Medical equipment quality safety evaluation early warning method and system
By constructing a standardized indicator system and automating data calculation, the problems of low efficiency and poor accuracy in the evaluation of medical equipment quality and safety have been solved, enabling scientific and intuitive multi-dimensional evaluation and timely identification of high-risk equipment.
Patent Information
- Application Number
- CN202511670977.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-11-14
- Publication Date
- 2026-03-10
AI Technical Summary
In existing technologies, the quality and safety evaluation of medical devices relies on manual calculation of scores, which is inefficient, has poor data accuracy, lacks standardized indicator construction and automated calculation, and makes it difficult to achieve a comprehensive and accurate evaluation.
A standardized indicator system was constructed using the analytic hierarchy process (AHP), and the indicators were revised using the Delphi expert consultation method. The weight coefficients of the primary and secondary indicators were calculated, the QSI index was calculated through automated data collection, and the results were displayed using a radar chart. Mandatory judgment rules for non-conformities were set.
It improves the scientific rigor and efficiency of the evaluation, ensures data accuracy, and enables the visualization and multi-dimensional comparison of evaluation results, allowing for the timely identification of high-risk equipment.
Smart Images
Figure CN121641373A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of medical equipment quality management, and particularly relates to a medical equipment quality and safety evaluation and early warning method and system. BACKGROUND
[0002] The quality and safety of medical equipment are directly related to the clinical diagnosis and treatment effect and patient safety, and the core is to identify risks in advance to ensure that the equipment is safe, effective and reliable throughout its life cycle. To protect patient safety, avoid misdiagnosis, missed diagnosis or treatment injury due to equipment failure, ensure effective equipment performance, and ensure accurate detection data and treatment effect.
[0003] In the prior art, the evaluation of the quality and safety of medical equipment relies on manual calculation of scores, which has the problems of low efficiency and poor data accuracy. Moreover, the evaluation system lacks standardized index construction methods and automated calculation processes, making it difficult to achieve comprehensive and accurate evaluation of the quality and safety of medical equipment. SUMMARY
[0004] To overcome the deficiencies of the prior art, the present application provides a medical equipment quality and safety evaluation and early warning method and system. The standardized index system construction method ensures the scientificity and authority of the evaluation, the automated data collection and calculation improves the evaluation efficiency and data accuracy, the QSI index and radar chart display realize the visualization and multi-dimensional comparison of the evaluation results, and the unqualified item forced judgment rule timely identifies high-risk equipment.
[0005] The technical solution of the present application is as follows: a medical equipment quality and safety evaluation and early warning method, comprising the following steps: S1, constructing a target layer, a first index layer and a second index layer based on the analytic hierarchy process, correcting the indexes through the Delphi expert consultation method, and calculating the first index weight coefficient and the second index weight coefficient; S2, obtaining the second index original score and part of the first index original score from the form of the medical equipment information system; S3, calculating the first index weighted score according to the second index original score and the corresponding second index weight coefficient; for the first index without a second index, using the original score as the weighted score; S4, calculating the QSI through normalization according to the first index weighted score and the corresponding first index weight coefficient, and determining the QSI grade according to the preset standard; if there is any unqualified item in the second index, the QSI grade is directly determined as unqualified; S5, displaying the QSI and the first index weighted score in numerical and radar chart forms, and issuing a warning instruction based on the QSI grade.
[0006] As a preferred embodiment of the present invention, in S1, the expression for calculating the expert authority coefficient is as follows: , In the above formula, As an authority coefficient, The score is used as the basis for judgment. Score based on familiarity; An expert's authority is deemed satisfactory if the score is ≥0.70.
[0007] In a preferred embodiment of the present invention, in S1, the weight coefficients of the secondary indicators and the weight coefficients of the primary indicators are calculated, as shown in the following expressions: , In the above formula, For the first Weighting coefficients for each primary indicator For the first The first primary indicator The weighting coefficients of each secondary indicator For the first The expert on the first The scores of each primary indicator For the first The expert on the first The scores of each secondary indicator, The number of secondary indicators. The number of primary indicators. The number of experts.
[0008] As a preferred embodiment of the present invention, in S3, the weighted score of the primary indicator is calculated, and the expression is as follows: , In the above formula, For the first The weighted scores of each primary indicator For the first The first primary indicator The scores for each secondary indicator are directly proportional to their respective values. For the first The first primary indicator The weighting coefficients of each secondary indicator.
[0009] In a preferred embodiment of the present invention, in S4, QSI is calculated, and the expression is as follows: , In the above formula, The quality and safety index score, For the first The weighted scores of each primary indicator For the first a first-level index weight coefficient.
[0010] As a preferred scheme of the present application, in S4, the QSI grade determination standard is: 80-100 points for excellent, 40-80 points for good, 20-40 points for poor, and 0-20 points for unqualified.
[0011] As a preferred scheme of the present application, in S5, the early warning instruction includes: when the QSI grade is unqualified, a first-level early warning is issued, the LED light is enabled to display red, the voice player is enabled to play a first-level early warning sound, and the short message push unit is enabled to send a first-level early warning information; when the QSI grade is poor, a second-level early warning is issued, the LED light is enabled to display yellow, the voice player is enabled to play a second-level early warning sound, and the short message push unit is enabled to send a second-level early warning information; when the QSI grade is good, a third-level early warning is issued, the LED light is enabled to display green, and the voice player is enabled to play a third-level early warning sound.
[0012] A medical device quality and safety evaluation and early warning system, comprising: an index system construction module, which is configured to construct an evaluation index system comprising a target layer, a first-level index layer, and a second-level index layer based on an analytic hierarchy process, and to correct the indexes by a Delphi expert consultation method, and to calculate a first-level index weight coefficient and a second-level index weight coefficient; a data acquisition module, which is configured to be connected to an existing medical device information system of a hospital, and to acquire second-level index original scores and part of first-level index original scores from forms of the information system; a score calculation module, which is connected to the index system construction module and the data acquisition module, and is configured to calculate first-level index weighted scores according to the second-level index original scores and corresponding second-level index weight coefficients; for the first-level indexes without second-level indexes, the original scores collected by the data acquisition module are directly used as the weighted scores; a QSI calculation and grade determination module, which is connected to the score calculation module, and is configured to calculate a QSI by normalization according to the first-level index weighted scores and corresponding first-level index weight coefficients, and to determine a QSI grade according to a preset standard; if any unqualified item exists in the second-level indexes collected by the data acquisition module, the QSI grade is directly determined as unqualified; a result display module, which is connected to the QSI calculation and grade determination module, and is configured to display the QSI and the first-level index weighted scores in a numerical form, and to display performance differences of the first-level indexes in a radar chart form; a result early warning module, which is connected to the QSI calculation and grade determination module, and is configured to issue an early warning instruction based on the QSI grade, and to execute the early warning by at least one of an LED light, a voice player, and a short message push unit.
[0013] As a preferred scheme of the present application, the first-level index layer comprises at least one index of fault maintenance, performance detection, preventive maintenance, inspection, usage management, adverse events, electrical safety detection, mandatory metering, technical data integrity, training and service life.
[0014] The present application has the following advantages: 1. In the present application, the standardized index system construction method ensures the scientificity and authority of the evaluation; 2. In the present application, automatic data acquisition and calculation improve the evaluation efficiency and data accuracy; 3. In the present application, the QSI index and radar chart display realize the visualization and multi-dimensional comparison of the evaluation results; the unqualified item mandatory judgment rule timely identifies high-risk equipment. BRIEF DESCRIPTION OF DRAWINGS
[0015] Figure 1 is a schematic diagram of the system of the present application; Figure 2 is a schematic diagram of the first-level index of the system of the present application; Figure 3 is a schematic diagram of the second-level index of the system of the present application; Figure 4 is a flowchart of the method of the present application; In the figure: 1, index system construction module; 2, data acquisition module; 3, score calculation module; 4, QSI calculation and grade determination module; 5, result display module; 6, result early warning module. DETAILED DESCRIPTION
[0016] In order to make the technical problems solved by the present application, the technical solutions adopted and the technical effects achieved more clear, the technical solutions of the embodiments of the present application will be further described in detail below with reference to the drawings. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.
[0017] Embodiment one As shown in Figures 1 to 3 , a medical device quality and safety evaluation and early warning system comprises: An index system construction module 1 constructs an evaluation index system comprising a target layer, a first-level index layer and a second-level index layer based on the analytic hierarchy process, and corrects the indexes by the Delphi expert consultation method, calculates the first-level index weight coefficient and the second-level index weight coefficient; A data acquisition module 2 is connected with the existing medical device information system of the hospital, and is used to acquire the second-level index original score and part of the first-level index original score from the form of the information system; The score calculation module 3 is connected with the index system construction module 1 and the data acquisition module 2, and is used for calculating the weighted score of the primary index according to the original score of the secondary index and the corresponding weight coefficient of the secondary index; for the primary index without the secondary index, the original score collected by the data acquisition module 2 is directly used as the weighted score; The QSI calculation and grade determination module 4 is connected with the score calculation module 3, and is used for calculating the quality safety index (QSI) through normalization according to the weighted score of the primary index and the corresponding weight coefficient of the primary index, and determining the QSI grade according to the preset standard; if any unqualified item exists in the secondary index collected by the data acquisition module 2, the QSI grade is directly determined as unqualified; The result display module 5 is connected with the QSI calculation and grade determination module 4, and is used for displaying the QSI and the weighted score of each primary index in the form of a numerical value, and displaying the performance difference of each primary index in the form of a radar chart; The result warning module 6 is connected with the QSI calculation and grade determination module 4, and issues a warning instruction based on the QSI grade, and executes the warning through at least one of an LED lamp, a voice player and a short message pushing unit.
[0018] In the embodiment, the index system construction module 1 is used for constructing an evaluation index system including a target layer, a primary index layer and a secondary index layer based on the analytic hierarchy process, and correcting the indexes and calculating the weight coefficient of the primary index and the weight coefficient of the secondary index through the Delphi expert consultation method; The primary index layer includes fault maintenance , performance detection , preventive maintenance , inspection , use management , adverse events , electrical safety detection , mandatory metering , technical data integrity , training , service life , a total of 11 primary indexes. Fault maintenance corresponds to 6 secondary indexes, which are fault frequency , internal cause of fault , external cause of fault , severity , fault repeatability and risk level ; performance detection includes a plurality of secondary indexes, each of which corresponds to a detection item; preventive maintenance corresponds to 4 secondary indexes, which are appearance and accessory state , equipment function state , maintenance and wearing parts replacement ; inspection Corresponding to three secondary indicators, respectively, the appearance and accessories state , functional status and use environment ; use management Corresponding to four secondary indicators, respectively, self-check execution rate , self-check results , use inspection and cleaning and disinfection ; adverse events Corresponding to four secondary indicators, respectively, the number of occurrences , root cause , injury degree and risk level ; electrical safety detection , mandatory metering , technical data integrity , training and service life No secondary indicators.
[0019] According to the requirements of laws and regulations such as “Medical Device Supervision and Management Regulations”, combined with the use, management, maintenance and quality control of medical equipment, a three-level structure of target layer, primary indicator layer and secondary indicator layer is built by analytic hierarchy process. Then, experts who meet the conditions such as associate professor and above title or master and above education, more than 5 years of relevant work experience, etc. are selected to design Likert 5-point scale questionnaire, and the indicators are revised through three rounds of expert consultation. Finally, combined with the expert authority coefficient, the weight coefficients of primary indicators and secondary indicators are calculated through the preset formula, and the consistency of expert scoring is verified through Kendall coordination coefficient to ensure the scientificity and authority of the index system. The Kendall coordination coefficient is calculated by SPSS software to verify the consistency of expert scoring. When the coordination coefficient is greater than or equal to 0.5, it is determined that the consistency is medium to high.
[0020] In this embodiment, the data acquisition module 2 is used to automatically acquire the secondary indicator original score and part of the primary indicator original score from the form of the medical equipment information system.
[0021] The data acquisition module 2 is connected with the existing medical equipment information system of the hospital, reads the form data of equipment failure records, performance test results, maintenance records, adverse event reports and other stored in the system, extracts the original scores of secondary indicators and part of primary indicators, and directly transmits to the score calculation module 3 to realize the automation and real-time of data acquisition.
[0022] In the embodiment, the score calculation module 3 is connected with the index system construction module 1 and the data acquisition module 2 respectively, and is used for calculating the weighted score of the primary index according to the secondary index original score and the corresponding weight coefficient.
[0023] The score calculation module 3 receives the secondary index original score transmitted by the data acquisition module 2 and the secondary index weight coefficient output by the index system construction module 1, and performs weighted calculation according to the score calculation expression of the primary index to obtain the weighted score of each primary index. For the primary index without secondary index, the original score collected by the data acquisition module 2 is directly used as the weighted score, and after the calculation is completed, all the weighted scores of the primary index are transmitted to the QSI calculation and grade determination module 4.
[0024] In the embodiment, the QSI calculation and grade determination module 4 is connected with the score calculation module 3, and is used for calculating the quality safety index (QSI) through normalization according to the weighted score of the primary index and the corresponding weight coefficient, and determining the QSI grade according to the preset standard; if there is an unqualified item of the secondary index, the QSI is directly determined as unqualified.
[0025] The QSI calculation and grade determination module 4 receives the weighted score of the primary index from the score calculation module 3, combines the weight coefficient of the primary index given by the index system construction module 1, and performs normalization calculation through the QSI calculation formula to convert the total score into 100-point system. Then, the QSI grade is determined according to the preset grade standard, wherein the excellent is 80-100 points, the good is 40-80 points, the poor is 20-40 points, and the unqualified is 0-20 points.
[0026] The result warning module 6 sends a warning instruction based on the QSI grade, and if the QSI grade is unqualified, a first-level warning instruction is sent; if the QSI grade is poor, a second-level warning instruction is sent; and if the QSI grade is good, a third-level warning instruction is sent.
[0027] If the data acquisition module 2 collects any unqualified item of the secondary index, the grade determination rule is directly triggered, the QSI grade of the device is determined as unqualified, and a first-level warning instruction is sent to ensure that the high-risk device is identified in time.
[0028] In the embodiment, the result display module 5 is connected with the QSI calculation and grade determination module 4, and is used for displaying the quality safety index and the weighted score of each primary index in the form of numerical value, and displaying the performance of each evaluation dimension in the form of radar chart.
[0029] The result display module 5 receives the QSI value, the grade and the weighted score of each primary index output by the QSI calculation and grade determination module 4, and displays the QSI total score and the score of each primary index in numerical form, and visualizes the performance difference of each primary index in radar chart form. Meanwhile, the result display module 5 supports multi-dimensional horizontal comparison and display, including QSI comparison of different departments, different brands, different models and different year devices, to help managers quickly locate problem devices, problem departments and potential risk points.
[0030] In the embodiment, the result warning module 6 is connected with the QSI calculation and grade determination module 4, and the result warning module 6 performs warning based on a warning instruction. The result warning module 6 is provided with an LED lamp, a voice player and a short message pushing unit. When a first-level warning is performed, the LED lamp, the voice player and the short message pushing unit are simultaneously enabled, the LED lamp displays red, the voice player plays a first-level warning sound, and the short message pushing unit sends a first-level warning information to a specified mobile phone. When a second-level warning is performed, the LED lamp, the voice player and the short message pushing unit are simultaneously enabled, the LED lamp displays yellow, the voice player plays a second-level warning sound, and the short message pushing unit sends a second-level warning information to the specified mobile phone. When a third-level warning is performed, the LED lamp and the voice player are simultaneously enabled, the LED lamp displays green, and the voice player plays a third-level warning sound.
[0031] Embodiment Two As shown in Figure 4 , a medical device quality and safety evaluation and warning method comprises the following steps: S1, constructing a target layer, a primary index layer and a secondary index layer based on the analytic hierarchy process, correcting the indexes through the Delphi expert consultation method, and calculating the weight coefficients of the primary indexes and the weight coefficients of the secondary indexes; S2, obtaining the secondary index original scores and part of the primary index original scores from the form of the medical device information system; S3, calculating the weighted scores of the primary indexes according to the secondary index original scores and the corresponding secondary index weight coefficients, and using the original scores as the weighted scores for the primary indexes without secondary indexes; S4, calculating the QSI through normalization according to the weighted scores of the primary indexes and the corresponding primary index weight coefficients, and determining the QSI grade according to a preset standard; if there is any unqualified item in any secondary index, the QSI grade is directly determined as unqualified; S5, displaying the QSI and the weighted scores of each primary index in numerical and radar chart forms, and issuing a warning instruction based on the QSI grade.
[0032] In step S1, the target layer, the first index layer and the second index layer are constructed based on the analytic hierarchy process, the indexes are corrected through three rounds of Delphi expert consultation, and the weight coefficients of the first indexes and the second indexes are calculated in combination with the expert authority coefficients.
[0033] In the index system construction module 1, the expert authority coefficient calculation expression is as follows: , In the above formula, is the authority coefficient, is the judgment basis score, is the familiarity score; ≥0.70 is determined as the expert authority qualification.
[0034] For subsequent calculation, is constructed as a diagonal matrix , , Among them, is the first expert.
[0035] The first index score matrix is obtained , and the adjusted weight score is obtained by multiplying the expert authority coefficient matrix : , Among them, is the score of the first expert to the first first index.
[0036] The second index score matrix under each first index is obtained , and the adjusted weight score is obtained by multiplying the expert authority coefficient matrix : , Among them, is the score of the first expert to the first second index.
[0037] The second index weight coefficient calculation standard is that each score of the expert is multiplied by its authority coefficient to equal the true score, the sum of each column true score is calculated, and the proportion of the score of each second index in the total score is the weight coefficient of the second index. The calculation formula is as follows: , The first index weight coefficient calculation standard is: , In the above formula, is the first first index weight coefficient, is the weight coefficient of the th secondary index under the th primary index, is the score of the th primary index given by the th expert, is the score of the th secondary index given by the th expert, is the number of secondary indexes, is the number of primary indexes, is the number of experts.
[0038] In step S2, the secondary indexes and part of the primary indexes are extracted from the form data of the medical equipment information system, such as the equipment failure records, performance test results, maintenance records, and adverse event reports stored in the system, by connecting with the existing medical equipment information system of the hospital.
[0039] In step S3, the secondary index raw scores and the secondary index weight coefficients output by the index system construction module 1 are received, and the weighted scores of each primary index are calculated according to the primary index score calculation expression. For the primary index without secondary index, the raw score collected by the data acquisition module 2 is directly used as its weighted score.
[0040] The primary index score calculation expression is as follows: , In the above formula, is the weighted score of the th primary index, is the direct score of the th secondary index under the th primary index, is the weight coefficient of the th secondary index under the th primary index.
[0041] In step S4, the primary index weighted scores are received, and the total score is converted to 100 points by normalization calculation through the QSI calculation formula in combination with the primary index weight coefficients given by the index system construction module 1. Then, the QSI level is determined according to the preset level standard, wherein excellent is 80-100 points, good is 40-80 points, poor is 20-40 points, and unqualified is 0-20 points.
[0042] The QSI calculation formula expression is as follows: , In the above formula, is the quality safety index score, For the first The weighted scores of each primary indicator For the first The weighting coefficients of each primary indicator.
[0043] Based on the QSI level, an early warning command is issued to the result early warning module 6. If the QSI level is unqualified, a level 1 early warning command is issued; if the QSI level is poor, a level 2 early warning command is issued; if the QSI level is good, a level 3 early warning command is issued.
[0044] If the data acquisition module 2 detects any non-compliant item in any secondary indicator, it will directly trigger the level determination rule, determine the QSI level of the device as non-compliant, and issue a first-level warning command to ensure that high-risk devices are identified in a timely manner.
[0045] In step S5, the system receives the QSI value, grade, and weighted scores of each primary indicator from the QSI calculation and grading module 4. Two display formats are used: a numerical format clearly presenting the total QSI score and the scores of each primary indicator; and a radar chart format visually displaying the performance differences of each primary indicator. Simultaneously, it supports multi-dimensional horizontal comparisons, including QSI comparisons of equipment from different departments, brands, models, and years, helping managers quickly locate problematic equipment, problematic departments, and potential risk points.
[0046] When a Level 1 warning is issued, the LED light, voice player, and SMS push unit are activated simultaneously. The LED light displays red, the voice player plays the Level 1 warning sound, and the SMS push unit sends the Level 1 warning information to the designated mobile phone. When a Level 2 warning is issued, the LED light, voice player, and SMS push unit are activated simultaneously. The LED light displays yellow, the voice player plays the Level 2 warning sound, and the SMS push unit sends the Level 2 warning information to the designated mobile phone. When a Level 3 warning is issued, the LED light and voice player are activated simultaneously. The LED light displays green, and the voice player plays the Level 3 warning sound.
[0047] This invention ensures the scientific rigor and authority of the evaluation through a standardized indicator system construction method; improves evaluation efficiency and data accuracy through automated data collection and calculation; achieves intuitive and multi-dimensional comparison of evaluation results through QSI index and radar chart display; and promptly identifies high-risk equipment through mandatory non-conformity judgment rules. It can be applied to the quality and safety evaluation of various medical equipment in hospitals, providing reliable support for equipment management, risk control, and decision-making, and contributing to improving the overall quality and safety level of medical equipment.
[0048] While the preferred embodiments of the application have been described, additional variations and modifications can be made to these embodiments by those skilled in the art once they have the benefit of the foregoing description without departing from the spirit and scope of the application. Accordingly, it is intended that such additions and modifications be included within the scope of the application.
Claims
1. A medical device quality and safety evaluation and early warning method, characterized in that, The method comprises the following steps: S1, constructing a target layer, a first index layer and a second index layer based on an analytic hierarchy process, correcting indexes through a Delphi expert consultation method, and calculating a first index weight coefficient and a second index weight coefficient; S2, obtaining second index original scores and part of first index original scores from forms of a medical equipment information system; S3, calculating first index weighted scores according to the second index original scores and corresponding second index weight coefficients; for a first index without a second index, using the original score as the weighted score; S4, calculating QSI through normalization according to the first index weighted scores and corresponding first index weight coefficients, and determining the QSI grade according to a preset standard; if there is any unqualified item in the second index, directly determining the QSI grade as unqualified; S5, displaying the QSI and the first index weighted scores in the form of numerical values and radar charts, and issuing a warning instruction based on the QSI grade.
2. The medical device quality safety evaluation and early warning method according to claim 1, characterized in that, In S1, the expert authority coefficient calculation expression is as follows: ， In the above formula, is the authority coefficient, is the judgment basis score, is the familiarity score; ≥ 0.70 is determined as the expert authority qualification.
3. The medical device quality and safety evaluation and early warning method according to claim 2, characterized in that, In S1, the second index weight coefficient and the first index weight coefficient are calculated, and the expression is as follows: ， In the above formula, is the first primary indicator weight coefficient, is the first primary indicator weight coefficient, is the first primary indicator weight coefficient, is the score of the first expert on the first primary indicator, is the score of the first expert on the first primary indicator, is the score of the first expert on the first primary indicator, is the number of secondary indicators, is the number of primary indicators, is the number of experts. 4. The medical device quality and safety evaluation and early warning method according to claim 3, characterized in that, In S3, the first index weighted score is calculated, and the expression is as follows: ， In the above formula, For the first The weighted scores of each primary indicator For the first The first primary indicator The direct scores for each secondary indicator For the first The first primary indicator The weighting coefficients of each secondary indicator.
5. The medical device quality and safety evaluation and early warning method according to claim 4, characterized in that, In S4, the QSI is calculated, and the expression is as follows: ， In the above formula, is the mass safety index score, is the weighted score of the first primary indicator, is the weight coefficient of the first primary indicator.
6. The medical device quality and safety evaluation and early warning method according to claim 5, characterized in that, In S4, the QSI grade determination standard is: 80-100 points for excellent, 40-80 points for good, 20-40 points for poor, and 0-20 points for unqualified.
7. The medical device quality and safety evaluation and early warning method according to claim 6, characterized in that, In S5, the warning instruction includes: When the QSI grade is unqualified, a first-level warning is issued, the LED light is turned on to display red, the voice player plays a first-level warning sound, and the short message pushing unit sends a first-level warning message; When the QSI grade is poor, a second-level warning is issued, the LED light is turned on to display yellow, the voice player plays a second-level warning sound, and the short message pushing unit sends a second-level warning message; When the QSI grade is good, a third-level warning is issued, the LED light is turned on to display green, and the voice player plays a third-level warning sound.
8. A medical device quality and safety evaluation and early warning system, which is suitable for the medical device quality and safety evaluation and early warning method of any one of claims 1-7, characterized in that, It comprises: An index system construction module, which constructs an evaluation index system comprising a target layer, a first index layer and a second index layer based on an analytic hierarchy process, corrects indexes through a Delphi expert consultation method, and calculates a first index weight coefficient and a second index weight coefficient; A data acquisition module, which is connected with an existing medical equipment information system of a hospital, and is used for obtaining second index original scores and part of first index original scores from forms of the information system; A score calculation module, which is connected with the index system construction module and the data acquisition module, and is used for calculating first index weighted scores according to the second index original scores and corresponding second index weight coefficients; for a first index without a second index, directly using the original score collected by the data acquisition module as the weighted score; A QSI calculation and grade determination module, which is connected with the score calculation module, and is used for calculating QSI through normalization according to the first index weighted scores and corresponding first index weight coefficients, and determining the QSI grade according to a preset standard; if the data acquisition module collects any unqualified item in the second index, directly determining the QSI grade as unqualified; The result display module is connected with the QSI calculation and grade determination module, and is used for displaying the QSI and the weighted scores of each first-level index in a numerical form, and displaying the performance differences of each first-level index in a radar chart form; The result warning module is connected with the QSI calculation and grade determination module, and is used for issuing a warning instruction based on the QSI grade, and executing the warning through at least one of an LED lamp, a voice player and a short message pushing unit.
9. The medical equipment quality safety evaluation and early warning system according to claim 8, characterized in that, The first-level index layer includes at least one index of fault maintenance, performance detection, preventive maintenance, inspection, use management, adverse events, electrical safety detection, mandatory metering, technical data integrity, training and service life.