CN112000068A - Medical instrument performance quality management system based on block chain technology - Google Patents

Medical instrument performance quality management system based on block chain technology Download PDF

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Publication number
CN112000068A
CN112000068A CN202010444172.3A CN202010444172A CN112000068A CN 112000068 A CN112000068 A CN 112000068A CN 202010444172 A CN202010444172 A CN 202010444172A CN 112000068 A CN112000068 A CN 112000068A
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instrument
detection
parameters
difference
module
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Chinese (zh)
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康雅婷
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Shanghai Flying Fish Medical Technology Co ltd
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Shanghai Flying Fish Medical Technology Co ltd
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Priority to CN202010444172.3A priority Critical patent/CN112000068A/en
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    • GPHYSICS
    • G05CONTROLLING; REGULATING
    • G05BCONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B19/00Programme-control systems
    • G05B19/02Programme-control systems electric
    • G05B19/418Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control [DNC], flexible manufacturing systems [FMS], integrated manufacturing systems [IMS], computer integrated manufacturing [CIM]
    • G05B19/41875Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control [DNC], flexible manufacturing systems [FMS], integrated manufacturing systems [IMS], computer integrated manufacturing [CIM] characterised by quality surveillance of production
    • GPHYSICS
    • G05CONTROLLING; REGULATING
    • G05BCONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B2219/00Program-control systems
    • G05B2219/30Nc systems
    • G05B2219/32Operator till task planning
    • G05B2219/32368Quality control

Abstract

The invention relates to the field of medical instrument quality detection, in particular to a medical instrument performance quality management system based on a block chain technology. Including a plurality of different types of detection node for gather instrument parameter, the management node includes: a storage module; a classification module; and the correction module is connected with the classification module and used for receiving the instrument parameter set, correcting all instrument parameters in the instrument parameter set to obtain a correction coefficient corresponding to the instrument parameters and outputting the correction coefficient to the detection node. The beneficial effects of the above technical scheme are: the constructed instrument quality performance management system can effectively solve various existing non-specifications in the field of medical detection instruments, safely and efficiently monitor the performance and quality of the medical detection instruments, and realize real-time data storage, risk analysis and feedback and data encryption protection.

Description

Medical instrument performance quality management system based on block chain technology
Technical Field
The invention relates to the field of medical instrument quality detection, in particular to a medical instrument performance quality management system based on a block chain technology.
Background
In recent years, the in vitro diagnosis mode can quickly and accurately diagnose diseases in early stage, plays an extremely important role in the fields of treatment monitoring of diseases, precise medical treatment and related medical research, and the stability of the performance of medical instruments is the basis for ensuring clinical diagnosis.
However, the quality management, performance evaluation, maintenance and the like of the existing clinical diagnosis medical instruments and equipment have various defects, such as unstable performance of the medical instruments, defective design, failure information processing and the like, which cannot be read in time, failure hidden dangers cannot be found and eliminated in time, and ineffective comparison methods for the performance of the medical instruments and equipment produced by different manufacturers are lacked in effective management of the medical instruments and equipment.
In addition, some medical instruments and equipment of the same type and different manufacturers are applied to the same biological reference interval, and the detection result is not met due to the difference of different equipment performances, so that the detection quality difference is difficult to control.
Disclosure of Invention
In view of the above-mentioned drawbacks of the prior art, the present invention provides a system for managing performance and quality of a medical instrument based on a block chain technique, which is used for detecting the performance of a plurality of medical instruments, and is characterized by comprising a plurality of detection nodes of different types, wherein the detection nodes are used for collecting instrument parameters obtained by detecting different detection items of the medical instruments in the whole process of production, transportation and use, and the instrument parameters are associated with the types of the detection items in the detection nodes;
the instrument performance quality management system further comprises a management node, the management node and the corresponding detection nodes are integrated to form a network, and the management node comprises:
the storage module is connected with the detection nodes and used for receiving the instrument parameters output by all the detection nodes;
the classification module is connected with the storage module and used for classifying all the instrument parameters according to the detection project models to obtain and output a plurality of instrument parameter sets;
and the correction module is connected with the classification module and used for receiving the instrument parameter set, correcting all instrument parameters in the instrument parameter set to obtain correction coefficients corresponding to the instrument parameters and outputting the correction coefficients to the detection nodes.
Preferably, a standard value is preset in the correction module, a ratio between all the instrument parameters and the standard value is obtained, and the ratio is used as the correction coefficient and output to the detection node.
Preferably, the management node further includes a first difference module, where a plurality of difference blocks are preset in the first difference module, and the first difference module is connected to the correction module, and is configured to correct all the instrument parameters by using the correction coefficient to obtain corrected instrument parameters and obtain an average value of the instrument parameters, calculate the average value and the instrument parameters to obtain a difference value, determine the difference value according to the difference block to obtain a first determination result, and output the first determination result to the detection node.
Preferably, the types of the instrument parameters include:
the instrument production parameters are used for recording instrument parameters obtained by the detection nodes of the first node type in the production process of detecting the instrument;
and the instrument detection parameters are used for recording instrument parameters obtained by the detection nodes of the second node type in the process of detecting the instrument in the laboratory.
Preferably, the management node further includes a second difference module, where the second difference module is connected to the correction module and the first difference module, and is configured to correct the instrument production parameter and the instrument detection parameter by using the correction coefficient to obtain the corrected instrument production parameter and the corrected instrument detection parameter, calculate a first difference between the instrument production parameter and the average value, and a second difference between the instrument detection parameter and the average value according to an average value of the instrument parameters, and determine the first difference and the second difference to obtain a second determination result, and output the second determination result to the detection node.
Preferably, the instrument production parameter comprises a test calibration of the instrument.
Preferably, the instrument detection parameter comprises an actual detection value of the instrument.
Preferably, the detection node encrypts the instrument parameter by using a preset encryption mode, and outputs the encrypted instrument parameter.
Preferably, the management node encrypts the correction coefficient by using a preset encryption method, and outputs the encrypted correction coefficient.
Preferably, the preset encryption mode is a symmetric encryption mode.
The beneficial effects of the above technical scheme are: the constructed medical instrument performance quality management system can effectively solve various existing non-specifications in the field of medical detection medical instruments and equipment, safely and efficiently monitor the performance and quality of the medical detection medical instruments and equipment, and realize real-time data storage, risk analysis and feedback and data encryption protection.
Drawings
FIG. 1 is a schematic diagram of a medical instrument performance quality management system in a preferred embodiment of the present invention;
FIG. 2 is a schematic structural diagram of a management node in a preferred embodiment of the present invention;
FIG. 3 is a schematic diagram of a first difference module according to a preferred embodiment of the present invention;
fig. 4 is a schematic structural diagram of a second difference module in a preferred embodiment of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that the embodiments and features of the embodiments of the present invention may be combined with each other without conflict.
A medical instrument performance quality management system based on a block chain technology is used for detecting the performance of a plurality of medical instruments, and comprises a plurality of detection nodes 1 of different types as shown in figure 1, wherein the detection nodes 1 are used for collecting instrument parameters detected by different detection items of the medical instruments in the whole process of production, transportation and use, and the instrument parameters are related to the types of the detection items in the detection nodes 1;
the medical instrument performance quality management system further comprises a management node 2, the management node 2 and the corresponding detection nodes 1 are integrated to form a network, and the management node 2 comprises:
the storage module 21 is connected with the detection nodes 1 and used for receiving instrument parameters output by all the detection nodes 1;
the classification module 22 is connected with the storage module 21 and is used for classifying all instrument parameters according to the detection project models to obtain and output a plurality of instrument parameter sets;
and the correcting module 23 is connected with the classifying module 22 and is used for receiving the instrument parameter set, correcting all instrument parameters in the instrument parameter set to obtain a correction coefficient corresponding to the instrument parameters, and outputting the correction coefficient to the detection node 1.
Specifically, different manufacturers adopt different production processes, medical instrument tools, measurement standards, and the like to produce medical instruments, so that the set instrument parameters, instrument accuracy, and sensitivity of the finally shipped medical instruments are not completely the same. If the operator uses the medical instruments to perform item detection, the instrument parameters of the detection items are not completely the same, and the judgment of the detection result of the user using the detection items of different instrument parameters may affect the physical performance of the user. Even the same medical instrument may be detected in a detection center with a qualified detection result, or in a detection center with an unqualified detection result.
Therefore, the invention adopts a plurality of detection nodes 1 to measure the instrument parameter performance of the medical instrument, the instrument parameter is related to the manufacturer of the medical instrument, the detection node 1 outputs the instrument parameter to the management node 2, the management node 2 corrects the instrument parameter to obtain a correction coefficient and feeds the correction coefficient back to the corresponding detection node 1, and an operator correspondingly adjusts the production of the medical instrument according to the judgment result received by the detection node 1.
Further, the management node 2 can also perform analysis according to the instrument parameters of the medical instruments of different manufacturers sent by the detection node 1 to generate a performance difference analysis result of the medical instrument, and construct a uniform performance difference analysis standard according to a performance difference analysis structure.
Further, when the correction module processes the instrument parameters, a standard value can be set, the ratio between the instrument parameters and the standard value is calculated to obtain a final correction coefficient, when the standard value is set, all instrument parameters of the classification module can be selected for analysis and comprehensive analysis to obtain the standard value, and the instrument parameters of a medical instrument of a manufacturer can be preset as the standard value.
In a preferred embodiment of the present invention, the management node 2 further includes a first difference module 24, the first difference module 24 is preset with a plurality of difference intervals, the first difference module 24 is connected to the correction module, and is configured to correct all instrument parameters by using the correction coefficient, obtain corrected instrument parameters and obtain an average value of the instrument parameters, calculate the average value and the instrument parameters to obtain a difference value, determine the difference value according to the difference interval to obtain a first determination result, and output the first determination result to the detection node 1.
Specifically, a first difference module 24 is arranged in the management node 2, the correction coefficient has a corresponding relationship with the medical instrument and the detection item model, after the correction module processes the correction coefficients corresponding to all the instrument parameters in the instrument parameter set, the first difference module 24 corrects the instrument parameters according to the correction coefficients to obtain corrected instrument parameters, the instrument parameters in the instrument parameter set at the moment have a uniform numerical standard, a plurality of difference sections are preset in the first difference module 24, the average value in the instrument parameter set at the moment is calculated, the average value and each instrument parameter are calculated to obtain difference values, the difference sections corresponding to different difference values are different, the calculated difference values are compared and judged with the difference sections, and then the first judgment result of the difference section corresponding to the instrument parameter can be obtained, if the grade of the differential interval is too high in the first judgment result, the instrument parameter of the medical instrument has serious deviation, the first judgment result is sent to the detection node 1, a worker who performs medical instrument detection at the detection node 1 can be warned, after receiving the first judgment result, the worker can analyze the detection process of the detection node 1, whether factors influencing the detection result change during detection, namely, operation and error are not performed according to the specification, so that the correctness of the instrument detection parameter is improved, and the condition that continuous deviation occurs in the subsequent judgment process due to operation errors is avoided.
Further, risk level and risk prompt information rules are set in the first difference module 24, and comprehensive analysis of the performance of different medical instruments and equipment can be performed through data sharing at the management node.
In a preferred embodiment of the invention, the types of instrument parameters include:
the instrument production parameters are used for recording instrument parameters obtained by the detection node 1 of the first node type in the production process of detecting the medical instrument;
and the instrument detection parameters are used for recording instrument parameters obtained by the detection node 1 of the second node type in the process of detecting the medical instrument in the laboratory.
Specifically, the medical instruments may include various instruments for detecting patient specimens, medical detection items for containing injections and swallows of patients, and the like, and here, for the medical instruments producing the detection items, the detection node 1 may detect instrument production parameters and instrument detection parameters of the medical instruments for determining performance conditions of the medical instruments.
Furthermore, the detection node 1 of the first node type obtains instrument production parameters in the production process of detecting the medical instrument, the detection node 1 of the second node type obtains instrument detection parameters in the laboratory detection process of detecting the medical instrument, quality control products can be obtained in the detection process of detecting the medical instrument, and performance parameters obtained in the production work of the medical instrument and actual parameters of the quality control products are compared and analyzed, so that the instrument production parameters and the instrument detection parameters of the medical instrument are obtained.
In a preferred embodiment of the present invention, the management node 2 further includes a second difference module 25, where the second difference module 25 is connected to the correction module and the first difference module 24, respectively, and is configured to correct the instrument production parameter and the instrument detection parameter by using the correction coefficient to obtain the corrected instrument production parameter and the corrected instrument detection parameter, calculate a first difference between the instrument production parameter and the average value, and a second difference between the instrument detection parameter and the average value according to an average value of the instrument parameters, determine the first difference and the second difference to obtain a second determination result, and output the second determination result to the detection node 1.
In particular, considering that there are a plurality of different types of test nodes 1 in the performance management system, it is common to distinguish between a first node type for testing in production and a second node type for testing in a laboratory, which may be subject to deviation due to operator's operating specifications, environmental factors, test errors, etc. Therefore, the second difference module 25 is arranged, the difference between the instrument production parameter and the average value and between the instrument detection parameter and the average value are calculated by correcting the instrument production parameter and the instrument detection parameter, and the first difference and the second difference are analyzed, so that the reason for the deviation of the medical instrument can be found.
Further, in the process of analyzing the first difference and the second difference, a system risk level and a risk prompt information rule of the performance of the medical instrument device can be set, and the quality control problem of the medical instrument in the production design and the installation and debugging process can be solved by using the second difference module 25.
In a preferred embodiment of the present invention, the instrument production parameters include a test calibration of the medical instrument.
In a preferred embodiment of the present invention, the instrument test parameter comprises an actual test value of the medical instrument.
In a preferred embodiment of the present invention, the detection node 1 encrypts the instrument parameters by using a preset encryption method, and outputs the encrypted instrument parameters.
In a preferred embodiment of the present invention, the management node 2 encrypts the correction coefficient by using a preset encryption method, and outputs the encrypted correction coefficient.
In a preferred embodiment of the present invention, the first encryption scheme is a symmetric encryption scheme.
Specifically, in order to ensure that the medical instrument performance quality management system can realize data confidentiality of detected instrument parameters and judgment results while monitoring the medical instrument in a full-flow real-time manner, the detection node 1 sends the encrypted instrument parameters to the management node 2 through an encryption key of an encryption scheme, the management node 2 decrypts and judges the instrument parameters through a decryption key of the encryption scheme to obtain correction coefficients, and then the correction coefficients are sent to the detection node 1 through encryption.
Further, in consideration of encryption and decryption between the detection node 1 and the management node 2, symmetric encryption is selected here as the encryption scheme. For example, when a detection party is used as the detection node 1 of the first node type and the detected instrument parameter is output to the management node 2, the instrument parameter is encrypted by using a symmetric encryption scheme and the encrypted instrument parameter is output to the management node 2.
Further, in order to ensure the stability of the instrument parameters and the judgment results in the transmission process, the encrypted instrument parameters are sent to the management node 2 at the detection node 1, and the encrypted correction coefficients are sent to the detection node 1 by the management node 2 in a transaction mode, when the instrument parameters are sent to the management node 2 by the detection node 1 through the transaction, the management node 2 produces a corresponding transaction value and feeds the transaction value back to the detection node 1; when the management node 2 sends the judgment result to the detection node 1 through the transaction, the detection node 1 will produce a corresponding transaction value and feed back to the management node 2.
Further, in order to ensure the stability of the management node 2 in the process of receiving the instrument parameters, in the process of receiving the instrument parameters by the management node 2, the encrypted instrument parameters are subjected to hash operation by using a hash function to generate a hash tree of a data structure of a binary tree, and the attack resistance of the hash function determines that the transmitted instrument parameters can resist malicious attack and tampering, so that a detection result that a foreign person can obtain and tamper the medical instrument is avoided.
Furthermore, the detection nodes can detect medical instruments of the same manufacturer and different manufacturers, the application management nodes can perform whole-process quality data classification analysis on the medical instruments from production to application and transmit the data to the set detection nodes in an encryption feedback mode, and the detection nodes can output results to manufacturers and/or applicators and timely acquire the operating conditions and operating results of the performance and quality management system of the medical instruments.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention.

Claims (10)

1. A medical instrument performance quality management system based on a block chain technology is used for detecting the performance of a plurality of medical instruments and is characterized by comprising a plurality of detection nodes of different types, wherein the detection nodes are used for collecting instrument parameters obtained by detection of different detection items of the medical instruments in the whole process of production, transportation and use, and the instrument parameters are related to the types of the detection items in the detection nodes;
the instrument performance quality management system also comprises a management node, the management node is integrated with a plurality of corresponding detection nodes to form a network, and the management node comprises:
the storage module is connected with the detection nodes and used for receiving the instrument parameters output by all the detection nodes;
the classification module is connected with the storage module and used for classifying all the instrument parameters according to the detection project models to obtain and output a plurality of instrument parameter sets;
and the correction module is connected with the classification module and used for receiving the instrument parameter set, correcting all instrument parameters in the instrument parameter set to obtain correction coefficients corresponding to the instrument parameters and outputting the correction coefficients to the detection node.
2. The system according to claim 1, wherein a standard value is preset in the correction module, and a ratio between all the instrument parameters and the standard value is obtained, and the ratio is outputted to the detection node as the correction coefficient.
3. The system according to claim 1, wherein the management node further includes a first difference module, the first difference module is preset with a plurality of difference segments, and the first difference module is connected to the correction module, and configured to correct all the instrument parameters by using the correction coefficient to obtain an average value of the instrument parameters, calculate the average value and the instrument parameters to obtain a difference value, and judge the difference value according to the difference segment to obtain a first judgment result, and output the first judgment result to the detection node.
4. The system of claim 1, wherein the types of instrument parameters comprise:
the instrument production parameters are used for recording instrument parameters obtained by the detection nodes of the first node type in the production process of detecting the instrument;
and the instrument detection parameters are used for recording instrument parameters obtained by the detection nodes of the second node type in the process of detecting the instrument in the laboratory.
5. The system according to claim 4, wherein the management node further includes a second difference module, and the second difference module is connected to the correction module and the first difference module, respectively, and configured to correct the instrument production parameter and the instrument detection parameter by using the correction coefficient to obtain the corrected instrument production parameter and the corrected instrument detection parameter, calculate a first difference between the instrument production parameter and the average value, and a second difference between the instrument detection parameter and the average value according to an average value of the instrument parameters, and determine the first difference and the second difference to obtain a second determination result, and output the second determination result to the detection node.
6. The system of claim 4, wherein the instrument production parameters comprise a measurement calibration of the instrument.
7. The system of claim 4, wherein the instrument detection parameter comprises an actual detection value of the instrument.
8. The system according to claim 1, wherein the detection node encrypts the instrument parameters by a predetermined encryption method and outputs the encrypted instrument parameters.
9. The system according to claim 1, wherein the management node encrypts the correction coefficient by a predetermined encryption method and outputs the encrypted correction coefficient.
10. The system for performance quality management of medical instruments based on block chain technology as claimed in claim 8 or 9, wherein the predetermined encryption scheme is a symmetric encryption scheme.
CN202010444172.3A 2020-05-22 2020-05-22 Medical instrument performance quality management system based on block chain technology Pending CN112000068A (en)

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