CN116617434A - Automatic disinfection effect verification system capable of reusing medical equipment - Google Patents
Automatic disinfection effect verification system capable of reusing medical equipment Download PDFInfo
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- CN116617434A CN116617434A CN202310534161.8A CN202310534161A CN116617434A CN 116617434 A CN116617434 A CN 116617434A CN 202310534161 A CN202310534161 A CN 202310534161A CN 116617434 A CN116617434 A CN 116617434A
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- 238000012795 verification Methods 0.000 title claims abstract description 46
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Classifications
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
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- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
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- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B08B3/00—Cleaning by methods involving the use or presence of liquid or steam
- B08B3/04—Cleaning involving contact with liquid
- B08B3/10—Cleaning involving contact with liquid with additional treatment of the liquid or of the object being cleaned, e.g. by heat, by electricity or by vibration
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- B08B3/04—Cleaning involving contact with liquid
- B08B3/10—Cleaning involving contact with liquid with additional treatment of the liquid or of the object being cleaned, e.g. by heat, by electricity or by vibration
- B08B3/12—Cleaning involving contact with liquid with additional treatment of the liquid or of the object being cleaned, e.g. by heat, by electricity or by vibration by sonic or ultrasonic vibrations
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
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- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
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- C—CHEMISTRY; METALLURGY
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- C12M33/00—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus
- C12M33/14—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus with filters, sieves or membranes
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M37/00—Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
- C12M41/12—Means for regulation, monitoring, measurement or control, e.g. flow regulation of temperature
- C12M41/14—Incubators; Climatic chambers
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
- C12M41/30—Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration
- C12M41/36—Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration of biomass, e.g. colony counters or by turbidity measurements
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
- C12Q1/22—Testing for sterility conditions
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B21/00—Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects
- F26B21/001—Drying-air generating units, e.g. movable, independent of drying enclosure
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B23/00—Heating arrangements
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/17—Combination with washing or cleaning means
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- A—HUMAN NECESSITIES
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- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
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- Wood Science & Technology (AREA)
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- Mechanical Engineering (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Business, Economics & Management (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Physics & Mathematics (AREA)
- Clinical Laboratory Science (AREA)
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- Biophysics (AREA)
- Primary Health Care (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
The invention discloses an automatic disinfection effect verification system of reusable medical equipment, and relates to the technical field of disinfection effect verification systems. The bacterial liquid simulation pollution drying module, the disinfection module and the cleaning drying module pollute, disinfect, clean and dry instruments, and then carry out elution and recovery of residual microorganisms through the residual elution and recovery module; the eluent is filtered, collected and counted by a residual microorganism filtering, collecting and counting module, and data are transmitted to a system control module to carry out operation and judgment of verification results; the automatic disinfection effect verification system has the advantages of high automation degree, high efficiency, accurate verification result, safety of treatment personnel and the like, and fills up the industry blank of the automatic disinfection effect verification system capable of repeatedly using medical equipment.
Description
Technical Field
The invention relates to the technical field of disinfection effect verification systems, in particular to an automatic disinfection effect verification system for reusable medical instruments.
Background
A reusable medical device (Reusable Medical Devices) refers to a medical device that is reused on the same or different patients, and that is subjected to appropriate reprocessing procedures between uses (including cleaning, disinfection and sterilization procedures, cleaning being the use of physical means to remove contaminants such as blood, tissue, interstitial fluid, body fluids, etc., disinfection or sterilization to inactivate microorganisms). Both the us FDA and CE have placed requirements on the safety of reusable medical device reprocessing procedures: first, the instrument manufacturer needs to fully consider the problem of easy operation and effectiveness of reprocessing in subsequent use at the beginning of design; second, the instrument manufacturer needs to make explicit reusable medical instrument reprocessing related information (including reprocessing methods, equipment, reagents, parameters, etc.), and to ensure that the reprocessing information provided above is validated and confirmed. NMPA has also released the "reusable medical apparatus reprocessing verification method and sign register technology examination guiding principle" at present, the "reusable medical apparatus reprocessing description and confirming method register technology examination guiding principle" solicit comments, will also put forward the corresponding regulatory requirement to the reprocessing effect confirmation of reusable medical apparatus in the later stage. Therefore, with the increasing of the supervision of reusable medical devices at home and abroad, the verification/confirmation of the reprocessing effect of reusable medical devices is particularly important.
Medical devices can be classified into critical, semi-critical and non-critical devices according to the Studies classification, and advice is given to the reprocessing process they need based on the degree of potential risk of infection they may cause. For critical instruments, the user is required to sterilize after thorough cleaning. For semi-critical instruments, the user is required to reprocess them by sterilization after thorough cleaning; if the instrument design does not allow sterilization (e.g., the instrument material cannot withstand the sterilization process), a high level of sterilization should be used. For non-critical instruments, the user is required to perform thorough cleaning and then moderate or low level disinfection depending on the nature and extent of contamination.
The reusable medical device manufacturer should fully define the reprocessed information, and the manufacturer should maintain a verification record of the relevant reprocessed information in the system file according to the requirements of the medical device production quality management specifications, proving that the reprocessed information is verified and easy for the user to understand and has operability. For the sterilization process in reprocessing, the manufacturer should formulate the corresponding sterilization (high, medium, low level) method according to the intended use of the instrument; it should be noted that whatever sterilization method is used should be confirmed and described in the instructions for use of the instrument; confirmation of the sterilization process should prove effective in removing contaminants and achieving the intended sterilization effect after sterilization.
Disinfection refers to the treatment of eliminating or killing pathogenic microorganisms on a transmission medium to make them harmless. Depending on the nature of the disinfectant, the microbial inactivation rate of the disinfection process may vary, thereby separating the nature of the disinfectant into the following sub-categories: high level disinfection-a lethal process using a sterilant below sterilization conditions. This process kills all forms of microorganisms except for a large number of bacterial spores; moderate level disinfection-a lethal process using disinfectants that kill viruses, mycobacteria, fungi, and vegetative bacteria but not bacterial spores; low level disinfection-a lethal process using disinfectants that kill bacteria, some fungi, and lipid virus propagules.
Currently, chemical sterilization methods are an absolute advantage in reprocessing sterilization processes, and are not alternatives. At present, the confirmation process of the disinfection effect is based on manual operation (basically divided into wiping, spraying, immersing and the like according to different disinfection levels and disinfectants), and the verification of the disinfection effect by the manual operation has a plurality of defects: 1. the whole disinfection effect verification process is complex in steps, the manual operation is low in efficiency on one hand, and large test errors are brought by complex steps on the other hand, so that verification result deviation is large; 2. due to the inherent corrosiveness, volatility, pungent odor, sensitization, and cell/biotoxicity characteristics of chemical disinfectants (including alcohols, aldehydes, acids, phenols, peroxides, etc.), there is a greater risk of occupational exposure for the treating personnel. The automatic disinfection effect verification system for the reusable medical instrument is designed and disclosed, so that the verification efficiency, the verification result and the safety of the treatment personnel are fully ensured, and meanwhile, the industry blank of the automatic disinfection effect verification system for the reusable medical instrument is made up.
Disclosure of Invention
The invention aims to provide an automatic disinfection effect verification system for reusable medical equipment, which solves the problems in the background technology.
In order to achieve the aim of the invention, the invention adopts the following technical scheme:
the invention provides an automatic disinfection effect verification system for reusable medical instruments, which comprises a bacterial liquid simulated pollution drying module, a disinfection module, a cleaning drying module, a residue eluting and recycling module, a residual microorganism filtering, collecting and counting module, a system control module and an instrument temporary storage bin, wherein the bacterial liquid simulated pollution drying module is used for cleaning and drying the medical instruments;
the bacterial liquid simulated pollution drying module is used for inoculating bacterial suspension onto the instrument and drying the inoculated instrument; the disinfection module is used for disinfecting the inoculated instrument; the cleaning and drying module is used for removing the disinfectant remained on the surface of the disinfected instrument; the residue eluting and recycling module is used for eluting and recycling the cleaned instrument to obtain eluent; the residual microorganism filtering, collecting and counting module is used for filtering and culturing the eluent and identifying and counting the residual microorganisms; the system control module is used for calculating the number of the residual microbial colonies and giving a judgment conclusion to the verification result according to the preset evaluation standard of the system; the instrument temporary storage bin is used for temporarily storing instruments with verified disinfection effects.
Further, the device also comprises a shell and a disinfection basket, wherein a pollution drying bin, a disinfection bin, a cleaning drying bin and an eluting recovery bin are respectively arranged in the shell from left to right; and all be provided with perpendicular automatic rising sealing door between pollution dry storehouse, disinfection storehouse, washing dry storehouse and the elution recovery storehouse, the disinfection basket is located the inside of casing and is used for holding the apparatus, and the bottom of disinfection basket is provided with moving mechanism, so that the disinfection basket is pollution dry storehouse, disinfection storehouse, washing dry storehouse and elution recovery storehouse between automatic the removal, fungus liquid simulation pollution dry module, disinfection module, washing dry module and residue elution recovery module set up respectively in pollution dry storehouse, disinfection storehouse, washing dry storehouse and the elution recovery storehouse.
Further, one side of pollution drying storehouse is provided with the operation mouth, operation mouth department is provided with biological seal door, fungus liquid simulation pollution drying module is including locating operation panel, high-efficient air cleaner, fan and the disinfection ultraviolet fluorescent tube in the pollution drying storehouse, disinfection basket can be through moving mechanism removal to the operation panel on.
Further, the disinfection module comprises a wiping component and a spraying component, the wiping component comprises a circular disc which is assembled at the center of the top of the disinfection bin and can rotate by 360 degrees, the circular disc is horizontally arranged, and a plurality of long-bristle flexible rolling brushes which can stretch out and draw back along the direction perpendicular to the circular disc are arranged at the bottom of the circular disc along the circumferential direction of the circular disc; the long-bristle flexible rolling brush is parallel to the disc and can rotate along the circumferential direction of the disc, and the spraying assembly comprises two first rotary high-pressure spraying arms which are respectively arranged at the top and the bottom of the disinfection bin, and a first liquid injection assembly which can pump disinfectant into the first rotary high-pressure spraying arms.
Further, the cleaning and drying module comprises a cleaning assembly and a drying assembly, wherein the cleaning assembly comprises two second rotary high-pressure spray arms respectively arranged at the top and the bottom of the cleaning and drying bin, a second liquid injection assembly capable of pumping sterile water into the second rotary high-pressure spray arms, and a first ultrasonic generator arranged in the cleaning and drying bin; the drying component comprises a PTC ceramic air heater communicated with the cleaning bin, a temperature sensor and a heating element which are arranged in the cleaning drying bin, and an exhaust pipe arranged at the top of the cleaning drying bin.
Further, the residue elution recovery module comprises a third liquid injection assembly for injecting sterile water into the elution recovery bin and a second ultrasonic generator arranged in the elution recovery bin.
Further, the module is collected and counts in filtration of remaining microorganism includes the box, the bottom of box is provided with the baffle to make the box form working chamber and collection chamber from top to bottom, the bottom of working chamber evenly is provided with the base that a plurality of runs through the baffle, the top of base is fixed with the filter bowl that the upper and lower end is link up, the bottom of filter bowl is provided with filter membrane and culture medium absorption pad, the collection chamber is connected with the negative pressure suction filter device that is used for collecting the inside gaseous suction of chamber, the bottom of collection chamber is provided with the drain pipe, and is provided with electronic valve on the drain pipe, the inside of working chamber is provided with the constant temperature equipment that controls the inside temperature of working chamber, remaining microorganism filters collection and counts the module still including be used for pouring into the first injection subassembly of eluent into a plurality of filter bowl respectively, pour into aseptic water's second injection subassembly and pour into liquid culture medium's third injection subassembly into to and carry out formation of image, count the microorganism that grows on the filter membrane.
Further, the operation formula of the system control module is as follows:
Δlg=lgC 0 V 0 -lg(N 1 D 1 +N 2 D 2 +......+N M D M )/M
in the formula:
Δlg-log reduction of microbial content before and after instrument sterilization;
C 0 -bacterial liquid mimics concentration of bacterial suspension (CFU/mL) inoculated by the instrument in the contamination drying module;
V 0 -bacterial liquid mimics the volume of bacterial suspension (mL) inoculated by the instrument in the contamination drying module;
the number of the bacterial Colonies (CFU) on the filter membrane with the bacterial colony number between 10 and 100 in the N-residual microorganism filtering, collecting and counting module;
d-the corresponding dilution factor (n, 2n, 4n … … n (n.gtoreq.2) corresponding to the filter membrane);
m-number of filters with colony count between 10 and 100.
Further, the system preset evaluation criteria of the system control module are as follows:
high level disinfection selects mycobacterium, and the disinfection is reduced by not less than 6 orders of magnitude (delta lg is more than or equal to 6.0);
staphylococcus aureus, pseudomonas aeruginosa, escherichia coli, klebsiella and mycobacterium are selected for medium-level disinfection, bacteria are reduced by not less than 6 orders of magnitude (delta lg is not less than 6.0) after disinfection, and mycobacteria are reduced by not less than 3 orders of magnitude (delta lg is not less than 3.0);
the staphylococcus aureus, the pseudomonas aeruginosa, the escherichia coli and the klebsiella are selected at a low level, and the sterilizing speed is reduced by not less than 6 orders of magnitude (delta lg is more than or equal to 6.0).
Compared with the prior art, the above technical scheme has the following beneficial effects:
the invention completes bacterial suspension inoculation pollution of the instrument in a sterilizing basket of a bacterial liquid simulated pollution drying module; the dried instruments are transported to a disinfection module for disinfection (high, medium and low level disinfection, corresponding disinfection modes can be set) through a disinfection basket; after the disinfection is finished, the instruments are transported to a cleaning and drying module through a disinfection basket to clean and dry residual disinfectants; then the instrument is transported to a residue eluting and recovering module through a sterilizing basket for eluting and recovering the residual microorganisms; transferring the eluent to a residual microorganism filtering, collecting and counting module for filtering, collecting and counting residual microorganisms; after the microorganism counting in the residual microorganism filtering, collecting and counting module is completed, transmitting data to a system control module to perform Δlg operation and judgment of a verification result; if the effect verification and judgment are qualified, transferring the instrument into an instrument temporary storage bin for temporary storage and waiting for taking; if the medical instrument is unqualified, the instrument returns to the bacterial liquid simulated pollution drying module according to the original path to wait for further verification after the disinfection parameters are adjusted, so that the automatic disinfection effect verification system has the advantages of being high in automation degree, high in efficiency, accurate in verification result, capable of guaranteeing the safety of processing staff and the like, and fills up the industry blank of the automatic disinfection effect verification system capable of reusing the medical instrument.
In addition, it is specially noted that the system can be used as a disinfection effect verification system and a medical instrument daily disinfection system, after the disinfection effect verification is completed and qualified, the system can record different disinfection parameters corresponding to different instruments, and then the instruments are subjected to subsequent daily disinfection by using the verified disinfection parameters, so that the system is convenient, reliable and safe.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention.
FIG. 1 is a schematic view of a housing structure of the present invention;
FIG. 2 is a schematic view of the internal structure of the housing of the present invention;
fig. 3 is a schematic view of the internal structure of the case of the present invention;
FIG. 4 is a schematic view of the structure of the filter bowl of the present invention;
fig. 5 is a schematic overall flow diagram of the present invention.
In the figure:
100. a housing; 110. pollution drying bin; 120. a disinfection bin; 121. a first liquid discharge pipe; 122. a first electromagnetic valve; 130. cleaning a drying bin; 131. a second liquid discharge pipe; 132. a second electromagnetic valve; 140. eluting and recycling bin; 150. an operation port; 160. a vertical automatic lifting sealing door;
200. A sterilizing basket; 210. a moving mechanism; 211. a mechanical drive wheel; 212. clamping the rail;
310. an operation table; 320. a high efficiency air filter; 330. a blower; 340. sterilizing the ultraviolet lamp tube;
410. a disc; 420. long brush flexible rolling brush; 430. a first rotary high pressure spray arm;
510. the second rotary high-pressure spray arm; 520. a first ultrasonic generator; 530. an exhaust pipe; 610. a second ultrasonic generator;
710. a case; 720. a partition plate; 711. a working chamber; 712. a collection chamber; 730. a base; 740. a filter cup; 750. a filter membrane; 760. a medium absorbing pad; 770. a negative pressure suction filtration device; 780. a thermostat device; 790. an imaging system; 800. an eluent line; 900. a sterile water line; 1000. a liquid medium line; 1100. an electric track; 1200. pipeline storage/disinfection bin.
Description of the embodiments
In order that those skilled in the art will better understand the present application, a technical solution in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in which it is apparent that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the present application without making any inventive effort, shall fall within the scope of the present application.
Referring to fig. 1-5, the invention provides an automatic disinfection effect verification system for reusable medical instruments, which comprises a bacterial liquid simulated pollution drying module, a disinfection module, a cleaning drying module, a residue eluting and recycling module, a residual microorganism filtering, collecting and counting module, a system control module and an instrument temporary storage bin;
the device also comprises a shell 100 and a disinfection basket 200, wherein a pollution drying bin 110, a disinfection bin 120, a cleaning drying bin 130 and an elution recovery bin 140 are respectively arranged in the shell 100 from left to right; the vertical automatic lifting sealing doors 160 are arranged among the pollution drying bin 110, the disinfection bin 120, the cleaning drying bin 130 and the elution recycling bin 140, sealing rubber strips are arranged around the vertical automatic lifting sealing doors 160, the front bin and the rear bin are sealed in an isolated manner after the vertical automatic lifting sealing doors 160 are closed, the disinfection basket 200 is arranged in the shell 100 and used for containing instruments, the bottom of the disinfection basket 200 is provided with a moving mechanism 210, in particular, the moving mechanism 210 comprises mechanical driving wheels 211 arranged at two sides of the bottom of each bin, and clamping rails 212 matched with mechanical driving pulleys are arranged at the bottom of the disinfection basket 200, the mechanical driving wheels 211 in each bin rotate to enable the disinfection basket 200 to automatically move among the pollution drying bin 110, the disinfection bin 120, the cleaning drying bin 130 and the elution recycling bin 140, wherein the mechanical driving wheels 211 in each bin are completely consistent in horizontal space and are in the same plane, the connection stability is guaranteed, the disinfection basket 200 can smoothly move in each bin, and thus the processes of each bin are completed, the moving mechanism 210 can also be a mechanism capable of realizing the movement of the disinfection basket 200 in each bin, such as a sliding rail, and the like;
The bacterial liquid simulated pollution drying module is arranged in the pollution drying bin 110 and is used for inoculating bacterial suspension onto the instrument and drying the inoculated instrument; to simulate the worst clinical use case (dry bacterial suspensions are more difficult to sterilize);
specifically, the pollution drying bin 110 is an improved biosafety cabinet, an operation port 150 is provided on one side of the pollution drying bin 110, a bioseal door is provided at the operation port 150, the bacterial liquid simulated pollution drying module comprises an operation table 310, a high-efficiency air filter 320, a fan 330 and a disinfection ultraviolet lamp 340, which are arranged in the pollution drying bin 110, and the disinfection basket 200 can be moved onto the operation table 310 through a moving mechanism 210.
When the method is applied, different types of microorganisms are selected according to the disinfection level to be achieved by reprocessing the multiplexing apparatus, mycobacterium is selected for high-level disinfection, staphylococcus aureus, pseudomonas aeruginosa, escherichia coli, klebsiella and mycobacterium are selected for the level, and staphylococcus aureus, pseudomonas aeruginosa, escherichia coli and klebsiella are selected for the low level; after preparing a culture of the required microorganism into a bacterial suspension with a proper concentration, inoculating a proper amount of bacterial suspension to the whole clinical use surface of the instrument and uniformly dispersing the bacterial suspension (the inoculation position is important to consider the least easily disinfected parts such as a joint gap, an elongated inner cavity and the like), and drying after the inoculation is finished, wherein the preparation, the inoculation and the drying processes of the bacterial suspension are all finished in a pollution drying bin 110, so that operators and test samples are protected and biological safety requirements are met; the high-efficiency air filter 320 and the fan 330 of the pollution drying bin 110 are used for filtering and purifying air in the bin, maintaining negative pressure in the bin through partial discharge of air, ensuring cleanliness in the bin and preventing microorganisms from overflowing; the operation platform is made of 316L stainless steel, so that later cleaning and disinfection are convenient; a sterilizing ultraviolet lamp 340 for daily sterilization; during inoculation, the disinfection basket 200 can be moved to the operation platform to facilitate inoculation and drying after inoculation of bacterial suspension on the internal instruments, and the disinfection basket 200 adopts a hollowed-out design to enhance the omnibearing air flow effect around the medical instruments on the panel, thereby being beneficial to quick drying of the surfaces of the instruments after inoculation of bacterial suspension, wherein the drying time can be adjusted by a system control module;
The disinfection module is arranged in a disinfection bin 120 and is used for disinfecting the inoculated instruments;
specifically, the bottom of the disinfection bin 120 is provided with a first liquid discharge pipe 121, and the first liquid discharge pipe 121 is provided with a first electromagnetic valve 122, the disinfection module comprises a wiping component and a spraying component, the wiping component comprises a disc 410 which is assembled at the center of the top of the disinfection bin 120 and can rotate 360 degrees, the disc 410 is horizontally arranged, and the bottom of the disc 410 is provided with a plurality of long brush hair flexible rolling brushes 420 which can stretch along the direction perpendicular to the disc 410 along the circumferential direction; the long bristle flexible rolling brush 420 is parallel to the disc 410 and can rotate along the circumferential direction of the long bristle flexible rolling brush 420, more specifically, the center of the disc 410 can be connected with the output end of a motor fixed at the top of the disinfection bin 120 through a rotating shaft so as to realize 360-degree rotation of the disc 410, a folding arm or an electric telescopic rod is arranged at the bottom of the disc 410 along the circumferential direction of the disc, and then the long bristle flexible rolling brush 420 is arranged at the bottom of the electric telescopic rod or the folding arm, wherein the output shaft of the long bristle flexible rolling brush 420 is connected with a driving motor so as to realize the extension and retraction of the long bristle flexible rolling brush 420 in the direction perpendicular to the disc 410 and the autorotation of the long bristle flexible rolling brush 420, but the invention is not limited thereto; the spraying assembly comprises two first rotary high-pressure spraying arms 430 respectively arranged at the top and the bottom of the disinfection bin 120 and a first liquid injection assembly capable of pumping disinfection liquid into the first rotary high-pressure spraying arms 430, more specifically, the first liquid injection assembly comprises a disinfection liquid storage tank and a high-speed peristaltic pump, an input pipe of the high-speed peristaltic pump is communicated with the disinfection liquid storage tank, and an output pipe of the high-speed peristaltic pump is connected with input ports of the two first rotary high-pressure spraying arms 430 through a pipeline so as to pump the disinfection liquid into the two first rotary high-pressure spraying arms 430, but the spraying assembly is not limited to the disinfection liquid.
When the device is applied, after clinical pollution is simulated on the devices, the vertical automatic lifting sealing door 160 between the pollution drying bin 110 and the disinfection bin 120 can be lifted to a set position, then the disinfection basket 200 carrying the dried devices is moved into the disinfection bin 120 through the moving mechanism 210, after the whole disinfection basket 200 is moved to the right center of the disinfection bin 120, the vertical automatic lifting sealing door 160 between the pollution drying bin 110 and the disinfection bin 120 is lowered to the bottom to isolate and seal the pollution drying bin 110 and the disinfection bin 120, and then the disinfection module can carry out wiping, spraying, immersing/soaking disinfection operation on the devices according to the high, medium and low disinfection levels required by multiplexing the devices and the selected disinfectant types and the using methods thereof (the three methods basically cover the using methods of all chemical disinfectants in the market);
wherein wiping and spraying can be performed simultaneously, wiping operation is completed by the wiping component, and the wiping component is generally used for medium-level and low-level disinfection, in particular low-level disinfection; the specific wiping mode is that firstly, a plurality of long-bristle flexible rolling brushes 420 which can stretch along the direction perpendicular to the disc 410 are stretched to be close to the instrument, and revolution and autorotation can be realized by driving the disc 410 to rotate and the long-bristle flexible rolling brushes 420 to rotate, so that the rotary omnibearing wiping can be performed on the instruments with different shapes, and the disinfection effect is improved; the spraying procedure is completed by a spraying component, which is generally used for medium and low level disinfection, specifically, a first liquid injection component pumps disinfectant into two first rotary high-pressure spraying arms 430 of the disinfection bin 120, a plurality of spraying holes with different angles are designed on the spraying arms of the first rotary high-pressure spraying arms 430, and the disinfectant can thoroughly spray and disinfect the instruments in the hollow disinfection basket 200 without dead angles through high-speed rotation; more specifically, the system control module can set the spraying time, the spraying flow and various spraying disinfection modes: 1. spraying continuously for a fixed time (single-stage procedure); 2. the fixed spraying time, the fixed acting time of the disinfectant after stopping spraying, the fixed spraying time, the fixed acting time of the disinfectant after stopping spraying (multi-stage program) and the like; after the spraying disinfection is finished, the disinfection basket 200 can be arranged to shake left and right through the moving mechanism 210 so as to remove disinfectant liquid drops possibly existing on the surfaces of the instruments and the disinfection basket 200, and prevent the situation that the instruments possibly produce disinfectant drops on the way of being transferred into the next bin from damaging equipment/polluting the environment (the shaking speed and time can be adjusted at will in the system control module according to the types of the instruments); when the above operation is completed, the first solenoid valve 122 of the first drain pipe 121 of the sterilizing compartment 120 is opened, the sterilizing agent of the sterilizing compartment 120 is discharged into the waste liquid tank to be treated, the disk 410 and the long bristle flexible rolling brush 420 stop rotating, and the long bristle flexible rolling brush 420 is reset by mechanical folding.
While the submerged/soaked sterilization operation, which is generally used for high-level sterilization, may be performed by injecting liquid into the sterilization chamber 120 through the spray assembly, i.e., discharging the liquid from the first rotary high-pressure spray arm 430, so that the instruments on the sterilization basket 200 are submerged and sterilized; the volume of disinfectant and immersion time required by immersion can be set in a system control module according to the size of the instrument and the requirements of the disinfectant/instrument; during immersion disinfection, the disinfection basket 200 can be arranged to shake left and right through the moving mechanism 210, so that bubbles possibly existing on the surface of the instrument in an immersed state are removed, and the sufficient contact between the disinfectant and the surface of the instrument is ensured, so that the effect of immersion disinfection is ensured (the shaking speed and time can be adjusted at will in a system control module according to the type of the instrument); after the immersed disinfection time is over, a first electromagnetic valve 122 of a first liquid discharge pipe 121 of the disinfection bin 120 is opened, and disinfectant in the disinfection bin 120 is discharged into a waste liquid barrel to be treated; the sterilization basket 200 may then be set to shake left and right by the moving mechanism 210 to remove any disinfectant drops on the surface of the instrument and on the sterilization basket 200, and prevent the instrument from damaging the instrument/polluting the environment due to the disinfectant drops that may be generated during the transfer to the next module (the shaking rate and time may be arbitrarily adjusted in the system control module according to the instrument type).
The cleaning and drying module is arranged in the cleaning and drying bin 130 and is used for removing the disinfectant remained on the surface of the disinfected instrument;
specifically, the bottom of the cleaning and drying bin 130 is provided with a second liquid drain pipe 131, and a second electromagnetic valve 132 is arranged on the second liquid drain pipe 131, the cleaning and drying module comprises a cleaning component and a drying component, the cleaning component comprises two second rotary high-pressure spray arms 510 respectively arranged at the top and the bottom of the cleaning and drying bin 130, a second liquid injection component capable of pumping sterile water into the second rotary high-pressure spray arms 510, and a first ultrasonic generator 520 arranged in the cleaning and drying bin 130; more specifically, the second liquid injection assembly includes a sterile water tank and a high-speed peristaltic pump, the input pipe of the high-speed peristaltic pump is communicated with the sterile water tank, and the output pipe of the high-speed peristaltic pump is connected with the input ports of the two second rotary high-pressure spray arms 510 through a pipeline, so as to pump sterile water into the second rotary high-pressure spray arms 510, but not limited thereto; the drying assembly includes a PTC ceramic hot air blower in communication with the washing tub, a temperature sensor and a heating member (both not shown) provided in the washing tub, and an exhaust pipe 530 provided at the top of the washing tub 130, more specifically, the heating member may be a heating pipe, but is not limited thereto.
When the device is applied, the cleaning and drying module has the function of removing the residual disinfectant on the surface of the device, and preventing the residual disinfectant from affecting the subsequent microorganism recovery culture (clinically preventing the residual disinfectant from damaging the subsequent patient); after the sterilized instruments in the sterilizing module are automatically transferred to the washing and drying module through the sterilizing basket 200, the vertical automatic lifting sealing door 160 of the sterilizing compartment 120 and the washing and drying compartment 130 is lowered and closed so that the washing and drying compartment 130 forms a closed space; the cleaning and drying module can finish the processes of spray rinsing, immersion shaking rinsing, immersion ultrasonic rinsing, immersion shaking+spray rinsing, immersion ultrasonic+spray rinsing and hot air drying, and the processes can be flexibly set in the system control module according to the type of the instrument;
wherein, spray the washing flow: is generally applicable to medical instruments with easy-to-clean cleaning agents such as ethanol and isopropanol and smooth surfaces; the second liquid injection assembly pumps sterile water into the second rotary high-pressure spray arm 510, a plurality of spray holes with different angles are designed on the second rotary high-pressure spray arm 510, and the sterile water can thoroughly spray and rinse the instruments in the hollow disinfection basket 200 without dead angles through high-speed rotation so as to remove disinfectant residues on the surfaces of the instruments (the spray time, the spray water quantity and the spray rate can be set in a system control module); at the same time of spray flushing, the second electromagnetic valve 132 of the second liquid discharge pipe 131 of the cleaning and drying bin 130 is opened, and the cleaning water is discharged into the waste liquid barrel to be treated;
Immersing, shaking and cleaning: is generally applicable to medical instruments with easy-to-clean cleaning agents such as ethanol and isopropanol and smooth surfaces; sterile water enters the cleaning and drying bin 130 through the second liquid injection assembly and the second rotary high-pressure spray arm 510, and the devices in the sterilization basket 200 are immersed; after immersing, the disinfection basket 200 shakes left and right through the moving mechanism 210, and shakes and cleans the apparatus, thereby improving the cleaning efficiency of the apparatus. (the volume of sterile water required for immersion, immersion shake cleaning time, shake rate may be arbitrarily adjusted at the system control module depending on the type of instrument and its nature).
Immersing ultrasonic cleaning flow: is generally applicable to medical instruments with dead corners, inner cavities and relatively rough surfaces; sterile water enters the cleaning and drying bin 130 through the second liquid injection assembly and the second rotary high-pressure spray arm 510, the equipment in the sterilization basket 200 is immersed, then an ultrasonic generator in the cleaning and drying bin 130 is started, and the equipment immersed in the sterile water is subjected to ultrasonic cleaning (parameters such as the volume of the sterile water required by immersion, immersion ultrasonic time, ultrasonic frequency and the like can be set in a system control module according to the size and type of the equipment); after the immersed ultrasonic time is over, a second electromagnetic valve 132 of a second liquid discharge pipe 131 of the cleaning and drying bin is opened, and cleaning water is discharged into a waste liquid barrel to be treated; the immersed ultrasonic cleaning flow can be repeated for a plurality of times in the system control module, and water changing, ultrasonic and water draining during the process are automatically completed.
Immersing ultrasonic and spraying flushing processes: the cleaning agent is generally suitable for medical instruments with dead angles, inner cavities, relatively rough surfaces and high requirements on cleaning effects; the immersed ultrasonic cleaning is operated firstly, and then the spraying flushing is operated.
And (3) drying flow: after the cleaning process is finished, the PTC ceramic air heater communicated with the inner cavity of the cleaning and drying bin 130 is automatically started to dry the instruments in the disinfection basket 200; the air inlet of the PTC ceramic air heater is provided with an air filter, so that the cleanliness of blown hot air is ensured, and the cleanliness of instruments in the cabin is ensured; the temperature sensor of the drying bin 130 is cleaned, and the temperature in the bin is controlled by controlling the start and stop of the heating element (the temperature in the bin is maintained in a proper tolerable range of the instrument while ensuring the drying effect, so that the influence of the temperature on different types of instruments is reduced to the greatest extent); the exhaust pipe 530 for cleaning the top of the drying bin 130 can balance the internal and external air pressure, and further, the exhaust pipe 530 can be inserted into the recycling bin, so that condensed water generated by liquefying steam can be recycled while the internal and external air pressure is balanced (the temperature and the drying time in the bin can be set in the system control module).
The residue eluting and recovering module is arranged in an eluting and recovering bin 140 and is used for eluting and recovering the cleaned instrument to obtain eluent;
Specifically, the residue eluting and recovering module includes a third liquid injecting component for injecting sterile water into the eluting and recovering bin 140 and a second ultrasonic generator 610 disposed in the eluting and recovering bin 140, and more specifically, the third liquid injecting component includes a sterile water storage tank and a high-speed peristaltic pump, an input pipe of the high-speed peristaltic pump is communicated with the sterile water storage tank, and an output pipe of the high-speed peristaltic pump is communicated with the eluting and recovering bin 140, so as to inject sterile water into the eluting and recovering bin 140, but not limited thereto.
Based on the above design, after the cleaned and dried instruments in the washing and drying module are automatically transferred to the elution and recovery bin 140 through the sterilizing basket 200, the vertical automatic lifting sealing door 160 between the elution and recovery bin 140 and the washing and drying bin 130 is lowered and closed so that the elution and recovery bin 140 forms a closed space; sterile water is pumped into the elution recovery bin 140 through the third liquid injection assembly, instruments in the sterilization basket 200 are immersed (the volume of the sterile water required for immersing can be set in a system control module according to the volume/size of the instruments), and then shaking elution recovery or ultrasonic elution recovery can be carried out according to the properties of the instruments, so that eluent is obtained;
the residual microorganism filtering, collecting and counting module is used for filtering and culturing the eluent and identifying and counting the residual microorganisms;
Specifically, the residual microorganism filtering, collecting and counting module includes a box 710, a partition board 720 is disposed at the bottom of the box 710, so that a working chamber 711 and a collecting chamber 712 are formed from top to bottom in the box 710, a plurality of bases 730 penetrating through the partition board 720 and penetrating through the inside are uniformly disposed at the bottom of the working chamber 711, a filter cup 740 penetrating through the upper end and the lower end is fixed at the top of the base 730, a filter membrane 750 and a culture medium absorbing pad 760 are disposed at the bottom of the filter cup 740, the collecting chamber 712 is connected with a negative pressure suction filtration device 770 for sucking out air in the collecting chamber 712, a drain pipe is disposed at the bottom of the collecting chamber 712, an electronic valve is disposed on the drain pipe, a thermostat 780 for controlling the temperature in the working chamber 711 is disposed in the working chamber 711, and the residual microorganism filtering, collecting and counting module further includes a first injection assembly for injecting eluent into the plurality of filter cups 740, a second injection assembly for injecting sterile water and a third injection assembly for injecting a liquid culture medium, and an imaging system 790 for imaging and counting microorganisms growing on the filter membrane 750; more specifically, the first injection assembly includes an eluent collection canister, a first pump body, and an eluent line 800; the second injection assembly comprises a sterile water collection tank, a second pump body and a sterile water line 900; the third injection assembly comprises a liquid culture medium collecting tank, a third pump body and a liquid culture medium pipeline 1000, an electric track 1100 is arranged in the box 710, and an eluent pipeline 800 of the first injection assembly, a sterile water pipeline 900 of the second injection assembly and the liquid culture medium pipeline 1000 of the third injection assembly are all fixed on the electric track 1100 through electric sliding so as to inject eluent, sterile water and liquid culture medium (the eluent pipeline 800, the sterile water pipeline 900 and the liquid culture medium pipeline 1000 are flexible pipelines or telescopic pipelines) into a plurality of filter cups 740, wherein the eluent is the eluent collected by the residue eluting recovery module. Further, a pipeline storage/disinfection bin 1200 is further disposed at the electric rail 1100, wherein an ultraviolet lamp and a PTC ceramic air heater are installed inside the pipeline storage/disinfection bin 1200, and the pipeline storage/disinfection bin 1200 can be moved to the pipeline storage/disinfection bin 1200 after the eluent pipeline 800, the sterile water pipeline 900 and the liquid culture medium pipeline 1000 finish working, and the ultraviolet lamp and the PTC ceramic air heater in the pipeline storage/disinfection bin 1200 can dry and disinfect each pipeline.
In use, the base 730 of the module for filtering, collecting and counting residual microorganisms has 8 filter cups, namely 8 filter cups, respectively designated as filter cups 0 to 7 (capacity 100 mL), and the respective corresponding eluent amounts (mL) are: 0 (blank), V/n, V/2n, V/4n, V/8n, V/16n, V/32n, V/64n (n.gtoreq. 2;V is the eluent volume of the single instrument, i.e. the sterile water volume of the immersed instrument in the residue elution recovery module provided in the system control module). Imaging system 790 is prior art and primarily scans for microorganisms growing on filter membrane 750 of filter bowl 740; after the imaging was completed, microorganisms growing on the filter 750 of filter cups 740 No. 1 to No. 7 were identified and counted by built-in software with the image of the filter 750 of filter cup 740 No. 0 as a background (blank). Before the verification system is started, filter cups 740 of No. 0 to No. 7 are sequentially installed on a base 730 in advance, according to the property of the verified instrument and the prediction of the disinfection condition of the verified instrument, the system control module is provided with a filtering coefficient n of a residual microorganism filtering, collecting and counting module (n is more than or equal to 2, the larger n value is more than or equal to the prediction of the disinfection condition), after the residual microorganism filtering, collecting and counting module is started, sterile water is pumped into a sterile water pipeline 900 through a high-speed peristaltic pump, the sterile water pipeline 900 sequentially passes through the center position above the preset filter cups of No. 0 to No. 7 along an electric track 1100, sterile water is sequentially injected into each filter cup 740 according to the sterile water amount required by a film wetting preset in the system control module, and the sterile water pipeline 900 returns to a pipeline storage/disinfection bin 1200 after the injection is completed. And then the negative pressure suction filtration device 770 is self-started (the suction filtration time can be set in the system control module according to the liquid amount), and the liquid in the filter cup 740 is subjected to suction filtration to complete the membrane wetting process (the membrane wetting can enable the pore diameter of the filter membrane to be more uniform and accurate).
The negative pressure pumping device 770 then continues to operate, and the eluent line 800 is identical to the sterile water line 900, and the eluent is sequentially injected into each of the filter cups 740 according to the amount of eluent preset in the system control module (injection and pumping are performed simultaneously, and injection and pumping rates are kept consistent to prevent the overflow of liquid in the filter cup), and after the injection is completed, the eluent line 800 returns to the line storage/sterilization bin 1200. After the eluent is filtered, the negative pressure filter 770 is closed, residual microorganisms are trapped on the filter membrane 750, and the filtered liquid is discharged through a drain pipe.
And then the sterile water pipe is started again, 100mL of sterile water is sequentially injected into each filter cup 740, the negative pressure suction filtration device 770 is started automatically after the water injection is completed, the sterilizing agent possibly remained on the filter membrane 750 is washed by suction filtration (if the sterilizing agent remains, the culture count of microorganisms can be affected), the washing is usually repeated for 2-3 times (the washing times can be set in a system control module), and the washing and suction filtration time for the last time is properly prolonged to ensure that the moisture in the culture medium absorption pad 760 is pumped out as much as possible, so as to prepare for the absorption of the subsequent culture medium.
After the suction filtration is finished, pumping the liquid culture medium into a culture medium pipeline through a high-speed peristaltic pump, sequentially passing the culture medium pipeline through the center position above the preset No. 0-7 filter cups 740 along the electric track 1100, sequentially injecting the culture medium into each filter cup 740 according to the preset culture medium amount in the system control module, and returning the culture medium pipeline to the pipeline storage/disinfection bin 1200 after the injection is finished; the liquid culture medium is absorbed by the culture medium absorbing pad 760 which is tightly attached to the lower surface of the filter membrane 750 through the filter membrane 750, and the culture medium is locked to provide nutrition for the growth of microorganisms on the upper surface of the filter membrane 750.
Then the thermostat 780 is started automatically, so that the temperature in the filtering, collecting and counting module of the residual microorganisms is maintained at the optimal growth temperature of the target microorganisms, and the residual microorganisms on the filter membrane 750 are cultured (the culture temperature and time can be set in the system control module); after the cultivation is completed, an imaging system 790 positioned at the top of the residual microorganism filtering, collecting and counting module is automatically started, and scanning and imaging are respectively carried out on microorganisms growing on a filter membrane 750 of a No. 0-7 filter cup 740; after the imaging was completed, microorganisms grown on filter membrane 750 of filter cups No. 1 to No. 7 were identified and counted by built-in software with the image of filter membrane 750 of filter cup No. 0 as a background (blank).
The system control module is used for calculating the number of the residual microbial colonies and giving a judgment conclusion to the verification result according to the preset evaluation standard of the system;
specifically, after the microorganism counting in the residual microorganism filtering, collecting and counting module is completed, data is transmitted to the system control module, the system automatically screens out the colony count on the filter membrane 750 with the colony count between 10 and 100, and performs operation and analysis, and a judgment conclusion is given to the verification result according to the evaluation standard preset by the system, wherein the operation formula of the system control module is as follows:
Δlg=lgC 0 V 0 -lg(N 1 D 1 +N 2 D 2 +......+N M D M )/M
In the formula:
Δlg-log reduction of microbial content before and after instrument sterilization;
C 0 -bacterial liquid mimics concentration of bacterial suspension (CFU/mL) inoculated by the instrument in the contamination drying module;
V 0 -bacterial liquid mimics the volume of bacterial suspension (mL) inoculated by the instrument in the contamination drying module;
the number of Colonies (CFU) on the filter 750 between 10 and 100 colonies in the N-residual microorganism filtration collection and counting module;
d-the corresponding dilution factor (n, 2n, 4n … … n (n.gtoreq.2) corresponding to filter 750);
m-the number of filters 750 with colony counts between 10 and 100.
The system of the system control module presets the following evaluation criteria:
high level disinfection selects mycobacterium, and the disinfection is reduced by not less than 6 orders of magnitude (delta lg is more than or equal to 6.0);
staphylococcus aureus, pseudomonas aeruginosa, escherichia coli, klebsiella and mycobacterium are selected for medium-level disinfection, bacteria are reduced by not less than 6 orders of magnitude (delta lg is not less than 6.0) after disinfection, and mycobacteria are reduced by not less than 3 orders of magnitude (delta lg is not less than 3.0);
the staphylococcus aureus, the pseudomonas aeruginosa, the escherichia coli and the klebsiella are selected at a low level, and the sterilizing speed is reduced by not less than 6 orders of magnitude (delta lg is more than or equal to 6.0).
The instrument temporary storage bin is used for temporarily storing instruments with verified disinfection effects;
specifically, after the system control module completes operation analysis, if the disinfection effect is verified, the instruments in the residue eluting and recycling module are directly transferred into an instrument temporary storage bin and to be taken out, and the system automatically records all the verified disinfection parameters; if the disinfection effect is verified to be not passed, the instruments in the residue eluting and recovering module are returned to the bacterial liquid simulated pollution drying module according to the original path to wait for further verification after the disinfection parameters are adjusted, and the system automatically records all the disinfection parameters which are not verified.
The foregoing is only a preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art, who is within the scope of the present invention, should make equivalent substitutions or modifications according to the technical scheme of the present invention and the inventive concept thereof, and should be covered by the scope of the present invention.
Claims (9)
1. The automatic disinfection effect verification system for the reusable medical instrument is characterized by comprising a bacterial liquid simulated pollution drying module, a disinfection module, a cleaning and drying module, a residue eluting and recycling module, a residual microorganism filtering, collecting and counting module, a system control module and an instrument temporary storage bin;
The bacterial liquid simulated pollution drying module is used for inoculating bacterial suspension onto the instrument and drying the inoculated instrument; the disinfection module is used for disinfecting the inoculated instrument; the cleaning and drying module is used for removing the disinfectant remained on the surface of the disinfected instrument; the residue eluting and recycling module is used for eluting and recycling the cleaned instrument to obtain eluent; the residual microorganism filtering, collecting and counting module is used for filtering and culturing the eluent and identifying and counting the residual microorganisms; the system control module is used for calculating the number of the residual microbial colonies and giving a judgment conclusion to the verification result according to the preset evaluation standard of the system; the instrument temporary storage bin is used for temporarily storing instruments with verified disinfection effects.
2. The automated sterilization effect verification system of reusable medical instruments according to claim 1, further comprising a housing and a sterilization basket, wherein the housing is internally provided with a contamination drying bin, a sterilization bin, a washing drying bin, and an elution recovery bin, respectively, from left to right; and all be provided with perpendicular automatic rising sealing door between pollution dry storehouse, disinfection storehouse, washing dry storehouse and the elution recovery storehouse, the disinfection basket is located the inside of casing and is used for holding the apparatus, and the bottom of disinfection basket is provided with moving mechanism, so that the disinfection basket is pollution dry storehouse, disinfection storehouse, washing dry storehouse and elution recovery storehouse between automatic the removal, fungus liquid simulation pollution dry module, disinfection module, washing dry module and residue elution recovery module set up respectively in pollution dry storehouse, disinfection storehouse, washing dry storehouse and the elution recovery storehouse.
3. The automated sterilization effect verification system of reusable medical instruments according to claim 2, wherein an operation port is provided on one side of the contaminated drying cabinet, a bio-sealing door is provided at the operation port, the bacterial liquid simulated contaminated drying module comprises an operation table, a high efficiency air filter, a fan and a sterilizing ultraviolet lamp tube, which are provided in the contaminated drying cabinet, and the sterilizing basket can be moved onto the operation table by a moving mechanism.
4. The automated sterilization effect verification system of reusable medical instruments according to claim 3, wherein the sterilization module comprises a wiping assembly and a spraying assembly, the wiping assembly comprises a circular disk which is assembled at the center of the top of the sterilization chamber and can rotate 360 degrees, the circular disk is horizontally arranged, and a plurality of long bristle flexible rolling brushes which can extend and retract along the direction perpendicular to the circular disk are arranged at the bottom of the circular disk along the circumferential direction of the circular disk; the long-bristle flexible rolling brush is parallel to the disc and can rotate along the circumferential direction of the disc, and the spraying assembly comprises two first rotary high-pressure spraying arms which are respectively arranged at the top and the bottom of the disinfection bin, and a first liquid injection assembly which can pump disinfectant into the first rotary high-pressure spraying arms.
5. The automated sterilization effect verification system of reusable medical instruments according to claim 4, wherein the wash and dry module comprises a wash assembly and a dry assembly, the wash assembly comprising two second rotary high pressure spray arms disposed at the top and bottom of the wash and dry bin, respectively, a second liquid injection assembly capable of pumping sterile water into the second rotary high pressure spray arms, a first ultrasonic generator disposed within the wash and dry bin; the drying component comprises a PTC ceramic air heater communicated with the cleaning bin, a temperature sensor and a heating element which are arranged in the cleaning drying bin, and an exhaust pipe arranged at the top of the cleaning drying bin.
6. The automated sterilization effect verification system of reusable medical instruments according to claim 5, wherein the residue eluting recovery module comprises a third infusion assembly for infusing sterile water into the interior of the eluting recovery cartridge and a second ultrasonic generator disposed in the eluting recovery cartridge.
7. The automated sterilization effect verification system for reusable medical instruments according to claim 6, wherein the residual microorganism filtering, collecting and counting module comprises a box body, a partition plate is arranged at the bottom of the box body, so that a working cavity and a collecting cavity are formed from top to bottom in the box body, a plurality of bases penetrating through the partition plate are uniformly arranged at the bottom of the working cavity, filter cups penetrating through the upper end and the lower end of the bases are fixed at the tops of the bases, a filter membrane and a culture medium absorption pad are arranged at the bottoms of the filter cups, the collecting cavity is connected with a negative pressure suction filter device for sucking out gas in the collecting cavity, a drain pipe is arranged at the bottom of the collecting cavity, an electronic valve is arranged on the drain pipe, a constant temperature device for controlling the temperature in the working cavity is arranged in the working cavity, and the residual microorganism filtering, collecting and counting module further comprises a first injection assembly for injecting eluent into the filter cups, a second injection assembly for injecting sterile water and a third injection assembly for injecting a liquid culture medium, and an imaging system for imaging and counting microorganisms growing on the filter membrane.
8. The automated sterilization effect verification system of reusable medical instruments according to claim 7, wherein the system control module operates as follows:
Δlg=lgC 0 V 0 -lg(N 1 D 1 +N 2 D 2 +......+N M D M )/M
in the formula:
Δlg-log reduction of microbial content before and after instrument sterilization;
C 0 -the bacterial liquid simulates the concentration of the bacterial suspension inoculated by the instrument in the pollution drying module;
V 0 -the bacterial liquid simulates the volume of bacterial suspension inoculated by the instrument in the contamination drying module;
the number of the bacterial colonies on the filter membrane of which the number of the bacterial colonies is between 10 and 100 in the N-residual microorganism filtering collection and counting module;
d is a corresponding dilution factor, and n, 2n and 4n … … n are corresponding to the filter membrane, wherein n is more than or equal to 2;
m-number of filters with colony count between 10 and 100.
9. The automated sterilization effect verification system of reusable medical instruments according to claim 8, wherein the system preset evaluation criteria of the system control module are as follows:
high level disinfection selects mycobacterium, and the disinfection is reduced by no less than 6 orders of magnitude;
the medium level disinfection is performed by selecting staphylococcus aureus, pseudomonas aeruginosa, escherichia coli, klebsiella and mycobacterium, wherein bacteria are reduced by not less than 6 orders of magnitude after disinfection, and the mycobacteria are reduced by not less than 3 orders of magnitude;
The low level of staphylococcus aureus, pseudomonas aeruginosa, escherichia coli and klebsiella are selected, and the level should be reduced by not less than 6 orders of magnitude after disinfection.
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