Medical device, medical system, and method for controlling a medical device and method for determining the need to train a user of medical devices

Abstract

The invention relates to a medical device, a medical system, and a method for controlling a medical device and a method for determining the need to train a user of medical devices. According to the invention, the user-specific usage data from at least one medical device are collected, and it is determined on the basis of the comparison with specifications whether there is a need to train the user in using the at least one medical device or in a particular operating mode. In advantageous embodiments, a user is automatically informed about their potential need to be trained after identifying themselves at a medical device.

Description

[0001] Medical device, medical system and method for controlling a medical device and method for determining the training needs of a user of medical devices

[0002] The invention relates to a medical device, a medical system comprising at least one medical device and a method for controlling a medical device.

[0003] Furthermore, the invention relates to a method for determining the training needs of a user of medical devices.

[0004] When it comes to medical devices, and especially medical devices used in emergency medicine, such as ventilators or defibrillators, it is of considerable importance for the success of medical treatment that the respective users are able to operate the medical devices correctly.

[0005] Modern medical devices can be used to implement a variety of specific operating modes and functions, so that special operating modes or functions are usually only rarely used in daily applications.

[0006] In emergency medicine, the users of such medical devices are typically emergency responders such as paramedics, emergency medical technicians, paramedical assistants, or emergency physicians. Proper operation of medical devices can only be learned and practiced, or the relevant knowledge acquired, through regular training and exercises and / or the use of the devices in emergency situations. It is therefore important to continually assess the training needs of individual emergency responders and train them on the respective medical devices according to their identified needs.

[0007] According to the state of the art, for example in rescue services, the personal data on the training level of the emergency responders with the individual medical devices used must be laboriously recorded, stored and processed manually in order to determine and monitor the respective training needs.

[0008] It is therefore an object of the invention to provide an improved medical device which solves at least some of the aforementioned problems.

[0009] This object is achieved according to the invention by a medical device according to patent claim 1.

[0010] It is a further object of the invention to provide a medical technology system which solves at least some of the aforementioned problems.

[0011] This problem is solved by a medical technology system according to patent claim 9.

[0012] Furthermore, it is an object of the invention to provide a method for controlling a medical device which solves at least some of the aforementioned problems.

[0013] This object is achieved according to the invention by a method for controlling a medical device according to patent claim 14.

[0014] It is also an object of the invention to provide a method for determining the training needs of a user of medical devices, which solves at least some of the aforementioned problems.

[0015] This object is achieved according to the invention by a method for determining the training needs of a user of medical devices according to patent claim 19.

[0016] Advantageous embodiments of the invention are claimed in the dependent patent claims. The features of a medical device, a medical system, a method for controlling a medical device, and a method for determining the training needs of a user of medical devices disclosed below are part of the invention both individually and in all feasible combinations.

[0017] A medical device according to the invention has at least one data acquisition module and a communication device.

[0018] In embodiments of the invention, the medical device, which is designed, for example, as a ventilator, a defibrillator, an automatic external defibrillator (AED), an ECG device or a monitor system, has a therapy and / or monitoring module.

[0019] A therapy module is designed to provide medical therapy to a patient, for example through the controlled delivery of breathing air in a ventilator or through the delivery of electrical shocks in a defibrillator.

[0020] A monitoring module is designed to measure and output and / or monitor at least one vital parameter of a patient, for example pulse rate, blood oxygen saturation, an electrocardiogram, etc.

[0021] The data acquisition module is designed to collect usage data from the medical device.

[0022] In embodiments of the invention, the data acquisition module is designed to acquire usage data such as the usage time, the operating mode used and / or operating parameters selected by the user.

[0023] The operating mode of medical devices designed as combined defibrillator-monitor systems can be, for example, pacing, cardioversion, defibrillation or capnography.

[0024] In preferred embodiments of the invention, the data acquisition module is designed to acquire the usage data of the therapy and / or monitoring module.

[0025] Furthermore, the data acquisition module has an identification device for identifying a user using the medical device. In embodiments of the invention, the identification module is designed to identify the user by capturing a login that includes at least one user-specific user name and / or a user-specific password, capturing biometric data of the user, and / or capturing a user-specific ID tag.

[0026] If the identification module is designed to identify the user by capturing a login, the identification module has input means or is designed to use input means of the medical device with which a user name and / or password can be entered. For example, the identification module and / or the medical device has a keyboard and / or buttons and / or switches and / or a touch display.

[0027] If the identification module is designed to identify the user by capturing the user's biometric data, the identification module has a biometric capture device or is designed to use a biometric capture device of the medical device. For example, the biometric capture device is designed as a fingerprint sensor and / or an iris scanner and / or a facial scanner.

[0028] If the identification module is designed to identify the user by detecting a user-specific ID tag, the identification module has a reading device for ID tags or is designed to use a reading device for ID tags of the medical device. For example, the reading device for ID tags is designed as a barcode or QR code scanner, an NFC reader, or a card reader.

[0029] In preferred embodiments of the invention, the identification module is designed to compare the recorded identification data for identifying a user with the identification features of known users stored in a user database.

[0030] In embodiments of the invention, the data acquisition module is designed to collect usage data and link the usage data to a user ID.

[0031] In preferred embodiments of the invention, the data acquisition module is also designed to link the usage data to a device ID. The communication device is designed to receive and send data to an external evaluation and control unit, such as a server or web server with a corresponding application.

[0032] In embodiments of the invention, the communication module is configured for communication via Bluetooth, WLAN, and / or a radio network such as a satellite radio network or a mobile radio network. In alternative embodiments, wired communication devices are implemented additionally or solely.

[0033] In advantageous embodiments of the invention, the medical device has a training module which is designed to train users with regard to the use of the medical device.

[0034] For example, the training module is designed to simulate an operation in which, based on simulated vital parameters of a simulated patient, a user is to treat the simulated patient using the medical device.

[0035] In preferred embodiments of the invention, the medical device is designed for the automated retrieval of user-specific data from an external database, for example a central database on a web server, so that after identification of a user, the user can be automatically informed whether training with the respective medical device is required or will be required in the near future.

[0036] A medical technology system according to the invention comprises at least one medical technology device according to the invention and at least one evaluation and control unit which, in preferred embodiments of the invention, is located outside the medical technology device.

[0037] At least one medical device is connected to the evaluation and control unit for mutual data transmission.

[0038] In embodiments of the invention, the evaluation and control unit is embodied as a web server with a corresponding application for evaluation and control. In preferred embodiments, with the evaluation and control unit located outside the medical device, data transmission between the at least one medical device and the evaluation and control unit takes place via the internet.

[0039] Particularly preferably, the medical technology system is designed for encrypted data transmission in order to ensure appropriate data security.

[0040] In embodiments of the invention, the evaluation and control unit is integrated into the medical device.

[0041] The evaluation and control unit is designed to receive and evaluate user-specific usage data from at least one medical device.

[0042] The user-specific usage data can be stored in a storage device and retrieved from there by the evaluation and control unit.

[0043] With the help of the evaluation and control unit, the user-specific usage data for one or more medical devices can be compared with predetermined values, and training needs for each user can be determined based on this comparison. The user-specific usage data can be filtered using specific criteria.

[0044] For example, for a medical device, a usage time of at least 10 hours is defined as a predetermined value for a specific period of time as a filter criterion, e.g., for 12 months prior to the current date. The usage time value stored in the user-specific usage data can then be filtered according to the filter criterion and compared with the predetermined value. If the usage time of the respective user is less than the predetermined value of 10 hours, a training need is determined. If the usage time of the respective user is at least 10 hours, no training need is determined.

[0045] The data regarding a user's training needs can be retrieved from the evaluation and control unit of at least one medical device and / or actively transmitted from the evaluation and control unit to the medical device or multiple medical devices. Depending on the training needs of an identified user, the medical device is configured to output the user's existing training needs in order to prompt the user to participate in training and / or to start a training module.

[0046] In embodiments of the invention, the medical technology system comprises at least one individual ID tag per user.

[0047] A method according to the invention for controlling a medical device comprises at least the following method steps:

[0048] 1. Identification of the user of a medical device and determination of a user ID assigned to the user,

[0049] 2. Collecting usage data during the user’s use of the medical device in regular operation and / or during training,

[0050] 3. Linking the collected usage data with the user’s recorded user ID,

[0051] 4. Transfer of the linked data to an external evaluation and control unit,

[0052] 5. Adding the usage data to an existing record for the user or creating a new record for the user,

[0053] 6. Evaluation of usage data for at least one user,

[0054] 7. Comparison of at least one value of the usage data of a user per medical device and / or operating mode of a medical device with predetermined values,

[0055] 8. Determining the need for training of the respective user with a medical device or a specific operating mode of a medical device,

[0056] 9. Transmission of the user's training needs to the respective medical device or to multiple medical devices. In preferred embodiments of the invention, the medical device offers the user, after the user has been identified on the medical device, a corresponding training session based on the user's training needs and / or generates an output to inform the user of an existing training need.

[0057] In a preferred embodiment of the method according to the invention, the medical device actively retrieves the user profile with the individual training needs stored therein after the user has been identified on the device. This approach has the advantage that the user is not limited to a specific medical device with regard to information about the required training, and the data on a user's training needs do not have to be preemptively transmitted from the evaluation and control unit to all available medical devices.

[0058] In embodiments of the invention, the user profiles are initially created in a database accessible by the evaluation and control unit. The user ID is stored in the database so that the collected usage data can later be assigned to the user profile via the user ID.

[0059] For example, the user profiles are created and managed by the management of the emergency services on a web platform.

[0060] In embodiments of the invention, the at least one medical device regularly connects to this web platform and synchronizes the usage data of the respective user.

[0061] The user's identification on the medical device is possible, for example, in the following variants. According to variant 1, the user logs on to the medical device at the start of the shift by entering their assigned personal ID (e.g., username and / or password). According to variant 2, the user logs on to the medical device at the start of the shift using authentication via an NFC tag.

[0062] The following variants are conceivable for logging the user off the medical device. According to variant 1, the user logs off the medical device manually at the end of the shift, for example, by pressing an analog or digital log-out button. According to variant 2, the user logs off the medical device at the end of the shift by reading their individual NFC tag. According to variant 3, the user logs off automatically at a specified time. This time can be set, for example, by the management of the emergency services.

[0063] When the usage data is collected, the data is stored locally on the medical device, at least temporarily.

[0064] As soon as the user-specific usage data has been transferred to the evaluation and control unit, it is stored in a database permanently or at least for a period of at least 12 months.

[0065] In embodiments of the invention, the user-specific usage data stored locally on the medical device are deleted as soon as they have been transferred to the evaluation and control unit.

[0066] In embodiments of the invention, the user-specific usage data are exchanged during each connection between the medical device and the evaluation and control unit, even if the reason for establishing the connection is different (e.g., uploading of functional control results, telemetry application, etc.).

[0067] After the user has been identified, the medical device, in preferred embodiments of the invention, automatically checks whether a training requirement has been identified for the identified user on the medical device.

[0068] In embodiments of the method according to the invention, the determination of a user's training needs with a specific medical device or a specific function of a medical device is carried out by comparing user-specific usage data with predetermined values ​​for specific usage data. A training need is determined if a usage criterion is not met. In particular, this can be the case if the respective value of the user-specific usage data is below a predetermined minimum value.

[0069] In preferred embodiments of the method according to the invention, the usage data of the at least one user stored in the database can be filtered using at least one filter criterion. Such a filter criterion can be, for example, a specific period of time, a specific medical device, or a specific functionality of a medical device.

[0070] In embodiments, the evaluation and control unit compares detailed usage data of at least one user with at least one target specification (e.g., the course of a treatment with a predetermined sequence of treatment steps and / or predetermined setting values). Based on this comparison, the quality of the treatment(s) performed by the user is assessed and a quality index is assigned.

[0071] In advantageous embodiments of the invention, a training need of the user is determined from the quality assessment by comparing the respective quality index with a predetermined minimum value for the quality index if the quality index is below the predetermined minimum value.

[0072] In preferred embodiments of the method according to the invention for controlling a medical device, a medical device according to the invention or a medical system according to the invention is used.

[0073] A method according to the invention for determining the training needs of a user of medical devices comprises at least the following method steps

[0074] 1. Identification of the user and determination of the user ID,

[0075] 2. Collecting usage data during use of the medical device in regular operation and / or for training,

[0076] 3. Linking the collected usage data with the user ID,

[0077] 4. Transfer of the linked data to an external evaluation and control unit,

[0078] 5. Adding the usage data to an existing record for the user or creating a new record for the user,

[0079] 6. Evaluation of usage data for at least one user 7. Comparison of usage data for each medical device and / or operating mode of a medical device with predetermined values

[0080] 8. Determining the need for training of the respective user with a medical device or a specific operating mode of a medical device

[0081] 9. Distribution of the determined training needs for each user and device to one or more responsible persons.

[0082] The responsible persons according to step 9 are in particular persons active in the organization and / or management of rescue services who inform the respective users about a training need / organize training for and / or with the respective users.

[0083] In embodiments of the invention, the user-specific usage data is transmitted to a web portal. There, the data is graphically presented for each user so that, for example, the emergency services management can determine the device usage level of each user. This allows the emergency services management to determine where training is needed.

[0084] Usage data within the meaning of this invention are in particular data which, individually or in combination, can provide information about whether and how a medical device was used by a user.

[0085] For example, such usage data is selected individually or in any combination from the following data:

[0086] - The device runtime

[0087] - The number of uses of the medical device

[0088] - The running time of the different operating modes

[0089] --> with a defibrillator monitor: e.g. AED mode, monitor mode, manual mode, pacemaker mode)

[0090] --> with an AED: e.g. AED mode, manual mode

[0091] --> for a ventilator: e.g. ventilation mode (IPPV, CPAP, SIM, PCV, Bi-Level, etc.), NIV mode, CPR mode, RSI mode

[0092] - The number of defibrillations performed

[0093] - The number and duration of CPR feedback sensor uses

[0094] - The number of 12-lead diagnostic ECGs - The number of functional checks performed

[0095] - The number of live data connections

[0096] - The number and duration of menu uses

[0097] - The number and duration of replay views

[0098] - The number and type of prints

[0099] - The number of blood pressure measurements taken

[0100] - The number of data transfers to an external documentation system

[0101] - The number of data transfers to a central operational data server

[0102] - The number of times ventilation is initiated via emergency mode

[0103] - The number of entries into ventilation via patient data such as patient size and gender

[0104] - The duration of the display of curves (e.g. ECG, flow, CO2, pressure, etc.)

[0105] Particularly in embodiments of the invention with an external evaluation and control unit for use with a plurality of different medical devices, the usage data is linked not only to the user ID of the respective user, but also to a device ID. This device ID is defined either individually for each individual medical device or individually for groups of similar medical devices (e.g., five ventilators of the same type). This also makes it possible to distinguish between different medical devices in the database in which the user-specific usage data is stored.

[0106] In embodiments of the invention, one or more different training units are available on the at least one medical device, with which the user can be trained as needed. Each training unit is linked to specific attributes through which the level of training can be increased in a differentiated manner according to the specific types of device use. If, during the evaluation of device usage using the evaluation and control unit, it is determined that a deficit exists (e.g. no defibrillation in the last year, no pacemaker therapy in the last year, only 2x start of ventilation due to body size and gender, etc.), the user is suggested to carry out the corresponding training unit by means of a corresponding output on the medical device.In embodiments of the invention, the level of device usage at which a training session is suggested to the user can be set by the emergency services management by adjusting the predefined values ​​and / or filter criteria. The figure explained below illustrates, by way of example, an embodiment of a medical-technical system (10) according to the invention and the sequence of an embodiment of a method according to the invention for controlling a medical-technical device (1).

[0107] The medical device (1) is designed as a defibrillator monitor and is connected to an evaluation and control unit (3) designed as a cloud server via a communication interface (2), in this case as an internet connection. A server application is installed and started on the cloud server, which implements the required process steps on the evaluation and control unit (3).

[0108] According to the procedure shown, a user first switches on the medical device (1). The user then identifies themselves on the medical device (1). After identification, the medical device (1) automatically checks whether the identified user needs training on or with the medical device (1) by querying the user-specific data on training requirements from the evaluation and control unit (3). If there is a need for training with the medical device, a training recommendation is automatically output to the user. The medical device (1) is then used by the user in regular service operations or for training. The usage data is recorded, assigned to the identified user, and stored in the memory of the medical device (1). The next time there is a connection to the evaluation and control unit (3), the data associated with the user ID and, if applicable,Additionally, usage data linked to the device ID is transmitted to the evaluation and control unit (3) and stored. The usage data is then evaluated in a further process step, user behavior is processed, and any training needs are derived. Based on the derived training needs for the respective user, suitable training scenarios are automatically selected and suggested to the user after identification on a suitable medical device.

Claims

Claims: Medical device (1) comprising at least one data acquisition module for recording usage data of the medical device (1) and a communication device for sending data to an external or receiving data from an external evaluation and control unit (3), the data acquisition module comprising an identification device for identifying a user of the medical device (1). Medical device (1) according to claim 1, characterized in that it comprises at least one therapy and / or monitoring module. Medical device (1) according to claim 2, characterized in that the data acquisition module is configured for recording the usage data of the therapy and / or monitoring module.Medical device (1) according to one of the preceding claims, characterized in that the identification module is designed to identify the user by means of capturing a login which includes at least one user-specific username and / or one user-specific password, capturing biometric data of the user and / or capturing a user-specific ID tag. Medical device (1) according to one of the preceding claims, characterized in that the data acquisition module is configured to collect usage data and link the usage data to a user ID. Medical device (1) according to claim 5, characterized in that the data acquisition module is further configured to link the usage data to a device ID. Medical device (1) according to one of the preceding claims, characterized in that it comprises a training module configured to train users in the use of the medical device (1). Medical device (1) according to one of the preceding claims, characterized in that it is configured to automatically retrieve user-specific data from an external database, for example, a central database on a web server.is trained. Medical technology system (10) comprising at least one medical device (1) according to one of claims 1 to 8 and at least one evaluation and control unit (3), wherein the at least one medical device (1) is connected to the evaluation and control unit (3) via a communication interface (2) for mutual data transmission, and wherein the evaluation and control unit (3) is configured to receive and evaluate user-specific usage data from at least one medical device (1), wherein the user-specific usage data can be stored in a storage device by the evaluation and control unit and can be retrieved from it, and wherein the user-specific usage data for one or more medical devices (1) can be compared with predetermined values ​​using the evaluation and control unit (3), and a training requirement can be determined for each user based on this comparison.wherein the data on the training needs of a user are retrievable from the evaluation and control unit (3) of the at least one medical device (1) and / or actively transmitted from the evaluation and control unit (3) to the medical device (1) or several medical devices (1), and wherein the at least one medical device (1) is designed to determine, in accordance with the training needs of an identified user, any existing training needs of the user, to issue a message to request training and / or to start a training module. Medical device system (10) according to claim 9, characterized in that the evaluation and control unit (3) is arranged outside the at least one medical device (1). Medical device system (10) according to claim 10, characterized in that the evaluation and control unit (3) is configured as a web server with a corresponding application for evaluation and control. Medical device system (10) according to any one of claims 9 to 11, characterized in that the evaluation and control unit (3) is configured to filter the user-specific usage data based on at least one of its filter criteria. Medical device system (10) according to any one of claims 9 to 12, characterized in that it comprises at least one individual ID tag per user.A method for controlling a medical device (1) comprising at least the following process steps: a. Identification of the user of a medical device (1) and determination of a user ID assigned to the user; b. Collection of usage data during the use of the medical device (1) by the user in regular operation and / or during training; c. Linking the collected usage data with the recorded user ID of the user; d. Transmission of the linked data to an external evaluation and control unit (3); e. Adding the usage data to an existing data record for the user or creating a new data record for the user; f. Evaluation of the usage data for the at least one user; g. Comparison of at least one value of the usage data of a user per medical device (1) and / or operating mode of a medical device (1) with predetermined values. h. Deriving the need for training of the respective user with a medical device (1) or a specific operating mode of a medical device (1), i. Transmitting the user's training requirement to the respective medical device (1) or to several medical devices (1). Method for controlling a medical device (1) according to claim 14, characterized in that the medical device (1), after the user's identification at the medical device (1), offers the user appropriate training according to the user's training requirement and / or generates an output to inform the user about an existing training requirement.A method for controlling a medical device (1) according to one of claims 14 and 15, characterized in that the medical device (1) actively retrieves the user profile with the individual training requirements stored therein after the user has been identified at the medical device (1). A method for controlling a medical device (1) according to one of claims 14 to 16, characterized in that the at least one medical device (1) regularly connects to the evaluation and control unit (3) and synchronizes the usage data of the respective user. A method for controlling a medical device (1) according to one of claims 14 to 17, characterized in that a medical device (1) according to one of claims 1 to 8 or a medical system (10) according to one of claims 9 to 13 is used.Method for determining the training needs of a user of medical devices (1) comprising at least the following process steps: a. Identification of the user and determination of the user ID, b. Collection of usage data during the use of the medical device (1) in regular operation and / or for training, c. Linking the collected usage data with the user ID, d. Transfer of the linked data to an external evaluation and control unit (3), e. Adding the usage data to an existing data record for the user or creating a new data record for the user. f. Evaluation of usage data for at least one user; g. Comparison of usage data per medical device (1) and / or operating mode of a medical device (1) with predetermined values; h. Determination of the need for training of the respective user with a medical device (1) or a specific operating mode of a medical device (1); i. Output of the determined training requirement per user and medical device (1). Method for determining the training requirement of a user of medical devices (1) according to claim 19, characterized in that a medical device (1) according to one of claims 1 to 8 or a medical system (10) according to one of claims 9 to 13 is used.

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