CN113032998A - Medical instrument life evaluation method and device - Google Patents
Medical instrument life evaluation method and device Download PDFInfo
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Abstract
The invention provides a method and a device for evaluating the service life of a medical instrument, wherein the method comprises the following steps: determining evaluation parameters of the medical instrument to be evaluated; wherein different types of medical instruments correspond to different evaluation parameters; determining at least two groups of acceleration stress parameters according to the evaluation parameters and the medical instrument to be evaluated; acquiring performance data of the evaluation parameters within preset test time; the performance data is obtained by testing the medical instrument to be evaluated by utilizing at least two groups of accelerated stress parameters under the preset testing time; analyzing the performance data to obtain degradation data corresponding to the medical instrument to be evaluated; constructing a degradation model of the medical instrument to be evaluated by using the degradation data and the preset test time; and obtaining the expected life of the medical instrument to be evaluated according to the degradation model and the preset test time. The scheme can improve the service life evaluation efficiency of the medical instrument.
Description
Technical Field
The invention relates to the technical field of reliability detection, in particular to a method and a device for evaluating the service life of medical equipment.
Background
In the field of medical devices, standards and requirements for products are very strict, and life tests are required for each type of medical device. However, as the length of use and the number of uses of medical devices increase, the performance of the products gradually degrade. In the conventional reliability test process, the degradation process is slow, and degradation data cannot be acquired within a short time, so that the test period for performing the life test is long, and the test efficiency is low.
Disclosure of Invention
The embodiment of the invention provides a method and a device for evaluating the service life of a medical instrument, which can improve the service life evaluation efficiency of the medical instrument.
In a first aspect, the present invention provides a method for assessing the lifetime of a medical device, comprising:
determining evaluation parameters of the medical instrument to be evaluated; wherein different types of medical instruments correspond to different evaluation parameters;
determining at least two groups of acceleration stress parameters according to the evaluation parameters and the medical instrument to be evaluated;
acquiring performance data of the evaluation parameters within preset test time; the performance data is obtained by testing the medical instrument to be evaluated by utilizing the at least two groups of acceleration stress parameters in the preset testing time;
analyzing the performance data to obtain degradation data corresponding to the medical instrument to be evaluated;
constructing a degradation model of the medical instrument to be evaluated by using the degradation data and the preset test time;
and obtaining the expected life of the corresponding medical instrument to be evaluated according to the degradation model and the preset test time.
Optionally, the preset test time includes at least three test time points arranged according to a time sequence;
analyzing the performance data to obtain degradation data corresponding to the medical instrument to be evaluated comprises:
for each test time point, performing:
determining the number of the performance data exceeding a preset threshold range in the performance data;
determining a ratio of the number and the number of medical devices to be evaluated and determining the ratio as degradation data corresponding to the test time point.
Optionally, the constructing a degradation model of the medical device to be evaluated by using the degradation data and the preset test time includes:
for each set of acceleration stress parameters, performing:
performing acceleration operation on the set of acceleration stress parameters by using a Hallberg-Peck model to obtain acceleration factors corresponding to the set of acceleration stress parameters;
determining standard test time under corresponding normal stress parameters according to the acceleration factor and the preset test time; the standard test time is obtained by multiplying the acceleration factor by the preset test time;
according to the preset test time, combining the degradation data corresponding to the set of acceleration stress parameters with the standard test time;
constructing a degradation model from the combined degradation data and the standard test time.
Optionally, the constructing a degradation model according to the combined degradation data and the standard test time includes:
carrying out logarithm operation on the standard test time to obtain an independent variable;
determining corresponding reliability data according to the degradation data, and sequentially performing reciprocal operation, logarithm operation and logarithm operation on the reliability data to obtain a dependent variable;
determining corresponding independent variables and dependent variables according to the combined degradation data and the standard test time;
performing linear fitting on the corresponding independent variable and dependent variable to obtain a target linear relation; wherein the target linear relationship comprises an intercept and a slope;
using the slope as a shape parameter of the degradation model;
determining a size parameter of the degradation model according to the slope and the intercept;
determining the degradation model according to the shape parameter and the size parameter.
Optionally, the obtaining the expected life of the medical device to be evaluated according to the degradation model and the preset test time includes:
for each set of acceleration stress parameters, performing:
determining shape parameters and scale parameters according to the degradation model corresponding to the set of acceleration stress parameters; wherein the shape parameter and the scale parameter are two parameters in the degradation model;
determining the average failure life according to the shape parameter, the scale parameter and a preset failure threshold corresponding to the medical instrument to be evaluated;
determining the weight of the at least two groups of acceleration stress parameters according to the normal stress range of the medical instrument to be evaluated;
determining the expected life of the medical instrument to be evaluated according to the weight corresponding to each group of accelerated stress parameters and the determined average failure life;
wherein the average failure life is calculated according to the following formula:
wherein, tiFor characterizing the average failure life determined at the i set of accelerated stress parameters; etaiScale parameters for characterizing a degradation model corresponding to the i-th set of acceleration stress parameters; beta is aiCharacterizing shape parameters of a degradation model corresponding to the i-th set of acceleration stress parameters; p is used for representing a preset failure threshold corresponding to the medical instrument to be evaluated.
Optionally, each set of acceleration stress parameters includes at least two stress parameters;
determining the weights of the at least two groups of acceleration stress parameters according to the normal stress range of the medical instrument to be evaluated comprises the following steps:
for each set of acceleration stress parameters, performing:
acquiring a normal stress parameter and a limit stress parameter of the medical instrument to be evaluated; wherein the normal stress parameter and the extreme stress parameter each include the same at least two stress parameters as in the acceleration stress parameter;
determining the proportion of each stress parameter in the set of accelerated stress parameters according to the set of accelerated stress parameters, the ultimate stress parameters and the normal stress parameters;
and determining the weight of the set of acceleration stress parameters according to the specific gravity of each stress parameter.
Optionally, after obtaining the expected lifetime of the medical device to be evaluated, the method further includes:
acquiring the current use time of the target medical instrument; wherein the target medical instrument and the medical instrument to be evaluated are the same type of medical instrument;
performing difference operation on the obtained expected life and the current service time to obtain the remaining service life of the target medical instrument;
determining identification information of the target medical instrument according to the residual service life; wherein the identification information is used to identify a current maintenance strategy of the target medical instrument.
In a second aspect, the present invention provides a medical device life assessment apparatus, comprising:
the parameter determination module is used for determining the evaluation parameters of the medical instrument to be evaluated and determining at least two groups of acceleration stress parameters according to the evaluation parameters and the medical instrument to be evaluated; wherein different types of medical instruments correspond to different evaluation parameters;
the acquisition module is used for acquiring the performance data of the evaluation parameters determined by the parameter determination module within preset test time; the performance data is obtained by testing the medical instrument to be evaluated by utilizing the at least two groups of acceleration stress parameters in the preset testing time;
the processing module is used for analyzing the performance data acquired by the acquisition module to acquire degradation data corresponding to the medical instrument to be evaluated;
the construction module is used for constructing a degradation model of the medical instrument to be evaluated by utilizing the degradation data obtained by the analysis of the processing module and the preset test time;
and the life determining module is used for obtaining the expected life of the medical instrument to be evaluated according to the degradation model constructed by the construction module and the preset test time.
In a third aspect, an embodiment of the present invention provides a medical instrument life evaluation apparatus, including: at least one memory and at least one processor;
the at least one memory to store a machine readable program;
the at least one processor is configured to invoke the machine-readable program to perform the method according to the first aspect or any possible implementation manner of the first aspect.
In a fourth aspect, an embodiment of the present invention provides a computer-readable medium, on which computer instructions are stored, and when executed by a processor, the computer instructions cause the processor to perform the method provided by the first aspect or any possible implementation manner of the first aspect.
The invention provides a method and a device for evaluating the service life of a medical instrument, wherein the method comprises the steps of determining evaluation parameters of the medical instrument to be evaluated, determining at least two groups of acceleration stress parameters of the medical instrument to be evaluated according to the evaluation parameters, obtaining performance data of the evaluation parameters obtained by testing the medical instrument to be evaluated at preset testing time by using the acceleration stress parameters, analyzing the performance data to obtain degradation data, constructing a degradation model based on the degradation data and the preset testing time, and obtaining the expected service life of the medical instrument to be evaluated through the degradation model and the preset testing time. Therefore, based on the medical instrument service life evaluation method, the evaluation parameters and the acceleration stress parameters which are required to be determined for testing the medical instrument to be evaluated can be automatically obtained, the performance data of the evaluation parameters obtained by testing can be obtained after the testing is finished, and the expected service life of the medical instrument to be evaluated can be calculated by constructing the degradation model by utilizing the performance data. Therefore, the actual life test conditions are optimized by using the accelerated stress parameters, the test time is reduced, the expected life of the corresponding medical instrument can be quickly evaluated, the accuracy of the expected life is ensured by establishing the degradation model, and the life evaluation efficiency of the medical instrument can be improved.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.
FIG. 1 is a flow chart of a method for assessing the longevity of a medical device according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of an apparatus for evaluating the lifetime of a medical device according to an embodiment of the present invention;
FIG. 3 is a schematic diagram of a medical device life assessment apparatus according to an embodiment of the present invention;
fig. 4 is a flowchart of another method for assessing the lifespan of a medical device according to an embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer and more complete, the technical solutions in the embodiments of the present invention will be described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention, and based on the embodiments of the present invention, all other embodiments obtained by a person of ordinary skill in the art without creative efforts belong to the scope of the present invention.
As shown in fig. 1, an embodiment of the present invention provides a method for evaluating the lifespan of a medical device, which may include the following steps:
step 101: determining evaluation parameters of the medical instrument to be evaluated; wherein different types of medical instruments correspond to different evaluation parameters;
step 102: determining at least two groups of acceleration stress parameters according to the evaluation parameters and the medical instrument to be evaluated;
step 103: acquiring performance data of the evaluation parameters within preset test time; the performance data is obtained by testing the medical instrument to be evaluated by utilizing at least two groups of accelerated stress parameters under the preset testing time;
step 104: analyzing the performance data to obtain degradation data corresponding to the medical instrument to be evaluated;
step 105: constructing a degradation model of the medical instrument to be evaluated by using the degradation data and the preset test time;
step 106: and obtaining the expected life of the medical instrument to be evaluated according to the degradation model and the preset test time.
The embodiment of the invention provides a medical instrument service life evaluation method, which comprises the steps of determining evaluation parameters of a medical instrument to be evaluated so as to determine at least two groups of acceleration stress parameters of the medical instrument to be evaluated, obtaining performance data of the evaluation parameters obtained by testing the medical instrument to be evaluated at preset test time by using the acceleration stress parameters, analyzing the performance data to obtain degradation data, constructing a degradation model based on the degradation data and the preset test time, and obtaining the expected service life of the medical instrument to be evaluated through the degradation model and the preset test time. Therefore, based on the medical instrument service life evaluation method, the evaluation parameters and the acceleration stress parameters which are required to be determined for testing the medical instrument to be evaluated can be automatically obtained, the performance data of the evaluation parameters obtained by testing can be obtained after the testing is finished, and the expected service life of the medical instrument to be evaluated can be calculated by constructing the degradation model by utilizing the performance data. Therefore, the actual life test conditions are optimized by using the accelerated stress parameters, the test time is reduced, the expected life of the corresponding medical instrument can be quickly evaluated, the accuracy of the expected life is ensured by establishing the degradation model, and the life evaluation efficiency of the medical instrument can be improved.
In the embodiment of the invention, the life characteristic under the normal stress level is extrapolated by using the life characteristic under the high stress through the accelerated stress parameter, so that the simulation optimization of the life test scheme is realized, the test time is reduced, the test precision is increased, and the cost-effectiveness ratio of the test is improved.
In the embodiment of the present invention, in step 101, different types of medical instruments correspond to different evaluation parameters, and the corresponding relationships thereof are stored in a preset table, so that the corresponding evaluation parameters can be determined according to the types of the medical instruments to be evaluated. The evaluation parameter is a characteristic life parameter used for representing whether the medical instrument to be evaluated fails, when the performance data corresponding to the evaluation parameter exceeds a preset threshold range, the medical instrument is judged to fail, and the corresponding running time is the real life of the medical instrument. For example, the assessed parameter of a cardiopulmonary resuscitation machine is tidal volume; the evaluation parameter of the infusion pump is the infusion speed.
In an embodiment of the present invention, step 102 may determine at least two sets of acceleration stress parameters based on the evaluation parameters and the corresponding normal stress range and the limit stress range of the medical device to be evaluated. Wherein the ultimate stress range may be obtained directly from the specifications of the medical device to be evaluated, and may be obtained by the HALT test; determining multiple groups of acceleration stress parameters by determining a difference value between the limit stress range and the normal stress range, and determining at least two combinations comprising at least two groups of acceleration stress parameters by performing a model experiment on the multiple groups of acceleration stress parameters, wherein the preset test time corresponding to each combination is different. It should be noted that the at least two sets of acceleration stress parameters determined in step 102 are different according to the default settings of the user (i.e., different preset test times). Therefore, different acceleration stress parameters can be flexibly selected according to preset test time, better experience is provided for users, and meanwhile, the precision of the expected service life can be improved based on multiple groups of acceleration stress parameters.
Optionally, in the method for evaluating the life of a medical device shown in fig. 1, the preset test time includes at least three test time points arranged in time sequence;
for each test time point, performing:
determining the number of the performance data exceeding the preset threshold range in the performance data;
a ratio of the number and the number of medical instruments to be evaluated is determined and determined as degradation data corresponding to the test time point.
It should be noted that, in order to obtain a more accurate expected lifetime, the test time is preset as a time sequence including at least three test time points arranged in time sequence. For example, the preset test time is 12h, 24h, 36h, 48h, 60h, 72h, 84 h.
In the embodiment of the invention, each group of acceleration stress parameters is used for testing the medical instrument to be evaluated at each testing time point, so that the performance data of the medical instrument to be evaluated at each testing time point can be obtained. Corresponding to each set of acceleration stress parameters, aiming at the obtained performance data of each test time point, firstly determining the number of the performance data exceeding the preset threshold range in the performance data, namely determining the number of the failed medical instruments, and determining the ratio as the degradation data of the test time point by calculating the ratio of the number of the failures and the number of the medical instruments to be evaluated participating in the set of acceleration stress parameters. In particular, the degradation data is used to characterize the probability of the medical instrument failing at the test time point.
Optionally, in the method for evaluating the life of a medical device shown in fig. 1, step 105 constructs a degradation model of the medical device to be evaluated by using the degradation data and the preset test time, where the method includes:
for each set of acceleration stress parameters, performing:
performing acceleration operation on the set of acceleration stress parameters by using a Hallberg-Peck model to obtain acceleration factors corresponding to the set of acceleration stress parameters;
determining standard test time under corresponding normal stress parameters according to the acceleration factor and preset test time; the standard test time is obtained by multiplying an acceleration factor by preset test time;
according to the preset test time, combining the degradation data corresponding to the set of acceleration stress parameters with the standard test time;
a degradation model is constructed from the combined degradation data and standard test time.
In the embodiment of the present invention, it should be noted that each set of accelerated stress parameters at least includes two stress parameters, namely temperature and humidity; the Hallberg-Peck model can more accurately describe the accelerated life test performed under the temperature and humidity conditions, wherein the calculation formula of the acceleration factor is as follows:
wherein A isFAn acceleration factor for characterizing the set of acceleration stress parameters; hsA value for characterizing the relative humidity included in the set of acceleration stress parameters; h0A value for characterizing the relative humidity included in the corresponding normal stress parameter; ea is used to characterize the activation energy; k is used for representing Boltzmann constant; t issA value for characterizing a temperature included in the set of acceleration stress parameters; t is0For characterizing the value of the temperature included in the corresponding normal stress parameter.
In the embodiment of the present invention, the normal stress parameter is a parameter generally used for the medical device to be evaluated, and is a fixed value. After the Hallberg-Peck model is used for calculating the acceleration factor corresponding to the set of acceleration stress parameters, multiplication operation can be carried out on the acceleration factor and the preset test time to obtain standard test time, the standard test time is equivalent test time for testing the medical instrument to be tested under the normal stress parameters, then degradation data corresponding to the same preset test time and the standard test time are combined respectively, and the degradation model is constructed by using the combined data. Therefore, the change rule of the degradation data along with the standard test time can be intuitively determined based on the degradation model, and the change rule of the degradation data along with the test time is also equivalent to the change rule of the degradation data along with the test time obtained in the normal stress parameter test, so that the expected life of the medical instrument to be evaluated can be more accurately determined through the degradation model.
For example, as described in the previous example, if the preset test time is 12h, 24h, 36h, 48h, 60h, 72h, 84h, the standard test time corresponding to the set of acceleration stress parameters is 12AFh、24AFh、36AFh、48AFh、60AFh、72AFh、84AFh。
Optionally, in the method for evaluating the lifetime of a medical device shown in fig. 1, constructing a degradation model according to the combined degradation data and standard test time includes:
carrying out logarithm operation on the standard test time to obtain an independent variable;
determining corresponding reliability data according to the degraded data, and sequentially performing reciprocal operation, logarithm operation and logarithm operation on the reliability data to obtain a dependent variable;
determining corresponding independent variables and dependent variables according to the combined degradation data and the standard test time;
performing linear fitting on the corresponding independent variable and dependent variable to obtain a target linear relation; wherein, the target linear relation comprises intercept and slope;
taking the slope as a shape parameter of the degradation model;
determining a size parameter of the degradation model according to the slope and the intercept;
and determining a degradation model according to the shape parameter and the size parameter.
It should be noted that each set of acceleration stress parameters corresponds to a degradation model.
In the embodiment of the invention, in order to simplify the complex relation between the degradation data in the degradation model and the standard test time, the shape parameters and the size parameters in the degradation model are determined, so that the degradation model is converted into a simple linear model, the processing process is simplified, and the shape parameters and the size parameters can be acquired more accurately and quickly.
In the embodiment of the invention, firstly, logarithm operation is carried out on standard test time to obtain the independent variable of a linear model; secondly, the degraded data is operated to obtain a dependent variable of the linear model; and according to the original combined degradation data and standard test time, combining the converted independent variable and dependent variable to construct data points in the linear model, performing linear fitting on the obtained data points to obtain a target linear relation between the independent variable and the dependent variable, determining an intercept and a slope from the determined target linear relation, wherein the slope is the shape parameter of the corresponding degradation model, and further operating according to the slope and the intercept to determine the size parameter of the corresponding degradation model.
In particular, the degradation data is used to characterize the probability of failure of the medical instrument at the test time point, the probability of failure plus the reliability being 1. The intercept value is equal to the negative of the product of the dimension parameter and the slope after the logarithm operation is carried out.
Optionally, in the method for evaluating the life of a medical device shown in fig. 1, the step 106 of obtaining the expected life of the medical device to be evaluated according to the degradation model and the preset test time includes:
for each set of acceleration stress parameters, performing:
determining shape parameters and scale parameters according to the degradation model corresponding to the set of acceleration stress parameters; wherein the shape parameter and the scale parameter are two parameters in the degradation model;
determining the average failure life according to the shape parameters, the scale parameters and the preset failure threshold corresponding to the medical instrument to be evaluated;
determining the weight of at least two groups of acceleration stress parameters according to the normal stress range of the medical instrument to be evaluated;
determining the expected life of the medical instrument to be evaluated according to the weight corresponding to each group of accelerated stress parameters and the determined average failure life;
wherein, the calculation formula of the average failure life is as follows:
wherein, tiFor characterizing the average failure life determined at the i set of accelerated stress parameters; etaiScale parameters for characterizing a degradation model corresponding to the i-th set of acceleration stress parameters; beta is aiCharacterizing shape parameters of a degradation model corresponding to the i-th set of acceleration stress parameters; p is used to characterize a preset failure threshold corresponding to the medical device to be evaluated.
It should be noted that the preset failure threshold is an increase rate of a maximum value in a preset threshold range with respect to the initial performance data or a decrease rate of a minimum value in the preset threshold range with respect to the initial performance data, where the increase rate and the decrease rate are both numerically the same. For example, as described in the previous example, for a cardiopulmonary resuscitation machine, the initial performance data corresponding to tidal volume is 444.5mL, wherein the preset threshold range is 444.5 ± 88.9mL, wherein the maximum value of the preset threshold range is 533.4mL (i.e., 444.5+88.9mL), and the minimum value of the preset threshold range is 355.6mL (i.e., 444.5-88.9mL), the increase rate of 533.4mL relative to 444.5mL is 20%, and the decrease rate of 355.6mL relative to 444.5mL is 20%, i.e., the preset failure threshold is 20%.
In the embodiment of the invention, for each set of acceleration stress parameters, the shape parameters and the scale parameters of the degradation model determined by the acceleration stress parameters are determined, and the average failure life under the set of acceleration stress parameters is calculated according to the shape parameters, the scale parameters and the preset failure threshold. And determining the weight of each group of acceleration stress parameters according to the normal stress range of the medical instrument to be evaluated, and comprehensively determining the expected life of the medical instrument to be evaluated according to the average failure life calculated according to each group of acceleration stress parameters and the weight thereof. Therefore, the expected life is calculated based on the weight of each group of acceleration stress parameters, the average failure life calculated by each group of acceleration stress parameters is measured in different degrees, and the average value operation is not performed on all the obtained average failure lives, so that the actual situation is better fitted, and the accuracy of the expected life is improved.
Optionally, in the method for evaluating the lifetime of a medical device shown in fig. 1, each set of accelerated stress parameters includes at least two stress parameters;
determining the weights of at least two groups of acceleration stress parameters according to the normal stress range of the medical instrument to be evaluated, wherein the weights comprise:
for each set of acceleration stress parameters, performing:
acquiring normal stress parameters and limit stress parameters of the medical instrument to be evaluated; the normal stress parameters and the limit stress parameters respectively comprise at least two stress parameters which are the same as those in the acceleration stress parameters;
determining the proportion of each stress parameter in the set of accelerated stress parameters according to the set of accelerated stress parameters, the ultimate stress parameters and the normal stress parameters;
the weight of the set of accelerating stress parameters is determined according to the specific gravity of each stress parameter.
In an embodiment of the present invention, each set of acceleration stress parameters includes at least two stress parameters. For each set of acceleration stress parameters, normal stress parameters of the medical instrument to be evaluated in normal operation are firstly obtained, and the proportion of each stress parameter is determined by comparing the difference value of each stress parameter in the acceleration stress parameters and the stress parameter in the normal stress parameters so as to determine the weight of the set of acceleration stress parameters. Wherein the sum of the weights of at least two stress parameters is 1.
For example, the first set of accelerated stress parameters is temperature 46 ℃ and humidity 66%, the second set of accelerated stress parameters is temperature 50 ℃ and humidity 70%, the normal stress parameters is temperature 25 ℃ and humidity 40%, and the ultimate stress parameters is temperature 55 ℃ and humidity 90%. The temperature is closer to 25 ℃ and the humidity is closer to 40% in the first set of accelerated stress parameters than in the second set of accelerated stress parameters, wherein the corresponding determined weight is larger. The first set of acceleration stress parameters is thus determined to be weighted more heavily than the second set of acceleration stress parameters. Specifically, the difference between the temperature and the limit temperature in the normal stress parameter is 30, and the difference between the humidity and the limit humidity in the normal stress parameter is 50, so that the specific gravity of the temperature in the first set of accelerated stress parameters can be determined to be (55-46)/30, and the same humidity is occupiedThe specific gravity is (90-66)/50, and accordingly, the preliminary weight of the first set of acceleration stress parameters can be determined to be (55-46)/30+ (90-66)/50-0.78; similarly, the preliminary weight for the second set of acceleration stress parameters may be determined to be 0.56; therefore, based on the two preliminary weights, it can be finally determined that the first set of acceleration stress parameters is weighted to 0.58(0.78/0.78+0.56) and the first set of acceleration stress parameters is weighted to 0.42(0.56/0.78+ 0.56). Thus, the expected lifetime of the medical device to be evaluated may be expressed as 0.58t1+0.42t2Wherein, t1Average failure life, t, determined for a first set of acceleration stress parameters2An average failure life determined for the second set of accelerated stress parameters.
Optionally, in the method for evaluating the life of a medical device shown in fig. 1, after obtaining the expected life of the medical device to be evaluated in step 106, the method further includes:
acquiring the current use time of the target medical instrument; wherein the target medical instrument and the medical instrument to be evaluated are the same type of medical instrument;
performing difference operation on the obtained expected service life and the current service time to obtain the remaining service life of the target medical instrument;
determining identification information of the target medical instrument according to the remaining service life; wherein the identification information is used to identify a current maintenance strategy for the target medical instrument.
In the embodiment of the invention, after the expected life of the medical instrument to be evaluated is obtained, the expected life and the currently acquired service time of the target medical instrument can be used for accurately calculating the remaining service life of the target medical instrument, and marking the identification information of the target medical instrument according to the remaining service life so as to arrange the subsequent maintenance of the target medical instrument, monitor the target medical instrument when the service life of the target medical instrument expires in time and the like, so that the identification information is used for realizing more intuitive unified management on the running medical instrument, and the management and maintenance personnel can conveniently carry out regular maintenance in different degrees according to the identification information.
As shown in fig. 2 and 3, an embodiment of the present invention provides a medical instrument life evaluation device. The device embodiments may be implemented by software, or by hardware, or by a combination of hardware and software. From a hardware level, as shown in fig. 2, a hardware structure diagram of a device in which the medical apparatus and device life assessment apparatus according to the embodiment of the present invention is located is provided, where in addition to the processor, the memory, the network interface, and the nonvolatile memory shown in fig. 2, the device in the embodiment may also include other hardware, such as a forwarding chip responsible for processing a message. Taking a software implementation as an example, as shown in fig. 3, as a logical apparatus, the apparatus is formed by reading, by a CPU of a device in which the apparatus is located, corresponding computer program instructions in a non-volatile memory into a memory for execution. The present embodiment provides a medical device life assessment apparatus, including:
the parameter determining module 301 is configured to determine an evaluation parameter of the medical instrument to be evaluated, and determine at least two sets of acceleration stress parameters according to the evaluation parameter and the medical instrument to be evaluated; wherein different types of medical instruments correspond to different evaluation parameters;
an obtaining module 302, configured to obtain performance data of the evaluation parameter determined by the parameter determining module 301 within a preset test time; the performance data is obtained by testing the medical instrument to be evaluated by utilizing at least two groups of accelerated stress parameters under the preset testing time;
a processing module 303, configured to analyze the performance data acquired by the acquisition module 302 to obtain degradation data of the medical instrument to be evaluated;
the construction module 304 is used for constructing a degradation model of the medical instrument to be evaluated by utilizing the degradation data obtained by the analysis of the processing module 303 and the preset test time;
and a life determining module 305, configured to obtain an expected life of the medical device to be evaluated according to the degradation model constructed by the constructing module 304 and a preset testing time.
Optionally, on the basis of the medical device life evaluating apparatus shown in fig. 3, the preset test time includes at least three test time points arranged in time sequence;
the processing module 303 is further configured to perform the following operations:
for each test time point, performing:
determining the number of the performance data exceeding the preset threshold range in the performance data;
a ratio of the number and the number of medical instruments to be evaluated is determined and determined as degradation data corresponding to the test time point.
Optionally, on the basis of the medical device life evaluating apparatus shown in fig. 3, the building module 304 is further configured to perform the following operations:
for each set of acceleration stress parameters, performing:
performing acceleration operation on the set of acceleration stress parameters by using a Hallberg-Peck model to obtain acceleration factors corresponding to the set of acceleration stress parameters;
determining standard test time under corresponding normal stress parameters according to the acceleration factor and preset test time; the standard test time is obtained by multiplying an acceleration factor by preset test time;
according to the preset test time, combining the degradation data corresponding to the set of acceleration stress parameters with the standard test time;
a degradation model is constructed from the combined degradation data and standard test time.
Optionally, on the basis of the medical device life evaluating apparatus shown in fig. 3, the building module 304 is further configured to perform the following operations:
carrying out logarithm operation on the standard test time to obtain an independent variable;
determining corresponding reliability data according to the degraded data, and sequentially performing reciprocal operation, logarithm operation and logarithm operation on the reliability data to obtain a dependent variable;
determining corresponding independent variables and dependent variables according to the combined degradation data and the standard test time;
performing linear fitting on the corresponding independent variable and dependent variable to obtain a target linear relation; wherein, the target linear relation comprises intercept and slope;
taking the slope as a shape parameter of the degradation model;
determining a size parameter of the degradation model according to the slope and the intercept;
and determining a degradation model according to the shape parameter and the size parameter.
Optionally, on the basis of the medical instrument life assessment apparatus shown in fig. 3, the life determination module 305 is further configured to perform the following operations:
for each set of acceleration stress parameters, performing:
determining shape parameters and scale parameters according to the degradation model corresponding to the set of acceleration stress parameters; wherein the shape parameter and the scale parameter are two parameters in the degradation model;
determining the average failure life according to the shape parameters, the scale parameters and the preset failure threshold corresponding to the medical instrument to be evaluated;
determining the weight of at least two groups of acceleration stress parameters according to the normal stress range of the medical instrument to be evaluated;
determining the expected life of the medical instrument to be evaluated according to the weight corresponding to each group of accelerated stress parameters and the determined average failure life;
wherein, the calculation formula of the average failure life is as follows:
wherein, tiFor characterizing the average failure life determined at the i set of accelerated stress parameters; etaiScale parameters for characterizing a degradation model corresponding to the i-th set of acceleration stress parameters; beta is aiCharacterizing shape parameters of a degradation model corresponding to the i-th set of acceleration stress parameters; p is used to characterize a preset failure threshold corresponding to the medical device to be evaluated.
Optionally, on the basis of the medical device life evaluation device shown in fig. 3, each set of accelerated stress parameters includes at least two stress parameters;
the lifetime determination module 305 is further configured to:
for each set of acceleration stress parameters, performing:
acquiring normal stress parameters and limit stress parameters of the medical instrument to be evaluated; the normal stress parameters and the limit stress parameters respectively comprise at least two stress parameters which are the same as those in the acceleration stress parameters;
determining the proportion of each stress parameter in the set of accelerated stress parameters according to the set of accelerated stress parameters, the ultimate stress parameters and the normal stress parameters;
the weight of the set of accelerating stress parameters is determined according to the specific gravity of each stress parameter.
Optionally, on the basis of the medical device life assessment apparatus shown in fig. 3, the apparatus further comprises: an identity determination module to:
acquiring the current use time of the target medical instrument; wherein the target medical instrument and the medical instrument to be evaluated are the same type of medical instrument;
performing difference operation on the obtained expected service life and the current service time to obtain the remaining service life of the target medical instrument;
determining identification information of the target medical instrument according to the remaining service life; wherein the identification information is used to identify a current maintenance strategy for the target medical instrument.
Because the content of information interaction, execution process, and the like among the modules in the device is based on the same concept as the method embodiment of the present invention, specific content can be referred to the description in the method embodiment of the present invention, and is not described herein again.
In order to more clearly illustrate the technical solution and advantages of the present invention, as shown in fig. 4, the following detailed description of the method for evaluating the lifetime of a medical device provided by the embodiment of the present invention specifically includes:
step 401: and determining an evaluation parameter and an acceleration stress parameter of the medical instrument to be evaluated.
Specifically, determining an evaluation parameter of a medical instrument to be evaluated; determining at least two groups of acceleration stress parameters according to the evaluation parameters and the medical instrument to be evaluated; wherein different types of medical instruments correspond to different evaluation parameters; at least two stress parameters are included in each set of acceleration stress parameters.
Step 402: and acquiring performance data of the evaluation parameters within preset test time.
Specifically, the performance data is obtained by testing the medical instrument to be evaluated by using at least two groups of acceleration stress parameters under the preset test time.
Step 403: degradation data corresponding to the medical instrument to be evaluated is obtained.
Specifically, the preset test time includes at least three test time points arranged according to a time sequence;
for each test time point, performing:
determining the number of the performance data exceeding the preset threshold range in the performance data;
a ratio of the number and the number of medical instruments to be evaluated is determined and determined as degradation data corresponding to the test time point.
Step 404: and constructing a degradation model.
Specifically, for each set of acceleration stress parameters, the following is performed:
performing acceleration operation on the set of acceleration stress parameters by using a Hallberg-Peck model to obtain acceleration factors corresponding to the set of acceleration stress parameters;
determining standard test time under corresponding normal stress parameters according to the acceleration factor and preset test time; the standard test time is obtained by multiplying an acceleration factor by preset test time;
according to the preset test time, combining the degradation data corresponding to the set of acceleration stress parameters with the standard test time;
constructing a degradation model from the combined degradation data and standard test time, comprising:
carrying out logarithm operation on the standard test time to obtain an independent variable;
determining corresponding reliability data according to the degraded data, and sequentially performing reciprocal operation, logarithm operation and logarithm operation on the reliability data to obtain a dependent variable;
determining corresponding independent variables and dependent variables according to the combined degradation data and the standard test time;
performing linear fitting on the corresponding independent variable and dependent variable to obtain a target linear relation; wherein, the target linear relation comprises intercept and slope;
taking the slope as a shape parameter of the degradation model;
determining a size parameter of the degradation model according to the slope and the intercept;
and determining a degradation model according to the shape parameter and the size parameter.
Step 405: the expected life of the medical device to be evaluated is obtained.
Specifically, for each set of acceleration stress parameters, the following is performed:
determining shape parameters and scale parameters according to the degradation model corresponding to the set of acceleration stress parameters; wherein the shape parameter and the scale parameter are two parameters in the degradation model;
determining the average failure life according to the shape parameters, the scale parameters and the preset failure threshold corresponding to the medical instrument to be evaluated;
determining the weights of at least two groups of acceleration stress parameters according to the normal stress range of the medical instrument to be evaluated, wherein the weights comprise:
a1, for each set of acceleration stress parameters, performing: acquiring normal stress parameters and limit stress parameters of the medical instrument to be evaluated; each group of acceleration stress parameters comprises at least two stress parameters, and the normal stress parameters and the limit stress parameters comprise at least two stress parameters which are the same as those in the acceleration stress parameters;
a2, determining the proportion of each stress parameter in the set of acceleration stress parameters according to the set of acceleration stress parameters, the limit stress parameters and the normal stress parameters;
a3, determining the weight of the set of acceleration stress parameters according to the proportion of each stress parameter;
determining the expected life of the medical instrument to be evaluated according to the weight corresponding to each group of accelerated stress parameters and the determined average failure life;
wherein, the calculation formula of the average failure life is as follows:
wherein, tiFor characterizing the average failure life determined at the i set of accelerated stress parameters; etaiScale parameters for characterizing a degradation model corresponding to the i-th set of acceleration stress parameters; beta is aiCharacterizing shape parameters of a degradation model corresponding to the i-th set of acceleration stress parameters; p is used to characterize a preset failure threshold corresponding to the medical device to be evaluated.
Step 406: the remaining useful life of the target medical instrument is determined.
Specifically, the current use time of the target medical instrument is obtained; wherein the target medical instrument and the medical instrument to be evaluated are the same type of medical instrument;
performing difference operation on the obtained expected service life and the current service time to obtain the remaining service life of the target medical instrument;
determining identification information of the target medical instrument according to the remaining service life; wherein the identification information is used to identify a current maintenance strategy for the target medical instrument.
An embodiment of the present invention further provides a device for evaluating a lifetime of a medical device, including: at least one memory and at least one processor;
the at least one memory to store a machine readable program;
the at least one processor is configured to invoke the machine-readable program to perform the method according to any embodiment of the invention.
Embodiments of the present invention further provide a medical device life assessment apparatus, where the computer readable medium has stored thereon computer instructions, which, when executed by a processor, cause the processor to execute the method according to any of the embodiments of the present invention.
It is to be understood that the illustrated construction of the embodiments of the invention does not constitute a specific limitation on the means for simulating a medical device transportation environment. In other embodiments of the present invention, the medical device longevity evaluation apparatus may include more or fewer components than shown, or some components may be combined, some components may be separated, or a different arrangement of components. The illustrated components may be implemented in hardware, software, or a combination of software and hardware.
Specifically, a system or an apparatus equipped with a storage medium on which software program codes that realize the functions of any of the above-described embodiments are stored may be provided, and a computer (or a CPU or MPU) of the system or the apparatus is caused to read out and execute the program codes stored in the storage medium.
In this case, the program code itself read from the storage medium can realize the functions of any of the above-described embodiments, and thus the program code and the storage medium storing the program code constitute a part of the present invention.
Examples of the storage medium for supplying the program code include a floppy disk, a hard disk, a magneto-optical disk, an optical disk (e.g., CD-ROM, CD-R, CD-RW, DVD-ROM, DVD-RAM, DVD-RW, DVD + RW), a magnetic tape, a nonvolatile memory card, and a ROM. Alternatively, the program code may be downloaded from a server computer via a communications network.
Further, it should be clear that the functions of any one of the above-described embodiments may be implemented not only by executing the program code read out by the computer, but also by causing an operating system or the like operating on the computer to perform a part or all of the actual operations based on instructions of the program code.
Further, it is to be understood that the program code read out from the storage medium is written to a memory provided in an expansion board inserted into the computer or to a memory provided in an expansion unit connected to the computer, and then causes a CPU or the like mounted on the expansion board or the expansion unit to perform part or all of the actual operations based on instructions of the program code, thereby realizing the functions of any of the above-described embodiments.
It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising a" does not exclude the presence of other similar elements in a process, method, article, or apparatus that comprises the element.
Those of ordinary skill in the art will understand that: all or part of the steps for realizing the method embodiments can be completed by hardware related to program instructions, the program can be stored in a computer readable storage medium, and the program executes the steps comprising the method embodiments when executed; and the aforementioned storage medium includes: various media that can store program codes, such as ROM, RAM, magnetic or optical disks.
Finally, it is to be noted that: the above description is only a preferred embodiment of the present invention, and is only used to illustrate the technical solutions of the present invention, and not to limit the protection scope of the present invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention shall fall within the protection scope of the present invention.
Claims (10)
1. A medical device life assessment method, comprising:
determining evaluation parameters of the medical instrument to be evaluated; wherein different types of medical instruments correspond to different evaluation parameters;
determining at least two groups of acceleration stress parameters according to the evaluation parameters and the medical instrument to be evaluated;
acquiring performance data of the evaluation parameters within preset test time; the performance data is obtained by testing the medical instrument to be evaluated by utilizing the at least two groups of acceleration stress parameters in the preset testing time;
analyzing the performance data to obtain degradation data corresponding to the medical instrument to be evaluated;
constructing a degradation model of the medical instrument to be evaluated by using the degradation data and the preset test time;
and obtaining the expected life of the corresponding medical instrument to be evaluated according to the degradation model and the preset test time.
2. The method of claim 1, wherein the predetermined test time includes at least three test time points arranged in time sequence;
analyzing the performance data to obtain degradation data corresponding to the medical instrument to be evaluated comprises:
for each test time point, performing:
determining the number of the performance data exceeding a preset threshold range in the performance data;
determining a ratio of the number and the number of medical devices to be evaluated and determining the ratio as degradation data corresponding to the test time point.
3. The method of claim 1, wherein the constructing a degradation model of the medical device under evaluation using the degradation data and the preset test time comprises:
for each set of acceleration stress parameters, performing:
performing acceleration operation on the set of acceleration stress parameters by using a Hallberg-Peck model to obtain acceleration factors corresponding to the set of acceleration stress parameters;
determining standard test time under corresponding normal stress parameters according to the acceleration factor and the preset test time; the standard test time is obtained by multiplying the acceleration factor by the preset test time;
according to the preset test time, combining the degradation data corresponding to the set of acceleration stress parameters with the standard test time;
constructing a degradation model from the combined degradation data and the standard test time.
4. The method of claim 3, wherein constructing a degradation model from the combined degradation data and standard test time comprises:
carrying out logarithm operation on the standard test time to obtain an independent variable;
determining corresponding reliability data according to the degradation data, and sequentially performing reciprocal operation, logarithm operation and logarithm operation on the reliability data to obtain a dependent variable;
determining corresponding independent variables and dependent variables according to the combined degradation data and the standard test time;
performing linear fitting on the corresponding independent variable and dependent variable to obtain a target linear relation; wherein the target linear relationship comprises an intercept and a slope;
using the slope as a shape parameter of the degradation model;
determining a size parameter of the degradation model according to the slope and the intercept;
determining the degradation model according to the shape parameter and the size parameter.
5. The method of claim 1, wherein deriving the expected lifetime corresponding to the medical device under evaluation from the degradation model and the preset test time comprises:
for each set of acceleration stress parameters, performing:
determining shape parameters and scale parameters according to the degradation model corresponding to the set of acceleration stress parameters; wherein the shape parameter and the scale parameter are two parameters in the degradation model;
determining the average failure life according to the shape parameter, the scale parameter and a preset failure threshold corresponding to the medical instrument to be evaluated;
determining the weight of the at least two groups of acceleration stress parameters according to the normal stress range of the medical instrument to be evaluated;
determining the expected life of the medical instrument to be evaluated according to the weight corresponding to each group of accelerated stress parameters and the determined average failure life;
wherein the average failure life is calculated according to the following formula:
wherein, tiFor characterizing the average failure life determined at the i set of accelerated stress parameters; etaiScale parameters for characterizing a degradation model corresponding to the i-th set of acceleration stress parameters; beta is aiCharacterizing shape parameters of a degradation model corresponding to the i-th set of acceleration stress parameters; p is used for representing a preset failure threshold corresponding to the medical instrument to be evaluated.
6. The method of claim 5, wherein each set of acceleration stress parameters includes at least two stress parameters;
determining the weights of the at least two groups of acceleration stress parameters according to the normal stress range of the medical instrument to be evaluated comprises the following steps:
for each set of acceleration stress parameters, performing:
acquiring a normal stress parameter and a limit stress parameter of the medical instrument to be evaluated; wherein the normal stress parameter and the extreme stress parameter each include the same at least two stress parameters as in the acceleration stress parameter;
determining the proportion of each stress parameter in the set of accelerated stress parameters according to the set of accelerated stress parameters, the ultimate stress parameters and the normal stress parameters;
and determining the weight of the set of acceleration stress parameters according to the specific gravity of each stress parameter.
7. The method of any of claims 1 to 6, further comprising, after said obtaining a life expectancy corresponding to the medical device under evaluation:
acquiring the current use time of the target medical instrument; wherein the target medical instrument and the medical instrument to be evaluated are the same type of medical instrument;
performing difference operation on the obtained expected life and the current service time to obtain the remaining service life of the target medical instrument;
determining identification information of the target medical instrument according to the residual service life; wherein the identification information is used to identify a current maintenance strategy of the target medical instrument.
8. Medical device life evaluation apparatus, characterized by comprising:
the parameter determination module is used for determining the evaluation parameters of the medical instrument to be evaluated and determining at least two groups of acceleration stress parameters according to the evaluation parameters and the medical instrument to be evaluated; wherein different types of medical instruments correspond to different evaluation parameters;
the acquisition module is used for acquiring the performance data of the evaluation parameters determined by the parameter determination module within preset test time; the performance data is obtained by testing the medical instrument to be evaluated by utilizing the at least two groups of acceleration stress parameters in the preset testing time;
the processing module is used for analyzing the performance data acquired by the acquisition module to acquire degradation data corresponding to the medical instrument to be evaluated;
the construction module is used for constructing a degradation model of the medical instrument to be evaluated by utilizing the degradation data obtained by the analysis of the processing module and the preset test time;
and the life determining module is used for obtaining the expected life of the medical instrument to be evaluated according to the degradation model constructed by the construction module and the preset test time.
9. Medical device life evaluation apparatus, characterized by comprising: at least one memory and at least one processor;
the at least one memory to store a machine readable program;
the at least one processor, configured to invoke the machine readable program to perform the method of any of claims 1 to 7.
10. A computer readable medium having stored thereon computer instructions which, when executed by a processor, cause the processor to perform the method of any of claims 1 to 7.
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