Method and system for reprocessing reusable medical instruments
12129065 ยท 2024-10-29
Assignee
Inventors
- Franciscus Maria VERHOEVEN (Eindhoven, NL)
- Paul Herman Maria PESSERS (Eindhoven, NL)
- Theo Alex Eduard VAN DER LEIJ (Eindhoven, NL)
- Jolande Wilhelmina BAKKER-VAN DE KERKHOF (Eindhoven, NL)
Cpc classification
A61B90/70
HUMAN NECESSITIES
A61B2050/006
HUMAN NECESSITIES
A61L2202/24
HUMAN NECESSITIES
B65B55/027
PERFORMING OPERATIONS; TRANSPORTING
B08B3/08
PERFORMING OPERATIONS; TRANSPORTING
International classification
B65B55/02
PERFORMING OPERATIONS; TRANSPORTING
A61B50/00
HUMAN NECESSITIES
Abstract
A method and system for reprocessing a reusable medical instrument. The method includes providing a container including a tray and a lid, the tray having an opening for inserting therethrough the medical instrument into an inner space of the tray, and the lid being arranged for closing the opening. The method includes inserting the container into a decontamination device, inside the decontamination device decontaminating the tray, the lid and the medical instrument while the lid is positioned away from the opening. The method includes, inside the decontamination device, a container handler of the decontamination device closing the container by closing the lid onto the tray for closing the opening, and removing the closed container containing the decontaminated medical instrument from the decontamination device.
Claims
1. A method for reprocessing a reusable medical instrument, including: providing a container including a tray and a lid, the tray including one or more supports supporting the medical instrument, the tray having an opening for inserting therethrough the medical instrument into an inner space of the tray, and the lid being arranged for hermetically closing the opening; inserting the container into a decontamination device; inside the decontamination device decontaminating the tray, the lid and the medical instrument while the lid is positioned away from the opening; inside the decontamination device, a container handler of the decontamination device hermetically closing the container by closing the lid onto the tray for closing the opening; reducing gas pressure inside the container prior to closing the container and maintaining said reduced gas pressure inside the container after removing the closed container from the decontamination device; and removing the closed container containing the decontaminated medical instrument from the decontamination device.
2. The method of claim 1, including maintaining the tray in an upright position with the opening extending in an upright plane, while decontaminating.
3. The method of claim 1, wherein the container is inserted into the decontamination device while the container is in a non-sealed state.
4. The method of claim 1, wherein during the step of decontaminating the container is subsequently held in a first chamber and a second chamber.
5. The method of claim 4, wherein the first chamber and the second chamber are positioned with their respective main planes of extension substantially parallel.
6. The method of claim 4, wherein the container is closed while being moved from the first chamber to the second chamber.
7. The method of claim 1, including inside the decontamination device applying a label to the container.
8. The method of claim 3, wherein in the non-sealed state a perforation of the lid and/or tray provides an open connection from an inner space of the container to ambient air.
9. The method of claim 8, including closing the perforation with a label while the container is inside the decontamination device.
10. The method of claim 1, wherein the container includes a further lid, the tray having a further opening, preferably opposite the first opening, the method including inside the decontamination device decontaminating the tray, the lid, the further lid and the medical instrument while the lid is positioned away from the opening and the further lid is positioned away from the further opening; and inside the decontamination device, the container handler closing the lid onto the tray for closing the opening, and closing the further lid onto the tray for closing the further opening.
11. The method of claim 1, wherein the step of inserting includes inserting the container into the decontamination device while the lid is closed onto the tray.
12. The method of claim 11, including inside the decontamination device removing the lid from the opening.
13. The method of claim 1, including the container handler gripping the container by the tray and by the lid.
14. The method of claim 1, wherein the decontaminating includes one or more of rinsing, washing, disinfecting, sterilizing, and drying.
15. The method of claim 14, including performing washing in a first chamber of the decontamination device, and performing sterilizing in a second chamber of the decontamination device.
16. The method of claim 1, wherein the step of closing includes closing the container such that a microbial barrier is formed preventing microbes from entering the inner space.
17. The method of claim 1, including the decontamination device reading decontamination instructions from an identification of the container.
18. The method of claim 10, wherein the step of inserting includes inserting the container into the decontamination device while the further lid is closed onto the tray, removing the lid from the opening inside the decontamination device.
Description
BRIEF DESCRIPTION OF THE DRAWING
(1) The invention will further be elucidated on the basis of exemplary embodiments which are represented in a drawing. The exemplary embodiments are given by way of non-limitative illustration. It is noted that the figures are only schematic representations of embodiments of the invention that are given by way of non-limiting example.
(2) In the drawing:
(3)
(4)
(5)
(6)
(7)
(8)
(9)
DETAILED DESCRIPTION
(10)
(11) Here, the container 1 includes a first lid 14. The first lid is arranged for closing the first opening 8. In this example, the first lid 14 includes a first circumferential seal 16. In normal use, with the bottom 15 facing downwards, opening the first lid 14 allows easy access to the medical instrument(s) 2 inside the container 1 via the first opening 8, which then extends on an upper side of the tray 4.
(12)
(13) Here, the container 1 includes a first lid 14. The first lid is arranged for closing the first opening 8. In this example, the first lid 14 includes a first circumferential seal 16.
(14) In the example of
(15) When used for inserting medical instruments 2 into the container, and/or taking medical instruments 2 from the container, the container 1 will normally be placed with the second lid 20 resting on a carrier surface, such as a counter top or table top. The second lid 20 then acts as a bottom of the container 1.
(16) In normal use, with the second lid 20 facing downwards, opening the first lid 14 allows easy access to the medical instrument(s) 2 inside the container 1 via the first opening 8, which then extends on an upper side of the tray 4.
(17) In the examples of
(18)
(19) The decontamination device 24 includes a container handler 28 arranged for holding the container 1 in the decontamination device. The decontamination device 24 includes a decontamination unit 30 arranged for decontaminating the container 1 and the medical instrument 2. The decontamination device includes an exit 32 for removing the closed container 1 containing the decontaminated medical instrument 2 from the decontamination device.
(20) In this example, the decontamination device 24 includes a reader 38 for reading the machine readable identification 34.
(21) Here, the decontamination device 24 includes a processor 40. The processor 40 is communicatively connected with a memory 42. The processor 40 is communicatively connected with a user interface 44.
(22) In this example the decontamination unit 30 includes a first chamber 30A and a second chamber 30B.
(23) The decontamination device 24 as described thus far can be used as follows with reference to
(24) A container 1 and a medical instrument 2 to be decontaminated are presented at the decontamination device 24. In this example, the contaminated medical instrument 2 is included inside the inner space 12. Here, the container 1 is closed. The container 1 is presented at the entrance 26. The reader 38 reads the identification 34 of the container. In this example, a stack of containers 1 is presented at the entrance 26 (see
(25) In this example, the processor 40 retrieves from the memory 42 a record associated with the identification 34 of the container 1. In this example, the record includes data representative of processing instructions for the decontamination of the container 1. It is possible that data representative of the processing instructions is displayed on the user interface 44. For instance, the user interface may display a cleaning cycle as retrieved from the record. It will be appreciated that it is possible that the user interface 44 allows manual manipulation of the processing instructions. It is also possible that the processor 40 does not retrieve processing instructions from the memory 42, and that the user interface 44 prompts the user to enter processing instructions for the container.
(26) The container 1 at the bottom of the stack is engaged by the container handler 28 (see
(27) In this example, the jaws 48, 52, 54 include grooved side members 70A, 70B arranged for engaging a front side 72A and a rear side 72B of the rims 50, 53, 56, respectively. Here the grooved side members 70B are biased by a resilient element 74, such as a spring, to close around the respective rim. By moving the grooved side members 70B against the biasing force, a distance between the grooved side members 70A, 70B can be enlarged for gripping the respective rim.
(28) In this example, the container 1 is moved to the first chamber 30A while the container 1 is maintained in its closed state. Here the container handler 28 moves the container 1 from the bottom of the stack horizontally to above the second chamber 30A. Then the container handler 28 tilts the container 1 such that the openings 8, 18 (although still closed by the lids 14, 20) extend in a vertical plane (see
(29) Once in the first chamber (or while or before entering the first chamber) the first lid 14 is moved away from the first opening 8 by the second jaw 52 and the second lid 20 is moved away from the second opening 18 by the third jaw 54 (see
(30) Now the container 1 is in the first chamber 30A in an opened state. The internal faces of the container, and the contained instrument(s) can be decontaminated. It will be appreciated that in this example, the external faces of the container can also be decontaminated.
(31) In this example, decontamination includes the following process steps. In this example, a first process step is rinsing. For rinsing, jets of a liquid, such as cold water, are directed at the internals of the container 1. During rinsing, the container 1 may be moved up and down relative to the jets to improve rinsing. In this example, a second process step is washing. For washing, in this example the first chamber 30A is filled with a washing liquid to a level that is sufficient for submerging the entire container. During washing, ultrasonic cleaning may be used in the liquid bath in which the container and instruments are submerged. In this example, a third process step is disinfecting. For disinfecting, in this example, jets of a liquid, such as hot water containing a disinfectant, are directed at the internals of the container 1. During disinfecting, the container 1 may be moved up and down relative to the jets. In this example, a fourth process step is drying. For drying, a drying gas, such as hot air, is flown through the opened container.
(32) It will be appreciated that in view of the above process steps, the decontamination device can include one or more nozzles for generating jets, rinsing liquid supply means, washing liquid supply means, disinfection liquid supply means, liquid pumps for feeding the nozzles, liquid pumps for filling the chamber, liquid pumps for emptying the chamber, liquid heating means, gas heating means, blowing means, and an ultrasound transducer.
(33) The nozzles can be placed on a structure extending from a bottom of the first chamber (see
(34) It will be appreciated that the decontamination process may be modified to suit the decontamination needs of the medical instruments included in the container. For example, one or more process steps may be omitted if desired. It is also possible that process parameters, such as liquid temperature, jet pressure, jet duration, ultrasound intensity, ultrasound duration, movement of the container during rinsing, washing, disinfecting and/or drying, gas temperature, etc. may be varied according to need.
(35) In this example after drying the container 1 is removed from the first chamber 30A. Here, during lifting of the container 1 out of the chamber 30A, the guide grooves 60A, 60B, 60C cause the container 1 to be closed again. Thus, the decontaminated closed container is provided at this point. In this example, the container 1 is transported (see
(36) In this example, the container 1 is lowered into the second chamber 30B for performing a further process step (see
(37) In the second chamber 30B in this example, a fifth process step is performed. In this example, the fifth process step is sterilizing. For sterilizing, in this example, the second chamber 30B is filled with a sterilizing gas, e.g. containing ozone. It will be appreciated that information on sterilization can also be included on the label 64. The label may be applied to the container before sterilization or after sterilization.
(38) In this example, a sixth process step is evacuation. Here, the second chamber is evacuated, e.g. to a predetermined pressure below ambient pressure. In this example during lifting of the container 1 in the second chamber 30B, the guide grooves 68A, 68B, 68C cause the container 1 to be closed again. Here, the container is closed inside the second chamber 30B while evacuated. Thus, the closed container includes gas, such as air or a protective gas, below ambient pressure. The container 1 can include an indicator arranged for indicating whether or not the pressure inside the container is below a predetermined threshold pressure. Thus, the sterilized closed container is provided at this point. In this example, the container 1 is transported to the exit 32 (see
(39)
(40) The decontamination device 24 includes a container handler 28 arranged for holding the container 1 in the decontamination device. The decontamination device 24 includes a decontamination unit 30 arranged for decontaminating the container 1 and the medical instrument 2. The decontamination device includes an exit 32 for removing the closed container 1 containing the decontaminated medical instrument 2 from the decontamination device.
(41) The decontamination device 24 can include a reader 38 for reading the machine readable identification 34. The decontamination device 24 can include a processor 40. The processor 40 can be communicatively connected with a memory 42. The processor 40 can be communicatively connected with a user interface 44.
(42) In this example the decontamination unit 30 includes a first chamber 30A, a second chamber 30B, a third chamber 30C, a fourth chamber 30D and a fifth chamber 30E. In this example, the first chamber 30A is arranged for washing the medical instrument 2 with a liquid, such as water e.g. including a detergent, at a low temperature, e.g. of 37 C. The first chamber 30A can include ultrasonic means 70 for ultrasonically cleaning the instrument 2. In this example, the second chamber 30B is arranged for washing the medical instrument 2 with a liquid, such as water e.g. including a detergent, at a high temperature, e.g. of 73 C. In this example, the third chamber 30C is arranged for disinfecting the instrument, e.g. at a temperature of 93 C. In this example, the fourth chamber 30D is arranged for drying the instrument 2 and the container 1. Here, the fourth chamber 30D is provided with drying means such as blowers 72 and/or heaters 74. In this example, the fifth chamber 30E is arranged for sterilizing the instruments 2.
(43) In this example, the chambers 30A, 30B, 30C, 30D, 30E are positioned with their respective main planes of extension substantially parallel. Herein, the main plane of extension indicates the directions of the two largest dimensions of the chamber. For example, for a chamber having a length exceeding a width, and the width exceeding a height, the largest dimensions are the length and the width. Hence, the main plane of extension is the plane defined by the length and the width of said chamber. Here the first through fifth chambers 30A, 30B, 30C, 30D, 30E are positioned with their respective main planes of extension substantially parallel, so that they occupy a compact volume. Hence, a compact build of the decontamination device is possible.
(44) The decontamination device 24 as described thus far can be used as follows with reference to
(45) A container 1 and a medical instrument 2 to be decontaminated are presented at the decontamination device 24. In this example, the contaminated medical instrument 2 is included inside the inner space 12. Here, the container 1 is closed. In this example, the closed container is in a non-sealed state. Here the lid 14 includes a perforation allowing air to enter or exit the inner space of the container. The container 1 is presented at the entrance 26. The reader 38 reads the identification 34 of the container. In this example, a stack of containers 1 is presented at the entrance 26. Hence, a next container including an instrument 2 to be decontaminated can be placed on top of the stack and wait to be processed by the decontamination device 24.
(46) In this example, the processor 40 retrieves from the memory 42 a record associated with the identification 34 of the container 1. In this example, the record includes data representative of processing instructions for the decontamination of the container 1. It is possible that data representative of the processing instructions is displayed on the user interface 44. For instance, the user interface may display a cleaning cycle as retrieved from the record. It will be appreciated that it is possible that the user interface 44 allows manual manipulation of the processing instructions. It is also possible that the processor 40 does not retrieve processing instructions from the memory 42, and that the user interface 44 prompts the user to enter processing instructions for the container.
(47) The container 1 at the bottom of the stack is engaged by the container handler 28. Here the container handler 28 rotates the container 1 from the bottom of the stack from a horizontal orientation to a vertical orientation. It will be appreciated that a deviation from exactly vertical is possible. In this example, the container 1 is moved to above the first chamber 30A while the container 1 is maintained in its closed state. Next, the container 1 is lowered into the first chamber 30A. It will be appreciated that the generally elongate medical instruments 2 are positioned in an upright position, with their longitudinal axis substantially vertical.
(48) Once in the first chamber (or while or before entering the first chamber) the first lid 14 is moved away from the first opening 8 and the second lid 20 is moved away from the second opening 18. Now the container 1 is in the first chamber 30A in an opened state. The internal faces of the container, and the contained instrument(s) can be washed. It will be appreciated that in this example, the external faces of the container can also be washed.
(49) In this example after washing in the first chamber 30A the container 1 is removed from the first chamber 30A. Here, during or before lifting of the container 1 out of the chamber 30A the container 1 is be closed again. Thus, the washed closed container is provided at this point. In this example, the container 1 is transported to above the second chamber 30B. Once in the second chamber 30B (or while or before entering the second chamber) the first lid 14 is moved away from the first opening 8 and the second lid 20 is moved away from the second opening 18. Now the container 1 is in the second chamber 30B in an opened state. The internal faces of the container, and the contained instrument(s) can be washed. It will be appreciated that in this example, the external faces of the container can also be washed.
(50) In this example after washing in the second chamber 30B the container 1 is removed from the second chamber 30B. Here, during or before lifting of the container 1 out of the chamber 30B the container 1 is be closed again. Thus, the washed closed container is provided at this point. In this example, the container 1 is transported to above the third chamber 30C. Once in the third chamber 30C (or while or before entering the third chamber) the first lid 14 is moved away from the first opening 8 and the second lid 20 is moved away from the second opening 18. Now the container 1 is in the third chamber 30C in an opened state. The internal faces of the container, and the contained instrument(s) can be disinfected. It will be appreciated that in this example, the external faces of the container can also be disinfected.
(51) In this example after disinfecting in the third chamber 30C the container 1 is removed from the third chamber 30C. Here, during or before lifting of the container 1 out of the chamber 30C the container 1 is be closed again. Thus, the disinfected closed container is provided at this point. In this example, the container 1 is transported to above the fourth chamber 30D. Once in the fourth chamber 30D (or while or before entering the third chamber) the first lid 14 is moved away from the first opening 8 and the second lid 20 is moved away from the second opening 18. Now the container 1 is in the fourth chamber 30D in an opened state. The internal faces of the container, and the contained instrument(s) can be dried. It will be appreciated that in this example, the external faces of the container can also be dried.
(52) At this point, the container may be moved towards the exit 32 to provide the container containing the medical instruments that have been disinfected but not sterilized. Thereto, the perforation in the lid may be closed with a label as described hereinbelow.
(53) Alternatively, after drying in the fourth chamber 30D the container 1 is removed from the fourth chamber 30D. Here, during or before lifting of the container 1 out of the chamber 30D the container 1 is be closed again. Thus, the dried closed container is provided at this point. In this example, the container 1 is transported to above the fifth chamber 30E. Once in the fifth chamber 30ED (or while or before entering the third chamber) the first lid 14 is moved away from the first opening 8 and the second lid 20 is moved away from the second opening 18. Now the container 1 is in the fifth chamber 30E in an opened state. The internal faces of the container, and the contained instrument(s) can be sterilized. It will be appreciated that in this example, the external faces of the container can also be sterilized. After sterilizing in the fifth chamber 30E the container 1 is removed from the fifth chamber 30E. Here, during or before lifting of the container 1 out of the chamber 30E the container 1 is be closed again. Thus, the sterilized closed container is provided at this point.
(54) The container can be moved towards a labelling unit 62. The labelling unit 62 is arranged for applying a label 64 to the container 1, here to the first lid 14. The label can close the perforation in the lid 14. The label 64 can include human readable indications. The human readable indications can e.g. include information on the decontamination process performed on the (contents of the) container. The information can e.g. include a processing date and/or an expiration date.
(55) In this example, a sixth process step is evacuation. Here, the container may be evacuated, e.g. to a predetermined pressure below ambient pressure, at the labelling unit. Here, the container is closed while evacuated. Thus, the sterilized closed container is provided at this point. In this example, the container 1 is transported to the exit 32. In this example, the container is placed at the bottom of a stack of containers at the exit 32. The container can be retrieved from the exit 32, e.g. manually.
(56) The decontamination method as described above can be used as follows.
(57) In an example, an association is made of a predetermined set of medical instruments with a predetermined container or a predetermined type of container. The predetermined set of instruments can e.g. be a set required for performing a certain procedure on a patient. The predetermined container can be an identifiable container, e.g. a container having a predetermined indicator such as a number, a letter, a code, a color, an icon, a drawing, or the like on an external surface.
(58) The association of the predetermined set of medical instruments with a predetermined container or a predetermined type of container is stored in the memory 42 of the decontamination device, or is stored in a remote memory and is retrievable by the processor 40, e.g. via a communications network, such as an intranet or the internet. The association is stored in a record in memory. The record can include data representative of the set of instruments and the container. The record can also include data representative of a machine readable identification of the container. The record can include processing instructions (such as which decontamination process steps to follow, and using which parameters). It is possible that for a new association, such record can be created using the user interface 44. It is also possible that an existing association can be modified using the user interface 44.
(59) In the above example, when the reader 38 recognizes the container 1, the record can be retrieved from memory and the processing steps for the instruments in that container are automatically loaded in the processor 40. It will be appreciated that it is possible that the user interface provides the possibility of manually modifying or overriding the retrieved processing steps.
(60) Once the medical instrument, or set of medical instruments is associated with a (type of) container, the instrument(s) are intended to remain with that (type of) container. For example. The container including the decontaminated instrument(s) can be taken from the decontamination device, or from storage, and brought to a treatment space. There the decontaminated instrument(s) is (are) taken from the container (e.g after inspection of the tamper evidence) and used for the procedure. After the procedure, the contaminated instrument(s) is (are) repositioned in the container. The container with the contaminated instruments can then be presented at the decontamination device again.
(61) Herein, the invention is described with reference to specific examples of embodiments of the invention. It will, however, be evident that various modifications and changes may be made therein, without departing from the essence of the invention. For the purpose of clarity and a concise description features are described herein as part of the same or separate examples or embodiments, however, alternative embodiments having combinations of all or some of the features described in these separate embodiments are also envisaged.
(62) In the examples, the process steps rinsing, washing, disinfecting and drying are performed in the first chamber, while sterilizing and evacuating is performed in the second chamber. It will be appreciated that it is also possible that the process steps are assigned to the chambers differently. It will be appreciated that it is also possible that all process steps are performed in one single chamber. It is also possible that more than two chambers are used for performing the process steps. It will be appreciated that one or more of the process steps may be omitted in view of the requirements of the medical instrument to be decontaminated.
(63) Herein, the invention is described with reference to specific examples of embodiments of the invention. It will, however, be evident that various modifications, variations, alternatives and changes may be made therein, without departing from the essence of the invention. For the purpose of clarity and a concise description features are described herein as part of the same or separate embodiments, however, alternative embodiments having combinations of all or some of the features described in these separate embodiments are also envisaged and understood to fall within the framework of the invention as outlined by the claims. The specifications, figures and examples are, accordingly, to be regarded in an illustrative sense rather than in a restrictive sense. The invention is intended to embrace all alternatives, modifications and variations which fall within the spirit and scope of the appended claims. Further, many of the elements that are described are functional entities that may be implemented as discrete or distributed components or in conjunction with other components, in any suitable combination and location.
(64) In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word comprising does not exclude the presence of other features or steps than those listed in a claim. Furthermore, the words a and an shall not be construed as limited to only one, but instead are used to mean at least one, and do not exclude a plurality. The mere fact that certain measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to an advantage.