FR2839889A1 - Method for pre-disinfection of medical instrumentation, comprises automatic stages for immersion in disinfectant/detergent, use of ultrasonic energy, rinsing and recording on labels - Google Patents

Abstract

The fixed installation has a water tank (2) which receives cold water (47) and strong disinfectant (61) from storage drums. The water tank has high and low level detectors (26,27), an overflow (102) and an output (76). A pump sends the product to a mobile disinfecting tank which incorporates ultrasonic and rinsing equipment and is linked to data processing equipment able to produce labels and records of the disinfecting operation. An Independent claim is also included for fixed and mobile equipment able implement the method of disinfecting, subjecting to ultrasonic waves and rinsing over a number of theatres.

Description

C: \ Documents r.nd Senings \ nrh \ Bureau \ 21 147.drJc - May 20, 2003

  MOBILE INSTRUMENTATION PRE-DISINFECTION UNIT

  MEDICO CRUGICAL OPERATING AND DENTAL BLOCK WITH

  TRACEABILITY OF THE PROCESS AND IMPLEMENTATION

  The invention relates to a method and an apparatus consisting of one or more automated mobile units for the pre-disinfection of medical and surgical instrumentation.

operating and dental unit.

  Currently, the pre-disinfection is carried out in the following way: a plastic tray placed on a cart is brought to the operating room with water and a disinfectant product in which the instrumentation is placed. It is then brought back to the devastation room where sometimes it is necessary to carry out manual brushing of the instrumentation. In addition, no tra, cability of the operation: soaking time, the presence of the disinfectant product in the water, the good percentage of the infectious product preconected by the supplier depending on the quantity of water used. This is the reason why I propose a device composed of a fixed unit in the devastation room and one or more mobile units which will be transported in the operating rooms. The whole automated which will allow to have: no manual manipulation of the instrumentation before going to the washing machine, the certainty that all the parameters of a quality disinfection will have been made. A tra, cabilite on paper will prove it as well as on a hard disk. Wile has two very distinct stages: - treatment of instrumentation - tra, cability of the process and the cycle; storage of traceability on hard disk and on paper,

  transmission by computer network inside and outside the establishment.

  The present invention relates to the pre-disinfection of medical instrumentation.

  surgical and dental with traceability of the process, where it is necessary to ensure a

  excellent quality of hygiene and control vis-à-vis the patient and staff.

  o More specifically, the invention relates to an automatic process for the pre-disinfection of medico-surgical instrumentation in operating and dental units, with control and

  traceability of the cycle before going through the washing machine and autoclave.

  a) by immersion in water with an appropriate disinfectant and detergent solution. The implementation of ultrasound with the aim of detaching the particles from the instrumentation and

  : 5 thus ensuring an almost perfect quality of pre-disinfection of the material.

  b) One or more labels with the cycle sequence and other parameters desired by the user will be printed c) the implementation of this process requires the following supplies: electrical, water,

  waste water evacuation, compressed medical air.

  d) the method consists in soaking the instrumentation in water with a disinfectant product, suitable detergent, operating the ultrasound for

  time determined by users.

  e) a rinse, dynamic cage of the whole.

  f) a static rinse with an anti-lime product.

  o g) a printed label will follow the different stages of the instrumentation and

  will accompany him in his treatment circuit.

  h) a second label on a paper roll will contain the same data as the label which accompanies the instrumentation in the different stages. This roll will be kept at the service in order to archive information about the processing of the pre-disinfected product. i) the traceability information recorded on hard disk can be transmitted by the computer network to one or more possessions inside or outside the establishment. j) an automaton will regulate the whole operation of the process taking into account the o level sensors, the safety contacts, the probes, the contact times set by the user, by acting on the solenoid valves, the booster pump, the pumps

  peristaltics, the start of ultrasound.

  k) several programs can be stored. The most used will be: program 1 pre-disinfection with dynamic rinsing; program 2 pre-disinfection with rinse, dynamic age and rinse, anti-lime cage; program 3 disinfection of the fixed and mobile unit assembly including the water tank and the pipelines with a product

more powerful disinfectant.

  Other characteristics and advantages of the invention will become apparent during the course of the

  detailed description of the elements, with reference to the attached figures.

  o - figure la: Represents the water tank

  FIG. 1b: represents the disinfection tank.

  -Figure lc: Represente] e connection cap to the cans.

  -Figure ld: Represents the principle of dis-connection to wastewater.

  FIG. 2a: Represents the description and the operation of the process.

  - Figure 3a: Shows a front view of the open door fixed unit.

  - Figure 3b: Shows a side view of ['fixed unit.

  - Figure 4a: Represents a front view of the mobile unit.

  - Figure 4b: Represents a side view of ['mobile unit. Figure 1a: Represents the configuration of the water tank 2, and the principle of dis connection of the water network of the establishment pipe 47 and pipe 61 which brings the powerful disinfectant product. Note the high level detector 26, the teas level detector 27, the starting connection point 76 used for emptying 0 of the water tank 2 and supplying the disinfection tank 1 through the pipe 48, the outlet overflow 102 connected to pipe 103. All angles of the water tank 2

  rounded wind and a slight slope stamces towards the connection point 76.

  Figure lb: Represents the configuration of the disinfection tank 1. Note the high level detector 34, the teas level detector 35, the ultrasound 37, the detector 36 for correct positioning of the cover 75, the top nozzles 46, the nozzle from the teas 45, the waterproof cover 75, the connection point of the start 74 for the pipe 54 used for emptying the disinfection tank 1. The angles of the disinfection tank are rounded

  and a slight slope begins towards connection point 74.

  Figure 1c: Represents the configuration of plugs 65-66-67 fitted with suction or cannulas 69-71-73, teas level probes 68-70-72, (defective cans) which allow the information displayed on the terminal 80 of the PLC as well as the operating authorization. These caps 65-66-67 respectively are used on cans of disinfectant / detergent 62, anti-lime 63, powerful disinfectant 64 Figure ld: Represents the principle of dis-connection 38 of the fixed unit networks 77

  pipes 50,54,103, with the wastewater network of the establishment.

  Figure 2a - Represents the description and conEguration of the operating process of

  ['invention; it includes: an inlet of cold water connected to a pipe 47 on which are inserted respectively a manual valve 13 provided with a filter and a solenoid valve 14. This pipe 47 dis-connected (European standard: NF EN 1717 August March 2001) is poured into a water tank 2. this water tank 2 has level detectors: high level 26, teas level 27, an outlet 76, a safety outlet 102 for overflow of the water tank 2, this outlet is located above the high level detector 26. (:: e overflow of safety 102 is spilled by the pipe 103 provided with a detector

  of passage 104 to the wastewater network of the establishment through the intermediary of the

  connection 38. The outlet 76 is connected to a pipe 48, it even connected to a T39; of this T39, a departure on a pipe 50 on which is interposed a solenoid valve 15 and which is poured into the waste water network of the establishment by the dis connection 38, a departure by the pipe 49 connected to the suction of the pump booster 3. The discharge of booster pump 3 is connected to line 51. On this line 51 are connected: T40- T41- T42- T43- T44-. On the T40, a start on a line 61 will bring the powerful disinfectant product 64 to the water tank 2. On this line 61 wind interposed a solenoid valve 16 and a non-return valve 20. This line 61 is disconnected from the water tank 2; a departure to the T41. On the T41, a departure on a pipe 55 connected below the metering device 10, on this pipe 55 wind interposed a peristaltic pump 4 and a non-return valve 21; the top of the dispenser is connected by line 56 to the can of disinfectant 62 via the cap 65, is interposed on this pipe 56 with a peristaltic pump 5. The dispenser includes adjustable level detectors: high level 28, teas level 29; a departure towards the T42. On the T42, a departure on a pipe 57 connected below the metering device 11; on this pipe 57 inter-wind a peristaltic pump 6 and a non-return valve 22; the top of the metering device 11 is connected by the pipe 58 to the can of anti-lime product 63 by means of the plug 66; o on this pipe 58 is interposed a peristaltic pump 7. The metering device includes adjustable level detectors: high level 30, teas level 31; a departure towards the T43. On the T43, a departure on a pipe 59 connected below the metering device 12; on this pipe 59 inter-wind a peristaltic pump 8 and a non-return valve 23; the top of the metering device 12 is connected by the pipe 60 to the can of powerful disinfectant product 64 by means of the plug 67; is interposed on this pipe 64 a peristaltic pump 9. The metering device includes adjustable level detectors: high level 32, teas level 33; a departure towards the T44. On the T44, a departure on a pipe 52 towards the top jets 46 of the disinfection tank 1, on this pipe 52 wind interposed a solenoid valve 17 a non-return valve 24; a start on a line 53 o to the nozzle of teas 45 of the disinfection tank 1, on this line 53 wind interpose a solenoid valve 18 a non-return valve 25. The start of the drain 74 of the desinfechon tank 1 is connected to the canalisabon 54 which pours into the waste water of the establishment by the dis-connection 38; on this line 54 is interposed a

  solenoid valve 19. The dosers 10,11,12, wind dis-connected product cans.

  Operation: the apparatus of the invention comprises a disinfection tank 1 supplied with water by means of the water tank 2 mixed with a detergent disinfectant product can 62. The water is sent to the disinfection tank 1 by the superpressor pump 3. The detergent disinfectant product 62 is brought into the metering device 10 by the pipe 56, on this pipe 56 is interposed a peristaltic pump 5 authorized to operate by the level detector teas 29 of the doser 10. The product is then taken up in the metering device 10 by the pipe 55; on this pipe 55 with interposed wind a peristaltic pump 4 o authorized to operate by the high level detector 28, of the metering device 10 and a non-return valve 21. This pipe 55 is connected to the T41. The product is then sent to the disinfection tank 1 through the pipes 51, 52; 53. The water plus product assembly immerses the instrumentation for a time predetermined by the user, during this period of immersion the ultrasound 377 starts operating for a time s predetermined by the user. Then a rinse, a dynamic cage starts moving along the water tank circuit 2, booster pump 3 disinfection tank 1. The disinfection tank 1 is vice by the drain 74 connected to the pipe 54 to pour into the waste water of the establishment by the dis-connection 38. A rinse, cage with an anti-limescale product is carried out with water and the product from the can 63. The circuit for bringing in the water and the anti-scale product is identical to the phase previous as well as the drain circuit. The contact time is predetermined by the user. The quantities of product are dehumidified according to the quantity of water used and the percentages recommended by the supplier and controlled by the high level detectors 28-30-32 of the respective dosers 10-11-12. The products in the 62-63-64 canisters are dis-connected when they arrive in the respective dosers 10-11-12. Wind product cans with caps: 65

  for the detergent disinfectant, 66 for the anti-scale, 67 for the powerful disinfectant.

  Each stopper has respectively a product suction cannula 69-71-73, a vice canister probe 68-70-72. A special disinfection cycle of the assembly of the mobile unit 95 and the fixed unit 77 is possible with the powerful disinfectant 64. The product is brought into the water tank 2 by the pipe 60 connected to the plug 67. On this pipe 60 is interposed the peristaltic pump 9 authorized to operate by the teas level detector 33 of the metering device 12; the product is then taken up in the metering device 12 through the pipe 59; on this pipe 59 intercales wind a peristaltic pump 8

  authorized to operate by the high level detector 32 of the metering device 12 and a non-return valve

  return 23. This line 59 is connected to the T43. The product is then conveyed through line 51 to the T40 which is connected to line 61; on this pipe 61 wind interposed a solenoid valve 16 and a non-return valve 20. The pipe 61 is disconnected from the water tank 2. Previously the water tank 2 had been supplied with water. The whole is regulated by the high level detector 26 and the teas level detector 27. Water plus product is then conveyed to the disinfection tank 1 by the pump on presser 3. A second dose of product is sent to the water tank 2; the water tank 2 is then supplied with water up to the safety evacuation level 102 (overflow of the tank o), a passagelO4 detector on the pipe 103 will stop the arrival of the water. The disinfection tank 1 will be emptied by the circuit listed above; while the water tank 2 will be emptied by the line 48 and 50 on which is interposed a solenoid valve, the line 50 is disconnected from the wastewater network of the establishment by the dis-connector 38. A rin, dynamic cage will be carried out in the disinfection tank by the

  1S regular circuit !, water tank 2, booster pump 3, top jets 46, teas nozzle 45.

  A dynamic rinsing of the water tank 2 will be separate and will be drained off with the waste water network by line 48 and 50, on which a solenoid valve 15 is inserted. The duration of the special disinfection cycle will be predetermined and stored by the user. After each pre-disinfection cycle the water tank 2 is emptied into the waste water network of the establishment by pipes 48 and 50 on which is interposed a solenoid valve 15. The different phases which wind described above are regulated by a PLC which takes into account the information transmitted by; the teas levels 27-29-31-33-35-68-70-72, the high levels 26-28-30-32-34 and the data programmed by the user. The automaton will control the opening and closing of the solenoid valves 14-15-16-17-18-19, the operation and stop of the pump on presser 3, the operation and stop of the peristaltic pumps 4-5- 6-7-8-9. It is located in the electrical cabinet 88 of the fixed unit 77. On the desk 78 of the fixed unit 77, a terminal will display and allow monitoring of the different phases of the cycle in progress and will mention the end of the cycle, I ' specific information of a can of vice product. A user code will make it possible to modify the sequence of a cycle and to create new specific programs. A technician code will allow troubleshooting on the fixed unit 77 and the mobile unit 95. It will also provide information on the number of cycles performed in order to ensure regular maintenance of the fixed unit assembly 77 and a mobile unit 95. A printer 79 will print the labels with the cycle sequence and other data useful for the processing, operation. The end of the cycle and the operating anomalies will be announced by a buzzer 81 and an indicator light 83 located on the

  desk 78 of the fixed unit 77. The anomalies will also be recorded on a label.

  s Figure 3a: Represente ['fixed disinfection unit 77 seen from the front with open doors. We can see on the left side the water tank 2, the partitioned and separate niches: 86 electrical networks - 87 fluid networks. The can of detergent disinfectant product 62, the can of anti-scale product 63, the can of powerful disinfectant product 64. The right side is reserved for the electrical cabinet 88 with its table 89 on which the safety equipment will be fixed. and operation of the system. In teas of the partition of partition, fluid network and electrical network, one notices the contacts of doors 90 active

  doors closed and which authorize energization.

  The top of the fixed unit 77 includes a control panel 78 on which there is a punch emergency stop button 85, an on / off button 84 for starting the assembly, an indicator light 82 of start-up control, a warning light 83 for signaling the end of the cycle, an alarm buzzer or end of cycle 81, a terminal 80 on which all the information of the cycle and the anomalies will be recorded preventing the functioning of the system. A printer 79 with double functions will print on the one hand a label which will accompany the instrumentation in its various courses, ravage sterilization until its use, on the other hand a label comprising the same indications on a roll, will be archived in the service for a possible

  control of product traceability.

  Figure 3b: Shows a side view of the fixed unit 77. Note the inclination of the control panel 78, the electrical connection sockets: weak currents 91, ^ 's strong currents 92, the fluids connection sockets : water and product supply

  94, emptying of the whole with waste water 93.

  Figure 4a: Represents a front view of the mobile unit 95 protections removed. We distinguish: the disinfection tank 1 with the drain fitting 74, the ultrasound 37 used to detach the soiling from the instrumentation during the immersion phase of the pre-disinfection .; partitioned and separate niches: electrical networks 96 - fluid networks

  97; on the top the waterproof cover 75 with the correct positioning contacts 36.

  Figure 4b: Shows a side view of the mobile unit 95 protections removed. We distinguish the disinfection tank 1 with the nozzles 46 on the upper part of the disinfection tank 1 and the nozzle 45 on the lower part of the disinfection tank 1, the high level detector 34 the teas level detector 35, we can also distinguish the electrical outlet of weak current 98, the electrical outlet of strong current 99, the outlet of connection of the water more product 101, the outlet of connection of the drain 100 to the waste water of the establishment. Above the waterproof cover 75, and the detectors 36 for correct positioning.

Claims (2)

  1 - Method for pre-disinfection of medical and surgical instrumentation in operating room with traceability of the procedure, characterized in that it comprises the successive automatic stages following a stage which consists in immersing the instrumentation in a disinfectant and detergent solution with water a stage which consists in starting a battery of ultrasound during the soaking of the instrumentation a stage which consists in making a rinse, dynamic cage of the instrumentation with water a stage which consists in rinse, static instrumentation cage with an anti-lime product one step which consists in emptying the water tank after each pre-disinfection cycle one step which consists in disinfecting the fixed and mobile unit with a more powerful disinfectant product a step which delivers one or more labels at the request of the user on which appears the tra, cycle cycle and other desired parameters, this information ve nt also processed by computer network 2 - Method according to claim 1 characterized in that the instrumentation is recovered from the operating room in a mobile unit 95 which is then connected to the fixed unit 77 located in the ravage room, which can process one or more mobile units 95 3 - A method according to claim 1 or 2 characterized in that it performs during the pre-disinfection soaking cycle the operation of ultrasound 37 to detach the soils from on the instrumentation, a rinse, dynamic cage to evacuate the water, the disinfectant and the soils which are blown off from the instrumentation, then a rinse, static cage with water and an anti-product limestone and to complete the emptying of the disinfection tank 1, the water tank 2 and the pipes to the wastewater network of the establishment 4 - Method according to claim 1 characterized in that it provides a label which will follow ['instrum entation in its devastation, sterilization circuit, until its use in the operating room, a second label printed on a roll with the same data will be archived in the department; we also have the possibility of storing and transmitting these traceability data to one or more possessions inside or outside the establishment per computer network s 5 - Method according to claim 1 characterized in that it performs a special disinfection with a relatively powerful product of the whole apparatus, fixed unit 77   mobile unit 95 including the water tank 2 and the pipes.   6 - Method according to claim 3 characterized in that the water tank 2 is supplied with cold water through the pipe 47 which is disconnected, the level detectors 26 -27 o of the water tank 2 and the level detectors 34 - 35 of the disinfection tank 1 inform the machine, and by means of a booster pump 3, the water is sent to the disinfection tank 1, the disinfectant detergent product 62 being sent to the disinfection tank 1 by peristaltic pumps 4 and 5 which are authorized to operate and to be stopped by the teas 29 and high 28 level sensors of the metering device 10, during the immersion the ultrasound 37 is applied for a predetermined time so as to detach the contamination from on the instrumentation, the time elapsed, the water, product and soiling being drained being carried out, the teas level detector 35 of the disinfection tank 1 authorizes the rinse, dynamic cage, and then a static rinsing with an anti-lime product 63, Water comes from in the disinfection tank 1 by the water tank circuit 2 and the booster pump 3, the anti-scale product 63 being sent directly to the disinfection tank 1 by peristaltic pumps 7 and 6 which are allowed to operate and stop by: adjustable teas 31 and high 30 level sensors of the metering device 11, the preprogrammed time has elapsed, the emptying being effected by the opening of the solenoid valve 19 positioned on the pipe 54, the information of the wind process recorded on the labels by the printer 79 and transmitted and stored by computer network 7 - Method according to claim 5 characterized in that the whole of the device is disinfected, fixed unit77, mobile unit 95, by a powerful disinfectant product 64 la water tank 2 being filled with water by line 47, a powerful disinfectant product 64 being poured into the water tank 2 by line 61 dis-connected, the powerful disinfectant product 64 being sent into the water tank 2 by peristaltic pumps 9 and 8 which are authorized to operate and to be stopped by the adjustable teas 33 and high 32 level sensors of the metering device 12, which is dis-connected with respect to the arrival of product 64, the canister of product 64 has a level probe has 72 and a suction cannula 73, the water with the product being sent to the disinfection tank 1 by the booster pump 3, a second dose of product 64 being sent to the water tank 2 by the same process listed above, it is then filled with water through line 47 until the safety evacuation 102, the passage of water in line 103 provided with a detector passage 104 stops the arrival of water, the preprogrammed time has elapsed, the emptying of the disinfection tank 1 is carried out by the opening of the solenoid valve 19 positioned on the pipe 54, while the emptying of the tank water 2 and pipes are through line 48 and line 50 through the opening of the solenoid valve 15, the information of the wind process recorded on the labels by the printer 79 and transmitted and stored by computer network 8 - Apparatus for the implementation of the pre-disinfection process of the medical and surgical instrumentation in block and dental surgery with traceability of the procedure according to   any one of the preceding claims characterized in that on the one hand ['unit   fixed 77 includes a water tank 2 dis-connected to the establishment's water network and which is fitted with teas 27 and high 26 level detectors and an overflow safety device 102, a pump on presser 3 sends the water in the disinfection tank 1 which includes a battery of ultrasound, teas 35 and high level detectors 34 the disinfection tank 1 being located on the mobile unit 95, a detergent disinfectant product 62 being sent to the tank disinfection 1, through the metering device 10 which is disconnected from the product inlet 62, the product container 62 has a teas level probe 68 and a suction cannula 69, rinsing with a anti-limescale product 63 being sent to the disinfection tank 1, via the metering device 11 which is disconnected with respect to the arrival of the product 63, the product can 63 has a teas 70 level probe and a cannula suction 71, the disinfection tank 1 is supplied with water by the nozzles from the top t 46 by the opening of the solenoid valve 17 and the nozzle of the teas 45 by the opening of the solenoid valve 18, the drain pipe 54 of the disinfection tank 1 is dis connected, passes through the solenoid valve 19, [the assembly is partly authorized to operate by the teas 35 and high 34 level sensors located on the disinfection tank 1, the disinfection tank 1 at all rounded angles and a slight slope towards the connection point of drain 74, the tarpaulin has water also has all the rounded corners and a