JP7332174B2 - Apparatus for cleaning surgical instruments and medical devices generally and procedures for pre-treating surgical instruments and medical devices - Google Patents

Description

TECHNICAL FIELD This patent relates to devices for cleaning surgical instruments and medical devices and, in particular, generally to novel apparatus for pre-treating surgical instruments and medical devices during cleaning and sterilization procedures, and surgical instruments and medical devices. and procedures for pre-treating medical devices.

Surgical instruments are widely known in the prior art and are used in the medical field (eg, surgery, dentistry, veterinary medicine, etc.) to perform treatments and operations on a patient's body.

After each use, surgical instruments should be cleaned, carefully sanitized, individually wrapped in sealed and sanitized wrappers, and placed inside a standard size basket for transport within a hospital facility, This wrapper is generally adapted for quick opening for removal of the instrument at the time and place of use by the surgeon or operator.

Specifically, for decontamination, heat sterilization, followed by a sterilization and disinfection process using specific equipment with high temperature steam above 121°C or with other chemical systems (ethylene oxide or peracetic acid) Before, surgical instruments and medical devices need to be prophylactically and thoroughly cleaned to completely remove all organic residue from metal surfaces.

Upon arrival of the carriage from the operating room or department in which it was used, the surgical instruments and medical devices are contained together in a closed basket and placed in a so-called "contaminated area", i.e., ready to be reprocessed. Stacked within the area of the disinfection unit used to receive material. Reprocessing of surgical instruments and medical devices generally involves an initial evaluation of the surface to be processed and the burr, cavity size, or roughness.

Participants create groups of instruments that are morphologically equivalent, based on type. Where possible, individual instruments and devices are disassembled into all separable components and prepared for processing to remove visible contaminants.

Pretreatment Stage In this first pretreatment stage, medical personnel flush each instrument, device, or component for an initial visual inspection, place the instrument individually under the water jet, and remove any surface contamination. Material is removed to uncover the support structure surface to assess the presence of attached tissue or contaminants.

In this case, in order to more effectively remove the presence of contaminants, medical personnel manually intervene with brushes, the bristles of which are made of different materials such as copper, brass, steel, or synthetic materials and Can be made out of firmness.

In order to improve the visibility of the treated surface, and thus to better visually verify the treated surface, the operator uses compressed air to remove water and any residuals from the instruments and equipment being treated. Remove contaminants.

These operations are performed by medical personnel working at sinks appropriate for such operations using personal protective devices such as gloves, face shields, and protective masks for the upper respiratory tract. Manual activity exposes the operator to the risk of abrasion and puncture injuries resulting from brushing actions, as well as apparently exposure to splashes and sprays of contaminated water during flushing.

Moreover, brushes do not always guarantee complete removal of organic residues, as the instruments used for this mechanical action cannot always reach crevices or cavity contamination. In addition to this, the residue produced when the organic material dries is particularly difficult to remove from the surface.

For this reason, in the first part of the pre-wash step, a system using an emollient solution bath is used since mechanical and/or chemical removal of organic residues from the most complex surfaces is preferred. be. However, these methods are not always effective.

Indeed, in particular, contaminants remaining in crevices and cavities become even more adhered by the subsequent heat disinfection process. The effectiveness of this last critical cleaning step is therefore compromised and poses a serious risk to the patient's health.

In the second part of the pre-wash stage, strongly adherent contaminants that are difficult to reach such as very fine or deep nicks, or complex mechanical parts, or those present on parts of instruments and devices. It is possible to use an ultrasonic alkaline bath to remove the However, this technique does not always lead to satisfactory results. A particular potential for recontamination of treated surfaces has been found with the bath of solution in which the instrument is immersed, especially since contaminants from the pretreatment are deposited in the bath of solution.

Subsequently, the device is exposed to a bath of solutions to neutralize the previously used substances. These require the use of acid products which serve to solubilize and completely remove the oxides formed during detergent washing. However, the acid solutions used can also lead to a corrosive action, particularly at metal-to-metal or metal-to-plastic contacts, creating suitable conditions for localized corrosion phenomena.

Finally, the described activity is performed by an operator who needs to be positioned in front of the sink for long periods of time, and depending on the position taken by the operator, causes troubling pain.

All of this, along with the length of the operation due to the number of surgical instruments to be processed, naturally reduces the operator's level of attention, resulting in a naturally reduced quality of cleaning. Sometimes cleaning quality can be compromised by the need to speed up operation due to the considerable volume of instruments processed in a set cycle.

All of this also creates an increased potential risk of injury to the operator.

Sterilization and subsequent disinfection of instruments and reprocessing devices, if the quality of cleaning resulting from the pretreatment step is compromised, will of course increase the risk of postoperative infection in patients subsequently treated with instruments or devices. A consistent decrease in the level of

In practice, the operations following this pretreatment step include the use of automatic washing devices designed for heat sterilization of instruments.

The instruments and devices are then packed and placed into an automatic disinfection device.

To overcome all the aforementioned drawbacks, a novel apparatus for pretreating surgical instruments and medical devices is used during cleaning procedures as well as during sterilization procedures and during procedures for pretreating surgical instruments and medical devices. designed and structured to allow

It is an object of the present invention to speed up and simplify the pre-treatment of contaminated instruments and devices for pre-washing and brushing operations performed according to the prior art.

This object is achieved by the device of claim 1 . The pretreatment operation is, in fact, confined within the closed cabin of the novel apparatus ensuring complete protection from either splashes of materials of organic and chemical origin or contaminated fluids.

In addition, the new equipment includes inside the cabin a dedicated device for discharging rinsing water (e.g. overhead spray or water jet) and a device for releasing cleaning substances for mechanical treatment of surfaces. Be prepared and replace the manual brush.

Another object achieved by the present invention is to minimize handling of instruments to be cleaned by the operator, providing the advantage of increasing safety and quality of work.

It is a further object of the present invention that all of the pretreatment operations performed by the device can be safely performed by the operator in a sitting position and thus without strenuous tasks and, as a result, less fatigue. The goal is to reduce the risk of damage caused by contamination and to maintain a high quality level of the cleaning performed.

The present invention also limits the movement of contaminated instruments and devices that remain inside the enclosed cabin of the apparatus, thus reducing the risk of accidents associated with the movement of instruments and devices. A further result is the fact that the working time is optimized and the efficiency of the cleaning process is increased.

Yet another important object of the present invention is to provide highly efficient mechanical removal of material deposited on all surfaces of instruments, while at the same time providing highly efficient washing, sterilization and possibly sterilization.

A further object of the present invention is to prevent bacterial growth from re-initiating on the surfaces of instruments to ensure continued sterilization and antimicrobial action.

A further important advantage of the present invention is also the reduction in wash time, which in turn reduces the relative costs considerably. The reason for this is that during the pretreatment, according to the new process, the abrasive action, the cleaning action and possibly also the sterilizing action and/or the biocidal action are all carried out.

A further advantage resulting from the use of the present invention is that the efficacy of the product is also ensured by utilizing the product with air, with or without water, unheated water, thus requiring no hot water. including the fact that it reduces energy costs.

These and other aims, which are direct and complementary, are directed to novel apparatus for pretreating surgical instruments and medical devices during cleaning and sterilization procedures, and for pretreating surgical instruments and medical devices. achieved by procedures and

The new device is
An enclosed cabin defining at least one work area with at least one first opening for inserting surgical instruments and medical devices to be cleaned and for removing surgical instruments and medical devices to be prepared. an enclosed cabin having at least one secondary opening and at least one additional opening through which at least one glove is installed to access the work area from the outside;
at least one work area inside the cabin;
at least one nozzle mounted within the cabin and positionable within the work area for ejecting rinsing water;
at least one nozzle mounted within the cabin and adapted to be positioned within the work area for ejecting a cleaning substance for mechanical treatment of surfaces of surgical instruments and medical devices.

Such cleaning substances include sodium bicarbonate salts, compounds thereof, and the like.

The at least one nozzle for the rinse water jet is preferably pedal operated so as to leave the operator's hands free. Similarly, nozzles for ejecting cleaning substances are also connected to the pedal active system.

The new device also appropriately
At least one mounting area for instruments to be cleaned located in the cabin near said first insertion opening, wherein one or more baskets containing instruments and devices to be cleaned are located in said at least one mounting area suitably positioned within the mounting area;
At least one collection area for pretreated instruments located within said cabin near said second removal opening, said one or more baskets containing pretreated instruments and devices. may include at least one integration area suitably positioned within the integration area;
The at least one work area is between the at least one mounting area and the at least one accumulation area.

The at least one rinse water nozzle and/or the at least one nozzle for discharging the cleaning substance may also be fastened inside the cabin or more appropriately operable or orientable.

The rinse water nozzle and/or the discharge nozzle may be manually or automatically movable.

In particular, the novel apparatus also comprises a cleaning substance supply system and further comprises at least one tank adapted to contain said cleaning substance, and using at least one duct, air flow and/or Or pressurized water sucks or pushes the cleaning substance from the at least one tank and transports the cleaning substance to at least one discharge nozzle located inside the cabin.

In a preferred embodiment, the delivery system and the nozzle are arranged such that the cleaning substance is discharged at high velocity onto the equipment to be cleaned inside the cabin.

To make operation more convenient, the cabin may include two openings with a pair of gloves positioned within the cabin so that the operator can perform pretreatment operations within the work area. can use both hands to

The cabin is provided with at least one window or area made of transparent material that allows the interior of the cabin to be seen.

Also, the novel device preferably comprises at least one air suction system from inside the cabin, possibly with a filtering system, to remove any aerosols that may be generated inside the cabin and thus reduce the environmental prevent pollutants from being discharged into

The novel apparatus may also include at least one compressed air drying gun mounted within the cabin and positionable inside the work area, the compressed air gun and water gun being used when intensive water washing is required. is particularly effective for

One or more supports may also be installed inside the cabin to position the surgical instruments to be cleaned without having to hold the surgical instruments, the supports being properly positioned within the work area.

These supports of the instruments to be cleaned can also be mechanized and move, translate and/or rotate.

The new device also comprises at least one waste water discharge system that can be suitably connected to the same sewage system currently used by the sinks in the disinfection room.

Said waste water discharge system preferably comprises at least one decanter and at least one duct conveying waste water from said cabin to said at least one decanter, by means of which the poured residue is separated from the liquid fraction. be. These residues and this liquid fraction are then treated appropriately, for example according to known procedures.

Therefore, the pretreatment procedure is
A step of inserting instruments to be cleaned, wherein the operator introduces one or more baskets into the loading area inside the cabin, the one or more baskets coming from the operating room or from the use area, the external loading area. containing surgical instruments and contaminated medical devices transported on trolleys to and opposite, within the collection area, at least one basket suitably ready to receive surgical instruments after pretreatment a step that needs to be located and
inserting the hand, the operator inserting his hand into a glove that is secured to a special opening in the cabin;
At least one rinsing step wherein the operator activates the rinsing jet nozzle by pedal control to rinse the surgical instrument and medical device to remove any particulate contaminants from the surface of the instrument. , thus highlighting the possible presence of organic tissue or contaminants adhering to the surface;
At least one mechanical treatment step and, if contaminants are present on the surface of the instrument, the operator activates a squirt of irrigant by pedal control to remove all surface contaminants from the instrument being treated in a matter of seconds. a step of removing
At least one further rinsing step, in which the operator then places the instrument or device to be treated under the rinsing water jets and then a second step to verify the quality of the work done. and performing two visual inspections. If the results are satisfactory, the operator places the instrument or device to be treated in a basket positioned within the collection area. On the other hand, if the qualitative results of the irrigation are not satisfactory, the operator performs a new mechanical treatment, activates the squirt of irrigation substance again, and then, after subsequent further rinsing with water, the quality of the work done. to reconfirm.

The mechanical treatment can be carried out using washing substances and the sodium bicarbonate salt can be used both dry and wet, i.e. the sodium bicarbonate salt is decomposed in water above the saturation limit and dissolved in and making a solution containing the salt in undissolved form.

A portion of the sodium bicarbonate salt in dissolved form in the solution actually does the washing, dissolving and leaching the organic material present on the surface of the device.

The sodium bicarbonate salt in undissolved form instead acts as an abrasive material.

The new process is particularly suitable for washing surgical instruments. This is because the process does not involve corrosive action, abrasive action of the material from which the device is made, or surface modification of the device.

In addition, sodium bicarbonate has strong bactericidal, antibacterial and antifungal effects.

Additionally, sodium bicarbonate is not dangerous to the operator and is not harmful to the environment. Sodium bicarbonate is biodegradable and 100% water soluble, ie, sodium bicarbonate does not pollute and therefore presents no particular restrictions on storage, handling, or manipulation thereof.

According to a possible embodiment of the new method, the cleaning substance is, in addition to sodium bicarbonate and water, also one with a sterilizing and/or biocidal effect, for example from 0.1 to 25% concentrate. Including additional chemicals above.

In this manner, both instrument washing and sterilization operations are performed in a single step.

The cleansing substance may also include one or more additional substances that have a cleansing and/or sterilizing effect and/or one or more specific action medical products.

The water used can be heated or even heated at room temperature. The reason for this is the use of sodium bicarbonate, specifically the addition of sterilants and/or biocides to ensure excellent cleaning and disinfection.

The new procedure therefore also allows for containment of energy and operating costs.

Once cleaning operations have been completed with all instruments and/or devices present in the original basket, the operator manually or automatically moves the basket of cleaning instruments and cleaning devices, if prescribed, to the appropriate external area. move to Once the sequence of cleaning actions for all pre-loaded baskets has been completed, the operator finds an external drain area and all baskets are ready for subsequent cleaning processes (e.g., the heat sterilization machine of an automatic washing machine, etc.). ready to be sent.

Cleaning operations of the cabin are thus carried out by the operator in a manner that is safe for him and his working environment, taking into account the limitations of the working area inside the cabin itself.

Using this novel device, the cleaning process is carried out inside an enclosed cabin, which, as noted, is protected from splashes of either chemical or organic origin materials, or in the case of contaminated liquids. Ensure absolute protection.

Additionally, the use of a bicarbonate irrigation system and a conventional flush shower for rinsing and a compressed air gun for drying allows for manual brush removal and protects the operator from possible accidents or injuries. Indeed, one object of the present invention is to further restrict operator manipulation of the instrument, device or surgical instrument to be cleaned in a manner that benefits safety and quality of work.

All pretreatment operations performed inside this cabin can be performed by the operator in a sitting position, thus reducing fatigue and increasing safety.

The new device ensures a considerable increase in the speed of cleaning and initial decontamination operations of surgical instruments and contaminated medical devices and an unprecedented improvement in the quality of the cleaning process.

These actions performed reduce health care worker fatigue, result in improved working conditions, lower risks associated with increased attention levels, and, in turn, higher levels of outcomes.

The new device can be used individually, or inserted as a module at the workbench, or the workbench and cabin itself with all the ancillary equipment necessary for its operation and/or any other desired accessories. Made of a single structure with This configuration also reduces the migration of contaminants within the work area, reduces the risk of accidents, optimizes work time, eliminates unnecessary steps and increases the efficiency of the system, among other things.

As mentioned, currently the decontamination system is generally organized into three stages. In the first pre-washing stage, washing is carried out with a special detergent and should be rinsed with water to ensure complete removal of organic residues present on the instruments and devices.

In addition, the pretreatment stage often uses chemicals, and some of the chemicals commonly used in the wash cycle have a rather adverse effect on the stainless steel of surgical instruments and medical devices, causing corrosion. bring. Additionally, surgical instruments and medical devices, including some with smooth surfaces and some with rough surfaces, crevices, and small cavities, contain organic impurities that are difficult to remove by prior art washing processes. accumulate. On this subject, the formation of 'biofilms' on the surfaces of instruments is a well-known problem and the subject of intensive research worldwide with respect to demonstrating its cause for the development of significant pathologies and the causes of pathology. The theory is still unexplained or unclear. Also, current methods of in-use cleaning and decontamination are known to be inefficient in removing such "biofilms", and indeed inefficiencies are sometimes associated with the formation of "biofilms". cause surface integration that further causes the

In contrast, instrument and device surfaces treated by the new apparatus, specifically using sodium bicarbonate, are always free of all residue and/or "biofilm" contaminants.

Improving the overall efficiency of the cleaning process therefore increases the proportion of infections in patients that are subsequently treated as a result of better and more effective cleaning of surgical instruments and medical devices when reprocessing surgical instruments and medical devices. clearly results in a considerable reduction in the As a result, the resulting costs are considerably reduced. Surgical instruments and medical devices are used more until they reach their normal wear, thus also saving money spent on their replacement.

The features of the new device will become better apparent from the following description, with reference to the drawings attached as non-limiting examples.

Figure 1 shows a novel apparatus (10) for pretreatment steps during cleaning and sterilization procedures of contaminated surgical instruments and medical devices (S). The general view of this apparatus is shown.

The novel apparatus (10) comprises an enclosed cabin (20) defining at least one internal work area (21).

On the wall of said cabin (20), at least one first mounting opening (22) is for inserting one or more baskets (S1) containing surgical instruments and medical devices (S) to be cleaned. and at least one second removal opening (23) is provided for removing one or more baskets (S2) containing surgical instruments and medical devices to undergo pretreatment.

On at least one wall of said cabin (20), for example on a wall intended to be positioned in front of the operator, in said working area (21), a glove (30) is located in said cabin (20). A further opening (24) is created which is placed inside the .

An internal loading area in which one or more baskets (S1) containing surgical instruments and devices (S) to be cleaned can be positioned inside the cabin (20) near said first loading opening (22). (25) exists.

Near the second removal opening (23), inside said cabin (20), there is a collection area (26) for instruments to be pretreated, in which the pretreatment is carried out. One or more baskets (S2) containing instruments and devices to receive can be positioned.

In addition, near the internal mounting area (25), there is an external mounting area (251) outside the cabin (20). It is envisaged to position the basket containing the instruments and devices to be cleaned.

Similarly, in the vicinity of said collection area (26), there is a non-equipped area (261) outside said cabin (20), in which the instruments contained in baskets (S2) and Position the basket (S2) to be pushed out of the cabin (20) after the end of the treatment of the device.

Inside the cabin (20) and between the at least one internal mounting area (25) and the at least one accumulation area (26) are accessible from the outside by the operator using the glove (30). There is at least one work area (21) where

Inside the cabin (20), at least one nozzle is mounted for ejecting rinsing water (40) which can be positioned within the work area (21). For example, the rinse water nozzle (40) is preferably fixed or operable or orientable in a manual and/or automatic manner.

At least one nozzle (50) is located inside said cabin (20) for discharging cleaning substances for mechanical treatment of surfaces of surgical instruments and medical devices (S) which can be positioned within said working area (21). installed in the For example, said nozzle (50) for discharging cleaning substance is preferably fixed or operable or orientable in manual and/or automatic mode.

At least one nozzle (40) for said rinse water and/or at least one nozzle (50) for discharging said cleaning substance is preferably connected to each pedal-operated active system.

The novel device (10) also preferably comprises at least one aspirator (60) of air inside the cabin (20).

FIG. 2 shows an overall view of the device.

The new device also comprises at least one wastewater drainage system (70) which can be suitably connected to the same sewage system currently used by the sinks in the disinfection room.

Said evacuation system (70) preferably comprises at least one decanter (71).

This specification will suffice to enable the practitioner to make the invention in practical application, as a result of which there may be variations without prejudice to the content of the innovative concept.

Accordingly, with reference to the foregoing description and accompanying drawings, the following claims are made.

Claims (13)

An apparatus (10) for pre-treating surgical instruments and medical devices (S) in cleaning and disinfection procedures, comprising:
At least one closed cabin (20) defining at least one internal working area (21) and for inserting one or more surgical instruments and/or medical devices (S) to be cleaned. and at least one second removal opening for removal from the interior of one or more of the surgical instruments and/or medical devices to be prepared ( 23) and at least one additional opening (24) provided for at least one glove (30) to access said working area (21) from the outside;
at least one jet of rinse water;
at least one instrument jet for cleaning surfaces of said surgical instrument and said medical device (S) and ejection means (40, 50);
said discharge means (40, 50) are mounted in said cabin (20) facing said jet at least within said working area (21), said washing substance comprising sodium bicarbonate , an apparatus (10) comprising:
Said device (10) comprises:
at least one internal mounting area (25) located within said cabin (20) near said first mounting opening (22), said mounting area (25) being washed; at least one internal mounting area (25), which may be equipped with one or more baskets (S1) containing surgical instruments and said medical devices (S);
At least one accumulation area (26) located within said cabin (20) near said second removal opening (23), said accumulation area (26) comprising: at least one collection area (26), which may in turn be equipped with one or more baskets (S2) containing said surgical instruments and said medical devices (S2);
Device (10), characterized in that at least one said working area (21) is located between at least one said mounting area (25) and at least one said collecting area (26). Said releasing means (40, 50) comprise:
at least one nozzle (40) mounted in said cabin (20) and adapted to be positioned in said work area (21) for discharging rinse water of said jet;
Mounted within said cabin (20) and adapted to be positioned within said work area (21), releasing said cleaning substance for mechanical treatment of surfaces of said surgical instruments and said medical devices (S). at least one nozzle (50) for
A device (10) according to claim 1, characterized in that it comprises: 2. CHARACTERIZED IN THAT said at least one nozzle (40) for rinsing water and/or at least one nozzle (50) for discharging said cleaning substance is connected to each pedal-operated active system. or the device (10) according to 2. characterized in that said at least one nozzle (40) of rinsing water and/or at least one nozzle (50) for discharging said cleaning substance are manually and/or automatically operable or orientable. A device (10) according to any one of claims 1 to 3, wherein Said device (10) also comprises a supply system for a cleaning substance, further comprising at least one tank adapted to contain said cleaning substance and at least one nozzle (50) for discharging said cleaning substance. A device (10) according to any one of the preceding claims, characterized in that it comprises at least one duct for transporting to ). The supply system is water-operated and the duct is configured to draw or push the cleaning substance from the tank to the discharge nozzle by a flow of water, whereby the released cleaning substance is dissolved in solution. including sodium bicarbonate in dissolved form and sodium bicarbonate in undissolved form, said water being heated or unheated to make A device (10) according to claim 5, characterized in that a. 7. Any one of claims 1 to 6, characterized in that the cabin (20) comprises at least one window or area made of a transparent material allowing to see the interior of the cabin (20). A device (10) according to any one of claims 1 to 3. Said device (10) comprises at least one aspirator (60) adapted to extract said air from inside said cabin (20) comprising means for filtering the extracted air. A device (10) according to any one of the preceding claims, characterized in that CHARACTERIZED IN THAT said apparatus (10) comprises at least one drying compressed air gun mounted within said cabin (20) and adapted to be positioned within said work area (21). A device (10) according to any one of clauses 1-8. 10. The device (10) according to any one of the preceding claims, characterized in that said device (10) comprises at least one wastewater discharge system (70) and at least one decanter (71) of said wastewater. device (10). Apparatus (10) according to any one of the preceding claims, characterized in that said cleaning substance is in a dry state. The cleaning substance comprises a dissolved substance in water above the saturation limit to create a solution, comprising the cleaning substance in both dissolved and undissolved form, wherein the water is heated or unheated. A device (10) according to any one of claims 1 to 11, wherein Said cleaning substance may also be one or more additional chemical substances having a sterilizing and/or biocidal effect, and/or one or more further substances providing a cleaning and/or sterilizing action, and/or one or more A device (10) according to any one of the preceding claims, characterized in that it comprises a medical product with a specific action.

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