Quality management system of intelligent medical instrument
By using the intelligent medical device quality management system and the GRITIC and GI methods for risk assessment, the problem of monitoring the entire life cycle of medical devices has been solved, and effective risk management and safety assurance have been achieved.
Patent Information
- Application Number
- CN202511425538.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-09-30
- Publication Date
- 2026-01-09
Smart Images
Figure CN121306478A_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of quality management technology, specifically to a quality management system for intelligent medical devices. Background Technology
[0002] Medical devices are essential tools for diagnosing and treating diseases, holding an irreplaceable position in modern medicine. Advances in science and technology drive professionals to apply more new technologies to the field of medical devices to meet clinical needs. Adverse events related to medical devices are crucial to the diagnostic and treatment effectiveness of the devices and the entire healthcare system, as well as the safety of users and patients. Therefore, conducting adverse event monitoring for medical devices is of paramount importance.
[0003] Therefore, establishing a universal monitoring process covering the entire lifecycle of medical devices is one of the urgent problems to be solved. Summary of the Invention
[0004] To address the technical problems mentioned above, this invention provides a quality management system for intelligent medical devices, enabling monitoring of the entire lifecycle of medical devices to a certain extent.
[0005] This invention provides a quality management system for intelligent medical devices, including: a user management module for user registration, login, and information modification; The medical device information acquisition module is used to acquire usage data of various testing indicators of medical devices throughout their life cycle; The risk assessment module is used to score the acquired usage data using the GRITIC and GI methods and generate a risk assessment report. The risk analysis module is used to make decisions and implement measures based on risk assessment reports to reduce risk or maintain risk at a specified level.
[0006] Furthermore, the system also includes a medical device information query module, used to achieve traceability of medical device information.
[0007] Furthermore, the medical device information acquisition module includes: The data verification unit is used to verify the acquired usage data and mark the verified usage data. The evaluation task generation unit generates evaluation tasks based on the labeled usage data and adds the evaluation tasks to the task table.
[0008] Furthermore, the risk assessment module includes: The preset unit is used to preset the evaluation indicators for the usage data of each detection indicator and to rank the importance of the evaluation indicators. The objective weight calculation unit is used to calculate the objective weights of preset evaluation indicators using the GRITIC method. The subjective weight calculation unit is used to calculate the subjective weights of the evaluation indicators based on the importance of predetermined evaluation criteria using the GI method. The comprehensive weight calculation unit is used to calculate the subjective and objective weights of each evaluation indicator using multiplication and normalization to obtain the comprehensive weight value; The comprehensive scoring calculation unit is used to score the usage data of each detection indicator based on the comprehensive weight value, so as to obtain the score of the usage data of each detection indicator; The report generation unit is used to generate risk assessment reports.
[0009] Furthermore, the risk analysis module includes: Risk assessment unit, used to describe information for risk assessment and risk acceptability criteria; Risk control unit, used to describe the risk control measures taken; Usability evaluation units are used to describe information in the usability engineering process; The recall unit describes the recall process for medical devices. The residual risk assessment unit is used to assess the residual risk after a decision has been made and measures have been implemented.
[0010] Furthermore, the system also includes a re-evaluation module for collecting production and post-production information of the medical device to determine whether a re-evaluation is required.
[0011] The beneficial effects of this invention are as follows: This invention employs a medical device information acquisition module to acquire usage data of various testing indicators of a medical device throughout its lifecycle; a risk assessment module to score the acquired usage data using the GRITIC and GI methods and generate a risk assessment report; and a risk analysis module to make decisions and implement measures based on the risk assessment report to reduce risk or maintain risk at a specified level, thereby contributing to the realization of monitoring of the entire lifecycle of medical devices to a certain extent. Attached Figure Description
[0012] The accompanying drawings, which form part of this invention, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an improper limitation of the invention.
[0013] Figure 1 This is a schematic diagram of the quality management system for an intelligent medical device according to the present invention. Detailed Implementation
[0014] The present invention will be further described below with reference to the accompanying drawings and embodiments.
[0015] It should be noted that the following detailed description is illustrative and intended to provide further explanation of the invention. Unless otherwise specified, each technical and scientific term used in these embodiments has the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.
[0016] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of exemplary embodiments according to the invention. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.
[0017] In this invention, terms such as "upper," "lower," "left," "right," "front," "back," "vertical," "horizontal," "side," and "bottom" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. These terms are used only to facilitate the description of the structural relationships of the various components or elements of this invention and do not specifically refer to any component or element in this invention. They should not be construed as limiting the invention.
[0018] In this invention, terms such as "fixed connection," "connected," and "linked" should be interpreted broadly, indicating a fixed connection, an integral connection, or a detachable connection; a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can determine the specific meaning of these terms in this invention based on the specific circumstances, and they should not be construed as limitations on the invention.
[0019] Example 1: like Figure 1 As shown, this embodiment provides a quality management system for intelligent medical devices, including: (a) User management module, used to implement user registration, login and information modification.
[0020] Specifically, user login requires administrator permission. During login, this module matches the login information with information in the database. If a match is found, the user is logged into the system. Simultaneously, this module verifies the user type and accesses the corresponding system portal. After successful login, users can change their password using their old password and also modify and save their personal information.
[0021] (ii) Device information query module, used to realize the traceability of medical device information.
[0022] Specifically, medical device information includes: information sources such as manufacturer information, distributor information, and user information, for example... Production enterprise information: {Production enterprise name, warehousing information, quality inspection information, person in charge information, packaging and other processing information, registration information, raw material information, raw material production enterprise information}.
[0023] Distributor Information: {Distributor Name, Warehousing Information, Logistics Information, Management Personnel Information, Packaging and other Processing Information}.
[0024] User unit information: {Management personnel information, maintenance and repair information, usage time information, user information, patient information}.
[0025] (ii) Medical device information acquisition module, used to acquire usage data of various testing indicators of medical devices throughout their life cycle; among which, production information includes: the name of the medical device manufacturer, warehousing information, quality testing information, and information of the person in charge.
[0026] Specifically, the medical device information acquisition module includes: The data verification unit is used to verify the acquired usage data and mark the verified usage data. The evaluation task generation unit generates evaluation tasks based on the labeled usage data and adds the evaluation tasks to the task table.
[0027] (iii) Risk assessment module, which is used to score the acquired usage data using the GRITIC method and GI method and generate a risk assessment report.
[0028] Specifically, the risk assessment module includes: The preset unit is used to preset the evaluation indicators for the usage data of each detection indicator and to rank the importance of the evaluation indicators. The objective weight calculation unit is used to calculate the objective weights of preset evaluation indicators using the GRITIC method. Specifically, it includes the following steps: A1: The raw data of each preset evaluation index are subjected to steel-free quantification using the 0 to 1 standardization method to obtain standardized index data; A2: Use the CRITIC method to calculate the objective weight values of the standardized indicator data to obtain the objective weight values of each indicator data.
[0029] The subjective weight calculation unit is used to calculate the subjective weights of the evaluation indicators based on the importance of predetermined evaluation criteria using the GI method. Specifically, it includes the following steps: B1: First, based on the importance of each pre-set evaluation criterion, sort the evaluation criteria in descending order; B2: Calculate the subjective weights using the following formula: ; ; ; Where n is the number of evaluation indicators, Users rate the importance of each evaluation criterion; the smaller the value of j, the lower the importance. Let be the subjective weight value of the j-th evaluation criterion.
[0030] The comprehensive weight calculation unit is used to calculate the subjective and objective weights of each evaluation indicator using multiplication and normalization to obtain the comprehensive weight value.
[0031] The comprehensive scoring calculation unit is used to score the usage data of each testing indicator based on the comprehensive weight value, so as to obtain the score of the usage data of each testing indicator.
[0032] The report generation unit is used to generate a risk assessment report, which includes: usage data for each detection indicator, a score for each usage data, and hazard information. The hazard information includes: the cause of the accident, the source of the accident hazard, and the hazardous situation of the accident.
[0033] (iv) Risk analysis module, used to make decisions and implement measures based on risk assessment reports to reduce risk or maintain risk at a specified level.
[0034] The risk assessment unit is used to describe the information for risk assessment and the acceptance criteria for risk; wherein, the risk assessment includes: determining the probability of the causal event and determining the probability of damage; the acceptance criteria for risk include: the basis for their formulation.
[0035] The risk control unit describes the risk control measures taken, including the analysis of the control plan, the risk assessment after control, and information related to the implementation of the control.
[0036] A usability evaluation unit is used to describe information in the usability engineering process, including the analysis of usage errors, the development of usability specifications, the development of usability verification plans, and the verification and validation of usability.
[0037] The recall unit describes the recall process for medical devices and provides all reporting modules in the recall process. The reporting modules include: Medical Device Investigation and Evaluation Report, Medical Device Recall Event Report, Recall Plan Report, Recall Notification Report, and Recall Plan Implementation Status Report.
[0038] The implementation unit is used to make decisions and implement measures based on the described risk control measures.
[0039] The residual risk assessment unit is used to assess the residual risk after a decision has been made and measures have been implemented.
[0040] (v) Reassessment module, used to collect information on the production and post-production of medical devices to determine whether reassessment is required.
[0041] The same or similar parts between the various embodiments in this specification can be referred to mutually. In particular, the terminal embodiments are basically similar to the method embodiments, so the description is relatively simple, and the relevant parts can be referred to the description in the method embodiments.
[0042] In the several embodiments provided by this invention, it should be understood that the disclosed systems and methods can... This can be achieved through other means. For example, the system embodiments described above are merely illustrative. For instance, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection shown or discussed may be through some interfaces; the indirect coupling or communication connection between systems or units may be electrical, mechanical, or other forms.
[0043] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.
[0044] Additionally, it should be noted that the flowcharts in the accompanying drawings illustrate methods according to embodiments of this disclosure. In the descriptions corresponding to the flowcharts or block diagrams in the drawings, the operations or steps corresponding to different blocks may occur in a different order than disclosed in the description; sometimes there is no specific order between different operations or steps. For example, two consecutive operations or steps may actually be executed substantially in parallel, or sometimes in reverse order, depending on the function involved. Each block in the block diagrams and / or flowcharts, and combinations of blocks in the block diagrams and / or flowcharts, can be implemented using a dedicated hardware-based system that performs the specified function or action, or can be implemented using a combination of dedicated hardware and computer instructions.
[0045] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.
Claims
1. A quality management system for intelligent medical devices, characterized in that, include: The user management module is used to enable user registration, login, and information modification; The medical device information acquisition module is used to acquire usage data of various testing indicators of medical devices throughout their life cycle; The risk assessment module is used to score the acquired usage data using the GRITIC and GI methods and generate a risk assessment report. The risk analysis module is used to make decisions and implement measures based on risk assessment reports to reduce risk or maintain risk at a specified level.
2. The quality management system for intelligent medical devices according to claim 1, characterized in that, The system also includes a medical device information query module, which is used to enable the traceability of medical device information.
3. The quality management system for intelligent medical devices according to claim 1, characterized in that, The medical device information acquisition module includes: The data verification unit is used to verify the acquired usage data and mark the verified usage data. The evaluation task generation unit generates evaluation tasks based on the labeled usage data and adds the evaluation tasks to the task table.
4. The quality management system for intelligent medical devices according to claim 1, characterized in that, The risk assessment module includes: The preset unit is used to preset the evaluation indicators for the usage data of each detection indicator and to rank the importance of the evaluation indicators. The objective weight calculation unit is used to calculate the objective weights of preset evaluation indicators using the GRITIC method. The subjective weight calculation unit is used to calculate the subjective weights of the evaluation indicators based on the importance of predetermined evaluation criteria using the GI method. The comprehensive weight calculation unit is used to calculate the subjective and objective weights of each evaluation indicator using multiplication and normalization to obtain the comprehensive weight value; The comprehensive scoring calculation unit is used to score the usage data of each detection indicator based on the comprehensive weight value, so as to obtain the score of the usage data of each detection indicator; The report generation unit is used to generate risk assessment reports.
5. The quality management system for intelligent medical devices according to claim 1, characterized in that, The risk analysis module includes: Risk assessment unit, used to describe information for risk assessment and risk acceptability criteria; Risk control unit, used to describe the risk control measures taken; Usability evaluation units are used to describe information in the usability engineering process; The recall unit describes the recall process for medical devices. The residual risk assessment unit is used to assess the residual risk after a decision has been made and measures have been implemented.
6. The quality management system for intelligent medical devices according to claim 1, characterized in that, The system also includes a re-evaluation module, used to collect information on the production and post-production of medical devices to determine whether a re-evaluation is required.