ITUB20159391A1 - STERILIZATION METHOD IN A MEDICAL, PREFERIBLY DENTAL STUDY - Google Patents

Description

METHOD OF STERILIZATION IN A MEDICAL OFFICE,

PREFERABLY DENTAL

[001] The present invention relates to the sterilization of medical instruments, preferably dental instruments.

[002] In the following the present description will specifically refer to a dental office, without thereby losing generality, since, mutatis mutandis, everything that happens inside a dental office also takes place in a doctor's office in which use of sharp and / or invasive instruments: for example in a dermatology office, or in a practice where any type of outpatient surgery is performed.

[003] Normally the trays containing the sterilized and wrapped instruments, specific for the type of therapy to be administered, are brought to the side of the patient's chair. Sterilized instruments are used on the individual patient by contaminating themselves. At the end of the therapy, the contaminated instruments are brought to the sterilization room to be washed, optionally disinfected, dried, bagged and sterilized. Once they have been sterilized, the wrapped instruments are placed in special cabinets where they remain until the moment of their use on a different patient.

[004] In general, the gold standard in the treatment of dental / medical instruments is sterilization by means of a steam autoclave; however, the effectiveness of the cycle is linked to the cleanliness of the instruments that are inserted into the autoclave. Consequently, it is common practice to pre-treat instruments before packing them and placing them in the autoclave.

[005] Inside the medical or dental office there is typically a sterilization room which contains all the devices necessary for the treatment of contaminated instruments, as well as a heat sealer for enveloping the instruments.

[006] Various types of devices have been known in the art for some time to carry out the pre-treatment of instruments to be sterilized:

a) ultrasonic baths for Γ immersion of instruments

These are tanks in which the instruments are immersed, inside which the instruments are subjected to the action of ultrasound, which allow to detach solid residues, in particular gypsum, dental cements, composite materials, present on the instruments themselves. Specific detergents / disinfectants can be added to the bath water. An apparatus of this type is described for example in DE29501963.

b) dishwasher

These are appliances with a configuration very similar to that of a traditional dishwasher, which wash with water that exerts a strong mechanical action, at high temperature (around 90 ° C). Also in this case specific detergents can be used. An apparatus of this type is described for example in EP2656768A1.

c) ultrasonic thermodisinfectors

These are equipment that wash with high temperature water (around 90 ° C); the action of water is combined with that of ultrasound. Also in this case specific detergents can be used. An apparatus of this type is described for example in WO2015150986 A1.

The ultrasonic baths are limited to effectively cleaning the instruments, while the ultrasonic washer-disinfectors and washer-disinfectors also guarantee a high degree of disinfection, thanks to the operating temperatures, and in the latter case, to the action of ultrasound.

[007] These pre-treatment devices allow to reduce the operator's risk related to the handling of sharp / stinging instruments, and to further standardize the type of treatment to which the instruments are subjected.

[008] However, to date each of the aforementioned apparatuses works in a totally independent way from the other apparatuses; often each appliance is made by a different manufacturer.

[009] In particular the autoclaves, but also other pre-treatment apparatuses are often provided with logic units for the control of the work cycles which have at least one output for a warning signal of the operating status of the apparatus such as start or end cycle or end of a treatment cycle step and start of the next.

[010] Furthermore, for Γ dental assistant / or who often has the dual role of dental assistant and instrument decontamination manager, it is important to know when an appliance has finished its cycle, in order to be able to move the instruments in the next device, reducing the overall treatment time of contaminated instruments thanks to the reduction of downtime.

[011] Given the possibility of transmitting infections (eg hepatitis B, C, HIV, tuberculosis, to name only the most serious) through dental instruments, it is important for a dentist to be able to demonstrate that he has operated correctly following the protocols for sterilization.

[012] It is also required by law to check that the autoclaves the dental practice is equipped with are working correctly. To this end, tests are required periodically to demonstrate the effectiveness of the autoclaves, such as the vacuum test, the Helix test, the Bowie & Dick test and microbiological tests.

[013] The vacuum test consists in reaching a vacuum threshold and maintaining the vacuum for a determined period of time: Γ the autoclave must be able to maintain the vacuum stably. The vacuum test is performed automatically through a special autoclave self-diagnosis program. The fact that the autoclave is able to maintain a vacuum is a prerequisite for carrying out any sterilization cycle.

[014] The Helix test is a test in which a strip of special paper is used which has the characteristic of turning, that is, of changing color, if exposed to airless water vapor (saturated vapor) at a certain temperature and for a certain period of time (the characteristics are indicated by the manufacturer). The paper is placed in a sealed test tube (capsule), communicated with the outside through a 1.5 meter long tube, with a 2 mm diameter circular hole. Confirmation of correct functioning occurs if at the end of the process the map has changed color (it is the test manufacturer who must provide the indications for its evaluation). If the test is not passed, it means that the steam has not penetrated optimally into the object, and therefore has not sterilized it,

[015] The Bowie & Dick test is a test which allows to verify the ability of air removal and steam penetration in the load, which is correlated to its effectiveness in the sterilization process. The basis of the test is the use of a special paper indicator that has the characteristic of turning, that is, of changing color, if exposed to a certain pressure of saturated water vapor. The map is placed inside a closed container and placed in the center of the device; the sterilization procedure is then started. Correct operation is confirmed if at the end of the process the map is completely and uniformly veered. Otherwise it means that the sterilization of materials with empty cavities or vacuums is not optimal.

[016] Microbiological tests are also periodically performed on the autoclaves, which consist in inserting in the autoclave spores of highly heat-resistant microorganisms, whose failure to survive the conditions present inside the autoclave indicates that the sterilization process has accomplished. For example, spores of Bacillus stearothermophilus and Bacillus subtilis, var. Niger. The spores are usually contained in vials associated with culture medium or on strips of paper to be sown on a plate.

[017] A further problem is that of guaranteeing a correct execution of the treatment cycles of contaminated instruments. As written in the Guidelines for Infection Control in Dentai Health-Care Settings issued by the Centers for Disease Control in 2003, dental staff must be trained in the treatment of contaminated instruments, as the health of the dental staff working in the practice is at stake. and the health of patients attending the study: “Staff are more likely to adhere to an infection control program and exposure control plan if they understand the rationale (5,13,16). Clearly written policies and guidelines can help ensure coherence, effectiveness and effective coordination of activities. Personnel subject to occupational exposure should receive education on infection control at the start of employment, when new assignments or procedures affect occupational exposure, and at least every year (13). Education and training should be appropriate to the duties assigned to the specific member of the dental staff (for example techniques to prevent cross-contamination or sterilization of instruments). "[018] Finally, patients are increasingly aware of the risks of cross-infection transmission, and often in the waiting rooms of dentists there is information addressed to patients regarding the disinfection / sterilization procedures performed in the dental office in order to preserve the health of their patients.

[019] Currently, the dental practice is faced with different types of problems:

- Coordination of the use and efficient use of the various equipment present in the dental office;

- Demonstration to the competent authorities of the correct functioning of the equipment used;

- Optionally, demonstration to the competent authorities and possibly to patients that each instrument used on a patient has undergone a correct course of treatment, in order to prevent the transmission of cross-infections;

- Training of dental staff to correctly carry out the treatment operations of contaminated dental instruments.

[020] The object of the present invention is to provide a system capable of:

to. allow efficient use of the disinfectant / sterilizing equipment present in the dental office;

b. keep the tests performed on the equipment in order to prove their efficiency over time;

c. optionally trace the use and sterilization cycles to which each instrument has been subjected;

d. provide information to patients regarding the procedures used in the dental office in order to safeguard their health;

And. allow the dental staff, even just hired, to correctly perform the procedures for the treatment of contaminated instruments.

[021] This object is achieved by means of a method and an apparatus which have the characteristics of the independent claims. Advantageous embodiments and refinements are specified in the respective dependent claims.

[022] The method according to the present invention provides the steps of;

- Uniquely identify the individual sterilization and pre-treatment sterilization devices;

- Detect data on the operating conditions of the same in the execution of the flow of steps necessary for the execution of the operating cycle of each of said devices and possibly the partial or total times of execution of the operating cycles;

- Process said data centrally to allow the human operator to view the correct execution of the operating steps of the treatment cycles of the individual devices provided by the individual devices.

[023] According to an improvement, the method further provides for the following steps:

- Display the progress status of the sterilization process both in the overall flow of said process and in the flow of execution of the treatment cycles of the individual devices;

- Monitor and detect the presence of anomalies, errors in the execution of the steps of the sterilization process or malfunctions of the sterilization and / or pre-sterilization devices.

[024] According to a further characteristic, the method provides for the further steps of:

- Identify each individual of the service personnel destined to carry out sterilization operations by means of a unique code;

- Associate each sterilization treatment process and / or each cycle with the service personnel who performed it by means of the said identification code;

- To transmit information on the progress of the sterilization process both in the overall flow of said process and in the flow of execution of the treatment cycles of the individual devices and any anomalies, any errors in the execution of the steps of the sterilization process or any malfunctions of the sterilization and / or pre-treatment equipment to the service personnel.

[025] In a preferred embodiment only the service person to whom the sterilization process is associated has access to the device.

[026] According to a still further refinement, the method involves the steps of:

- Identify each instrument to be treated through the sterilization process using a unique code;

- Generating a flow of sterilization treatment cycles and / or steps for said instrument;

- Associating said flow of cycles and / or sterilization steps to said instrument by means of the corresponding univocal identification code of the instrument; - Track the instrument during the execution of the sterilization process in relation to the cycles and sterilization steps envisaged in said flow of cycles or sterilization steps;

- Generate automatic alerts or on request for information relating to the instrument and its tracking data in the flow of cycles and / or sterilization steps envisaged for said instrument;

- Make these notices automatically or upon request visible to service personnel.

[027] The step related to making visible automatically or on request the notices of information relating to the instrument and its tracking data in the flow of cycles and / or sterilization steps envisaged for said instrument to the service personnel can provide two alternatives :

- A first alternative provides that the information is accessible to all users belonging to a group of people qualified as service personnel, for example by viewing the information on one or more displays.

- A second alternative instead provides that the univocal identification codes of one or more service persons and the univocal identification codes of the instruments to be processed that are under the responsibility of this or these persons are further associated, for which the information is made accessible, either automatically and passively or upon explicit request, only to this or these service personnel corresponding to the unique identification codes of the service person or persons associated with the unique identification codes of the instrument or instruments to be processed.

[028] While the first alternative is advantageous with regard to small medical or dental offices, the second alternative is advantageous for large clinics or when centralized management is exercised remotely for a large number of small dental cabinets that connect to a center management of the cloud type, or for example to a management server to which various studies, or even clinics, can be connected to obtain management services.

[029] According to a still further improvement, the method provides for determining the quantity of instruments and the type of same that is present in the warehouse or that will be present in the warehouse and available for use during a predetermined working period, depending on the total number of instruments and the type of ready-to-use instruments already in stock, the number and type of instruments being processed and the duration of the treatment,

[030] According to another improvement, the method provides for determining the quantity of instruments and the type of instruments that are present in the warehouse or that will be present in the warehouse and that will be available for use during a predetermined working period also in function the number of operations and the number of patients expected during the said period of work.

[031] Still according to a further characteristic, the method comprises the steps of indicating to the service personnel the activities to be performed for the treatment of a pre-established instrument on the basis of a database of tutoring information on the sterilization processes and on the methods of execution of the same , in particular steps for staff training.

[032] According to a further refinement, the method according to the invention also includes steps of:

- Unique identification of the patient treated through personal data or a unique identification code;

- Association of the univocal identification code of the instruments used in the treatment of said patient;

- Association of the individual devices used for the sterilization treatment of the individual instruments and the sterilization process performed on them;

- Recording of the time stamp of the patient's treatment with the said instruments and of the sterilization of the said instruments;

- Storage of said data in a log file of the treatment associated with said patient.

[033] Thanks to these steps, the method makes it possible to trace the instruments used to treat a specific patient and verify the condition of sterilization of the same in case of onset of complications due to infections or pathogens. In this way it is possible to verify the sterility of the instruments and demonstrate that the cause of the infection does not lie in a failure to sterilize the instruments used in the treatment of the specific patient.

[034] In particular, the invention concerns the networking of the various devices present inside a sterilization room, the saving and display of information relating to the treatment processes of contaminated instruments.

[035] In an embodiment suitable for the current methods of carrying out the sterilization processes, it is necessary to carry out further steps for identifying the individual instruments and associating them with univocal identification codes applied to storage bags of said instruments after the sterilization process .

[036] In this case, at the time of the sterilization process an additional code is associated with the envelope in which the instrument is sealed.

[037] This further identification step can be avoided, for example, by equipping each instrument with an identification tag that contains a unique identification code of the type and unit of the instrument, such as an RFID tag or similar appropriately programmed.

[038] Still according to a further improvement, the method provides for the archiving, even remote and centralized, of the results of functional tests such as for example vacuum tests, Helix tests, Bowie & Dick tests or microbiological tests, and / or automatic notification of the need to perform one of the said tests.

[039] Depending on the type of test, the results can be in the form of a file and therefore simply stored in a database or the results are on different types of media (eg paper, Petri dishes) and are acquired by reading the said media with scanners, readers and / or video cameras and transformed into digital files.

[040] For the implementation of the method according to the previous characteristics, it is possible to provide different methods.

[041] In one embodiment, the present invention consists in equipping each device involved in the execution of the sterilization process with:

- an internal logic unit of the corresponding apparatus which controls the execution steps of said apparatus and generates information on the operating status; - a network communication interface for a wired or Wi-Fi network connected to said internal logic unit for transmitting and receiving data or commands;

- networking of the equipment used for the treatment of contaminated instruments present in the dental office (at least one device for the pre-treatment of contaminated instruments, at least one heat sealer, at least one autoclave) through said interface, between them and with a remote server centralized management;

- at least one terminal equipped with a video monitor so as to allow viewing of the status of the devices present in the sterilization room.

[042] Preferably a terminal equipped with a monitor is present inside the sterilization room, while other terminals equipped with monitors may optionally be present in other points of the dental office, for example next to each patient treatment chair and also in the treatment room. wait. The information relating to what is happening inside the sterilization room is shown on these monitors, for example at what point in the cycle each device is at that moment. The server also allows you to store all information relating to tests performed on individual devices, such as vacuum tests, Helix tests, Bowie & Dick tests or microbiological tests.

[043] When at least part or all of the devices envisaged in the sterilization process are devoid of logic control units based on microprocessors or other CPUs and of network communication interfaces, it is possible to provide a data collection device associated with each device that has one or more sensors for detecting / measuring the operating conditions of the corresponding apparatus and stores them in a table of operating status parameters.

[044] For example, these sensors can be temperature sensors, clocks for measuring the duration of cycles or steps, cameras for reading displays indicating the operating status provided on the device, which sensors are connected to a central processing and storage unit of said data and their transformation into parameters indicating the type of process set for execution, the operating status and diagnostic conditions of the corresponding device, which data are associated with the unique identification code of said device and transmitted by means of the network to the remote centralized management server.

Further advantages and properties of the present invention are illustrated in the following description, in which an exemplary embodiment of the present invention is shown in detail based on the drawings:

Figure 1 Plan of a typical dental practice

Figure 2 Schematic representation of the typical devices contained in a sterilization room;

Figure 3 Schematic representation of the connection between the various devices connected to the network; by way of example, a LAN network is shown, but the same connection can take place with a wireless network;

Figure 4 Schematic flow chart of an embodiment of the method according to the present invention.

[046] Figure 1 shows a plan of a typical dental office, in which there are typically several armchairs 10 for patient treatment, a waiting room 13, a sterilization room I.

[047] Figure 2 shows the devices typically present inside a sterilization room 1: at least one device 2 intended for the pre-treatment of contaminated instruments (eg. Ultrasonic bath, or thermo washer disinfector, or ultrasonic thermo washer disinfector); at least one heat sealer 3; at least one water steam autoclave 4. Further shown are a server 5 and a terminal equipped with a monitor 6 for displaying information. The terminal equipped with a monitor 6 is coupled to a device 7 capable of identifying each human operator present in the office, for example in the form of a smartcard or RFID or fingerprint reader, NFC tag, or other.

[048] All the equipment 2, 3, 4 for the treatment of contaminated instruments are connected to a data network, which can be:

- a LAN (Local Area Network) through for example an Ethernet port or a similar device; in the case of a wired LAN network, it may be useful for this to be of the type known as POE (Power Over Ethernet), in order to also be able to supply power to devices such as cameras and readers of the human operator recognition system;

- a Wi-Fi network;

- a partially wired and partially wireless network.

[049] Figure 3 shows a diagram of the connection of the networked devices to a router 15: all the equipment 2, 3, 4 for the treatment of the instruments (pre-treatment device, heat sealer, autoclave) are connected to it, all the monitors 6, 9, 12 equipped or not with a terminal, a possible barcode printer 14.

[050] The server for the management of the sterilization room can be present inside the dental office itself, as shown in Figure 3, or it can be located in a place other than the office itself. In principle, there are three possibilities:

- In one embodiment, the server is a computer physically located within the dental office itself.

- In an alternative embodiment, in the event that the dentist is the owner of several practices, the same server can serve for the management of a plurality of sterilization rooms physically located at different addresses (for example, in two different cities).

- In a further embodiment, the server can be located at the premises of a third party and managed by it, for example the supplier (dealer) or the manufacturer of the sterilization equipment.

[051] In a preferred embodiment, the terminal equipped with a monitor 6 present inside the sterilization room J and the terminals equipped with a monitor 9 present next to each patient treatment chair 10 are touch monitors, therefore the human operator can interact with the system using I know screen itself, no need for other input tools (mice or keyboards). Alternatively, when you only want to show information, without the operator being able to interact with the sterilization system, for example in the waiting room, it is possible to use known type monitors without terminals, possibly also connected directly to the Ethernet or Wi-Fi network. -Fi.

[052] In an alternative embodiment, the terminal equipped with a monitor can instead be a portable terminal of a known type such as a tablet or a smartphone. However, even a tablet or smartphone can provide the security features provided by! system through an appropriate operator recognition system incorporated in the portable terminal itself.

[053] In a normal operating routine, the human operator takes a tray of contaminated instruments from one of the 10 patient chairs inside the dental office, and takes it to the sterilization room 1.

[054] Here the contaminated instruments are subjected to a pre-treatment by inserting them into an apparatus 2 which provides for washing and optionally for a first disinfection. The operator who is using the pre-treatment apparatus 2, before starting the pre-treatment cycle of the instruments, swipes his smartcard on the reader 7 present on the terminal equipped with monitor 6, in order to inform the system about who performed this operation. When a cycle is started, on the monitor 6 present in the sterilization room J, and on the monitors 9 present next to each chair 10 for the treatment of a patient, the cycle restart and the residual duration of the cycle are displayed. At the end of the cycle, the information that the cycle has finished appears on all monitors 6 and 9 and optionally 12, so that the operator can return to the room! sterilization, take the clean instruments from the pre-treatment device 2, check them, and if necessary dry them.

[055] At this point, each clean instrument must be enveloped by the human operator using at least one heat sealer 3. Optionally, each envelope can be equipped with a barcode, a QR code, or an RFID device, possibly resistant to high temperatures (typically able to withstand up to 200 ° C). These identification codes are provided by another device, for example a printer or an RFID code reader, so that from this point on, each envelope can be coupled with a unique identification code. This allows to uniquely identify the sterilization path to which the single instrument has been subjected.

[056] When all the pouches have been packaged, the pouches each containing an instrument to be sterilized are inserted into an autoclave 4; the human operator swipes his smartcard on the reader 7 on the terminal equipped with a monitor 6 inside the room! sterilization. The operator manually sets the cycle to be performed (normally there are different types available, depending on the object to be sterilized). A clock appears on monitors 6 and 9 and optionally 12 indicating that the cycle has started and the time left to! its completion.

[057 J When the autoclave 4 cycle is finished, the information appears on monitors 6 and 9 and optionally 12 that the cycle has ended. The operator 8, using one of the touch screens, can open the door of the autoclave 4 even from a distance; this is advantageous, as the instruments inside the autoclave are brought to temperatures over I00 ° C (typically 121-124 and 134-138 ° C), therefore opening the door allows the temperature of the sterilized instruments to be lowered more quickly and wrapped, so that the human operator does not burn by removing them from the autoclave 4.

[058 J In a preferred embodiment, the remote opening of the autoclave door is possible only if the operator first shows the system his identifier (smartcard or RFID or other) in order to increase the security of the system avoiding opening accidental / unwanted of the autoclave door.

[059 1 The human operator takes the sterilized and wrapped instruments and places them in a 1 1 cabinet until their next use.

[060] In a preferred embodiment, the cabinet 11 is equipped with a code reader that uniquely identifies the envelope (bar code, QR code, RFID device) in such a way as to load / unload into / from the system data relating to the location of the instruments themselves, and optionally link them to the patient data on which the instruments are used.

[061] Since sterilized instruments are subject to expiration (ie after a few months the instruments are no longer considered sterile), in one embodiment the system can issue warnings to signal the expiration of individual instruments stored in a warehouse.

[062] At Uni certifications, it is essential that the human operator identifies himself at each step, so as to be able to accurately reconstruct who performed a given operation (loading a device, extracting the instruments, bagging, etc.).

[063] In the most complete form of implementation, it is possible to link to each patient the information relating to which instruments have been used for the therapy, and the information relating to the cleaning / sterilization operations performed on the same instruments. To this end, the information made available by the present invention must be connected to the management system of the study, containing patient records and the therapies to which they are subjected.

[064] The following information can be saved within server 5:

- Execution date of a cycle

- Type of cycle

- Cycle completed successfully

- Optionally a lot number

- Optionally, the identification codes of the bags sterilized within a specific cycle (identified by barcode, QR code, RFID, etc.). A register of the cycles carried out by autoclave can be prepared which can then be printed, stamped and signed by the owner of the study and kept for certification purposes.

[065] Furthermore, according to a further embodiment that also allows to identify with precision the type of instrument that is undergoing the sterilization treatment or that has undergone the said treatment and that is available for use, with the identification code associated with each instrument in the various forms described above can be associated with the name of the type of instrument. By storing this data in a database, the database can be queried or can automatically provide data for each type of instrument on the quantity of instruments being sterilized or which have already been sterilized and are available and possibly on the number of instruments that may be available since are being treated in the sterilization cycle and when these tools will be available.

[066] Providing an appropriate management program executed by the server, it is possible that the program automatically detects this data and manages alarms that indicate the achievement of a minimum threshold of available instruments or any situations of lack of availability for certain instruments and the expected times to recover the availability of these tools.

[067] By interfacing the management program of the sterilization and storage process of sterilized instruments thanks to the unique combination of instrument type, identification code and data on the sterilization cycle relating to its execution, with a program for managing a calendar of sessions with patients it is possible to determine in advance how many sterilized instruments must be available within a predetermined period of time, such as one day or more days, and what are the forecasts relating to the type and number of each type of instrument that will be needed by the activities on patients in the said time frame. These data may be automatically reported to the staff or may be requested by the staff themselves.

[068] An executive example for the implementation of the method steps described above provides a control logic program loaded or loaded on the server or a management computer which program is executed or executable by said server or by said management computer. In combination there are provided means for reading the bar code (s) or identification signals generated and transmitted by tags associated with the envelopes or instruments and means for entering identification codes of the type of instrument. In addition, the server or the management computer are associated with means for displaying the results or an interface for entering requests for viewing the results.

[069] According to a further refinement, the results of the vacuum tests (issued directly from the autoclave) as well as the results of the Hetix, Bowie & Dick and microbiological tests can be saved on servers 5; generally the vacuum test must be performed every day, the other tests with a different periodicity (for example every 20 days), which can vary with the geographical location / nationality of the dental office. A register can also be compiled with the results of the tests, including the date and time of execution of the tests; the register can be printed, stamped and signed by the owner of the study and kept for certification purposes. If applicable law permits, the log can be saved in digital format on the server.

[0701 Optionally, the network comprising the apparatuses 2, 3 4 can be equipped with a small camera 16 capable of photographing the results of the Heìix, Bowie & Dick and microbiological tests; these results can also be saved on server 5 and printed, again for certification purposes, or stored in a typed format if the laws in force allow it.

[071J In the embodiment in which the server is remote, it is possible that the dealer or the manufacturer offers a service to the dentist, periodically providing him with the printed data register to be stamped and signed and kept in the dental office, or, if the law allows it , provide the service digitally.

[072] In a preferred embodiment, the system is set up to require the operator to perform the necessary tests on the pre-established days. Optionally, the autoclaves can be prevented from carrying out the sterilization cycle if the required device efficiency check has not been performed first.

[073] A tutorial can also be installed on server 5 that allows you to guide the human operator in the sequence of operations necessary to carry out a correct treatment of contaminated instruments. It is possible to set the tutorial to show that a particular human operator has followed it throughout its duration, as happens with distance education events, for example by interrupting the video with questions that the human operator must answer in order to to be able to continue in the vision; it is possible to permanently save the list of tutorials with the names of the operators who followed them within the server 5. This register can also be printed, stamped and signed by the owner of the study, and then be kept for certification purposes. This register could also be kept in digital format only, if the laws in force allow it.

[074] Statistics can be compiled on the data of the sterilization cycles: for example how many sterilization cycles were carried out during the day, how many sterilization cycles were carried out for each autoclave with which the study is equipped, etc. These statistics can be processed in a simple graphical form and displayed on the monitor 12 present in the waiting room 13, so that they can be seen by the patients waiting to undergo therapy.

[075] With reference to Figure 4, this schematically illustrates in a functional block diagram an embodiment of the method of the present invention.

[0761 Steps 101 to 105 require the association of a unique identification code to the device, the service person, the patient, the instrument and the process. Not all steps must necessarily be foreseen and this depends on the degree of improvement of the system to be obtained.

[077] Once the one or more unique identification codes to the steps have been determined! 10, 11, 112, and 113 the method provides for carrying out a definition of the cycles and process steps to be performed and for comparing this operating flow with a standard sterilization protocol. The tracking and monitoring step verifies that all process steps are carried out and that their execution has been correct.

[078] The information on the process execution modes is then generated which are associated with one or more of the unique identification codes detected in steps 101 to 105, while warnings 120 are issued from these data and / or the data 121 are stored or possibly by data relating to the number of instruments present, the various processes in execution and the expected sterilization execution times, statistics can also be generated on the number of instruments available during a period of activity and depending on the number of patients to be treated in the said period as indicated with 130.

[0791 Finally, it must be remembered that in practice it may happen that the dentist decides over time changes in his sterilization room, or that he has to replace faulty or obsolete equipment (2, 3, 4). In a preferred embodiment, said apparatuses are capable of self-configuring to connect automatically to a remote server, possibly to a cloud.

1. Sterilization room

2. Pre-treatment apparatus

3. Heat sealer

4. Autoclave

5. Server

6. Sterilization room monitor

7. Smartcard reader

8. Operator

9. Monitor on chair

10. Patient chair

1 1. Sterilized instrument cabinet

12. Waiting room monitor

13. Waiting room

14. Barcode printer

15. Router

16. Camera

101. Device ID

102. Service Person ID

103. Instrument ID

104. Patient ID

105. Process ID

1 10, Track and monitor process, cycles and steps

111, Compare with Execution Protocols

1 12, Generate data on process execution conditions

1 13 Associate one or more IDs

120. Issue Notices

121, Store data

130. Generates statistics and forecasts on the number of tools needed and the availability of tools possible

Claims (14)

CLAIMS 1. Method of remote control and certification of the sterilization process of instruments or the like in a medical office, preferably dental, comprising: - At least one or more sterilization devices such as an autoclave (4) or the like; - Optionally at least one or more pre-treatment devices (2) for carrying out preventive treatment steps for said instruments; characterized by the fact that the method involves the following steps: - Uniquely identify the individual sterilization and pre-treatment (2) devices (4); - Detect data on the operating conditions of the same in the execution of the flow of steps necessary for the execution of the operating cycle of each of said devices and possibly the partial or total times of execution of the operating cycles; - To process said data in a centralized way to allow a human operator to visualize the correct execution of the operating steps of the treatment cycles envisaged by the individual devices. Method according to claim 1 wherein the following steps are further provided: - Display the progress status of the sterilization process both in the overall flow of said process and in the flow of execution of the treatment cycles of the individual devices; - Possibly monitor and detect the presence of anomalies, errors in the execution of the steps of the sterilization process or malfunctions of the sterilization (4) and / or pre-treatment (2) devices. 3. Method according to claims 1 or 2, which provides for the further steps of: - Identify each individual of the service personnel destined to carry out sterilization operations by means of a unique code; - Associate each treatment, sterilization and / or cycle process with the service personnel who performed it by means of the said identification code; - To transmit to the service personnel the information on the progress of the sterilization process both in the overall flow of said process and in the flow of execution of the treatment cycles of the individual devices and any anomalies, any errors in the execution of the process steps sterilization or any malfunctions of the sterilization and / or pre-treatment equipment. 4. Method according to one or more of the preceding claims, in which the further steps of: - Identify each instrument to be sterilized by means of a unique instrument code; - Generating a flow of sterilization treatment cycles and / or steps for said instrument; - Associating said flow of cycles and / or sterilization steps to said instrument by means of the corresponding univocal identification code of the instrument; - Track the instrument during the execution of the sterilization process in relation to the cycles and sterilization steps envisaged in said flow of cycles or sterilization steps; - Generate automatic alerts or on request for information relating to the instrument and its tracking data in the flow of cycles and / or sterilization steps envisaged for said instrument; - Make these notices automatically or upon request visible to service personnel. 5. Method according to one or more of the preceding claims in which the access step and / or make the information notices relating to the sterilization (4) or pre-treatment (2) devices, the instrument and the the tracking data of the same in the flow of cycles and / or sterilization steps provided for the said instrument to the service personnel is performed according to one of the following two alternatives: - only the service person to whom the sterilization process is associated has access to the sterilization (4) and / or pre-treatment (2) sterilization device identified by the unique code of the device and / or instrument being treated and the service person and the aforementioned information; - the sterilization device (4) and / or pre-treatment (2) and / or the aforementioned information are accessible to all users belonging to a group of people qualified as service personnel, being in both cases further associated between them the univocal identification codes of one or more service persons and the univocal identification codes of the instruments to be processed which are under the responsibility of this or these persons, for which the information is made accessible both automatically and passively or upon explicit request only to this or these service personnel corresponding to the univocal identification codes of the service person or persons associated with the univocal identification codes of the instrument or instruments to be processed. 6. Method according to one or more of the preceding claims which further provides for the following steps: - Unique identification of the patient treated through personal data or a unique identification code; - Association of the univocal identification code of the instruments used in the treatment of said patient; - Association of the individual devices used for the sterilization of the individual instruments and the sterilization process performed on them; - Recording of the time stamp of the patient's treatment with the said instruments and of the sterilization of the said instruments; - Storage of said data in a log file of the treatment associated with said patient. 7. Method according to one or more of the preceding claims, in which the information collected by the system is chosen from one or more of the following items: - Conformity of execution of the operating steps of the treatment cycles of the individual devices and / or of the operating cycles of the various devices with a pre-established protocol or workflow for sterilization; - Progress status of the sterilization process both in the overall flow of the sterilization process and in the flow of execution of the individual treatment cycles of the individual devices; - Presence of anomalies, errors in the execution of the steps of the sterilization process or malfunctions of the sterilization (4) and / or pre-treatment (2) devices; or combinations of these items e - Identification codes of the individual pre-treatment sterilization and sterilization devices and / or of the service personnel and / or of the instruments to be sterilized and / or of the patient for whom a predetermined instrument has been used, which codes are associated to the information according to one or more of the aforementioned items for a corresponding specific sterilization process, and are stored in a historical report of the sterilization process, 8. Method according to one or more of the preceding claims, in which the step of calculating the quantity of instruments and the type of the same that is present in the warehouse or that will be present in the warehouse and available for use during a period of pre-established work, according to the total number of instruments and the type of ready-to-use instruments already in stock, the number and type of instruments being treated and the duration of the treatment and, if necessary, to determine the quantity of instruments and the type of that is present in the warehouse or that will be present in the warehouse and that it will be available for use during a predetermined work period also according to the number of interventions and the number of patients expected during the said work period. 9. Method according to one or more of the preceding claims further comprising the steps of indicating to the service personnel the activities to be performed for the treatment of a predetermined instrument on the basis of a database of tutoring information on the sterilization processes and on the methods of execution of the themselves, in particular steps for staff training. 10. Method according to one or more of the preceding claims in which Γ local or remote and centralized storage of the results of functional tests is provided, such as for example vacuum test, Helix test, Bowie & Dick test or microbiological tests, and / or warning automatic of the need to perform one of the said tests. 11. System for carrying out the method according to one or more of the preceding claims, which system provides for providing each apparatus envisaged for carrying out the sterilization process with - an internal logic unit of the corresponding apparatus which controls the execution steps of said apparatus and generates information on the operating status; - a network communication interface for a wired or Wi-Fi network connected to said internal logic unit for transmitting and receiving data or commands; - and in which the equipment used for the treatment of contaminated instruments present in the dental office (at least one device for the pre-treatment of contaminated instruments, at least one heat sealer, at least one autoclave) are networked through said interface, between them and with a centralized management server on which a centralized management program is loaded and from which it runs; and in which at least one terminal equipped with a video monitor allows viewing of the status of the devices present in the sterilization room. 12. System according to claim 11, in which at least part or all of the devices envisaged in the sterilization and / or pre-treatment process are devoid of logic control units based on microprocessors or other CPUs and of network communication interfaces, being one or more data collection devices associated with each apparatus are provided which have one or more sensors for detecting / measuring the operating conditions of the corresponding apparatus and at least one memory for storing said data in a table of operating status parameters, 13. Method according to one or more of the preceding claims 1 to 10 or system according to claim 11 or 12, in which the sterilization and / or pre-sterilization devices are selected alternatively or in combination between one or more of the following devices : - at least one autoclave (4); - at least one ultrasonic bath; - at least one instrument wash; - at least one ultrasonic thermodisinfector; - at least one heat sealer (3) for wrapping the instruments to be sterilized, 14. System according to one or more of the preceding claims which provides at least one or two or more communication terminals with the service personnel and / or at least one mobile terminal connected in a wired or wireless network with the server (5) and / or one or more sterilization and pre-treatment appliances.