APPARATUS FOR CLEANING SURGICAL INSTRUMENTS AND MEDICAL
DEVICES IN GENERAL AND PROCEDURE FOR THE PRE-TREATMENT OF
SURGICAL INSTRUMENTS AND MEDICAL DEVICES DESCRIPTION
The present patent relates to devices for cleaning surgical instruments and medical devices and in particular concerns a new apparatus for the pre-treatment of surgical instruments and medical devices in general during cleaning and sanitizing procedures, and the procedure for pre-treating surgical instruments and medical devices.
Surgical instruments are well known in the prior art and are used in the medical field, for example surgical, dental, veterinary, etc., to perform procedures and operations on the patient's body.
Surgical instruments must be cleaned and carefully sterilized after each use, individually packaged in sealed and sterile wrappers, placed inside standard size baskets for transport within hospital facilities, these wrappers being suited to be opened quickly so as to remove the instruments at the time and point of use by the surgeon or the operator in general.
In particular, before being subjected to the disinfection and sterilization process, using specific equipment for the decontamination, thermal disinfection and subsequently with high temperature steam, not lower than l2l°C, or with other chemical systems, ethylene oxide or peracetic acid, surgical instruments and medical devices must be preventively and thoroughly cleaned to completely remove all organic residue from the metal surface.
Upon the arrival of the trolleys from the operating rooms or departments in which they were used, the surgical instruments and the medical devices are contained in bulk in closed baskets and are stacked in the so-called "dirty area", that is, in the area of the sterilization unit used to receive contaminated material ready to be reprocessed. The reprocessing of surgical instruments and medical devices includes an initial evaluation of the surfaces to be treated and the size of the knurls, cavities or roughness in general.
The personnel form groups of instruments which are uniform morphologically and by type. When possible, individual instruments and devices are dismantled into all the separable components and prepared for the treatment to remove visible contaminants.
PRE-TREATMENT PHASE
In this first pre-treatment phase, healthcare personnel rinse each instrument, device or piece for an initial visual examination, placing the instruments individually under a jet of water to remove surface contaminants, uncovering the underlying surface, so as to evaluate the presence of attached tissues or contaminants.
In this case, for the more effective removal of the contaminants present, the healthcare worker intervenes manually with a brush, the bristles of which may be made of different materials and consistencies, such as copper, brass, steel or synthetic material.
In order to improve the visibility of the treated surfaces and therefore better visually examine them, the operator uses compressed air to remove water and any residual contaminants from the instruments and equipment treated.
These operations are carried out by healthcare personnel using personal protection devices, such as gloves, face shields and protective masks for the upper respiratory tract, working at sinks suitable for such operations. The manual activity obviously exposes the operator to risks of abrasions and punctures resulting from brushing operations as well as to splashes and nebulisations of contaminated water during rinsing.
Furthermore, brushing does not always guarantee the complete removal of organic residues, since the instruments used for this mechanical operation are not always able to reach the contaminated cracks or cavities. In addition to this, the residue that is generated when organic substances dry becomes particularly difficult to remove from the surface.
It is for this reason that in a first part of the pre-washing step, systems with emollient baths are used to favour the mechanical and/or chemical removal of organic residues from the most complex surfaces. However these methods are not always effective.
In fact, the contamination that remains, particularly in the cracks and cavities, become even more attached with the subsequent heat sterilization treatment. The effectiveness of this last important cleaning phase is therefore compromised, leading to serious risks for the health of patients.
In a second part of the pre-washing phase, it is possible to use ultrasonic alkaline baths for the removal of highly adherent contaminants or those present in parts of instruments and devices that are difficult to reach, such as very fine or deep knurling, or complex mechanical parts. With this technique, however, satisfactory results are not always achieved. Above all, the concrete possibility of recontamination of the treated surfaces has been found due to the bath in which the instruments are immersed, since contaminants from previous treatments are deposited therein.
Subsequently, the instruments are subjected to a bath to neutralize previously used substances. These require the use of acid products which serve to solubilise and completely remove the oxides formed during cleaning with detergents. However, the acid solutions used also have a corrosive action, in particular at metal-metal or metal-plastic contact points, where suitable conditions for localized corrosion phenomena may arise.
Finally, the activities described are carried out by operators who must be stationed in front of the sink for long periods of time with bothersome pains generated by their assumed posture.
All this, together with the length of operations due to the number of surgical instruments to be treated, causes a natural lowering of the operator's level of attention, generating a natural reduction in the quality of cleaning. The cleaning quality may sometimes be worsened by the need to speed up operations due to the considerable volume of instruments to be processed in the established period.
All this in turn generates the increased risk of possible injuries for the operator. If the quality of the cleaning resulting from the pre-treatment phase is reduced, it follows that there will be a consistent reduction in the level of disinfection and, subsequently, of sterilization of the instruments and of the reprocessed devices with the result of an increased risk of postoperative infections in patients subsequently treated with those instruments or devices.
In fact, the operations following this pre-treatment step consist of the use of automatic washing devices designed for the thermal disinfection of the instruments. The instruments and devices are then packed and put into automatic sterilization devices.
To overcome all the aforementioned drawbacks, a new apparatus for the pre- treatment of surgical instruments and medical devices has been designed and constructed, which can be used during cleaning and sanitizing procedures, as well as a procedure for pre-treating surgical instruments and medical devices.
The object of the present invention is to speed up and simplify the pre-treatment of contaminated instruments and devices, corresponding to the pre-washing and brushing operations carried out according to the prior art.
This object is achieved by the apparatus in claim 1. The pre-treatment operations are in fact confined in the closed cabin of the new apparatus which ensures the absolute protection from splashes of material of organic and chemical origin or in any case of contaminated fluids.
Moreover, the new apparatus comprises, inside the cabin, a device dedicated to the discharge of rinse water, for example an overhead spray or a jet of water, and a device for the emission of cleaning material for the mechanical treatment of surfaces, replacing manual brushing.
Another object achieved by the present invention is to minimize the handling of the instrument to be cleaned by the operators, with the advantage of increasing safety and quality of work.
A further object of the present invention is that all the pre-treatment operations carried out with the apparatus can be carried out safely by the operator in a sitting position, and therefore without strain, with the further consequence of lowering the risks of injuries due to fatigue and keeping the quality levels of the cleaning performed high.
The present invention also limits the movements of contaminated instruments and devices, which remain inside the closed cabin of the apparatus, thus reducing the risk of accidents connected to the movement of the instruments and devices. A further consequence is the fact that work times are optimized, increasing the efficiency of the cleaning process.
Still another important object of the present invention is to have a high efficiency of mechanical removal of the substances attached to the entire surface of the instruments and, at the same time, of washing, sanitizing and possible disinfection.
A further object of the present invention is to ensure a lasting disinfectant and antibacterial action, preventing bacterial proliferation from restarting on the surfaces of the instruments.
A further important advantage of the present invention is also the considerable reduction of the washing time and therefore of the relative costs, since during the pre-treatment according to the new process an abrasive action, a detergent action and possibly even a disinfecting and/or biocide action are all carried out.
A further advantage resulting from the use of the present invention consists in the fact of reducing energy costs, since the efficacy of the product is also guaranteed by applying the product with air, with or without water, not heated and therefore without the need for hot water.
These and other objects, direct and complementary, are achieved by the new apparatus for the pre-treatment of surgical instruments and medical devices during cleaning and sanitizing procedures, and the procedure for the pre-treatment of surgical instruments and medical devices.
The new apparatus comprises:
• a closed cabin defining a work area and having: at least one first opening for the insertion of surgical instruments and medical devices to be cleaned, at least one second opening for the removal of surgical instruments and medical devices subjected to pre-treatment, and at least one further opening on which at least one glove is installed for access to the work area from the outside;
• at least one work area inside the cabin;
• at least one nozzle for the jet of rinse water, mounted in the cabin and positionable in the work area;
• at least one nozzle for the emission of cleaning material for the mechanical treatment of the surface of surgical instruments and medical devices, mounted in the cabin and suited to be positioned in the working area.
Said cleaning material comprises sodium bicarbonate salts, its compounds or the like.
Said at least one nozzle for the rinse water jet is preferably pedal operated, so as to leave the operator's hands free. Similarly, the nozzle for the emission of cleaning material is also connected to a pedal activation system.
The new apparatus may also suitably include:
• at least one loading area for the instruments to be cleaned, located in the cabin near said first insertion opening, one or more baskets containing the instruments and devices to be cleaned being suitably positioned in said loading area;
• at least one deposit area for the instruments subjected to the pre-treatment, located in said cabin near said second removal opening, one or more baskets containing the instruments subjected to the pre-treatment being suitably positioned in said deposit area;
and where said working area is in-between the at least one loading area and said at least one deposit area.
Said at least one rinse water nozzle and/or said at least one nozzle for the emission of the cleaning material may also be fastened inside the cabin or more suitably manoeuvrable or orientable. Said rinse water nozzle and/or said emission nozzle may be movable manually or in an automated manner.
In particular, the new apparatus may also comprise a cleaning material supply system, in turn comprising at least one tank suited to contain said cleaning material, and wherein, by means of at least one duct, an air flow and/or pressurized water aspirates or pushes the cleaning material from said at least one tank and transports it up to the at least one emission nozzle, located inside said cabin.
In the preferred embodiment, said supply system and said nozzle are configured so that said cleaning material is emitted at high speed inside said cabin onto the instruments to be cleaned.
For greater operating convenience, said cabin may comprise two openings with a pair of gloves positioned in the cabin, so that an operator can use both hands to carry out the pre-treatment operations in said working area.
Said cabin is suitably provided with at least one window or area made of a transparent material which allows its interior to be seen.
The new apparatus also preferably comprises at least one air aspiration system from the inside of the cabin, with a possible filtration system, to remove any aerosol that may be generated inside the cabin and thus prevent the discharge of contaminants into the environment.
The new apparatus may also comprise at least one compressed air gun for drying, mounted in said cabin and positionable inside said working area, and where the compressed air and water gun is particularly effective when intense rinsing is needed.
One or more supports may also be installed inside the cabin to position the surgical instruments to be cleaned without having to hold them, said supports being suitably positioned in said working area.
These supports for the instruments to be cleaned may also be mechanized and mobile, translating and/or rotating. The new apparatus also comprises at least one wastewater discharge system, which can be suitably connected to the same sewer system currently used by sinks in the sterilization rooms.
Said waste water discharge system preferably comprises at least one decanter and at least one duct to conduct the waste water from said cabin to said at least one decanter, through which the decanted residues are separated from the liquid fraction. These residues and this liquid fraction will then be suitably treated for example according to known procedures.
The pre-treatment procedure therefore comprises the steps of:
insertion of the instruments to be cleaned: the operator introduces into the loading area inside said cabin one or more baskets containing the surgical instruments and contaminated medical devices coming from the operating rooms or from the areas of use and transported on trolleys up to a external loading area; in the opposite part, in said deposit area, at least one basket must be suitably positioned ready to receive the surgical instruments after the pre-treatment;
insertion of the hands: the operator inserts his/her hands in the gloves fixed to the special openings in said cabin;
at least one rinse: the operator activates said rinse jet nozzle with a pedal control and rinses said surgical instruments and medical devices in order to remove any loose contaminants from the surface of the instruments, thus highlighting the possible presence of organic tissues or contaminants adhering to the surface;
at least one mechanical treatment: if contaminants are present on the surface of the instruments, the operator activates the jet of cleaning material with a pedal control, in just a few seconds removing all surface contaminants from the instrument being treated;
at least one further rinse: the operator then places the instrument or the treated device under the jet of water for rinsing and then carries out a second visual inspection in order to verify the quality of the work performed. If the results are satisfactory, the operator will place the instrument or the device treated in the basket positioned in said deposit area. If, on the other hand, the qualitative result of cleaning is not satisfactory, the operator performs a new mechanical treatment, again activating the jet of cleaning material and then, after the subsequent and further rinse, rechecks the quality of the work performed.
Said mechanical treatment may take place using cleaning material wherein the sodium bicarbonate salts can be used both dry and wet, that is, they are dissolved in water beyond the saturation limit, to form a solution comprising salts in dissolved and non-dissolved form.
The part of sodium bicarbonate salts in dissolved form in the solution performs the actual washing, dissolving and lixiviating the organic material present on the surface of the instruments.
The sodium bicarbonate salts in an undissolved form act instead as an abrasive material.
The new process is particularly suitable for washing surgical instruments, since it does not involve corrosive actions on the material with which said instruments are made and the abrasive action, or surface modification of the instrument, is null. Furthermore, sodium bicarbonate has a strong sanitizing, antibacterial and antifungal effect.
Moreover, sodium bicarbonate is not dangerous for operators and is not harmful to the environment. It is biodegradable and 100% soluble; that is, it is not polluting, therefore it does not present particular restrictions for storage, handling or its manipulation.
According to a possible embodiment of the new method, said cleaning material comprises, in addition to the sodium bicarbonate salts and water, also one or more further agents with a disinfectant and/or biocidal effect, for example in a concentration between 0.1 and 25%. In this way, both the instrument washing operation and the disinfection operation are carried out in a single step.
The cleaning material may also comprise one or more additional substances with detergent and/or disinfectant effects and/or one or more specific-action medical products.
The water used may be heated or even at room temperature, since the use of sodium bicarbonate, particularly with the addition of disinfectant and/or biocidal agents, ensures excellent cleaning and sanitizing.
Therefore, the new procedure also enables the containment of energy and operating costs.
Once the cleaning operations have been completed on all the instruments and/or devices present in the original basket, the operator will manually or automatically, where provided for, remove the basket of clean instruments and devices to a suitable external area. Once the sequential cleaning operations of all the previously loaded baskets have been completed, the operator finds the external discharge area with all the baskets ready to be sent for subsequent cleaning treatments, such as for example to an automatic washer-thermal disinfector machine.
The cleaning operations in said cabin are therefore carried out by the operator safely for himself and for the work environment, given the confinement of the work area inside the cabin itself.
Using this new apparatus, the cleaning processes are carried out inside the closed cabin, which, as noted, ensures the absolute protection from splashes of materials of chemical or organic origin or in any case of contaminated liquids.
Furthermore, the use of the bicarbonate cleaning systems, as well as the traditional rinsing showers for rinsing and compressed air guns for drying, allows the elimination of manual brushing, protecting the operator from possible accidents or injuries. In fact, one object of the present invention is to further limit the manipulation by the operators of the instrument, device, or surgical instrument to be cleaned, to the benefit of safety and quality of work. All pre-treatment operations carried out inside this cabin can be carried out by the operator in a sitting position and therefore decreasing fatigue and increasing safety. The new apparatus ensures a significant increase in the speed of cleaning and initial decontamination operations of surgical instruments and dirty medical devices and an unprecedented increase in the quality of the cleaning process.
These operations, which are carried out with a reduction in the fatigue of the healthcare worker, lead to an improvement in the working conditions, a lowering of the risks linked to an increase in the level of attention, and therefore a higher level outcome.
The new apparatus can be used individually or inserted as a module in work benches, or made in a single structure comprising the work bench and the cabin itself with all the ancillary equipment necessary for its operation and/or any other desired accessory. This configuration further reduces the movement of contaminated materials within the working area, reducing the risks of accidents and above all optimizing work times, eliminating unnecessary steps and increasing the efficiency of the system.
As mentioned, decontamination systems are currently generally organized in three phases. In the first prewash phase, washing is carried out with special detergents and rinsing with water, which must ensure the complete removal of the organic residues present on the instruments and devices.
Moreover, in the pre-treatment phase, chemical products are often used and some of them, commonly used in the washing cycles, are too aggressive towards the stainless steels of surgical instruments and medical devices, resulting in corrosion. Furthermore, surgical instruments and medical devices comprise portions with a smooth surface and portions with a rough surface, cracks and small cavities, wherein organic impurities accumulate which are difficult to remove by washing processes of the prior art. With regard to this topic, the formation of a "biofilm" on the surface of instruments is a well-known issue and is the subject of in-depth studies worldwide to demonstrate its responsibility in the generation of significant pathologies the aetiology of which is still unknown or uncertain. It is also known that the current methods of cleaning and decontamination in use are ineffective for the removal of said "biofilm", in fact they are sometimes responsible for surface consolidations that even cause the formation of the "biofilm".
In contrast, the surfaces of the instruments and devices treated with the new apparatus, particularly using sodium bicarbonate, are always free of all residue and/or "biofilm" contaminant.
It is therefore evident that the improved efficiency of the entire cleaning process generates a significant reduction in the percentage of infection in patients treated subsequently as a result of better and more effective cleaning of surgical instruments and medical devices when they are reprocessed. Consequently, there is a significant reduction in the resulting costs: surgical instruments and medical devices are used more, up to their normal wear, thus also resulting in savings on investments dedicated to their replacement.
The characteristics of the new system will be better clarified by the following description with reference to the drawing, attached by way of a non-limiting example.
Figure 1 shows the new apparatus (10) for performing the pre-treatment step during cleaning and sanitizing procedures of contaminated surgical instruments and medical devices (S).
Figure 2 shows an overall view of the apparatus.
The new apparatus (10) comprises a closed cabin (20) defining at least one internal working area (21).
On the walls of said cabin (20) at least one first loading opening (22) is provided, for the insertion of one or more baskets (Sl) containing the surgical instruments and medical devices to be cleaned (S) and at least one second removal opening (23), for the removal of one or more baskets (S2) containing surgical instruments and medical devices subjected to pre-treatment. On at least one wall of said cabin (20), for example on the wall intended to be positioned frontally to an operator, further openings (24) are created on which gloves (30) are installed inside the cabin (20), in said working area (21).
Near said first loading opening (22), inside the cabin (20), there is an internal loading area (25) in which one or more baskets (Sl) containing the surgical instruments and devices to be cleaned (S) can be positioned.
Near the second removal opening (23), inside said cabin (20), there is a deposit area (26) for the instruments subjected to pre-treatment, in which one or more baskets (S2) to contain the instruments and devices subjected to pre-treatment can be positioned.
It is also envisaged that, in the vicinity of said internal loading area (25), there is an external loading area (251) on the outside of said cabin (20), in which the baskets containing the instruments and devices to be cleaned are positioned before being inserted into said cabin (20).
Similarly, in the vicinity of said deposit area (26), there is, outside said cabin (20), an unloading area (261), in which the baskets (S2) pushed out of the cabin (20) after the conclusion of the processing of the instruments and devices contained therein are positioned.
Inside said cabin (20), in a position in-between the at least one internal loading area (25) and the at least one deposit area (26), there is at least one working area (21), accessible from the outside by an operator using said gloves (30).
Inside said cabin (20) at least one nozzle is mounted for the jet of rinse water (40), which can be positioned in said working area (21). Said rinse water nozzle (40) is for example fixed or preferably manoeuvrable or orientable, in a manual and/or automatic manner.
At least one nozzle (50) is mounted inside said cabin (20) for the emission of cleaning material for the mechanical treatment of the surface of surgical instruments and medical devices (S), which can be positioned in said working area (21). Said nozzle (50) for the emission of cleaning material is for example fixed or preferably manoeuvrable or orientable, in a manual and/or automatic mode.
Said at least one jet (40) of rinse water and/or said at least one nozzle (50) for the emission of cleaning material are preferably connected to respective pedal activation systems.
The new apparatus (10) also preferably comprises at least one aspirator (60) of the air inside the cabin (20).
Figure 2 shows an overall view of the apparatus.
The new apparatus also comprises at least one wastewater discharge system (70), which can be suitably connected to the same sewer system currently used by sinks in the sterilization rooms.
Said discharge system (70) preferably comprises at least one decanter (71).
These specifications are sufficient for the expert person to make the invention, as a result, in the practical application there may be variations without prejudice to the substance of the innovative concept.
Therefore, with reference to the preceding description and the attached drawings the following claims are made.