] The identification process includes a step 140 for characterizing the medical device of interest 50 based on the assigned identifier. At the end of this step 140, at least one characteristic relating to the medical device of interest 50 imaged in the received image is obtained.
[0071] For example, when the identifier is associated with data relating to a type of medical device, the characterization step 140 includes determining the type of medical device of interest 50 imaged on the received image based on the assigned identifier.
[0072] For example, when the identifier is associated with recommendations for use of the medical device of interest 50, the characterization step 140 includes the determination of the recommendations for use of the medical device of interest 50 imaged on the received image based on the assigned identifier.
[0073] For example, when the identifier is associated with an internet link or a remote database, corresponding to a visual support relating to the use of the medical instrument of interest 50, the characterization step 140 includes the display of the visual support corresponding to the internet link or database associated with the assigned identifier.
[0074] For example, when the identifier is associated with one or more structural features, the characterization step 140 includes the determination of the structural feature(s) of the medical instrument of interest 50 imaged on the received image according to the assigned identifier.
[0075] The characterization step 140 is, for example, implemented by the calculator 10 in interaction with the product computer program 12; that is, it is implemented by the computer. For example, the characteristics are extracted from a database based on the assigned identifier.
[0076] Alternatively, characterization step 140 is implemented by an operator, such as a healthcare professional (medical device replacement, product injection). The operator will, for example, search a database for characteristics corresponding to the assigned identifier.
[0077] In one implementation example, the identification process includes a step 150 of manipulating the medical device of interest 50 according to the characterization performed. The manipulation is, for example, carried out by an operator, such as a healthcare professional.
[0078] For example, depending on the characterization performed, the medical device of interest 50 will be handled differently by healthcare personnel. For example, the manipulations and injected products may differ between a PICC catheter and a midline catheter.
[0079] Thus, this method allows for the identification of one or more medical instruments from a set of referenced medical instruments. This method therefore helps healthcare professionals identify an instrument with a reduced risk of confusion.
[0080] Identifying relevant medical devices also allows, through knowledge of usage recommendations and / or the characteristics of the identified device, for: limit the risks of injecting molecules not suitable for the access route of the instrument, respect good practices for the use and maintenance of the instrument, and be aware of the incompatibilities of the instrument with other medical devices.
[0081] A person skilled in the art will understand that the embodiments and variants previously described can be combined to form new embodiments provided they are technically compatible.
[0082] In particular, as an alternative or optional complement to the preceding embodiments, the identifier assigned to the medical device of interest is linked to a remote database from which information on the device's use is obtained. This allows access to information that is difficult to obtain at the patient's home or even in the hospital. This information is crucial for the safe use of the medical device. In particular, the following two typical examples can have serious consequences for the patient if this usage information is not known: Example 1: The maximum injection rate is not respected, leading to catheter rupture and potential extravasation. Example 2: Inaccurate knowledge of the catheter's presence in the central or peripheral venous system can result in the injection of venotoxic molecules peripherally, damaging the patient's venous system.
[0083] Thus, when the identifier assigned to the medical device of interest is linked to a remote database, the process allows access to such usage information. This usage information is typically manufacturer-specific (ensuring proper use) and / or established / supplemented by healthcare professionals with actual usage data. Examples of such usage information include: From the manufacturer (maximum flow), that is to say that they are not found by doing an internet search or in a bibliographic article, specifically and with certainty for the references concerned, and / or From the health professionals themselves (central or peripheral).
[0084] In an example implementation, the usage information initially includes default information, for example, information relating to a characteristic of the medical device defined by the manufacturer, such as central or peripheral access. Subsequently, the usage information is supplemented by the person operating the medical device (healthcare professional) by entering additional information into the database, such as: the name of the vein first used, the length of the implanted catheter, the implantation date, etc. This additional information thus complements the default data. Preferably, the usage information is also supplemented by any user of the medical device (healthcare professional) by adding supplementary information such as the type of treatment administered, as well as the quality of the injection (absence of pain, redness, etc.).) thus ensuring the traceability of the use of the medical device and its safety.
[0085] As an optional extra or alternative, usage information is archived in a database (within an application or memory) to ensure patient follow-up. For example, once a medical device is identified, the healthcare professional can return to the application to retrieve the previously detailed usage information (manufacturer and their own records). They will be able to find all scanned medical devices used and their usage history, thus ensuring traceability and safety of their actions.
[0086] Preferably, usage information should be extracted from this monitoring system (for example, all catheters inserted / used by an operator) to create a statistical report that can be used by healthcare professionals, for example, for medico-legal purposes or for monitoring clinical activity, or by the manufacturer as a post-market surveillance (post-CE marking) tool under the new MDR regulations. In this latter context, the objective is to create a database of medical device usage, particularly catheters.
[0087] As an alternative or optional addition, the identifier is associated with information relating to the environmental impact and / or eco-design of the medical device in question. Such information is provided, for example, by the manufacturer. This information includes, for example, a rating of the medical device. In particular, such information includes, for example, one or more of the following data: the carbon footprint, any additives used in the composition of the medical device, and information relating to the recycling (packaging) of the medical device.
Claims
1. A method of identifying medical devices, called medical devices of interest (50), the medical devices of interest (50) being devices intended for being inserted into the body of a patient or for being brought into contact with the body of a patient, or being devices intended for being connected to devices inserted into or in contact with a patient's body, each medical device of interest (50) having an outer part (54) outside the patient's body, the method comprising the following steps: a. the collection of images of outer parts of medical devices of interest (50), each image being labeled with an identifier of the medical device of interest (50) from a set of predefined identifiers, the collected images forming a training image database, the collection step being computer-implemented, b. the training of an identification model from the training image database in order to obtain an identification model trained to assign an identifier, from the set of predefined identifiers, to a medical device of interest (50) to be identified according to an image of the outer part (54) of the medical device (50), the training step being computer-implemented, c. the reception of an image of the outer part (54) of a medical device of interest (50) to be identified, the reception step being computer-implemented, d. the assignment, by the trained classification model, of an identifier to the medical device of interest (50) imaged on the received image, the classification step being computer-implemented, and e. characterizing the medical device of interest (50) according to the assigned identifier; wherein each identifier is associated with an Internet link and / or a remote database through which visual support is obtained with regard to the use of the medical device of interest (50), the characterization step comprising the display of the visual medium corresponding to the Internet link or to the database associated with the assigned identifier, the visual medium being e.g. a video, an image or an article.
2. The method according to claim 1, wherein the method comprises a step of handling the medical device of interest (50) according to the characterization performed.
3. The method according to claim 1 or 2, the training image database consisting of images of medical devices of interest (50) of at least two different types, the at least two types of medical devices (50) imaged on the images of the training image database being selected from the following types: medical tube, venous catheter, arterial catheter, enteral nutrition catheter, parenteral nutrition catheter, drainage catheter, epidural catheter, systemic catheter, peripheral insertion central venous catheter, called PICC, peripheral venous catheter, called Midline, central venous catheter, called CVC, umbilical catheter, Huber needle, cutaneous securement system for medical tubes, covering dressing, valve, closed system and stopper connected to a hub of a medical tube.
4. The method according to any of claims 1 to 3, wherein each identifier is associated with data relating to a type of medical device, the characterization step comprising determination of the type of the medical device of interest (50) imaged on the received image according to the assigned identifier.
5. The method according to any of claims 1 to 4, wherein each identifier is associated with recommendations for use of the medical device of interest (50), the characterization step comprising the determination of recommendations for use of the medical device of interest (50) imaged on the received image according to the assigned identifier.
6. The method according to claim 5, wherein the recommendations for use comprises one or a plurality of the following recommendations: a. the first route of medication to be used for the insertion of the medical device of interest (50), b. the maximum rate of injection of liquid into the medical device of interest (50), c. the maximum fault pressure of the medical device of interest (50), d. the frequency of change of a dressing, if any, applied to the medical device of interest (50), e. the compatibility of the medical device of interest (50) with other types of medical devices, f. the compatibility of the medical device of interest (50) with medicinal solutions, and g. the compatibility of the medical device of interest (50) with pre-defined medical examinations and, where appropriate, the conditions for carrying out the examinations.
7. The method according to any of claims 1 to 6, wherein each identifier is associated with at least one structural feature of the medical device of interest (50), the or at least one structural feature being chosen from: the brand name of the medical device of interest (50), the contact details of the legal manufacturer of the medical device of interest (50), the material or materials from which the medical device of interest (50) is made, the potential allergenic material(s), if any, from which the medical device of interest (50) is made, the size of the medical device of interest (50) and, when the medical device of interest (50) is a catheter or a medical tube, the diameter and the initial length of the catheter or the medical tube, the number of lumens in the catheter or the medical tube, the dead volume of each lumen of the catheter or of the medical tube, the flow rates, by gravity or by injection, via a pump or an injector of contrast substances, of the catheter or of medical tube, the characterization step comprising the determination of the structural feature(s) of the medical device of interest (50) imaged on the received image according to the assigned identifier.
8. The method according to any of claims 1 to 7, wherein each medical device of interest (50) has an inner portion (52) connected to the outer portion (54), the inner portion (52) being a tube or a needle inserted into the patient's body, the outer part (54) comprising at least one tube (59) and / or a connector to a tube (64; 70).
9. The method according to any of claims 1 to 8, wherein the identifier assigned to the medical device of interest is associated with a remote database from which information on the use of the medical device is obtained.
10. The method according to claim 9, wherein the information on use comprise data defined by the manufacturer and / or data defined by a healthcare professional when using the medical device on a patient.
11. The method according to claim 9 or 10, wherein the method comprises a step of updating the information for use of the medical device for a given patient and / or a given use, the information for use being archived so as to ensure a patient follow-up and / or a traceability of the medical device.
12. The method according to any of claims 1 to 11, wherein the identifier is associated with information with regard to the environmental impact and / or the eco-design of the medical device of interest.
13. A computer program product including program instructions stored on a computer-readable storage medium implementing steps of the identification method according to any of claims 1 to 12 when the computer program is executed on a computer.