WO2020094906A1

WO2020094906A1 - Device for handling hazardous drugs

Info

Publication number: WO2020094906A1
Application number: PCT/ES2019/070762
Authority: WO
Inventors: Sergio Giménez Miralles; Luis Miguel Sabater Climent; Sandra Sabater Escuder; Ana Cristina Cercós Lletí
Original assignee: Hospifar, Sl; Fundación Para El Fomento De La Investigación Sanitaria Biomédica De La Comunitat Valencia (Fisabio)
Priority date: 2018-11-08
Filing date: 2019-11-08
Publication date: 2020-05-14
Also published as: ES1223000U; ES1223000Y

Abstract

A device for handling hazardous drugs, comprising a metal chassis (1) which features a number of orifices (1a) connected to a central hollow equipped as a working area (1b) featuring a small cavity (1d) through which the drug travels toward the area equipped for the receiving thereof in a drug packaging machine, and where the chassis (1) features at the front part thereof a window (2) and at its rear part it features a hollow (1c) wherein a prefilter (3) is solidarily housed in order to filter the particles of a greater size; and which is associated with a body (4) comprising at least one first HEPA filter (4a) connected in turn with a second HEPA filter (4c) connected with an extractor motor (4b) which activates the suction of the content of the working area (1b); all the above operated by a logic control means (5).

Description

DESCRIPTION

DEVICE FOR HANDLING HAZARDOUS MEDICINES

Field of the Invention

The purpose of this report is a device for handling dangerous and / or non-dangerous drugs, consisting of a chassis as an isolation booth that has high-efficiency filtration media (HEPA, High Efficiency Particle Arrestance, for its initials in English), preferably designed for coupling to the medicine packaging systems of hospitals, pharmacies, clinics, laboratories or the like; and whose main distinctive advantage lies in protecting during the handling of dangerous drugs in the handling and "repackaging" process, avoiding exposure of personnel during dose preparation operations, and thus, ensuring the protection of the health of the itself, the medicine (avoiding possible contamination of the same and / or cross-contamination with other medicines of various types) and the environment (treating the excess contaminants in a safe and certified manner).

Background of the Invention

Currently, in the health field, "dangerous drugs" are those drugs that present a chemical risk to the personnel handling it, specifically, related to carcinogenic, teratogenic, genotoxic and toxic activity on the reproductive process or on a specific organ at low doses, or because it is a new drug similar to another with these types of risks, and among which are (among others) chemotherapy drugs, antivirals, hormones, drugs targeted by bioengineering, etc.

These types of medications were usually used, without an action plan on their specific risks, which according to the first indications of their danger to handling personnel (or other workers who may have more or less contact with it) obliged to review its management in all the organisms where they are used, incorporating safety procedures reserved for drugs used in cancer therapies. As can be inferred from what has been previously described, in terms of exposure, it represents a health risk for the health personnel who manipulate it, this has caused the intervention of the competent authorities that have regulated the regulations regarding the protection of workers related to exposure to chemical, carcinogenic or mutagenic agents, under the protection of the Occupational Risk Prevention Law (LPRL). Implementing a series of recommendations for safe handling, with preventive measures that guarantee the minimum possible exposure. The minimum exposure that is technically possible (ALARA principle) considering the prevailing preventive attitude always compared to the corrective one under the LPRP.

This exposure occurs mainly through inhalation and / or skin contact, which makes a specific action in this area essential, as carried out by the solution advocated here, which minimizes the risk of inhaling dangerous health products thanks to its double filtering (together with a pre-filtering) during its handling (which occurs in a closed environment, which avoids possible contamination of the environment).

All this is a consequence of the knowledge of the field of hospital pharmacy, where the medicines prescribed for a treatment are packaged in multidose or bulk format, and said department should be in charge of separating and assigning the patient the treatment prescribed by the doctor.

For this, the operator or user in charge of said operation must (manually) separate the medication from the multidose or bulk format and adapt it for each case, which inevitably exposes the operator to harmful particles (in many cases with imperceptible densities for the user himself).

To alleviate the problem described (the packaging of the drug), the applicants are aware of the existence of a multitude of machines for the packaging of drugs, which do not protect the operator during the handling of the same, which does not prevent contamination of the drug (and the patient), the manipulator and the environment.

Designed to solve the problem of contamination, the existence of safety booths is known, where the packaging is carried out manually, completely by hand, so that the packaging procedure is long and tedious; require ample space for installation and are not compatible with known medicine packaging equipment, which in most cases causes the operator to have to lean towards the realization of a certain solution when it comes to packaging (either work safely or work more efficiently).

The air expelled from the device free of contaminating particles, allows the equipment to be placed on close or shared work surfaces, since it does not need coupling with extractor equipment to the outside; its portability allows it to be independent of the technical requirements of the area where it is located.

Finally, clean rooms that are used for this type of work are also known, but they have as main drawbacks the need to require an entire instance enabled for this purpose, with a very high cost of installation and maintenance, which makes it totally unfeasible. in most hospital centers, or other locations such as clinics, pharmacies or even in certain types of laboratories.

In turn, the ergonomic design of the device, not contemplated in the devices known and / or currently marketed, does not guarantee occupational risks derived from the posture and repetitive task in the medication packaging process, so guaranteeing ergonomic risk is contemplated in the design of the equipment regarding the manipulator.

Likewise, the placement of the device with respect to the manipulator operator, regarding its inclination, allows a line of sight with respect to the horizontal of the work area, providing the maximum guarantees for the prevention of occupational risks.

For all the foregoing, the invention presented here, easily solves all the technical problems discussed above, since it provides a safe working environment where to handle medications, and is capable of joining on any packaging machine, shortening handling times. and packaging of medicines, and in turn, optimizing hospital resources, since it does not require more space than is already being used (it will only require the space already occupied by the packaging machine, since it will be placed on said machine).

Description of the Invention

The technical problem solved by the present invention is to obtain a ventilated device or cabin to handle dangerous and / or non-dangerous medicines, which allows its users to work safely (in accordance with current regulations) and which has a filtering system that eliminates the possibility of evacuating or extracting dangerous particles outside that can be inhaled by health workers and / or contaminate the environment.

For this, the device for the manipulation of dangerous medicines, object of the present utility model, is characterized in that it comprises a metal chassis with a prismatic shape, which has separate holes for the insertion of the operator's arms. These holes are located insofar as they allow maintaining an elevation of the arms with respect to the trunk and a flexion of the elbows and wrists that are compatible with the risk protection recommendations for posture and repetitive tasks. The holes are connected to a central recess enabled as a work area that has a small cavity through which the drug transits to the area enabled for receipt in a drug packaging machine, and where the chassis in its front-upper part incorporates a window that allows the visualization of the tasks carried out. And where, in its rear part, the chassis incorporates a hole in which a pre-filter in charge of filtering the largest particles is housed in solidarity; and where associated with said pre-filter is a body comprising at least a first HEPA filter connected to an extraction motor that drives the aspiration of the contents of the work area, which is finally associated, with a second HEPA filter; all this commanded by a logical means of control.

Thanks to its design, the device presented here will ensure the containment of dangerous medicines inside the chassis that makes up the device's cabin, during the time of preparing the dose (before packaging). In this way, the exposure of the personnel authorized for such operations (hospital pharmacy operators, or any personnel authorized for this type of manipulation) to contaminating agents and dangerous to their health will be avoided, respecting the protocols and conditions necessary for a way of working. sure. Likewise, the ventilation and air filtration system will allow the extracted air to be free of contaminants, being able to be eliminated in the same area as the work area or outside it.

Likewise, as a consequence of the recurring technical characteristics of the device presented here, it may be used in other technical fields, such as microbiology or the like, where a safe work environment capable of filtering and vacuuming is required. low-size particles, in a simple and safe way; in such a way that all the work protocols in this technical field are respected, together with the specific regulations on the prevention of occupational risks, providing a safe working environment for the operator.

In the same way, the device recommended here will be able to guarantee efficiency during its use, thanks to the presence of control and / or operation supervision systems, implemented in the electronic control means that command said device.

The device will only require an electrical connection for its operation, which will make its use more versatile, being able to be installed in any room where it can be enabled with the packaging machine, since its design and the different safety elements (will avoid possible cross contamination about the medicine).

Therefore, hazardous waste will remain inside the device, which will allow an appropriate treatment to the risk involved, and, therefore, will improve its environmental character. Since, the materials used in its manufacture allow cleaning by drag, decontamination, neutralization and the clearance of possible contaminants in the area in contact with dangerous drugs.

Since it does not require large technical requirements for its operation, it will become an economic and more efficient solution than the solutions known in the state of the art, since it does not require large sites for its installation, nor for the evacuation of filtered air. ; which makes it possible to adapt to the already crowded hospital pharmacy stays.

Throughout the description and claims, the word "comprises" and its variants are not intended to exclude other technical characteristics, additives, components or steps. For those skilled in the art, other objects, advantages, and features of the invention will emerge in part from the description and in part from the practice of the invention. The following examples and drawings are provided by way of illustration, and are not intended to restrict the present invention. Furthermore, the present invention covers all possible combinations of particular and preferred embodiments indicated herein.

Brief description of the drawings

In the following, a series of drawings that help to better understand the invention and that expressly relate to an embodiment of said invention that is presented as a non-limiting example of it, is briefly described. Figure 1 shows a front view of the device for handling dangerous drugs, object of the present specification.

Figure 2 shows a perspective view of the device for handling dangerous drugs.

Figure 3 shows a schematic view of the forming elements of the device recommended here.

Figure 4 shows a first plan view of the chassis (1) as part of the device for handling dangerous drugs.

Figure 5 shows a second view of the chassis (1) as part of the device for handling dangerous drugs.

Figure 6 shows a third view of the chassis (1) as part of the device for handling dangerous drugs.

Preferred embodiment of the invention

A preferred embodiment of the invention is shown in the attached figures. More specifically, the device for the manipulation of dangerous medicines, object of the present memory, is characterized in that it comprises a metal chassis (1) with a prismatic shape, which has separate holes (1a) for the insertion of the arms of the operator destined to work , and that they are connected to a central recess enabled as a work area (1 b). The holes (1a) will incorporate adjustment means, which allow their diameter to be adjusted to the diameter of the arm of the operator in charge of the operation.

The work area (1 b) will have a small cavity (1d) through which the medicine will transit to the area enabled for its reception in a medicine packaging machine. During use, the cavity (1d) may be covered during the preparation of the compound.

The chassis (1) on its front incorporates a window (2) preferably made of methacrylate, laminated safety glass or other material with equivalent mechanical characteristics; and it incorporates at least one closure (2a) that provides easier access to its interior, especially for those drug containers with large capacity, which will later be handled and repackaged; and in turn, prevents its opening until the end of the air renewal process. The window (2), in a preferred embodiment, will have an opening range of up to 180 °, its preferred opening measure being 180 °.

In a practical embodiment, the window (2) incorporates at least one closure (2a) which may be an electronic closure, an electromechanical closure or any equivalent closing means.

The chassis (1) will be made of stainless steel with polished corners or another material with equivalent mechanical characteristics; and presents inside, a spill tray also made of stainless steel or other material with equivalent mechanical characteristics.

In its rear part, the chassis (1) incorporates a hollow (1 c) where a pre-filter (3) is jointly housed in charge of filtering the largest particles; and where associated with said pre-filter (3) is a body (4) that comprises at least a first HEPA filter (4a) that is finally associated, with a second HEPA filter (4c), connected to an extraction motor (4b ) that activates the aspiration of the contents of the work area (1 b).

In a non-limiting practical embodiment, the body (4) will in turn house logical control means (5), which comprise at least a microcontroller or a PLC in charge of managing and operating the device, and where, among other functions, will be in charge of enabling the on and / or off of both the device itself, control over the lighting means, blocking, cleaning cycles, etc .; and where in addition, said logical control means (5) will comprise a plurality of sensors that determine pressure; air flow, hours of use; scheduled alarms; extractor operating status; electronic window opening lock (2) or the like.

In a particular embodiment, the electronic control means (5) will incorporate a sensor that determines the speed of the extraction flow. In another particular embodiment, the speed will be determined in the extraction motor itself (4b).

In turn, the electronic control means (5) will be programmed in such a way that they control the ventilation and hours of use of the device, and in this way, control and / or guarantee the operation of the device, even in the presence of the effects caused due to the progressive obstruction of the HEPA filters (4a, 4c).

In a particular embodiment, the logical control means (5) will be integrated in the logical means of control of a medicine packaging machine, connected and / or associated with the device described here.

The logical control means (5) will be operable either by means of a hand console or keypad with a display arranged on the external part of the body (4), or by means of a touch screen (6) attached or integrated into the chassis itself (1) of the device, or, by means of the action of the logical means of control of a packaging machine to which it is connected and / or associated. In a preferred embodiment, the two HEPA filters (4a, 4c) are located in-line and are of the H14 type with 99.995% MPPS efficiency.

In a preferred embodiment, the extraction motor (4b) is a centrifugal motor or a motor with equivalent mechanical characteristics.

The chassis (1) will house lighting means on the work surface, using lamps.

In a particular embodiment, the chassis (1) will be connected and / or attached to a data display screen (7), where the medicine data can be displayed, so that it can later be printed as a label for the medicine packaged by a machine packaging machine attached and / or connected to the device presented here.

Claims

1. Device for the handling of dangerous medicines that includes a metal chassis (1) with a prismatic shape, which has separate holes (1a) for the insertion of the operator's arms and where said holes (1a) are connected with a central enabled hole as a work area (1 b) that has a small cavity (1 d) through which the medicine transits to the area enabled for its reception in a medicine packaging machine, and where the chassis (1) on its front incorporates a window (2) and which is characterized in that in its rear part, the chassis (1) incorporates a hole (1c) where a pre-filter (3) is jointly housed in charge of filtering the larger particles; and where associated with said pre-filter (3) is a body (4) that comprises at least a first HEPA filter (4a) that is finally associated, with a second HEPA filter (4c) connected to an extraction motor (4b) that activates the aspiration of the contents of the work area (1 b); all this commanded by logical control means (5).

2. Device for handling dangerous medicines according to claim 1, wherein the chassis (1) will house lighting means on the work surface, using lamps.

3. Device for handling dangerous medicines according to any of claims 1 - 2, where the holes (1a) present in the chassis (1) incorporate adjustment means that allow their diameter to be adjusted to the diameter of the arm of the operator in charge of the operation.

4. Device for handling dangerous medicines according to any of claims 1 - 3, where the window (2) has an opening range of up to 180 °.

5. Device for handling dangerous drugs according to any of claims 1-4, where the window (2) is made of methacrylate, laminated safety glass or other material with equivalent mechanical characteristics.

6. Device for handling dangerous medicines according to any of claims 1-5, where it incorporates at least one closure (2a) that provides easier access to its interior and, in turn, prevents its opening until the end of the cleaning cycle.

[Claim 7]

7. Device for the handling of dangerous medicines according to any of claims 1-6, where the chassis (1) is made of stainless steel with polished corners or another material with equivalent mechanical characteristics.

8. Device for handling dangerous medicines according to any of claims 1-7, wherein the chassis (1) has inside a spill tray made of stainless steel or other material with equivalent mechanical characteristics.

9. Device for the manipulation of dangerous medicines according to any of claims 1-8 where the body (4) in turn houses the logical control means (5), which comprise at least a microcontroller or a PLC in charge of management and operation of the device; and where in addition, said logical control means (5) comprise a plurality of sensors that determine the pressure; Hours of use; scheduled alarms; operating state; electronic window opening lock (2) or the like.

10. Device for the manipulation of dangerous medicines according to any of claims 1-9, where the logical control means (5) incorporate a sensor that determines the speed of the extraction flow.

11. Device for the handling of dangerous medicines according to any of claims 1-9, where the extraction flow rate is determined by the extraction motor (4b)

12. Device for handling dangerous medicines according to any of claims 1-11, where the logical control means (5) are integrated into the logical control means of a medicine packaging machine, connected and / or associated with the device. .

13. Device for the manipulation of dangerous medicines according to any of claims 1-12 where the logical control means (5) are operable by means of a hand console or keypad with display arranged on the external part of the body (4).

14. Device for the manipulation of dangerous medicines according to any of claims 1-12 where the logical control means (5) are operable by a touch screen (6) attached or integrated in the device's own chassis (1).

15. Device for handling dangerous medicines according to claim 12, where the logical control means (5) are operable by means of the action of the logical control means of a packaging machine to which it is connected and / or associated .

16. Device for the manipulation of dangerous medicines according to claim 6, wherein the window incorporates two closures (2a).

17. Device for the handling of dangerous medicines according to any of claims 6-7, where the closure (2a) is an electronic closure, an electromechanical closure or any equivalent closure means.

18. Device for handling dangerous drugs according to any of claims 1-17, where the HEPA filters (4a, 4c) are located in-line and are of the H14 type with an efficiency of 99.995% MPPS.

19. Device for handling dangerous drugs according to any of claims 1-18, wherein the extraction motor (4b) is a centrifugal motor or a motor with equivalent mechanical characteristics.

20. Device for the handling of dangerous medicines according to any of the preceding claims, wherein the chassis (1) is connected to a data display screen (7).