WO2018087225A1

WO2018087225A1 - Instrument reprocessing

Info

Publication number: WO2018087225A1
Application number: PCT/EP2017/078752
Authority: WO
Inventors: Niki Nicolas Grigoriou; Knud Aulkær ANDERSEN; Carsten Olsen; Lars Haunstrup ANDERSEN
Original assignee: Intelligent Systems A/S
Priority date: 2016-11-09
Filing date: 2017-11-09
Publication date: 2018-05-17
Also published as: EP3538164A1; WO2018087225A9

Abstract

The invention relates to a reprocessing facility for reprocessing instruments, the facility comprising: at least one desinficting station, at least one assembly station, at least one packaging station, at least one sterilizer, and at least one buffer, where these stations each are receiving and/or emitting stations for instruments, where the buffer may be used as an intermediate storage between other emitting and/or receiving stations, the reprocessing facility further comprising means for transferring the instruments or tray with instruments between an emitting and a receiving station as well as means for identifying the tray or instruments and where a control system is provided for controlling the transfer by the means for transferring the instruments from an emitting unit to a receiving unit based on information about the instruments identification.

Description

Title

Instrument reprocessing

Field of the invention

The present invention relates to the area of reprocessing instruments.

Background of the invention

The need for reprocessing instruments exists in many areas, where one of the most significant and well known areas is the area of hospitals and the instruments used in such. In this case the instruments may include surgical instruments and other instruments that are intended for multiple use. Although this area is of significant interest, also for the present invention, the invention may apply to other areas where the need for reprocessing instruments exists.

The reprocessing is part of a greater cyclic process, which serves the purpose of preparing instruments and sterilie disposable items for surgery and supplying these to the surgery departments of the hospitals. Instruments and sterilie disposable items are sent from the reprocessing facility and sterile storage to the surgery department where these are used for surgery in a surgery room. Following surgery the instruments are washed and returned to the reprocessing facility. The process of handling the instruments in the reprocessing facility is typically a manual process, which is labour intensive and with great risk of errors in handling.

From US 5374813 a system is known where surgical equipment is transport- ed to an external facility for cleaning and maintenance. The prior publication does not disclose the internal processes in the cleaning and maintenance facility.

From US 201 1/262250 discloses a system for automatic handling of surgical instruments in various stations. The prior publixcation does not disclose the area of control of internal logistics between the stations.

The efficiency of such systems is most often not satisfactory. Objective of the invention

The object of the present invention is to therefore provide for a reprocessing facility for reprocessing instruments, where a more efficient process may be achieved. Further the object of the invention is to provide a control system for controlling the reprocessing facility accoding to the invention.

Description of the invention

According to one aspect of the present invention the objective of the invention is achieved through a reprocessing facility for reprocessing instruments, the facility comprising: a number of receiving and/or emitting stations for in- struments or trays with instruments, the receiving and or emitting stations comprising at least one desinficting station, at least one assembly station, at least one packaging station, at least one sterilizer, and at least one buffer station, where these stations each are receiving and/or emitting stations for instruments, where the buffer station may be used as an intermediate stor- age between other emitting and/or receiving stations, the reprocessing facility further comprising means for transferring the instruments between an emitting and a receiving station as well as means for identifying the instruments and where a control system is provided for controlling the transfer by the means for transferring the instruments from an emitting unit to a receiving unit based on information about at least the instruments identification, the instrument condition and where the control system is adapted to determine the appropriate next receiving station for an instrument based on these informations and based on predetermined priorities.

By controlling the logistics between the various stations in this manner a more efficient use of a reprocessing facility may be achieved. When two or more stations of one or more types of stations form part of the reprocessing facility the complexity increases and the need for clear priorities and control of these becomes further necessary. In an embodiment the reprocessing facility comprises a number of containers holding instruments, where the control system based on identification input about the container allocates a receiving station for a container or where the instruments comprises individual identification and where the control system based on identification input about the instrument allocates a receiving sta- tion for the instrument.ln an embodiment the assembly station comprises devices for inspecting cleanness, mechanical condition and/or weight, and where the devices may be fully automised, semi automised or manually operated. In an embodiment the packaging stations comprises fully automised or semi automised packaging devices. A manual packaging may be foreseen.

In an embodiment the reprocessing facility further comprises a number of buffers, e.g. a buffer for each of the assembly, packaging or sterilizers and robotic devices in correspondence with the control system and adapted to handle equipment and/or containers based on received instructions from the control system.

In an embodiment of the reprocessing facility the assembly, packaging and buffer stations are arranged around a common work space, e.g. a longitudinal arrangement or a circumferential arrangement and where robotic devices in correspondence with the control system are provided and adapted to handle instruments and/or containers in accordance with instructions received from the control system. According to a further aspect of the invention the objective is achieved through a control system for performing the operation of the reprocessing facility according to the invention, the control system comprising input/output channels corresponding with detection devices, inspection devices, storing devices and transportation devices and further comprises internal logic providing output instructions according to received input information and predetermined priorities.

The priorities may comprise at least two of the following: requirement of availability of instruments, utilization of assembly stations, utilization of pack- aging stations, utilization of sterilizer station, utilization of disinfector station, utilization of transport devices. Of significant importance is the fact whether an instrument may be handled at a particular station, whether a particular station is occupied due to higher priority processing of urgently needed instruments and further how to best utilize the capacity available from the vari- ous stations.

In one embodiment the control system comprises a user interface where priorities may be changed. According to another aspect of the invention the objective of the present invention is achieved through a process for handling instruments in a reprocessing facility for reprocessing the instruments, the process comprising the steps :

a. Determining a location and status for each tray with instru- mentis or for each instrument; b. Transmitting the location and status information for the tray or instrument to a control system;

c. Based on the status of each instrument determining by the control unit a next step for the process;

d. Transmitting from the control system to a device for transferring the instrument to the next step of the process, the instructions for transferring the instrument to the next step;

e. Repeating steps a-d until entire process completed. The process may comprise, performing a cleaning operation in a disinfector; Identifying the instruments and position of instrument after cleaning and sending the identification and position information to a control system; Based on the instructions from the control system istributing the cleaned instrument between a number of assembly stations according to a predetermined plan or forecast. Plan can be updated if circumstances like availability of needed resources change. This may result in a recirculation of the plan. The process may be based on the identification of the equipment and availability of assembly stations; Performing at least one type of inspection of each instrument at the assembly stationt, providing an inspection status and sending the inspection status to the control system; Based on the instructions from the control system istributing the cleaned and inspected instrument to a packaging station according to a predetermined plan and based on the identification of the equipment, inspection status and availability of packaging station, or to a further assembly station for further inspection; Transferring the cleaned and packed equipment to a sterilizer; and transferring the cleaned, packed and sterilized equipment to a storage facility.

Brief description of the drawings

The invention will in the following be described with reference to embodi- ments illustrated in the drawings where: FIG. 1 is a schematic drawing showing the reprocessing system as a part of a larger cyclic process;

FIG. 2 is a schematic drawing showing functional steps through the process according to the invention;

FIG. 3 is a schematic drawing showing the basic elements of a reprocessing facility according to the invention;

FIG. 4 is a specific embodiment of the reprocessing facility;

FIG. 5 is a further specific embodiment of the reprocessing facility;

FIG. 6 is a diagram depicting various scenarios.

FIG. 7 is a further diagram depicting scenarios;

FIG. 8 is a diagram depicting the scenario involving a separate packaging station;

FIG. 9 is a diagram depicting the steps of the fully automised assembly station; and

FIG. 10 is diagram depicting the steps of a semi automatic assembly station. Description of embodiment

From FIG. 1 the cycle of the instruments that are handled in the area of the invention appears. The purpose of the invention is to provide an improvement to the entire process by providing a both more effective process in the area of cleaning and inspecting the instruments being processed and more secure process, hereby contributing to an overall more effective and secure cycle and hence an improvement in the patient treatment and safety. From FIG. 2 the process steps of the reprocessing appears schematically. It appeasr that the process involves a repeated identification of both trays and individual instruments. The instrument inspection is shown to involve weight detection, identification, cleanness verification, corrosion detection, open/closing momentum inspection, sharpness verification and possibly a lubrication in case this is needed for instruments with mutually movable parts. From FIG. 3 the main elements of general model of a reprocessing facility according to the invention appears schematically. The main elements are in this configuration shows the instrument containers being cleaned in a disin- fector for containers and instruments placed in trays or baskets for instru- ments are cleaned in another disinfector. Separate instruments, e.g. instruments that are to large to fit a tray or basket may be handled by separate placement in a rack. Following cleaning the containers are transferred to a packaging station and awaiting the instruments. The instruments are transferred to assembly stations, which may be fully automatic, semi automatic or manual. Following the assembly operation at the assembly station the instruments are transferred to packaging stations, which may be fully automatic, semi automatic or manual. The instruments are packaged with the containers already transferred to the packaging station. Following the packaging operation at the packaging station the packaged containers with instruments are transferred to sterilizers and finally to a sterile storage.

The containers, trays or baskets and/or the instruments are identified at a number of locations, in this case by RFID scanning of tags on the containers, trays or baskets or instruments. This ensures that the location of the individ- ual item is always known and ensures traceability. Other types of identification may be used, e.g. 2D or 3D barcode scanning.

Buffers are place on both the incoming side and the outgoing side of the assembly and packaging stations. A single buffer unit can be used for both in- going and outgoing items. Even though a design with separate in- and outgoing buffers is preferable in most cases.

All transferring of items going from one station to another is carried out using socalled automatic guided vehicles (AGV's), which is basically a robotic transferring unit. Transport can be manually with a manually driven trolley or automated using AGV or other sorts of automated transportation. At the assembly stations various inspections are carried out, which will be more detailed explaned in the following. All operations are carried out based on instructions from a control system, which receives information from the devices present at the various stations.

From FIG. 4 a specific embodiment of a reprocessing facility appears, where compared to the general model shown in FIG. 3, the buffer for the assembly and packaging stations has been laid out as a common central buffer unit that connects a number of workstations allowing trays and baskets with instruments and containers to be stored and transported between connected workstations. Workstations can be assembly stations, packaging stations or stations for performing other process steps either automatic or semi automat- ic.

From FIG. 5 another embodiment of the centralised buffer appears. The assembly and packaging stations are placed along a longitudinally extending workspace, with incoming and outgoing buffers at each end of a common central buffer that connects a number of workstations.

From FIG. 6 three different scanearios are shown related to the transfer from the disinfector(s) to the assembly station(s). In order to handle these scaneri- os efficiently the instrument trays are transferred to the assembly stations while still in the disinfector racks, which are then emptied at the relevant assembly station. These distribution scenarios are also handled by the central buffer unit, which allows trays or baskets to be extracted from disinfector racks and transported and stored and inserted into sterilizer racks individually after packaging. From FIG. 7 shows similar scenarios for the transfer from the packaging stations to the sterilisers. When maintaining the packaging at assembly stations a significant amount of transfer capacity is needed. In FIG. 8 the illustration shows distribution scenarios for optimal utilization og sterilizer units or when certain equipment has to be sterialized in a special facion. Illustration shows a possible need for distribution to different sterilizers. Hereby trays from sevceral assembly stations may be handled at the same packaging station and distributed to several sterilizers afterwards, re- suiting in a lower need for transfer capacity.

From FIG. 9 the various operational steps of the fully automatic assembly station appears.The incoming instrument tray is scanned, weighed and emptied. Subsequently att instruments are scanned and checked for cleanness e.g. by means of UV vision control or by multispectral vision control. Following this a number of tests may be carried out to verify certain usage aspects of the instruements, including opening/closing momentum, sharpness, curvature verification and further various types of maintenance operations like e.g. application of lubrication to certain parts of instruments. Having finalised the inspection the instruments are returned into trays and weighed again and based on the inspection results these may be transferred either to additional control at a further assembly station, possibly a manual assembly station, or may be transferred to a buffer before being transferred to the next process step. When a condition of an instrument is recognised that does not match the expectations, the instrument or the entire set of instruments is removed from the assembly station and transferred to alternative handling, e.g. manual handling, or the defective instrument may be removed and ex changed with an identical instrument meeting the requirements. In FIG. 108 a semi automatic assembly station is depicted, involving identification of tray and instruments by use of a RFID tunnel and further by weigh- ing, whereafter the instruments are manually inspected or undergoing maintenance.

The following gives in addition to the explanation in connection with FIG. 3 a functional explanation for the system.

The overall system comprises a disinfector for disinfecting instruments and instrument trays. The instruments and trays are placed in washer trays which are subsequently placed in disinfector racks or the instruments or trays are placed directly in a disinfector rack. The disinfector separates a clean side from a side by having access doors to both the clean side and the side . A separate disinfector for racks may be provided as well.

After the disinfection procedure in the disinfector the rack is transferred to the clean side of the disinfector. The rack or individual washer trays are transferred to a first location in the process, which may be a buffer or a assembly station.

At the assembly station the trays are emptied and the instruments are under- going an inspection to ensure the proper cleanness of these as well as proper function of the instruments. The various inspections are described in more detail below.

Following the procedures at the assembly station the tray is transferred to a packaging station, where the packed and inspected instruments are sealed in suitable packaging.

Following the packaging procedure at the packaging station the packaged tray with instruments is transferred to a sterilizer. The packaged tray is placed in a sterilizer rack and inserted into the sterilizer for treatment. Following the sterilizing in the sterilizer the packaged and sterilized instruments is ready for transfer to a storage facility and ready for further use.

The packaging station may as mentioned involve various inspections to en- sure the proper condition of the instruments. These inspections may be cleanness checks by use of vision systems, e.g. multi spectral vision systems, operational checks of instruments with mutually movable parts, e.g. opening/closing momentum for scissors, tongs, clamps or the like. The entire set of instruments may be subject to a weighing to check whether the instru- ments in the tray corresponds to the instruments intended to be in the tray.

One or more buffer stations may be provided in the system, either as central buffer stations or individual buffer stations for the individual process stations. The decision of whether to transfer to a buffer station or transfer to a next step station in the process is determined by the control system according to a series of priorities, which may be fixed priorities or may be customised priorities in case of emergency arised du to sudden need for specific instruments.

The assembly station procedures may be carried out using robotic solutions carrying out fully automised checks. All check results are transmitted to the control system and stored with the data for the set of instruments or the individual instruments.

Claims

1 . A reprocessing facility for reprocessing instruments, the facility com- prising: a number of receiving and/or emitting stations for instruments or trays with instruments, the receiving and or emitting stations comprising at least one desinficting station, at least one assembly station, at least one packaging station, at least one sterilizer, and at least one buffer station, where the buffer station may be used as an intermediate storage between other emitting and/or receiving stations, the reprocessing facility further comprising means for transferring the instruments between an emitting and a receiving station as well as means for identifying the instruments and where a control system is provided for controlling the transfer by the means for transferring the instruments from an emitting unit to a receiving unit based at least on information about the instruments identification and the instrument condition and where the control system is adapted to determine the appropriate next receiving station for an instrument based on these informations and based on predetermined priorities.

2. A reprocessing facility according to claim 1 , the reprocessing facility comprising a number of trays holding instruments, where the control system based on identification input about the tray allocates a receiving station for a tray or where the instruments comprises individual identification and where the control system based on identification input about the instrument allocates a receiving station for the instrument.

3. A reprocessing facility according to claim 1 or 2, where the assembly station comprises devices for inspecting cleanness, mechanical condi- tion and/or weight, and where the devices may be fully automised, semi automised or manually operated.

A reprocessing facility according to claim 1 or 2, where the packaging stations comprises fully automised, semi automised packaging devices or manual packaging.

5. A reprocessing facility according to any of the preceding claims, further comprising a number of buffer stations, e.g. a buffer station for each of the assembly or packaging stations or sterilizers and robotic devices in correspondence with the control system and adapted to handle equipment and/or containers based on received instructions from the control system. 6. A reprocessing facility according to any of the preceding claims, where a common central buffer unit that connects a number of assembly and packaging stations allowing trays and baskets with instruments and containers to be stored and transported between connected stations, e.g. a longitudinal arrangement or a circumferential arrangement and where robotic devices in correspondence with the control system are provided and adapted to handle instruments and/or trays in accordance with instructions received from the control system.

A control system for performing the operation of the reprocessing facility according to any of the preceding claims, the control system comprising input/output channels corresponding with detection devices, inspection devices, storing devices and transportation devices and further comprises internal logic providing output instructions according to received input information and predetermined priorities. A control system according to claim 7 or 8, where the priorities may comprise at least two of the following: requirement of availability of instruments, utilization of assembly stations, utilization of packaging stations, utilization of sterilizer station, utilization of disinfector station, utilization of transport devices.

9. A control system according to claim 7, 8 or 9, where the control system comprises a user interface where priorities may be changed.

10. A process for handling instruments in a reprocessing facility for reprocessing the instruments, the process comprising the steps :

a. Determining a location and status for each tray with instru- mentts or for each instrument;

b. Transmitting the location and status information for the tray or instrument to a control system;

c. Based on the status of each instrument determining by the control system a next step for the process;

e. Repeating steps a-d until entire process is completed.

1 1 . A process according to claim 10, the process comprising:

a. Performing a cleaning operation in a disinfector;

b. Identifying the instruments and position of instrument after cleaning and sending the identification and position information to a control system;

c. Based on the instructions from the control unit distributing the cleaned instrument between a number of assembly stations ac- cording to a predetermined plan and based on the identification of the equipment and availability of assembly stations; Perfornning at least one type of inspection of each instrument at the assembly station, providing an inspection status and sending the inspection status to the control unit;

Based on the instructions from the control unit distributing the cleaned and inspected instrument to a packaging station according to a predetermined plan and based on the identification of the equipment, inspection status and availability of packaging station, or to a further assembly station for further inspection. Transferring the cleaned and packed equipment to a sterilizer; and

Transferring the cleaned, packed and sterilized equipment to a storage facility.