A medical instrument cleaning and disinfecting process evaluation system

Abstract

The present application relates to the technical field of medical instrument disinfection, in particular to a medical instrument cleaning and disinfection process evaluation system, which comprises an instrument entrance identification module, a material bacteria spectrum adaptation module, a use disinfection path reconstruction module, a combined instrument standard comparison module and a disinfection intensity fitting verification module.In the present application, the state of the instrument entering the process is accurately identified through synchronous verification of the instrument binding code, serial number and response timing, and the matching rules between the heat conductivity, texture grade and bacteria toxicity are combined to determine the objects that cannot be directly disinfected.Based on the historical use trajectory and the deviation score, a disinfection mode set is dynamically constructed, the consistent mode number in the combined processing is selected through the intersection comparison between the mode conditions, and the mode parameters and instrument requirement values are further compared as needed to realize the full-process adaptation and verification of the path selection, mode condition and processing intensity, and to enhance the matching rationality and execution consistency in the multi-instrument processing process.

Description

Technical Field

[0001] This invention relates to the field of medical device disinfection technology, and in particular to an evaluation system for the cleaning and disinfection process of medical devices. Background Technology

[0002] The field of medical device disinfection technology involves cleaning, disinfecting, or sterilizing various medical devices before and after use to prevent cross-infection, improve surgical safety, and uphold clinical hygiene standards. Core aspects of this technology include the removal of organic contaminants from medical device surfaces, microbial inactivation, the selection and application of disinfectants or sterilization methods, equipment disinfection process management, and data traceability and evaluation of the cleaning and disinfection process. In practice, depending on the device's material, structural complexity, and risk level, physical methods such as high-temperature, high-pressure steam and plasma, or chemical methods such as glutaraldehyde and peracetic acid are typically used for treatment. Monitoring indicators or data systems are employed to determine the sterilization effectiveness, achieving a standardized and information-based device management system. Among them, the traditional medical device cleaning and disinfection process evaluation system refers to the tool system used to record and judge the cleaning and disinfection effect in the medical device disinfection process. The technical issue it addresses is how to conduct quality monitoring and process evaluation of key links in the entire cleaning and disinfection process of the device. Traditionally, the compliance of the process is judged by manually filling in record forms, reading physical or chemical monitoring indicator cards, and manually checking equipment operating parameters. The process correspondence and judgment analysis are based on the classification methods in national or industry standards, such as Class A for surgical instruments treated by pressure steam sterilizers and Class B for endoscopic instruments soaked in chemical disinfectant.

[0003] Existing technologies primarily rely on manual registration, equipment readings, and standard comparisons for evaluation. They lack structured identification methods for the dynamic changes in instrument status. In the initial stage of process triggering, they cannot accurately distinguish the mapping relationship between the order of instrument input and the binding number, leading to subsequent judgment chains relying on manual identification and inference. In scenarios where multiple instruments are processed simultaneously, it is easy to create an imbalance in the interaction between disinfection methods and conditions. It is difficult to establish logical connections between disinfection paths based on the characteristics of the instruments themselves, resulting in some path selections deviating from the actual instrument status. It is also difficult to effectively screen the matching of conditions in combined processing. When path prediction is required based on behavior frequency and historical methods, existing systems cannot complete dynamic scoring and method reorganization, which may lead to the hidden dangers of single cleaning path selection and lagging processing intensity adaptation. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of existing technologies and propose a medical device cleaning and disinfection process evaluation system.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: a medical device cleaning and disinfection process evaluation system comprising: The instrument entry identification module acquires the RFID code, the input port serial number and the receiving status command. By verifying successful reading, status matching and response time falling within a preset range, it filters out qualified numbers and generates a list of cleaning instruments. The material microbial spectrum adaptation module extracts the thermal conductivity, density, and texture level of the instruments based on the cleaning instrument list, collects the microbial species and toxicity labels, determines contact conflicts through matching rules, maps the marking results to the list number, and generates the sequence of items that cannot be directly disinfected. The purpose disinfection path reconstruction module extracts the number of times the instruments are cleaned, the frequency of operation, and the previous disinfection methods corresponding to the items that cannot be directly disinfected, constructs the behavior trajectory, fits the current operation record, screens out the deviation method number, matches the operation method, and generates a set of disinfection methods. The combined instrument standard comparison module analyzes whether the cleaning process involves multiple instruments based on the set of disinfection methods, extracts the content of all method numbers, compares whether the temperature, penetration characteristics and upper and lower limits of time are mutually exclusive, generates a set of matching consistency numbers, and transmits it to the disinfection intensity matching verification module.

[0006] As a further aspect of the present invention, the cleaning instrument list includes a unique instrument number, a binding identification code, and an entry sequence identifier; the items that cannot be directly disinfected include a bacterial species identification number, surface thermal conductivity parameters, and texture roughness level; the disinfection method set includes a recommended disinfection method number, a historical behavior method number, and a fitting deviation score; and the adaptation consistency number set includes an operating temperature range, liquid penetration parameters, and disinfection time requirements.

[0007] As a further aspect of the present invention, the instrument entry identification module includes: The encoding and reading submodule obtains the RFID binding code and entry serial number of the risky medical device entry point, and calculates and obtains the synchronous reading success rate based on the correspondence between the two codes; The status comparison submodule calls the synchronous reading success rate, calculates the timing deviation based on the overlap between the current received status command on the console and the process start timing, and obtains the timing deviation result. The list generation submodule filters based on the timing deviation result and the synchronization reading success rate, calculates the filter matching degree, and obtains the cleaning instrument list when the matching degree is greater than the set matching degree threshold.

[0008] As a further aspect of the present invention, the material microbial spectrum adaptation module includes: The surface structure extraction submodule, based on the cleaning instrument list, obtains the instrument's thermal conductivity, bulk density, and texture roughness level, extracts the correspondence between the list number and structural attributes, and obtains a structural attribute identifier sequence. The toxicity number filtering submodule calls the number information in the structural attribute identifier sequence, collects the corresponding bacterial species toxicity identifier, determines whether the toxicity exceeds the safety benchmark value, filters out the items that exceed the standard, and obtains a list of high toxicity numbers. The conflict screening submodule calls the highly toxic number list and the structural attribute identifier sequence, calculates the conflict index between instrument parameters and bacterial characteristics, compares the conflict index with the rejection threshold, filters out excess items, and generates a sequence of items that cannot be directly disinfected.

[0009] As a further aspect of the present invention, the application disinfection path reconstruction module includes: The trajectory parameter extraction submodule extracts the cleaning frequency, operation frequency and previous disinfection method number of the corresponding instrument in the current department based on the instrument number of the non-directly disinfectable items, and constructs the cleaning behavior trajectory of the instrument according to the number order to obtain the behavior trajectory matrix. The behavior deviation determination submodule calls the behavior trajectory matrix and the method number in the current operation record, compares the matching degree between the method number in the behavior trajectory and the current usage method number item by item, calculates the fitting score value of the device number, determines whether the deviation ratio between the score and the average score exceeds the deviation ratio threshold, and obtains the list of deviation numbers. The method set generation submodule calls the deviation number list and the method numbers corresponding to similar operation frequencies recorded in the behavior trajectory matrix, filters the method numbers whose operation frequency is higher than the preset frequency threshold and has not deviated, and combines them to form an operation mode set, generating a disinfection method set.

[0010] As a further aspect of the present invention, the combined medical device standard comparison module includes: The process structure identification submodule determines whether multiple instruments are being processed in parallel in the current cleaning process based on the method number in the set of disinfection methods. If parallel processing exists, the number is recorded to obtain the parallel number sequence. The method content extraction submodule calls all the numbering information in the parallel numbering sequence, extracts the operating temperature range, liquid penetration characteristics and disinfection time requirement parameters in the corresponding method content, establishes a method content parameter set, and obtains a method parameter combination set. The intersection judgment and screening submodule compares the temperature range, liquid penetration range and upper and lower time limits of multiple instruments according to the parameter combination set, and filters out the numbers with no intersection of the three parameters, generating a set of adaptation consistency numbers.

[0011] As a further embodiment of the present invention, the disinfection intensity matching verification module extracts the temperature, penetration depth and time values ​​corresponding to the matching consistency number set, compares them with the required values ​​of the instruments, screens out the instrument numbers that do not meet the standards, and generates a list of instruments with insufficient disinfection intensity. The list of instruments with insufficient disinfection intensity includes numbers for those that did not reach the required temperature, penetration depth, or contact time.

[0012] As a further aspect of the present invention, the disinfection intensity consistency verification module includes: The mode parameter extraction submodule extracts the temperature value, penetration depth value and action time value from the corresponding mode content based on the mode number of each device in the adaptation consistency number set, establishes a mode intensity parameter set, and generates a mode parameter matrix. The device demand matching submodule calls the method parameter matrix and the demand parameters corresponding to the device number, compares the temperature value, penetration depth value and action time value item by item to see if they meet the threshold range required by the device, marks the number of items that do not meet the standard, and obtains the sequence of non-compliant numbers; The insufficient intensity screening submodule summarizes and organizes all the numbers that do not meet the requirements according to the sequence of non-compliant numbers, establishes a corresponding list of instruments, and generates a list of instruments with insufficient disinfection intensity.

[0013] Compared with the prior art, the advantages and positive effects of the present invention are as follows: In this invention, the status of instruments entering the process is accurately identified by synchronously verifying the binding code, serial number, and response timing of instruments. Combining the matching rules between thermal conductivity, texture level, and bacterial toxicity, objects that cannot be directly disinfected are determined. A set of disinfection methods is dynamically constructed based on historical usage trajectory and deviation score. Consistent method numbers in combined processing are screened by comparing the intersection of method conditions. Furthermore, the parameters of each method are compared with the instrument requirements as needed to achieve full-process adaptation and verification of path selection, method conditions, and processing intensity, thereby enhancing the matching rationality and execution consistency in the multi-instrument processing process. Attached Figure Description

[0014] Figure 1 This is a system flowchart of the present invention; Figure 2 This is a flowchart of the instrument entry identification module of the present invention; Figure 3 This is a flowchart of the material microbial spectrum adaptation module of the present invention; Figure 4 A flowchart illustrating the disinfection path reconstruction module for the purposes of this invention; Figure 5 This is a flowchart of the combined medical device standard comparison module of the present invention; Figure 6 This is a flowchart of the disinfection intensity matching verification module of the present invention. Detailed Implementation

[0015] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0016] In the description of this invention, it should be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, in the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0017] Please see Figure 1 A medical device cleaning and disinfection process evaluation system includes: The device entry identification module acquires the RFID binding code, input port serial number and current receiving status command on the operating table when the risky medical device enters the process. Based on whether the simultaneous reading of the code and serial number is successful, whether the receiving status command and the process start sequence coincide, and whether the receiving response order between the three items falls within the preset time interval, the module screens out the device numbers that meet the requirements through cross-judgment of the three items and generates a list of cleaning devices. The material microbial spectrum adaptation module extracts the thermal conductivity, bulk density and texture roughness of the instrument surface based on the cleaning instrument list, collects the microbial species and toxicity labels to be removed, and determines whether there are conflicting items under contact conditions by matching the microbial species labels with the surface structure level through the matching rules. The labeling results are then mapped to the list number to generate the sequence of items that cannot be directly disinfected. The purpose disinfection path reconstruction module extracts the number of times the instrument is cleaned, the frequency of operation, and the previous disinfection method number in the current department based on the instrument number of the item that cannot be directly disinfected. It constructs the behavior trajectory corresponding to the instrument and fits the method number in the trajectory with the current operation record for a score. The number of the deviation ratio is higher than the preset threshold and is matched to the similar operation method number in the trajectory to generate a set of disinfection methods. The combined instrument standard comparison module determines whether multiple instruments are being processed simultaneously in the current cleaning process based on all the method numbers in the disinfection method set. If so, it extracts the method content associated with the number, compares whether there is mutual exclusion between the upper and lower limits of the action temperature range, liquid penetration characteristics and disinfection time requirements in the method content, and filters out the numbers that do not overlap before summarizing the numbers to generate a set of matching and consistent numbers. The disinfection intensity matching verification module extracts the temperature value, penetration depth value, and action time value of the configured disinfection method based on the content indicated by the method number of each instrument in the compatibility number set, and compares them with the required values ​​of the instrument item by item to determine whether there are any instrument numbers that do not meet the required range. The module then summarizes and records the numbers to generate a list of instruments with insufficient disinfection intensity.

[0018] The list of instruments to be cleaned includes the instrument's unique serial number, binding identification code, and entry sequence identifier. Items that cannot be directly disinfected include the bacterial species identification number, surface thermal conductivity parameters, and texture roughness level. The set of disinfection methods includes the recommended disinfection method number, historical behavior method number, and fit deviation score. The set of adaptation consistency numbers includes the operating temperature range, liquid penetration parameters, and disinfection time requirements. The list of instruments with insufficient disinfection intensity includes the number of instruments that did not reach the required temperature value, penetration depth, or operating time.

[0019] Please see Figure 2 The medical device entry identification module includes: The encoding and reading submodule obtains the RFID binding code and entry serial number of the risky medical device entry point, and calculates and obtains the synchronous reading success rate based on the correspondence between the two codes; Before each batch of operations, the encoding and reading submodule initializes the scanning program and begins reading the RFID tags carried by all high-risk medical devices from the entrance. Each tag is encoded with a 64-bit structure, and only the middle 16 bits are used as the binding code. For example, the RFID code "A01B9D7F6E3C2A1B" is intercepted and identified as "9D7F6E3C2A1B". Subsequently, a correspondence is established between this code and the entrance serial number. The serial number is generated using a sequential numbering logic. For example, the first device corresponds to "ESN001", the second device is "ESN002", and so on. When each device passes through the entrance area, the RFID reader completes the tag scanning and binds the serial number, while recording the reading status indicator. The reading process must complete data reception within 0.3 seconds. Only after successful parsing can a read be considered valid; otherwise, it is considered a failed read. In one operation, 90 devices were entered, and 78 devices were successfully read and bound, corresponding to a success rate of 78 / 90 = 0.867. This success rate is used to evaluate whether the current read task meets the requirements. The internally set read success rate threshold is 0.85, which is derived from the low-value statistics of the success rate during 30 consecutive batches of device reads. The three lowest batch success rates were 0.843, 0.851, and 0.856, and the average of the three values ​​was 0.850. This value is the minimum acceptable success rate when the operation is stable, that is, the read success rate must reach 85% or higher to be considered a batch read qualified. The current read success rate is 86.7%, which is higher than the threshold. Therefore, this batch task is recorded as a valid read.

[0020] The status comparison submodule calls the synchronous reading success rate, calculates the timing deviation based on the overlap between the current received status command on the console and the process start timing, and obtains the timing deviation result; The status comparison submodule compares the sequence of status commands issued by the operator console with the control timing in the process. For example, the operator console records the statuses as follows: "Initialization" time is 1.0 second, "Preparation" time is 2.6 seconds, and "Execution" time is 4.1 seconds, while the process timing is set as: "Initialization" 1.0 second, "Preparation" 2.4 seconds, and "Execution" 4.2 seconds. The corresponding comparison time differences for each status type are 0.0 seconds, 0.2 seconds, and 0.1 seconds, respectively. For each status signal, its time deviation is recorded, and the average deviation value is calculated. This average deviation is used to determine whether the command response is within the process timing tolerance range. If the deviation is too large, the process control is considered unstable. The deviation tolerance threshold is set to 0.3 seconds. This value is set as follows: During the execution of 50 batches of the process, all corresponding time-series deviation data for each state are recorded. The average deviation for each batch is sorted, and the 10th, 11th, and 12th deviation values ​​are selected as 0.295 seconds, 0.301 seconds, and 0.298 seconds, respectively. The average of these three values ​​is calculated to obtain 0.298 seconds, which is then rounded up to 0.3 seconds as the boundary of the allowable range, ensuring that the tolerance is acceptable in over 90% of the batches. In this example, the average deviation for each state is (0 + 0.2 + 0.1) / 3 = 0.1 seconds, significantly lower than the 0.3-second threshold. Therefore, the current batch operation is judged to be timely and meets the process timing requirements.

[0021] The manifest generation submodule filters based on timing deviation results and synchronization read success rate, using the following formula: ; The matching degree S is calculated, and the list of cleaning instruments is obtained by comparing the matching degree S with the set matching degree threshold. Where S represents the screening matching degree, R represents the synchronous reading success rate, T1 represents the start-up timing time, T2 represents the receiving status timing time, Δtᵢ represents the response sequence time difference, η1 represents the standardized score of the input port code value, η2 represents the standardized score of the RFID binding code value, and n represents the number of response items. The inventory generation submodule filters data based on timing deviation results and synchronization read success rate. First, it initiates read commands sequentially via antenna and detects the delay time of the RFID tag return signal carried by each device, recording it as the response time difference. Assuming a certain read operation contains 5 instruments in the tray, the actual response time differences for each detection are as follows: ; The total response time difference is: ; The set reception status time is: ; The time from the start of the read task to the completion of the initiation phase is: ; Four tags were successfully read, with a success rate of: ; The input port code is "G347", and its corresponding ASCII code is: ; The RFID code is "R516", and its corresponding ASCII code is: ; The difference between the two scores is: ; According to the formula: ; The calculation is as follows, with the parameter values ​​substituted: molecular: ; Denominator: ; Fractional value: ; Taking the square root of the absolute value: ; Final matching degree calculation: ; The set matching threshold is: ; because Therefore, it is determined that the current instrument group does not meet the screening requirements and is excluded from the final cleaning instrument list. This threshold is set by calculating the sum of the mean and standard deviation of 50 sets of experimental data, as shown in the table below; Table 1. Calculation and Judgment Table for Screening Match Degree; As shown in Table 1, the final matching degree is obtained by performing specific operations such as reading, timing, scoring, and calculation, and by calling each parameter in the formula one by one. The system determines whether a device group should be included in the list by combining the set thresholds.

[0022] Explanation of Formula Innovation: The advantage of the formula lies in introducing the sum of response time differences. Reflects the concentration of instrument feedback and is correlated with the reading success rate. Together they constitute the time response ratio, which is then added to the difference between the input port code and the RFID code score. This allows the screening matching degree to take into account both response efficiency and coding recognition differences, thereby enabling a more refined judgment of feedback signals from multiple instruments.

[0023] This result indicates that the matching degree Below the screening threshold This means that the batch of instruments has significant differences in response timing or insufficient code recognition matching during the current scanning process, and therefore should not be included in the cleaning instrument list.

[0024] Please see Figure 3 The material microbial spectrum adaptation module includes: The surface structure extraction submodule is based on the cleaning instrument list, obtains the instrument thermal conductivity, bulk density and texture roughness level, extracts the correspondence between the list number and the structural attributes, and obtains the structural attribute identification sequence. Upon receiving the instrument list, the surface structure extraction submodule sequentially calls the structural attribute database according to the instrument number in the list to extract three key structural parameters for each instrument: thermal conductivity, bulk density, and texture roughness level. Thermal conductivity and bulk density are measured values, while the texture roughness level is divided into five levels from R1 to R5 using discrete numbering. For example, instrument number E011 has a thermal conductivity of 13.7, a bulk density of 915, and a texture level of R3. These three parameters are then combined and linked one-to-one with the instrument number, recorded as {E011: 13.7, 915, R3}.}; and so on, each device in the list generates a structural identification unit of this type. The original records in the structural attribute database come from the fixed-point testing carried out during the device warehousing stage. Each piece of data is collected by the testing equipment and transmitted to the main control system. The final sample of the structural identification sequence is as follows: {E001: 12.4, 930, R4, E002: 15.6, 875, R2, E003: 9.8, 960, R5, ...}, which covers the number and corresponding structural attributes of all devices to be processed, and serves as the data basis for subsequent toxicity comparison and conflict index calculation.

[0025] The toxicity number filtering submodule calls the number information in the structural attribute identifier sequence, collects the corresponding bacterial species toxicity identifier, determines whether the toxicity exceeds the safety benchmark value, filters out the items that exceed the standard, and obtains a list of high toxicity numbers. The toxicity number screening submodule uses each number in the structural attribute identifier sequence as an index to retrieve the bacterial species identifiers that the number has come into contact with in past use, and finds the toxicity level value of the bacterial species. It compares the toxicity value corresponding to each bacterial species with the set safety benchmark threshold. If the toxicity value is greater than the benchmark threshold, the device number is marked as a toxicity exceeding the standard number and added to the high toxicity number list. For example, if the bacterial species contacted by number E003 is bacterial species A, its toxicity value is 3.5, and the set safety benchmark value is 3.0, then it is determined that 3.5 > 3.0, and E003 is listed as a high toxicity number. The safety baseline value of 3.0 is derived from the toxicity values ​​of the 20 most frequently occurring bacterial species in the statistical bacterial toxicity database. After removing the maximum and minimum values, the remaining 18 samples are sorted and the average of the two middle samples is taken, resulting in values ​​of 2.9 and 3.1. The average value of 3.0 is used as the toxicity screening baseline value, which meets the requirements for toxicity determination of most bacterial species and ensures that the determination standard is robust and consistent. In a screening task, if there are 40 devices in the list, and 9 devices correspond to bacterial toxicity values ​​exceeding 3.0, the numbers of these 9 devices are arranged into a high-toxicity number list for subsequent structural conflict identification.

[0026] By calling the list of highly toxicity numbers and the structural attribute identifier sequence, the conflict index μ between instrument parameters and bacterial strain characteristics is calculated using the following formula: ; Compare the conflict index with the rejection threshold ε, filter out items that exceed the limit, and generate a sequence of items that cannot be directly disinfected. in, As a conflict index, To score the density of the material, For penetration depth scoring, To score thermal conductivity properties, Rate it as rough. The attachment difficulty score for bacterial species j is given, and N is the number of bacterial species. After the conflict screening submodule calls the list of highly toxic numbers and the structural attribute identifier sequence, it matches the device information table with the high-risk bacterial species numbers in the bacterial species database. Through cross-comparison, it extracts the density information of the target device material and assigns it a value. The selected material is high-molecular-weight polycarbonate, whose actual density is... According to the scoring quantification rules, it falls within the "1.0–1.5" range, corresponding to a score of [score missing]. The penetration depth was measured using a transmission scanning electron microscope, and the average depth of its microporous structure was obtained as follows: Based on the scoring standard of "1.0–2.0" equals 7 points, the result is... Subsequently, the thermal conductivity of the material at room temperature was measured using a thermal conductivity meter. According to the rating mapping The surface roughness was measured using a laser interferometer, and its Ra value was determined. Based on the score of 3 (0.1–0.3), we can obtain... An adhesion experiment was conducted on five typical bacterial species (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Staphylococcus epidermidis), and the number of colonies per unit area was measured. By linearly mapping the CFU values ​​to the scoring system (1 point for every 200 CFU / cm²), the following results were obtained: ; Then calculate the conflict index using the formula: ; After substituting the data, the calculation is as follows: ; ; ; The calculated Value and preset rejection threshold Comparison, because The equipment is deemed acceptable and is not listed as items that cannot be directly disinfected. Note the threshold values. Based on the empirical critical value set after statistical analysis of 120 types of instruments that failed disinfection, in The average residual bacterial rate of the attached bacteria exceeded This value is used as the basis for the delineation.

[0027] The parameters in this formula are explained as follows: Material density rating: The material density is linearly mapped from 0 to 10 g / cm³ to a rating range of 1 to 10. : Penetration depth score, with structural depths ranging from 0 to 5 μm mapped to a score of 1 to 10; Thermal conductivity score: linear score for thermal conductivity in the range of 0.1–10 W / (m·K); Surface roughness score, mapped by Ra values ​​within the range of 0–1 μm; strains The attachment score is a linearly mapped score with colony counts between 200 and 2000 CFU / cm². : indicates all Sum of the bacterial attachment scores.

[0028] The formula's operational structure is as follows: First, the density score and the permeability score are multiplied to reflect the interaction of the material's dense structure. Then, the thermal conductivity score is added to obtain the structural thermal behavior evaluation item. The denominator is formed by adding the surface roughness score and the adhesion scores of various microbial species to constitute the microbial adhesion resistance index. Finally, the ratio of the two is processed by absolute value to form the conflict index index.

[0029] Table 2. Detailed Scoring of Materials and Microbial Strains; As shown in Table 2, all score values ​​have been collected and converted. All parameters satisfy the dimensionless property and are used in the formula calculation. Finally, the conflict index is obtained. , and preset threshold In contrast, the results fall within the safe range, indicating that the device is not listed as an item that cannot be directly sterilized. The advantage of the formula lies in its ability to quantitatively represent the degree of interaction between material physics and microbial characteristics by introducing a normalized ratio analysis of the density-structural property multiplication term and microbial adhesion.

[0030] Please see Figure 4 The disinfection pathway reconstruction module includes: The trajectory parameter extraction submodule extracts the cleaning frequency, operation frequency and previous disinfection method number of the corresponding instrument in the current department based on the instrument number of the item that cannot be directly disinfected, and constructs the cleaning behavior trajectory of the instrument according to the number order to obtain the behavior trajectory matrix. Based on the instrument numbers listed in the non-directly disinfectable item sequence, the historical behavior data of each instrument is retrieved one by one. The operation records of each instrument in the current department are searched, extracting the cumulative number of cleanings, the operation frequency value within the current cycle, and the disinfection method number used in all historical records. The number of cleanings is directly obtained from the registration system, and the operation frequency is calculated as the ratio of operation days to operation frequency. The method number is a standard number, such as W001, W002, W003, etc. These three pieces of information are integrated into a triplet according to the number order and arranged in ascending order to form a complete instrument cleaning behavior trajectory record. For example, instrument number E011 has been cleaned 14 times. The operation frequency is 0.8, the method number is W002, and the resulting record is {E011: 14, 0.8, W002}. Following this logic, all instruments that cannot be directly disinfected are treated in the same way. For example, if the instrument sequence is {E006, E008, E011, E015}, then the final behavior trajectory matrix is: {E006: 10, 0.5, W001, E008: 8, 0.6, W003, E011: 14, 0.8, W002, E015: 12, 0.7, W001}. This behavior trajectory matrix completely records the cleaning history of each instrument in the specified scenario, which can be used for comparison and analysis by subsequent modules.

[0031] The behavior deviation determination submodule calls the behavior trajectory matrix and the method number in the current operation record, compares the matching degree between the method number in the behavior trajectory and the current usage method number item by item, calculates the fitting score value of the device number, determines whether the deviation ratio between the score and the average score exceeds the deviation ratio threshold, and obtains the list of deviation numbers. After receiving the behavior trajectory matrix, the system begins reading the disinfection method number used by each instrument in the current operation record. It compares this method number with the historical method numbers recorded in the behavior trajectory matrix. If they match, the fit is considered successful. If they don't match, a fitting score is assigned based on the degree of difference in the method numbers: 3 points for complete consistency, 2 points for partial similarity (i.e., the first two digits of the method number are the same, such as W001 and W002), and 1 point for complete mismatch. For example, E006 was historically W001 and is currently W001, so it gets 3 points; E008 was historically W003 and is currently W001, so the significant difference in the numbering results in 1 point. The scores for all instruments are then summed to calculate the average fitting score. For example, E006 gets 3 points, E008 gets 1 point, E011 gets 2 points, and E01... If 5 scores 3 points, the average score is (3+1+2+3) / 4=2.25. Next, the deviation ratio between the fitted score and the average value of each item is judged, that is, (device score - average value) divided by the absolute value of the average value. If the deviation ratio exceeds the set deviation ratio threshold, it is marked as a behavioral deviation. The current deviation ratio threshold is set to 0.3. This value comes from screening out items with a score deviation greater than 30% from 100 batches of device scoring data. Their corresponding cleaning failure rate exceeds 85%, so this threshold is selected as the boundary standard. If a certain item has a fitted score of 1 and an average value of 2.25, the deviation ratio is (2.25-1) / 2.25=0.555, which is greater than 0.3. This item is added to the deviation number list. Finally, the behavioral deviation number sequence is screened out as {E008}.

[0032] The method set generation submodule calls the deviation number list and the method numbers corresponding to similar operation frequencies recorded in the behavior trajectory matrix, filters the method numbers whose operation frequency is higher than the preset frequency threshold and has not deviated, and combines them to form an operation mode set, generating a disinfection method set; After obtaining the list of deviation numbers, the system first retrieves instrument records from the behavior trajectory matrix that have similar operation frequencies to the deviation numbers. The "similar" operation frequency is defined as a range where the deviation instrument's operation frequency fluctuates by no more than 0.1. For example, if the operation frequency of E008 is 0.6, the similarity range is 0.5~0.7. E006 and E015 are also found to fall within this range in the trajectory matrix, with corresponding method numbers W001 and W001 respectively. From these numbers, those without deviation markers are selected, and the most frequently used method numbers are counted. Here, W001 is used twice and has no deviation, so it is determined to be a frequently used and non-deviational method number. These method numbers are then combined to form a set of recommended disinfection methods for E008. If multiple deviation numbers have similar operation frequencies, the method numbers are merged, taking the intersection or frequency priority. The final output method set is like {W001}, which records the currently recommended reusable disinfection method numbers.

[0033] Please see Figure 5 The combined medical device standard comparison module includes: The process structure identification submodule determines whether multiple instruments are being processed in parallel in the current cleaning process based on the method number in the disinfection method set. If parallel processing exists, the number is recorded to obtain the parallel number sequence. After receiving the set of method numbers output by the method set generation submodule, the cleaning process record is queried for each method number in the set. First, the correspondence between the instrument number and the method number in the current cleaning task schedule is extracted. In the task scheduling table, if two or more instruments share the same method number in the same time period and are scheduled to be processed on the same disinfection equipment, it is determined that the method number is used in parallel. For example, if the number W001 is used for both instruments E011 and E015, their task start time is exactly the same and their end time is not offset. W001 is then recorded as a storage method. In parallel operation, the scheduling status of the remaining numbers in the mode number set is then compared. For example, if W002 is only called by E006 and no other device uses this mode during the task time period of E006, it is determined that W002 has no parallel operation. All numbers in the mode number set are processed in turn. For example, in the set {W001, W002, W003, W004}, only W001 and W004 meet the condition that two or more devices are used in the same time period. Finally, W001 and W004 are organized into a parallel number sequence {W001, W004}, which serves as the source of objects for subsequent parameter extraction.

[0034] The method content extraction submodule calls all the numbering information in the parallel numbering sequence, extracts the operating temperature range, liquid penetration characteristics and disinfection time requirement parameters in the corresponding method content, establishes the method content parameter set, and obtains the method parameter combination set. After calling the previously obtained parallel number sequence, the detailed parameter records corresponding to each number are read sequentially. The read fields include the initial temperature value, the final temperature value, the liquid permeability characteristic level, and the standard disinfection duration. For example, the record value for number W001 is an initial temperature value of 50, a final temperature value of 75, a permeability characteristic level of P3, and a disinfection duration of 20. The corresponding parameters for number W004 are an initial temperature value of 60, a final temperature value of 85, a permeability characteristic level of P4, and a duration of 25. Each set of parameters is combined into a parameter set item according to its original order and stored by number, such as {W001: 50-75, P3, 20}, {W004: 6 ... -85, P4, 25}, In the processing, a standardized method level identification table is used, with penetration levels P1 to P5 representing the degree of penetration of different liquids into the instrument material. The five levels are distributed sequentially from the lowest to the highest. The standard definition is that each additional level increases the penetration efficiency by 10%. The value of the level is read without processing the actual percentage. After the parameters are collected, the completeness of each parameter is checked. If there is a missing item or an abnormal value, an identification failure prompt will be issued. After all normal data is read, the method parameter combination set is finally constructed. Assuming that there are 3 parallel numbers, the final parameter combination set contains 3 sets of complete parameter data, which are used for subsequent intersection judgment processing.

[0035] The intersection judgment and screening submodule compares the temperature range, liquid penetration range and time upper and lower limits of multiple instruments based on the combination set of method parameters to see if there is mutual exclusion. It then filters out the numbers with no intersection of the three parameters and generates a set of adaptation consistency numbers. The method parameter combination set is cross-compared across multiple numberings. Each item is checked for overlapping temperature ranges, excessive differences in liquid permeability levels, and uniform disinfection times. The first step determines if there is overlap in temperature ranges by comparing the start and end temperature values ​​of each pair of method numbers. If the highest starting value is less than or equal to the lowest ending value, there is an overlap. For example, the temperature range for number W001 is 50-75°C, and for W004 it is 60-85°C; the overlap is 60-75°C, thus indicating an overlap. The second step determines the permeability level. A difference of more than 2 levels is considered as no overlap. For example, W001 is P2, and W004 is P5; a difference of 3 levels indicates mutually exclusive permeability levels. This level threshold of 2 originates from the sample instrument permeability test, where using methods with a level difference of 3 or more results in a permeability uniformity difference greater than 30%, while a difference of 2 levels... The difference in residual cleaning of internal instruments is kept within 10%, so Level 2 is set as the level tolerance threshold. The third step is to determine whether the time is compatible. The time compatibility range is set to the difference between the longest and shortest time not exceeding 10 minutes. This value comes from 60 groups of different instrument tests, with 10 minutes as the dividing line. When the time difference exceeds 10 minutes, the residual rate of the instrument in the middle section increases significantly. Therefore, based on this setting, it is determined whether the time is mutually exclusive. For example, the time of W001 is 20 and the time of W004 is 35. The difference between the two is 15, which is judged as a time conflict. Finally, if a certain method number is mutually exclusive with other numbers in any aspect, the number is screened out of the adaptation consistency number set. If a number has no conflict with all parallel items, it is retained in the adaptation number set. Assuming that only W002 meets the three dimensions of no conflict, the final adaptation consistency number set is {W002}.

[0036] Please see Figure 6 The disinfection intensity consistency verification module includes: The mode parameter extraction submodule extracts the temperature value, penetration depth value and action time value from the corresponding mode content based on the mode number of each instrument in the adaptation consistency number set, establishes a mode intensity parameter set, and generates a mode parameter matrix. After obtaining the set of compatible consistency numbers, the structured information of the method used by each device is read according to the number. For each method number, three fixed attribute values ​​are extracted sequentially: temperature, penetration depth, and action time. The temperature value is the constant control point set for this method, the penetration depth value is the average penetration depth level that the disinfectant can achieve in the standard material surface test, and the action time value is the complete running time from start to finish. These three parameters are static settings that cannot be changed during registration. For example, the temperature value for device number W001 is 70, and the penetration depth is... With a degree of 6 and an action time of 20, the three parameters of the number W003 are 72, 5, and 18. For all adaptation numbers, such triples are extracted, and a complete mode parameter matrix is ​​constructed using the mode number as an index. Assuming the set of adaptation consistency numbers is {W001, W002, W003, W005}, the constructed matrix structure is: {W001: 70, 6, 20, W002: 68, 7, 22, W003: 72, 5, 18, W005: 74, 6, 21}. This parameter matrix serves as the key basis for subsequent device matching.

[0037] The device demand matching submodule calls the parameter matrix of the calling method and the demand parameters corresponding to the device number, compares the temperature value, penetration depth value and action time value item by item to see if they meet the threshold range required by the device, marks the number of the item that does not meet the standard, and obtains the sequence of the item that does not meet the standard. After receiving the method parameter matrix, the device number associated with each method number is retrieved, and the minimum processing requirements for that device are obtained. These requirements include three items: minimum acceptable temperature, minimum effective penetration level, and minimum treatment time. These three values ​​are standard values ​​set during device registration based on material, complexity, and clinical risk level. For example, device E012 has a set temperature requirement of 71°C, a penetration requirement of 6 levels, and a time requirement of 20 seconds. The corresponding method is W002. The parameters {68, 7, 22} of W002 are compared item by item with the requirement parameters {71, 6, 20} of E012. It is found that temperature 68 < 71 is not met, penetration 7 ≥ 6 is met, and time 22 ≥ 20 is met. Therefore, E012 is marked as unacceptable. For compliant medical devices, only insufficient temperature is recorded in the inventory. Subsequently, the same process is performed on all medical device numbers. The judgment logic is set so that if any parameter is not met, the entire device is marked as non-compliant. In the current task, the threshold judgment criteria are set as follows: the temperature requirement range is greater than or equal to the set value, the penetration level must reach the set level or higher, and the action time is not less than the set duration. The threshold setting is based on the observation that a temperature of less than 2 degrees is still tolerable in 300 cases of incompletely cleaned medical devices, while a penetration level of less than one level or an action time of less than 3 minutes will lead to an increase in the colony residue rate of more than 20%. Therefore, the minimum limit is finally set to the medical device label value itself not being lower than the specified value. The final result is a non-compliant number sequence such as {E012, E015, E019} for downstream module processing.

[0038] The insufficient intensity screening submodule summarizes and organizes all the numbers that do not meet the requirements according to the sequence of the numbers that do not meet the standards, creates a corresponding list of instruments, and generates a list of instruments with insufficient disinfection intensity. Upon receiving a sequence of non-compliant device numbers, the insufficient strength screening submodule performs a backtracking operation on each number. First, it reads the method number information corresponding to each number and then extracts the temperature, penetration depth, and action time values ​​recorded in the parameter matrix for that method number. Next, it performs a one-to-one match with the device's own requirement standards. For example, device number E012 uses method number W002, and its recorded actual parameters are temperature 68, penetration level 7, and time 22. The required parameters are temperature 71, penetration level 6, and time 20. After comparing these three parameters, the temperature does not meet the requirement, while the penetration level and time meet the requirements. Therefore, E012 is recorded as a device that does not meet the "temperature" requirement, with a difference of -3 between the actual and required values. The module then continues processing number E015, whose user... E015 is a device with the following parameters: temperature 74°C, penetration level 5, and time 21 seconds. The device requirements are temperature 72°C, penetration level 6, and time 20 seconds. After evaluation, it is found that the penetration level is insufficient, with a difference of -1. The other two parameters are met. Therefore, E015 is recorded as a device whose penetration level is not met. Then, E019 is read. Its method is W003, with the following parameters: temperature 72°C, penetration level 6, and time 18 seconds. The device requirements are temperature 70°C, penetration level 6, and time 20 seconds. It is determined that the action time is insufficient, with a difference of -2 seconds. The three devices are marked as objects with insufficient disinfection intensity due to different individual items not meeting the set threshold. Finally, all numbers, method numbers, and unmet items are archived and output as a text sequence as the input source for subsequent reconfiguration or task adjustment.

[0039] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention in any other way. Any person skilled in the art may make changes or modifications to the above-disclosed technical content to create equivalent embodiments that can be applied to other fields. However, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the protection scope of the present invention.

Claims

1. A medical device cleaning and disinfection process evaluation system, characterized in that, The system includes: The instrument entry identification module acquires the RFID code, the input port serial number and the receiving status command. By verifying successful reading, status matching and response time falling within a preset range, it filters out qualified numbers and generates a list of cleaning instruments. The material microbial spectrum adaptation module extracts the thermal conductivity, density, and texture level of the instruments based on the cleaning instrument list, collects the microbial species and toxicity labels, determines contact conflicts through matching rules, maps the marking results to the list number, and generates the sequence of items that cannot be directly disinfected. The purpose disinfection path reconstruction module extracts the number of times the instruments are cleaned, the frequency of operation, and the previous disinfection methods corresponding to the items that cannot be directly disinfected, constructs the behavior trajectory, fits the current operation record, screens out the deviation method number, matches the operation method, and generates a set of disinfection methods. The combined instrument standard comparison module analyzes whether the cleaning process involves multiple instruments based on the set of disinfection methods, extracts the content of all method numbers, compares whether the temperature, penetration characteristics and upper and lower limits of time are mutually exclusive, generates a set of matching consistency numbers, and transmits it to the disinfection intensity matching verification module.

2. The medical device cleaning and disinfection process evaluation system according to claim 1, characterized in that, The cleaning equipment list includes a unique equipment number, a binding identification code, and an entry sequence identifier. The items that cannot be directly disinfected include a bacterial species identification number, surface thermal conductivity parameters, and texture roughness level. The disinfection method set includes a recommended disinfection method number, a historical behavior method number, and a fitting deviation score. The adaptation consistency number set includes an operating temperature range, liquid penetration parameters, and disinfection time requirements.

3. The medical device cleaning and disinfection process evaluation system according to claim 2, characterized in that, The instrument entry identification module includes: The encoding and reading submodule obtains the RFID binding code and entry serial number of the risky medical device entry point, and calculates and obtains the synchronous reading success rate based on the correspondence between the two codes; The status comparison submodule calls the synchronous reading success rate, calculates the timing deviation based on the overlap between the current received status command on the console and the process start timing, and obtains the timing deviation result. The list generation submodule filters based on the timing deviation result and the synchronization reading success rate, calculates the filter matching degree, and obtains the cleaning instrument list when the matching degree is greater than the set matching degree threshold.

4. The medical device cleaning and disinfection process evaluation system according to claim 3, characterized in that, The material microbial spectrum adaptation module includes: The surface structure extraction submodule, based on the cleaning instrument list, obtains the instrument's thermal conductivity, bulk density, and texture roughness level, extracts the correspondence between the list number and structural attributes, and obtains a structural attribute identifier sequence. The toxicity number filtering submodule calls the number information in the structural attribute identifier sequence, collects the corresponding bacterial species toxicity identifier, determines whether the toxicity exceeds the safety benchmark value, filters out the items that exceed the standard, and obtains a list of high toxicity numbers. The conflict screening submodule calls the highly toxic number list and the structural attribute identifier sequence, calculates the conflict index between instrument parameters and bacterial characteristics, compares the conflict index with the rejection threshold, filters out excess items, and generates a sequence of items that cannot be directly disinfected.

5. The medical device cleaning and disinfection process evaluation system according to claim 4, characterized in that, The disinfection path reconstruction module includes: The trajectory parameter extraction submodule extracts the cleaning frequency, operation frequency and previous disinfection method number of the corresponding instrument in the current department based on the instrument number of the non-directly disinfectable items, and constructs the cleaning behavior trajectory of the instrument according to the number order to obtain the behavior trajectory matrix. The behavior deviation determination submodule calls the behavior trajectory matrix and the method number in the current operation record, compares the matching degree between the method number in the behavior trajectory and the current usage method number item by item, calculates the fitting score value of the device number, determines whether the deviation ratio between the score and the average score exceeds the deviation ratio threshold, and obtains the list of deviation numbers. The method set generation submodule calls the deviation number list and the method numbers corresponding to similar operation frequencies recorded in the behavior trajectory matrix, filters the method numbers whose operation frequency is higher than the preset frequency threshold and has not deviated, and combines them to form an operation mode set, generating a disinfection method set.

6. The medical device cleaning and disinfection process evaluation system according to claim 5, characterized in that, The combined medical device standard comparison module includes: The process structure identification submodule determines whether multiple instruments are being processed in parallel in the current cleaning process based on the method number in the set of disinfection methods. If parallel processing exists, the number is recorded to obtain the parallel number sequence. The method content extraction submodule calls all the numbering information in the parallel numbering sequence, extracts the operating temperature range, liquid penetration characteristics and disinfection time requirement parameters in the corresponding method content, establishes a method content parameter set, and obtains a method parameter combination set. The intersection judgment and screening submodule compares the temperature range, liquid penetration range and upper and lower time limits of multiple instruments according to the parameter combination set, and filters out the numbers with no intersection of the three parameters, generating a set of adaptation consistency numbers.

7. The medical device cleaning and disinfection process evaluation system according to claim 6, characterized in that, The disinfection intensity matching verification module extracts the temperature, penetration depth and time values ​​corresponding to the matching consistency number set, compares them with the required values ​​of the instruments, screens out the instrument numbers that do not meet the standards, and generates a list of instruments with insufficient disinfection intensity. The list of instruments with insufficient disinfection intensity includes numbers for those that did not reach the required temperature, penetration depth, or contact time.

8. The medical device cleaning and disinfection process evaluation system according to claim 7, characterized in that, The disinfection intensity matching verification module includes: The mode parameter extraction submodule extracts the temperature value, penetration depth value and action time value from the corresponding mode content based on the mode number of each device in the adaptation consistency number set, establishes a mode intensity parameter set, and generates a mode parameter matrix. The device demand matching submodule calls the method parameter matrix and the demand parameters corresponding to the device number, compares the temperature value, penetration depth value and action time value item by item to see if they meet the threshold range required by the device, marks the number of items that do not meet the standard, and obtains the sequence of non-compliant numbers; The insufficient intensity screening submodule summarizes and organizes all the numbers that do not meet the requirements according to the sequence of non-compliant numbers, establishes a corresponding list of instruments, and generates a list of instruments with insufficient disinfection intensity.

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