WO2020248005A1

WO2020248005A1 - A method and device for the high-level disinfection of medical instruments

Info

Publication number: WO2020248005A1
Application number: PCT/AU2020/000050
Authority: WO
Inventors: Guang Gao; Tong Liu; Andrew Kobylinski; Matthew Hollier; Bo Sun
Original assignee: Lumicare IP Pty Ltd
Priority date: 2019-06-13
Filing date: 2020-06-12
Publication date: 2020-12-17

Abstract

There is disclosed a method of performing high-level disinfection of medical instruments comprising: providing a disinfecting enclosure for receiving the medical instrument to be disinfected; actuating the disinfecting enclosure to apply disinfecting irradiation to a surface of the medical instrument; generating a disinfection status for the medical instrument based on the disinfecting irradiation applied to the medical instrument; and recording the disinfection status for the medical instrument.

Description

A M ETHO D AN D DEVI CE FO R TH E H I G H -LEVE L

DI SI N F ECTION O F M E DI CAL I NSTRU M ENTS

RELATED APPLICATION

The present application claims priority from Australian Provisional Patent Application No. 2019902067, the entire contents of which are incorporated herein by reference.

FIELD OF INVENTION

The present invention relates general ly to a method and device for the disinfection of medical instruments, and in particular, to a method and device capable of performing high-level disinfection of medical instruments, such as ultrasound transducers.

BACKGROUND OF THE I NVENTION

Within the medical industry, a variety of different types of sterilisation and disinfecting methods and systems have been proposed for use on a variety of different devices and equipment. The degree of sterilisation or disinfection required for a specific device or piece of equipment will largely depend upon the manner in which the device or equipment is used and the likel ihood of cross contamination between users of the device or equipment.

In the field of diagnostic ultrasound machines, ultrasound transducers are employed which are used to contact the human body in order to generate appropriate images for analysis by healthcare professionals. Such transducers are used in a variety of different applications depending upon the area of the body requiring imaging, including intraoperative tissue biopsy and venous intubation. In this regard, the transducers may be used in contact with individuals having healthy and intact skin, through to individuals with skin lacerations and other conditions where the transducer may be in direct contact with mucous membranes and blood, as wel l as other bodily secretions. Due to the large range of use of such transducers on individuals with a variety of different conditions, there is an increased likelihood that the surface of the transducer may be in contact with various microorganisms which are carried on the surface of the transducer. Thus, it is critically important that after use, such transducers undergo a high level disinfecting or sterilisation process, to eliminate any organisms that may be present on the surface thereof.

To achieve such a high-level degree of disinfection, there exist currently four processes capable of fulfilling this requirement. These processes include: chemical immersion or soaking, chemical aerosol, surface wiping, and UVC irradiation:

Chemical immersion or soaking is a process that requires placing the ultrasound transducer such that it is immersed into a chemical reagent. One example of such system is the GUS Disinfection Soak Station made by CIVCO Medical Solutions. Such processes generally require a soaking time for the transducer to be left immersed in the chemical reagent, which can range from around 8 minutes to 45 minutes. Whilst the appropriate level of disinfection may be achievable, the disadvantage of this process is that the chemical reagent is hazardous and any exposure to the chemical reagent may harm the operator and patient, and may cause damage to the medical instrument if not appropriately controlled. Further to this, the chemical waste generated by this method of disinfection may cause significant harm to the environment. Further, as care is required in handling the chemicals, this method is manually operated and time-consuming.

Chemical aerosol is a process whereby the ultrasound transducer is placed within a chamber that is flooded with a nebulised hydrogen peroxide. One example of such a commercially avai lable system that employs this process is the system developed by Nanosonics Ltd. under the brand Trophon. Typically, the transducer is placed within the chamber for between 7 to 12 minutes, depending on the specific conditions. Once again, due to the use of the chemical reagent, the disadvantage of this method is that the residual of chemical reagent left on transducers may harm the operators and patients.

It is possible to achieve the desired level of disinfection through the use of surface wipes. Such a process uses different chemical wipe combinations to manually wipe the surface of the transducer. The disinfecting chemical solution present within the wipes is able to contact the surface of the medical instrument to eliminate the presence of the microorganism on the surface of the medical instrument. Such a procedure requires steps of pre-cleaning, disinfection and rinsing. One example of such a commercially available method of using surface wipes is using chlorine dioxide formulation made by Tristel. However, a drawback with such a method is that it requires manual application and is prone to human error through uneven contact of the wipe on the surface of the instrument, and is costly and time intensive.

The remaining process for achieving such a high-level degree of disinfection is through the use of UVC irradiation, typical ly by way of lighting through mercury vapour tubes. By applying ultraviolet light of a specific wavelength onto a surface of a medical instrument, microorganisms present thereon can be eliminated by the irradiation. Such a process requires the medical instrument to be positioned within a chamber having multiple gas discharge lamps (mercury vapor tubes) arranged thereabout, to function as l ight sources for disinfection. There are several commercial systems available which util ise UVC irradiation to disinfect ultrasound transducers. However, all of these systems use mercury vapour tubes as their UVC light source. Such tubes pose a potential risk to operators who may be exposed to mercury vapour leakage from the tubes. In addition, the disposal of these mercury vapour tubes is harmful to the environment and requires additional cost and complexity to do so in a safe way. Such disposal problems are significant and have been raised by the UN Minamata Convention on Mercury in 2013, where an international treaty was enacted to protect human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds. This treaty sets down controlling measures over a variety of products containing mercury, the manufacture, import and export of which will be altogether prohibited by 2020.

In addition to the problems associated with continuing to use mercury vapour tubes, such tubes can only emit UVC with wavelength at 254nm, which is inefficient for germicidal efficacy, requiring longer exposure times to achieve the desired level of disinfection.

Irrespective of the type of high-level disinfecting method and device used, each system requires some form of recordal of the disinfection process to meet the hospital and regulatory body compliance requirements responsible for performing the medical procedure and to provide for the traceability of the disinfecting process. Thus, any regulatory body responsible for overseeing and/or administering such controlled disinfecting processes must: record the disinfecting cycle time; remove the ultrasound transducer from the device to rinse and store for use; and recording the disinfection result. This is typically conducted by way of a manual process which is not only inefficient and error-prone, but also inconvenient to archive and interrogate as required as the historical disinfection records for a medical instrument may be incomplete.

Thus, there is a need to provide an alternative process for achieving high-level disinfection of ultrasound transducers and the like, that is highly-efficient, safe and environmental ly friendly as well as a simple and effective means for recording disinfection history of medical instruments processed by such devices.

The above references to and descriptions of prior proposals or products are not intended to be, and are not to be construed as, statements or admissions of common general knowledge in the art. In particular, the above prior art discussion does not relate to what is commonly or well known by the person skilled in the art, but assists in the understanding of the inventive step of the present invention of which the identification of pertinent prior art proposals is but one part. STATEMENT OF INVENTION

The invention according to one or more aspects is as defined in the independent claims. Some optional and/or preferred features of the invention are defined in the dependent claims.

Accordingly, in one aspect of the invention there is provided a method of performing high-level disinfection of medical instruments comprising:

providing a disinfecting enclosure for receiving the medical instrument to be disinfected;

actuating the disinfecting enclosure to apply disinfecting irradiation to a surface of the medical instrument;

generating a disinfection status for the medical instrument based on the disinfecting irradiation applied to the medical instrument; and

recording the disinfection status for the medical instrument. The step of generating a disinfection status for the medical instrument may comprises measuring a cycle time for the application of the disinfecting irradiation to the surface of the medical instrument.

The step of generating a disinfection status for the medical instrument may comprise measuring an exposure dosage of a disinfecting irradiation applied to the surface of the medical instrument.

The step of generating a disinfection status for the medical instrument may comprise both measuring a cycle time for the application of the disinfecting irradiation to the surface of the medical instrument and measuring an exposure dosage of a disinfecting irradiation applied to the surface of the medical instrument.

An initial step of capturing an identity of an operator performing said high-level disinfection may be provided. The identity of the operator of the high-level disinfection may be temporarily stored in a temporary storage unit according to an operator login request. The identity of the operator of the high-level disinfection may be permanently stored with said disinfection status for the medical instrument.

An initial step of capturing an identity of the medical instrument to be disinfected may be provided. The identity of the medical instrument to be disinfected may be temporarily stored in a temporary storage unit according to an operator login request. The identity of the medical instrument to be disinfected may be permanently stored with said disinfection status for the medical instrument.

The disinfection status may comprises a disinfection start status and a disinfection end status. The disinfection status may be determined according to the cycle time such that if the cycle time exceeds a predetermined abnormal cycle time threshold, the disinfection status represents a disinfection abnormality.

The disinfection status may be determined according to the exposure dosage of the disinfecting irradiation in the disinfection enclosure such that if the exposure dosage of the disinfecting irradiation reaches a predetermined dosage value threshold, the disinfection status represents a disinfection normality.

Accordingly, in one aspect of the invention there is provided high-level disinfection device for disinfecting a medical instrument, comprising:

a disinfecting enclosure for receiving the medical instrument to be disinfected;

a disinfecting irradiation means mounted about the disinfecting enclosure for del ivering disinfecting irradiation to a surface of the medical instrument within the disinfecting enclosure;

a prompting unit mounted with respect to the disinfecting enclosure for obtaining a disinfection status according to a disinfection cycle time of exposure of the medical instrument to the disinfecting irradiation and/or an irradiation dosage level of the disinfecting irradiation received by the medical instrument within the disinfection enclosure; and

a recording unit for recording the disinfection status of the medical instrument.

The device may further comprise an operator temporary storage unit to temporarily store an operator identity ( I D) according to an operator login request.

The device may further comprise an operator permanent storage unit to store an operator identity (ID) of the according to a disinfection start request.

The device may further comprise a medical instrument temporary storage unit for acquiring the medical instrument (ID) for temporary storage.

The device may further comprise a medical instrument permanent storage unit for storing the medical instrument identity (I D) according to a disinfection start request.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be better understood from the following non-limiting description of preferred embodiments, in which: FIG. 1 is a flowchart of a high-level disinfection method in accordance with a first embodiment;

FIG. 2 is a flowchart depicting additional steps for the high-level disinfection method of FIG. 1;

FIG. 3 is a flowchart depicting additional steps for the high-level disinfection method of FIG. 1

FIG. 4 is a flowchart of a high-level disinfection method in accordance with a second embodiment;

FIG. 5 is a flowchart depicting preliminary steps for the high-level disinfection method of FIG. 1;

FIG. 6 is a simplified structural diagram of a high-level disinfection device of according to an embodiment of the present invention;

FIG.7 is a structural diagram of a variation of the high-level disinfection device of FIG. 6;

FIG. 8 is a structural diagram of a high-level disinfection device according to another embodiment of the present invention;

FIG. 9 is a structural diagram of a prompt unit according to an embodiment of the present invention;

FIG. 10 is a structural diagram of a high-level disinfection device according to another embodiment of the present invention;

FIG. 11 is a structural diagram of a high-level disinfection device according to yet another embodiment of the present invention; and

FIG. 12 is a structural diagram of an electronic device according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

Preferred features of the present invention wil l now be described with particular reference to the accompanying drawings. However, it is to be understood that the features il lustrated in and described with reference to the drawings are not to be construed as limiting on the scope of the invention.

The present invention wi l l be described below in relation to its application for use in disinfecting a transducer for a medical ultrasound device. However, it wil l be appreciated that the present invention could be used in a variety of different applications, both medical and non-medical, where a high-level degree of disinfection of an element is required. Referri ng to FIG. 1, a method 10 of performing high level disinfection of a medical ultrasound transducer is depicted, in accordance with an embodiment of the present invention is depicted.

The method 10 employs usage of a disi nfecting device in accordance with the present invention that uses UVC LEDs arranged about an enclosure and which are actuated to emit UVC l ight to irradiate al l surfaces of a medical instrument located within the enclosure. Thus, the first step 12 of the method 10 requires that the operator of the disinfecting device is prompted to i nitiate disinfection of the medical ultrasound transducer. This may involve the operator accessing the device and placing the medical ultrasound transducer that is to be disinfected, into the enclosure of the device.

Once the medical ultrasound transducer is correctly positioned within the enclosure for disi nfecting, the disinfecting process is initiated in step 14. This triggers the system to determine a d isinfection status for the ultrasound transducer according to the disinfection cycle time in which the instrument is maintained in the disi nfection enclosure or according to the irradiation dose of the disinfecting i llumination in the disi nfection enclosure.

At step 16, the disinfection status generated by the disinfecting device is recorded.

Such a h igh-level disi nfection method 10 ensures that the disinfection process is performed by an authorised disinfecting operator who is trai ned in the process and who has been prompted to initiate disinfection of the medical ultrasound transducer in accordance with authorised procedures. As part of the overal l method 10, the disinfection status of the medical ultrasound transducer is recorded according to the parameters of the process, such as the disinfection irradiation doses generated by the device within the disinfection enclosure, and/or the disinfection cycle time that the medical ultrasound transducer is present within the disinfection enclosure. By recording the disinfection status of the medical ultrasound transducer this information can be stored within an automatic electronic storage device associated with the disinfecting device.

Automatical ly storage of the recorded disinfecting status for each medical ultrasound transducer fol lowi ng a disinfecting procedure makes it possible for operators or users of the system to interrogate the electronic storage records of the storage device to ascertain not only the current status of the transducer but also the historical disinfection records of each medical ultrasound transducer. By providing a faci l ity to routinely interrogate and analyse such records for each medical ultrasound transducer, erroneous operation and incomplete disi nfection procedures can be read i ly identified and appropriate action can be taken to ensure all instruments are correctly disinfected to the appropriate level, prior to use.

It should be noted that the disinfection status generated for each instrument may include, but is not limited to, a disinfection start status and a disinfection end status. The disinfection start status includes, but is not limited to: the identity (I D) of the operator who is operating the disinfecting device; the identity (I D) of the medical ultrasound transducer to be disinfected; and, start times for the disinfection cycle. The end of disinfection status includes, but is not limited to: the success or otherwise of the disinfection procedure; the disinfection irradiation dose levels; the disinfection cycle end time; and, the cause of any errors in the disinfection cycle. It is worth noting that by recording at least the start of the disinfection cycle and the end of disinfection cycle, it is possible to clarify whether a complete disinfection cycle has been achieved or not. This can ensure that whether instruments have undergone a correct disinfecting process and avoids the likelihood of the instrument undergoing repeated unnecessary disinfecting procedures or being omitted from disinfection altogether. If, during a disinfection procedure, the procedure is terminated due to unforeseen factors such as power outages or computer controller error, there wi l l be no record of an end of disinfection status for the particular instrument undergoing disinfection. As there wi l l be a record of the start of disinfection, such an incomplete disinfecting process can be easily detected by the system which will flag an error event indicating that the disinfection process has been attempted, but was unsuccessful and that the instrument to be disinfected remains in a contaminated state.

It should be noted that for conventional disinfecting systems in the prior art, the record of the disinfection status for each instrument is typical ly manually completed by the operator through use of a standard form. As a result, due to human nature it is common for such records to become lost or misplaced or to be incorrectly completed. Thus, the creation of incomplete record and/or incorrect records is voided by the method of the present invention.

It should also be noted that the disinfection of a medical ultrasound transducer is directly related to whether the subsequent patient using the medical ultrasound transducer, becomes contaminated. In prior art systems, there is typical ly a great uncertainty in the level and amount of instrument disinfection which has been conducted prior to use, as such disinfecting processes have heavi ly relied upon the operator s sense of responsibility and proficiency in their work, even during times of being overworked and tired. Therefore, through the present inventions abi l ity to provide a prompt to the operator to disinfect the medical ultrasound transducers following use, the incidents of no or insufficient disinfection occurring can be significantly reduced. In this regard, the prompt may be provided in the form of a webpage interface reminder, a voice reminder, a light reminder, and the like, which can be displayed on the disinfecting device or personal computer interface which may be a smart phone, tablet, laptop or PC.

After the disinfection operator finishes disinfecting the medical ultrasound transducer, the identity (I D) of the medical ultrasound transducer (such as ultrasound transducer model number and serial number) can be manually input to the processor unit and stored in the memory unit for processing. Alternatively, the disinfecting device may include a scanner or reader which scans/reads a barcode or similar I D provided on the ultrasound transducer as it is inserted into the disinfecting device for disinfection. Once scanned, the instrument’s ID will be saved in the memory unit of the processor against the records for that instrument. As well as a barcode, a QR code or RFI D (Radio Frequency Identification) tag, or NFC tag may be located on the medical ultrasound transducer for scanning.

It should also be appreciated that in prior art systems, the disinfection status of the medical ultrasound transducer taken during the disinfection cycle is usually judged according to the operator’s experience. Thus, there has been great uncertainty in the accuracy of this traditional system. In the present invention, this is largely overcome as the disinfection cycle time that the medical ultrasound transducer is present in the disinfection enclosure is recorded, as well as, the disinfection illumination intensity of the irradiation occurring within the disinfection enclosure or the irradiation dose. Including such information within the status of disinfection provides clear guidance for operators and ensures that the disinfection status captured and saved for each instrument is clear and specific.

As previously discussed, as the disinfecting device of the present invention utilises illumination provided by ultraviolet light emitted by UV LEDs, or similar lighting, having a disinfecting function. The irradiation dose can be measured as an integral of the light intensity over cycle time. Thus, to obtain a reading of the irradiation dose, one or more sensor(s) is located within the disinfecting enclosure of the disinfecting device to detect the light intensity of the UV LEDs. This measurement is then sent to a processor unit associated with the disinfecting device, to obtain the irradiation dose by integrating the light intensity.

It will be appreciated that the specific step of prompting the operator for the disinfection status, may include determining whether the disinfection cycle time of the medical ultrasound transducer present in the disinfection enclosure exceeds a pre-set abnormal cycle time threshold. If so, a disinfection abnormality is triggered and recorded against the medical ultrasound transducer’s history.

Similarly, the specific step of prompting the disinfection status may include determining whether the irradiation dose of the disi nfecting i l lumination in the disinfecting enclosure reaches a pre-set dose value. If so, the disinfection process is determined as being completed in a satisfactory manner

Referri ng to F IG. 2 the high-level disinfection method 10 of FIG. 1 can be improved through the i nclusion of two additional steps.

I n step 18, the identity ( I D) of the operator of the disinfecting device is captured and temporari ly stored according to the operator login request, as discussed above. Whi lst in step 20, the identity (I D) of the operator of the disinfecting device is stored according to the disinfection start request.

The temporary storage of the I D of the operator occurs in the form of a temporary data storage, with the temporary data being cleared according to the status such as shutdown. Storage is a permanent preservation of data, such as savi ng on a hard disk.

I n a scenario whereby a breakout of infection has occurred due to a contaminated medical ultrasound transducer bei ng used (which may have resulted due to an operator error), it is usual ly necessary to trace the d isinfection operation record of the operator to identify other potential errors made by the individual. After receiving and parsing the disinfection start request, the processor unit permanently saves the disinfection operator identity ( I D) for traceabi l ity.

It wil l be appreciated that in accordance with the method of the present invention, the disinfection operator does not necessari ly initiate the disinfection start request, Temporarily storing the operator identity ( I D) of an individual operator who has not initiated the disinfection start request can faci l itate the disinfection of the operator, and avoids the permanent storage of such login information and the operator identity (I D) that is actually requested for disinfection. This may result in an excessive amount of traceability information, which is difficult to achieve high efficiency and accuracy tracing back.

Referri ng to F IG. 3 the high-level disinfection method 10 of FIG. 1 can be improved through the i nclusion of two additional steps.

I n step 22, the ultrasound transducer identity (I D) of the medical ultrasound transducer is obtai ned for temporary storage.

I n step 24 the ultrasound transducer identity (I D) according to the disinfection start request is recorded.

Once again, it will be appreciated that the temporary storage of the ultrasound transducer identity ( I D) is a kind of temporary data storage, and the temporary data is cleared according to the status such as shutdown, Storage is a permanent preservation of data, such as saving on a hard disk.

In this regard, it will be appreciated that in a scenario where an infection has broken out due to a contaminated medical ultrasound transducer (which may or may not be caused by an operator's incorrect operation), it is usually necessary to trace the specific medical ultrasound transducer to ascertain its disinfection history. After receiving and parsing the disinfection start request, the processor unit permanently saves the ultrasound transducer identity (I D) for traceability.

Referring to FIG. 4 an alternative high-level disinfection method 30 of the present invention is depicted. The method 30 includes steps 12, 14 and 16 of the method 20 of FIG. 1, but includes a further step 32.

In step 32, the disinfection status for the disinfecting process immediately carried out by the operator on the medical ultrasound transducer is output for printing by a printing device or for reading by the operator or client. In this regard, the disinfection status output for the medical ultrasound transducer can be reviewed by the operator or cl ient, or shared amongst users of the instrument.

Referring to FIG. 5, a preparation method 40 is depicted for initiating the high- level disinfection method 10 and 30 of FIGS 1 and 4,

In step 42, the operator of the disinfecting device is prompted to open the door of the disinfection enclosure to place the medical ultrasound transducer within the enclosure for disinfecting. The enclosure may include markings to assist the operator in positioning the medical ultrasound transducer to ensure that correct irradiation of the surface of the instrument occurs. The enclosure may also include mounts and the l ike to assist in holding the instrument in position.

In step 44, the operator is prompted to commence the disinfection procedure by closing the door to the enclosure of the disinfecting device. This will trigger a change in the status of the device to indicate the closed status of the door.

In step 46, upon the controller of the disinfecting device receiving a disinfection start command, the controller will control the door lock to a locked status.

It will be appreciated that the disinfecting irradiation resulting from the ultraviolet light emitted by the UVC LEDs may be harmful to operators of the disinfecting device if they are directly exposed. Therefore, in order to commence the disinfecting process the device controller must identify that the door is in a closed state (step 44) and that the door is locked to prevent inadvertent exposure to the irradiation (step 46). Further, if the disinfecting enclosure is opened before completion of the disinfecting process, the level of disinfection may be insufficient to remove the microorganisms present on the surface of the instrument. Thus, requiring a locked door status before the disinfecting start command can be processed, achieves safe disinfection and adequate disinfection.

In order to determine the status of the door, the door of the enclosure is configured such that when the door is closed or locked there is a change of current or of a voltage parameter generated. This changed current or voltage parameter is able to be sensed by an acquisition circuit or a sensing device present in the disinfecting device, to send an appropriate status signal to the device’s processor unit.

To provide such prompts to the operator, the frame of the high-level disinfecting device may be configured with a prompting unit 50, in the form of electronic screen with a graphic user interface (GUI) for delivering the prompt message. FIG. 6 depicts the basic structure of the high-level disinfecting device.

The prompting unit 50, is controlled by an electronic control ler to provide the operator with prompts to control the process. It is capable of obtaining the disinfection status according to the disinfection cycle time in which the medical ultrasound transducer is present within the disinfection enclosure or according to the irradiation dose of the disinfecting illumination within the disinfection enclosure.

A recording unit 52 is provided in electrical communication with the prompting unit so as to receive and record the disinfection status and other measured parameters associated with the disinfecting device. The recording unit 52 may be in the form of a conventional disc for recording the electronic measurements taken by the device control ler.

The high-level disinfection method of the medical ultrasound transducer provided by the present invention provides disinfecting of the medical ultrasound transducer by prompting the disinfection operator to perform tasks in a desired order, and to obtain the disinfection status of the instrument according to the time that the medical ultrasound transducer is present within the disinfection enclosure or the irradiation dose of the disinfecting illumination in the disinfection enclosure. This information is then delivered to the recording unit where it is recorded and stored such that the disinfection status can be fully understood. Through continuous recording and monitoring of the automatic electronic storage disinfection status, the disinfection efficiency of the high-level disinfection method is able to be monitored, and where appl icable, improved. The recording unit is able to be interrogated to receive enquiries as to the historical disinfection record for each instrument. This may also enable the disinfection to be fully performed to avoid any erroneous operation and incomplete disinfection from occurring. It should be noted that the disinfection status includes, but is not l imited to, a disinfection start status and a disinfection end status. The disinfection start status includes, but is not l imited to, the operator identity ( I D), the ultrasound transducer identity ( I D), and the start of the disinfection cycle time. The end of disinfection status i ncludes, but is not limited to, whether the disi nfection is successful, the disinfection dose, the d isinfection consumption cycle ti me, and the cause of any abnormal disinfection.

It is worth noting that by recording at least the start of disinfection and the end of disinfection, it is possi ble to clarify whether a complete disinfection process has been achieved or not, and to achieve the technical effect of avoiding repeated disinfection and omission of disinfection. When the disinfection is terminated due to sudden factors such as power outages or crashes, there is no record of the end of disi nfection status. However, since there is also a record of the start of disinfection, it can be said that the disinfection has been attempted, but the disinfection is abnormal ly terminated.

Referri ng to FIG. 7, there is provided a structural diagram of a high-level disinfection device 60 for a medical ultrasound transducer that is an extension of the device of FIG. 6 in accordance with an embodi ment of the invention.

The high-level disinfection device 60 general ly comprises an operator temporary storage unit 62 that temporarily stores the operator identity ( I D) of the medical ultrasound transducer according to an operator log in request;

An operator storage unit 64 is also provided to store the operator identity ( I D) of the medical ultrasound transducer according to the disinfection start request.

It should be noted that the temporary storage is a kind of temporary data storage, and the temporary data is cleared accord ing to the status such as shutdown. Storage is a permanent preservation of data, such as saving on a hard disk,

FIG. 8 depicts an alternative structural diagram of a high-level disi nfection device 70 for a medical ultrasound transducer.

I n this embodi ment, the ultrasound transducer temporary storage unit 72 acquires the identity (I D) of the medical ultrasound transducer for temporary storage. An ultrasound transducer storage unit 74, obtains a more permanent identity ( I D) of the medical ultrasound transducer for storage according to the disinfection start request generated by the control ler of the system.

It should be noted that the temporary storage is a kind of temporary data storage, and the temporary data is cleared accord i ng to the status such as shutdown. Storage in the ultrasound transducer storage unit 74 is a permanent preservation of data, such as saving on a hard disk.

FIG. 9 depicts the prompting unit 50 in more detai l. As depicted, the prompting unit 50 includes an abnormality prompting unit 80 and a normal completion prompting unit 82. The abnormality prompting unit 80 functions to provide a prompt to the operator of a disinfection abnormality. This occurs if the controller of the device senses that the disinfection cycle time of the medical ultrasound transducer present within the disinfection enclosure exceeds a preset abnormal cycle time threshold. The normal completion prompting unit 82 functions if the disinfection dose used for irradiating the enclosure reaches a preset disinfection illumination dosage value that indicates that the disinfection is performed normally.

Referring to FIG. 10, an alternative embodiment for the structure of a high-level disinfection device 86 for the medical ultrasound transducer is depicted. This embodiment is similar to the embodiment depicted in FIG. 6, but further includes an output unit 88. The output unit 88 outputs a disinfection status following a disinfecting procedure. The disinfection status may be in the form of a printed report which is sent to a printing device for review by the operator/client. The client may include a medical centre or system or the like. The printing device can be a virtual printer or the like.

FIG 11 depicts an alternative embodiment of a high-level disinfection device 90 for initiating the method 40 depicted in FIG. 5.

The device 90 comprises a door opening unit 92 that is employed to prompt the operator to open the door of the disinfection enclosure of the disinfecting device to place the medical ultrasound transducer therein for disinfection. The prompt may be in the form of a light or sound and in some instances the door may be opened.

Once the instrument has been positioned within the disinfection enclosure, the startup unit 94 acts to prompt the operator to start disinfection process by closing the door. Once the door to the disinfection enclosure is closed, the startup unit 94 records the closed status of the door as an indication that a disinfection process is to occur. The system then generates a disinfection start command which is received by the locking unit 96, which controls the door lock according to the disinfection start command to ensure that the door is locked during the disinfection process.

As discussed above, as exposure to the irradiation generated by the ultraviolet light emitted by the UVC LEDs may be harmful, the door to the disinfecting enclosure is locked during the disinfecting process to maximise safety for the operator. Further to this, by locking the door to the disinfection enclosure during the disinfection procedure, the procedure cannot be compromised, thereby ensuring not only safe disinfection but also adequate disinfection.

The startup unit 94 may include sensors that detect changes in current or voltage parameters when the door is closed or locked. The changed current or voltage parameters can be obtained by the acquisition circuit or the sensing device to the processor unit.

FIG. 12 is a structural diagram of a further embodiment of a disinfecting device 100 in accordance with the present invention.

The device 100 includes a memory unit 101 and a processor unit 102. The memory unit 101 is configured to store one or more computer programs to be executed by the processor unit 102 to implement any of the above methods.

The electronic device 103 may be provided integrally with the disinfection enclosure of the disinfecting device. In this regard, the body of the electronic device 103 may be provided separately from the disinfection enclosure of the disinfecting device. The processor unit 102 can also be connected to an input/output device 104 to facilitate the human-computer interaction between the operator and the processor unit 102.

The memory unit 101 may be configured to include a database for storing disinfection data for each instrument which is updated continuously. A user may interrogate the disinfection date for each instrument through the input/output device 104 by way of a network, such as an internet or intranet.

In a preferred embodiment, each disinfecting device is connected to the memory unit 101 and processing unit 102 by way of the network such that during each disinfection procedure, disinfection data for each instrument can be automatically collated and stored within the memory unit 101 without required operator input.

It should be understood that in the description of the present invention provided above, the term "storage medium" may be a medium that can store a computer program, such as a ROM, a RAM, a magnetic disk, or an optical disk, unless otherwise explicitly defined and defined. The term "processor unit" may be CPLD (Complex Programmable Logic Device), FPGA (Field -Programmable Gate Array), MCU (Microcontroller Unit), PLC (Programmable Logic Controller) A chip or circuit with data processing functions such as a CPU (Central Processing Unit). The term "electronic device" may be any device having data processing functions and storage functions, and may generally include a fixed terminal and a mobile terminal. Fixed terminals such as desktops. Mobile terminals such as mobile phones, tablets, and mobi le robots. Further, the technical features involved in the different embodiments of the present invention described later may be combined with each other as long as they do not constitute a conflict with each other.

The above are only the preferred embodiments of the present invention and are not intended to l imit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included in the range of protection of the present invention.

Throughout the specification and claims the word“comprise” and its derivatives are intended to have an inclusive rather than exclusive meaning unless the contrary is expressly Stated or the context requires otherwise. That is, the word“comprise” and its derivatives wil l be taken to indicate the inclusion of not only the listed components, steps or features that it directly references, but also other components, steps or features not specifically listed, unless the contrary is expressly stated or the context requires otherwise.

Orientational terms used in the specification and claims such as vertical, horizontal, top, bottom, upper and lower are to be interpreted as relational and are based on the premise that the component, item, article, apparatus, device or instrument will usually be considered in a particular orientation, typically with the enclosure uppermost.

It will be appreciated by those skilled in the art that many modifications and variations may be made to the methods of the invention described herein without departing from the spirit and scope of the invention.

Claims

The claims defining the invention are as follows:

1. A method of performing high-level disinfection of medical instruments comprising:

recording the disinfection status for the medical instrument.

2. A method according to claim 1, wherein the step of generating a disinfection status for the medical instrument comprises measuring a cycle time for the application of the disinfecting irradiation to the surface of the medical instrument.

3. A method according to claim 1, wherein the step of generating a disinfection status for the medical instrument comprises measuring an exposure dosage of a disinfecting irradiation applied to the surface of the medical instrument.

4. A method according to claim 1 wherein the step of generating a disinfection status for the medical instrument comprises both measuring a cycle time for the application of the disinfecting irradiation to the surface of the medical instrument and measuring an exposure dosage of a disinfecting irradiation applied to the surface of the medical instrument.

5. A method according to any one of the preceding claims, further comprising an initial step of capturing an identity of an operator performing said high- level disinfection.

6. A method according to claim 5, wherein the identity of the operator of the high-level disinfection is temporari ly stored in a temporary storage unit according to an operator login request.

7. A method according to claim 5, wherein the identity of the operator of the high-level disinfection is permanently stored with said disinfection status for the medical instrument.

8. A method according to any one of the preceding claims, further comprising an initial step of capturing an identity of the medical instrument to be disinfected.

9. A method according to claim 8, wherein the identity of the medical instrument to be disinfected is temporarily stored in a temporary storage unit according to an operator login request.

10. A method according to claim 8, wherein the identity of the medical instrument to be disinfected is permanently stored with said disinfection status for the medical instrument,

11. A method according to claim 1, wherein the disinfection status comprises a disinfection start status and a disinfection end status.

12. A method according to claim 2, wherein the disinfection status is determined according to the cycle time such that if the cycle time exceeds a predetermined abnormal cycle time threshold, the disinfection status represents a disinfection abnormality.

13. A method according to claim 3, wherein the disinfection status is determined according to the exposure dosage of the disinfecting irradiation in the disinfection enclosure such that if the exposure dosage of the disinfecting irradiation reaches a predetermined dosage value threshold, the disinfection status represents a disinfection normality.

14. A high-level disinfection device for disinfecting a medical instrument, comprising:

15. A high-level disinfection device according to claim 14, further comprising an operator temporary storage unit to temporari ly store an operator identity (ID) according to an operator login request.

16. A high-level disinfection device according to claim 14, further comprising an operator temporary storage unit to stores an operator identity (I D) of the according to a disinfection start request.

17. A high-level disinfection device according to claim 14, further comprising a medical instrument temporary storage unit for acquiring the medical instrument (ID) for temporary storage.

18. A high-level disinfection device according to claim 14, further comprising a medical instrument storage unit for storing the medical instrument identity (ID) according to a disinfection start request.