MXJL05000019A - Package of reusable and sterile surgical garment, and process for manufacturing the same - Google Patents

Abstract

Described herein is a process for manufacturing packages of reusable and sterile garment used in hospitals in different surgical processes for promoting the aseptic and safe use of direct action articles, which will benefit patients and medical personnel. The present invention further includes a package of reusable and sterile surgical garment resulting from the sterilization process thereof, the package content is particularly selected according to the surgical process to be used. Each garment package is packed in a medical-grade bag that is hermetically thermo sealed in order to preserve it under sterile conditions for at least six months.

Description

"BULLET OF STERILE SURGICAL CLOTHING, REUSABLE, AND PROCESS OF ELABORATION" BACKGROUND OF THE INVENTION 1. - Field of the Invention. The invention is intended to be applied in the field of the supply of sterile surgical clothing packaged for hospitals or clinics as reusable material for the different surgical procedures that take place in said sites. 2.- Previous Technique. The hospital environment may be contaminated with a variety of microorganisms. However, the presence of microorganisms in the environment alone does not constitute a risk of infection unless for some reason they come into contact with a gateway of a susceptible host in an infective dose. This situation can occur with materials and instruments used in the direct care of patients, particularly in invasive surgical procedures. Due to the above, hospitals must ensure that all direct care items receive the proper procedure to reduce the risk of infection for patients and / or the staff that uses them. In hospitals or health centers, the responsibility for the processing of direct care items is the Sterilization Service whose function is to provide high-level sterilized or disinfected material in conditions of use that do not involve risks of complications or accidents in patients and / or staff that uses them. To do this, we must have a qualified professional who actively participates in the decision-making process, both in the technical area, as well as in investments, renewal of equipment and supplies. Sterilization is the result of a process and not just exposure to the sterilizing agent. To obtain high-level sterile or disinfected material, a series of independent procedures must be carried out: washing, decontamination, inspection, preparation, packaging, exposure to the sterilization method, storage and delivery. The selection of the appropriate procedure for each article depends on the nature of the materials and the type of procedures for which they are intended. Each of the mentioned procedures has importance in the result and if there are faults in any of them, the material can not be considered sterile or disinfected, even when it has been subjected to a sterilization or disinfection method. Hospital care is currently an important challenge for the health team due to its high complexity and associated costs. The profile of patients treated in hospitals has changed enormously in recent years, as a result of the appearance of new diseases, the incorporation of new diagnostic or treatment technology and changes in the modalities of care. Among the most relevant changes can be mentioned: • the HIV / AIDS epidemic • the growing number of patients undergoing treatment with immunosuppressive drugs • the increase in endoscopic and laparoscopic interventions • the growing trend towards the use of alternatives to traditional hospital care (outpatient procedures) ) • the importance of protecting the environment • the social interest in the quality of health services and • the massification of information, among others.

New diseases produce new problems and challenges. The incorporation of technology has obvious benefits, however, it can increase the population susceptible to nosocomial infections due to being invasive or altering the immunity of patients. The vast majority of patients admitted to hospitals are subjected to some type of invasive surgical procedure of various kinds, from a simple intravenous puncture to a major surgical intervention with permanent implants. Hence, within the hospital organization, the services provided by the aforementioned articles and equipment must respond appropriately to the new demands in the health field, ensuring that the material used in direct care does not represent a risk for patients and that their processing represents a favorable cost / benefit for the organization. In the field of surgical textiles, from 1960 onwards, "non-woven" single use disposable surgical products were introduced into the market. Initially, they were manufactured from products derived from cellulose and polyester, and even today they remain in the market. At the end of the 20th century, the technology in disposable products has migrated to the elaboration of single-use materials made from 100% polypropylene synthetic material. However, one drawback of disposable surgical clothing represents the high cost of acquisition and disposal for organizations, also presenting a high negative impact on the environment. It is common that in hospitals the surgical packages are armed and wrapped using a double layer of Muslin (100% cotton with a minimum of 140 threads per square inch), which are stored in the Central Sterilized, (CEYE). It is not customary to use wrappers "Medical Grade". The wrappings that are not medical grade do not have a standardized elaboration that guarantees the necessary characteristics to assure the conditions of sterility of the articles contained in them. In general, this type of packaging does not have a guarantee of quality in terms of permeability, strength, or controlled porosity since they were not specifically designed as sterilization packages. Therefore, packages or wrappings of this material may not constitute an adequate barrier. These are materials made of natural woven fibers, whether cellulose, cotton, linen or a mixture of cotton and polyester. The highly used muslin must have a minimum of 140 strands per square inch and it is recommended to use it for double-layer wrapping or as a second wrap. The wrapped muslin wrappers should be washed between each use to restore moisture content and ensure the filtration capabilities of the fibers. However, continuous washes of textiles reduce their efficiency as a barrier so that storage time can be reduced. Since this type of material is susceptible to deterioration and suffer alterations due to its use, it must be rigorously examined before each use and in the case of perforations or tears, use adhesive patches and not darning because the weft is altered allowing the passage of particles. It must be borne in mind that the textile material is not water repellent, so precautions must be taken to avoid moisture by ensuring and protecting the packaging with plastic cover if they are going to be stored for a long time OBJECTS OF THE INVENTION The main object of the present invention is to propose the new Quiropaq® concept, as it will be referred to hereinafter as packages of sterile, reusable surgical clothing, which is born as a response to the market needs set forth above. In a preferred embodiment, the Quiropaq® package or package is characterized in that it consists of: a) a special medical grade bag or wrapping, and b) a set of direct-acting articles, particularly clothing or textile material, to be used in surgical procedures, which are contained in the packing bag that has been hermetically sealed. Previously, the package has been subjected to a process of sterilization of the surgical articles to fully guarantee their sterility conditions. Another additional object of the invention is to propose a novel process for sterilization of surgical clothing, reusable, and conformation of Quiropaq sterile surgical clothing packages.

BRIEF DESCRIPTION OF THE FIGURES Figure 1 is a schematic representation of the complete process for forming packages of sterile, reusable surgical clothing. Figure 2 is a perspective view of an example of the Quiropaq® package or surgical package.

DETAILED DESCRIPTION OF THE PREFERRED MODALITY OF THE INVENTION The present invention Quiropaq® consists of a system of packages or packages (100) of reusable sterile surgical clothing, such as that shown in figure 2 by way of example, whose conformation is selected especially to cover the needs of surgical clothing. sterile in different surgical procedures performed in hospitals or health institutions and in compliance with international hospital standards that guarantee protection and comfort for the patient, medical staff and furniture. The garments (10) that make up the Quiropaq® packages (100) are made of fabric, whose composition can vary from 100% polyester, blends of polyester-cotton and 100% cotton (only the surgical towel). Said composition is determined depending on the final use of the garment, since its application derives the necessary characteristics of the type of textile.

Advantages offered by Quiropaq® against disposable materials and / or internal laundry services and sterilization process in hospitals are the following: Quiropaq® clothing is made with specialized textiles, whose characteristics outweigh the garments made of 100% cotton in the following aspects: • Decrease in the generation of lint. • Greater resistance to tearing and tension when dry or wet.

• They provide an adequate barrier to the penetration of liquids and microorganisms in the garments that require it. • Longer useful life, which is reflected in the quality of the product and its cost-benefit ratio.

Compared to disposable products, the advantages offered by Quiropaq® are as follows: • Because they are "woven" garments, they provide comfort. It is not a stiff garment. • They allow adequate transpiration • Adequate penetration of the steam for the sterilization process. "They do not smell unpleasant. • Greater resistance to tearing • Do not generate toxic byproducts to the environment. (Dioxins and furans: highly polluting substances related to cancer and hormonal disease in living beings). • After discarding due to quality standards, the textile is recycled by yarn manufacturers.

A package or sterile surgical package (100) of Quiropaq® is formed by a wrapping or bag (20) of medical grade packaging inside which have been preselected surgical garments (10) depending on their use in a specific surgical procedure. The term medical grade of the wrappings used in Quiropaq® was defined by the sterilization packaging industry to refer to materials specially designed for that purpose and whose elaboration is standardized. This type of packaging has a controlled porosity of no greater than 0.5 microns and water repellency. In order for sterilization of surgical materials by steam to be carried out properly, 4 factors must be controlled: • adequate contact • sufficient temperature • adequate exposure time and • humidity of the steam (sterilizing agent).

However, in the clinics and hospitals most failures in sterilization occur because there is not adequate control of some of the characteristics indicated above. Unlike the sterilization processes traditionally used, in the conformation of the Quiropaq® packages, mechanical and physicochemical indicators are used that indicate that the package has been subjected to a sterilization process, in addition to the use of a biological indicator (it contains a strain of a highly resistant non-pathogenic bacterium Bacillus stearotermophifs), with which at the end of the process it is verified that the microorganisms were eliminated and with this the complete sterilization of the linen package is guaranteed. The quality assurance level of Quiropaq® complies with the requirements of the FDA (Federal Drug Administration), which requires that sterilization methods must document that the probability of finding a non-sterile article is less than in one million (1 X 10"6), or what is known as the" Sterility Assurance Level. "In contrast, most of the hospitals do not use biological controls and / or physicochemical controls to validate the sterilization process The most commonly used indicator is the Test Tape, whose color vire does not guarantee the quality of the process, simply indicates that it was subjected to a process where the temperature of the process varied, if the storage requirements are met and the product is handled properly, due to the type of packaging used in Quiropaq®, the shelf life is greater than one year. The following table shows a comparative analysis of the shelf life of Quiropaq® and other products that use a different packaging: Although the shelf life of Quiropaq® is extraordinarily long (more than one year), Quiropaq® packages are marked with a stricter limit of 6 months for greater safety of patients and medical personnel. Additionally, from the ecological or environmental protection point of view, unlike disposable products, the reusable products of Quiropaq® contribute favorably to diminish the damage caused to the environment that is produced by the incineration of hospital waste, or its confinement in landfills.

PROCESS OF STERILIZATION AND PRODUCTION OF THE QUIROPAO PACKAGE.

The process begins in the sanitizing phase (washing and drying) of the surgical clothing in which the following operations are carried out: A) DRAWING OR CLASSIFICATION. The process begins with the drawing or sorting stage of the surgical clothing collected from the hospital centers. The garments are received in the lottery or classification area and the name of the customer from where they come is registered and placed on a conveyor belt (whose technical characteristics are described below) to separate them by type of garment as indicated below: (A) Funda may and pierneras. (B) Surgical sheets (C) Surgical fields (D) Surgical gowns (E) Surgical towels B) WASHING Next, the laundry washing phase begins, where the conditions of temperature, times and dosage of chemicals vary depending on the equipment in which the clothes are processed. For purposes of illustration only, reference will be made to laundry in a tunnel Milnor and the reprocessing in the washer extractors, whose technical characteristics will be described later. 4 different washing formulas are used, the 4 formulas being established within the washing conditions mentioned below: - Towels and fields are washed with the same formula. - Time the clothes last in each module of the tunnel: 3:02 minutes.

Washing conditions Milnor Tunnel: The following are indicated, by way of example, of some chemicals used in the sanitizing (washing) process: • Builder C (alkaline) 48% sodium hydroxide (NaOH) • Detergent MP Nonylphenol ethoxylated 20 molar units Detergent for laundry Clout 2000 Nonylphenol ethoxylate 100 molar units Degreaser or emulsifier Oxi-brite Hydrogen peroxide (H202) at 35% Chlorine liberator • Destainer Sodium hypochlorite Na (OCl) 3 13% Remove stains and disinfect • Sour Plus Hydrofluorosilicic acid F6SiH2 * 2H20 Neutralizing soda In addition, as part of the process of sanitizing surgical clothing, the following analyzes and laboratory tests are made periodically on textiles: Sanitizing tests (bimonthly): • Microbiology of surfaces: • Total coniformes: less than 400 colony forming units / total cm • Mesophilic aerobes: less than 200 colony forming units / cm2 Sample: Bulk of major surgery (the most complicated to sterilize due to its size and weight).

Textile Tests (Quarterly) :, Internacional Fabricare Institute (IFI) • Loss of tension, • Yellowing • Removal of blood • Removal of dirt • Effectiveness of bleaching C) DRYING. For this phase of the sanitizing process apply the formulas in the following table that correspond to the type of dryers used in the process.

D) BENDING OF GARMENTS. Once the process of sanitizing the surgical textile material is completed, the clothes are transported to the Quiropaq® area (which is a sterile room) in covered trolleys. All material that enters the Quiropaq® area is heavy and controlled. In this area we proceed to the folding of the garments for which they are placed on the folding table and are visually inspected by trained personnel for the detection of possible defects according to the appearance Master of the surgical garments. The defects detected in the sanitized and dry garments are classified according to that indicated in the visual aid for classification deprendas with defects of the following form: • Reprocess: Orange container • Discard: Red container • Oxide: Yellow container Reprocess: Means that at the end of each production phase the reprocessing carts separated by type of garment are weighed and transferred to the lottery area. Discard: Means that at the end of each production shift, the discarded cars separated by type of garment are transferred to the sewing area to be repaired or removed from the process.

Rust: Means that the garment with rust stain is to be treated with an oxalic acid solution and separated in the corresponding container. At the end of each production phase the container is weighed and transferred to the lottery area for reprocessing. The bending that is made of each garment is a surgical fold, showing a reference point from where the garment is taken for proper handling, avoiding contamination of the garment when it is removed from the package (example: a corner of the field or towel of bent surgery). The folding is performed as indicated in the visual aid for folding Quiropaq® garments.

E) ARMING OF BULKS.

The bundles of cowry are armed and wrapped according to the content and shape of the garments shown in the visual aid for the assembly of packages. In the internal part of each package is placed a physicochemical control element (not shown) for monitoring purposes of the process described below. The assembly and content of a package must respond to the following: • Need for use • Easy to use • Procedural safety The above means that a surgical package must: • Contain the necessary amount of material for a single procedure or benefit. • Be designed to allow the easy use of its content, this is in relation to its size, internal ordering, aseptic opening, etc.

• To consider itself safe with regard to the procedure of its preparation, that is, to allow the free circulation of the sterilizing agent in all its content, not to overload, not to compress, etc.

For surgical textiles it is necessary to fulfill the following conditions: • Arm with surgical bending • Do not compress it • Do not overload • Maximum size 30.5 cm x 30.5 cm x 50.8 cm (manual AMSCO sterilizer) • Maximum weight 5.5 kg (manual AMSCO sterilizer) • Density factor: < do not exceed 0.115 g / cm (manual AMSCO sterilizer) The following table is proposed as an example to indicate the content of the current Quiropaq® packages.

F) PACKAGING AND SEALING.

F.l) Wrappers.

The package (20) of the package or surgical package (100) plays a very important role. The purpose of the wrapper is to provide a barrier to prevent bacterial contamination of the bundles of clothing (10) and allow their handling aseptically. The materials to be used as wrappers must meet certain characteristics that make them suitable for submitting them to the sterilization process. Here are some of them: • allow the penetration and diffusion of the sterilizing agent • provide a suitable bathtub to the dust and microorganisms «be resistant to punctures and manipulation • allow an aseptic presentation • allow a hermetic seal. • allow the identification of contents To meet the objectives of ensuring the sterility of the packages, the packaging material must have the following characteristics: 1. Porosity: The pores of the packaging material must not be greater than 0.5 microns to prevent the passage of microorganisms and particles. 2. Permeability: It must be permeable to the sterilizing agent (vapor) and resist the physical conditions of it. 3. Sealing: It must allow a hermetic seal to avoid contamination of the article once the process is finished. 4. Impermeabilidad: It must be resistant to the humidity and the passage of microorganisms 5. Resistance to the air: It must allow the evacuation of the air without producing damage or rupture and resisting changes of pressures. 6. Resistance to handling: It must allow the packages to be handled without altering their indemnity. 7. Non-toxic: Free of toxic substances as these can pass to the contents of the package and harm the patient and / or the personnel that manipulates them. It must not be combined or reacted with the sterilizing agent. 8. Free of threads or fibers: They can alter the indemnity of the packaging. Lint or any other type of particles should not be released into the environment. 9. Free of odor: should not give off any odor. 10. Without memory: When bending it, no marks should be produced that could eventually cause breakage or alterations in its surface.

F.2) Types of packaging Medical Grade Packaging: The term medical grade is used by the sterilization packaging industry to refer to materials specially designed for that purpose and whose elaboration is standardized. This type of packaging has a controlled porosity of no greater than 0.5 microns and water repellency.

Non-woven fiber paper Medical Grade: Conesponde to a special paper compatible with sterilization in steam autoclave and ethylene oxide. It is also known as creped paper. Its characteristics have been defined in British standards (BS 6254: 1989). It is conformable, repellent to liquids, does not give off lint, does not irritate the skin, is resistant and has no memory.

Conditions required for medical grade paper: • Manufacturer's guarantee for biomedical use • Wood pulp (bleached chemical pulp) • Weight: 60 g / m2 • pH between 4.5 and 8 Does not contain: optical brighteners, starch, nor sizing and non-controlled shaders for biomedical use Mixed paper: It is a combination of medical grade paper and polymer (polypropylene) transparent. It is compatible with sterilization in steam autoclave, ethylene oxide and formaldehyde vapor. It is composed of a transparent sheet that allows you to see the article and an opaque sheet (medical grade paper). It is resistant to stress, explosion and tearing, heat sealable, easy to open and has built-in chemical indicators.

This material comes in the form of sleeves adaptable to materials of different sizes and envelopes. The table below includes specifications for the medical grade bag that is currently used for the Quiropaq® package or package.

SPECIFICATIONS OF THE MEDICAL GRADE BAG F.3) Thermosealing of the medical grade bag. Once the surgical packages have been assembled as determined according to what is specified in the corresponding table, heat sealing of the medical grade bags (20) is carried out. The process used is safe and allows a subsequent aseptic opening of the package (100) and is easy to avoid falling or breaking the material.

F.4) Identified - Grading Once the sealing operation of the bags has been concluded, the packaging materials are labeled. This procedure can be manual or mechanical. • Mechanical labeling is done with machines or templates designed for this purpose.

• Manual labeling is done with the printing of an ink stamp or by placing self-adhesive labels (30) previously printed or with spaces destined to write information about them.

Care must be taken not to damage the packaging in this process. In case this happens, the package will be discarded and the package will have to be packed again. Writing on the paper constituting the wrapping of the material should be avoided and if a label is used, it should be placed on the polypropylene part of the medical grade bag.

The surgery package (100) must contain at least the following data: • Name of the package or product • Expiration date • Lot number F.5) Preparation of the test package: "Test package" is called that of a batch of packages that are going to be sterilized and inside which a physicochemical control and biological control is placed according to the visual aid for the preparation of the test package. Next, the test package is placed in the central part of the canopy with the other surgical packages to be sterilized. The type and number of armed packages is recorded in the Production Record of packages sterilized in Quiropaq®. The arrangement of the packages in the sterilizer canopy should be continuous but not too close together to allow an adequate flow of steam. Once the dogs have the full load to sterilize, they are transported to the sterilizer area. At the beginning of each production day, the sterilizers are cleaned with wet towels, washing the filter and verifying that there is adequate paper to register the sterilizer cycles.

G) STERILIZATION OF BAGS FOR HUMID HEAT G.l) Sterilization conditions: As a sterilizing agent in the process, saturated water vapor at higher than normal pressure and at temperatures greater than or equal to 121 ° C is used. The saturated vapor must be free of condensate and dirt. The main mechanism responsible for microbial death is the coagulation of proteins, by the action of saturated water vapor. It causes a reversible denaturation of enzymes and structural proteins. Because the saturated water vapor is a sterilizing agent that acts only by contact, releasing heat energy equivalent to the latent heat of vaporization (540 cal / g), care must be taken that the textiles are arranged in such a way that the intimate contact of all its parts with steam. Some of the advantages that are had by the process of sterilization by humid heat are mentioned below: • Process with a high sterilization safety margin, if the time and temperature parameters are met.

• It is considered a quick, effective and easily accessible method.

• Absence of environmental toxicity.

• Does not cause adverse effects as it does not leave toxic residues in the sterilized material The operation of the sterilizers to carry out the sterilization process described above is classified, according to the manner of elimination of the air contained in the chamber, in two ways: • Gravitational: the elimination of air from the chamber is carried out by gravitational displacement.

• With pre-vacuum and drying: the previous vacuum allows the total elimination of the air contained inside the chamber and the materials, thus guaranteeing a homogenous distribution of the steam, a fundamental requirement to achieve sterilization. Regarding drying, it is essential to avoid contamination of sterilized materials.

Materials that can be sterilized with steam: Textile material, glassware, rubber material, surgical instruments made of stainless steel, aqueous solutions and all material whose manufacturer certifies can be sterilized by steam. This system is especially recommended for all those materials capable of supporting water vapor with temperatures ranging from 121 ° C to 134 ° C, including porous loads. The sterilizers can be programmed by vacuum or gravity cycles, just as the temperature can be adjusted within the range of 121 to 134 ° C. Depending on the temperature and the type of cycle chosen, the time of exposure to the sterilizing agent is determined. The minimum time and temperature conditions recommended by the manufacturer of the sterilizer are shown below: Steam sterilization cycles a) Prevacuum: * It is recommended to sterilize with pre-vacuum cycles ** Some loads may need additional drying time, open the door approx. 15 cm / 15-30 min *** If you are using combined loads, always use longer drying periods.

For the present case, the sterilization process is carried out by pre-vacuum cycles, at a temperature of 132-134 ° C, time of exposure to the sterilizing agent of 4 minutes and drying time: 20 minutes. However, as mentioned above, the process variables may vary depending on the materials and conditions.

G.2) Monitoring of the sterilization process. To validate the sterilization process it is necessary to perform a routine monitoring combining physical, chemical and biological indicators as parameters. Next, each type of mentioned indicator is described.

Physical or Mechanical Indicators: It is a printed record that is obtained from the sterilization equipment itself indicating physical parameters, such as temperature, humidity, pressure and duration of the cycle.

Physical-chemical indicators Physical-chemical indicators are designed to respond with a physical or chemical characteristic to the change of one or more parameters in the sterilizer chamber (temperature, time, pressure, etc.). With the use of physicochemical indicators a vire of color is produced in the chemical reagent as a positive response of the process. In addition, the fundamental advantage of using a chemical indicator is that they give an immediate reading and, together with the physical parameters (pressure, humidity, temperature, time, etc.), provide the first indication of whether the conditions have been met during the cycle of the predefined sterilization process, allowing the operator the possibility of storing the processed materials or devices while waiting for the result of the biological indicator. The physicochemical indicators do not provide information on whether the sterilization of the load has been carried out successfully. Rather, they indicate that the predetermined conditions of the process have been reached during the sterilization cycle. To guarantee the capacity of sterilization of the cycle, it is better to wait for the result of the reading of the biological indicator. The physicochemical indicators vary among themselves according to their placement in the surgical package, for example: • External: consist of stamps printed on the medical grade paper of the wrappers. They are generally used to verify that the package has been exposed to sterilized conditions.

• Internal: consist of strips of paper impregnated with reactive chemical substance and are placed inside the package (place of difficult access for the sterilizing agent). They are used to verify that the internal part of the package was subjected to a sterilization process.

• Heat sensitive indicator: consists of a self-adhesive witness tape that can be placed internally or externally. It does not guarantee that the sterilization has been achieved, but it serves to indicate if any mechanical or internal operation problem occurred within the sterilizer.

The color change of said indicators must be observable in each of the units processed in order to attest that they have gone through the process. It is recommended that such indicators be used on each package that is inserted inside the sterilizer. Biological Indicators: On the other hand, biological indicators are the only system capable of integrating all the variables involved in a sterilization cycle and it is the best system to control a "Biological Objective", such as sterility. When a microbial load is exposed to a sterilization method, the death of microorganisms exposed to a given sterilization method occurs in logarithmic form, the number of microorganisms dying each minute is a constant percentage of the number of surviving microorganisms at the beginning of each minute. The microorganisms have different degrees of resistance to physical and chemical agents. This response is related to the structure of microorganisms such as the ability to form spores, the presence of certain components in the cell wall (for example, lipids) or the thickness of it. Therefore, the resistance is different in the different microbial species.

Differences in resistance have allowed the selection of indicator strains for high-level sterilization and disinfection and the preparation of biological indicators. For these purposes, the most resistant species for the process is selected and if it is destroyed it is assumed that it also destroys the least resistant microorganisms. In the steam sterilization process that is carried out for the case of the present invention, the biological indicators are prepared from non-pathogenic spores of the Bacillus Stearothermophilus microorganism, highly resistant to the sterilization process and therefore are useful and effective in establishing the capacity that the sterilization cycle has to destroy specific microorganisms. Alternatively, biological indicators can be used in separate systems, where the spore strip and medium are contained within a single plastic vial. After sterilization, the inner glass vial is broken, allowing the medium to come into contact with the spore strip. In addition, they include a pH indicator (bromocresol purple), which changes color when exposed to acid derivatives originating in the growth of organisms. The incubation time required is 24/48 hours, so it is possible to carry out the incubation in the central sterilization. Recently, the biological rapid reading indicators were introduced for the control of sterilization by "flash", steam sterilization cycles by prevacuum and ethylene oxide. This indicator detects the presence of an enzyme, aD-glucosidase, associated with the spores, and provides a fluorescent reading that allows an assessment on the effectiveness of sterilization after 1 hour (flash sterilization), 3 hours (steam sterilization). ) and 4 hours (sterilization by ethylene oxide).

The reading is done in a rapid incubator using a light system. The green light indicates satisfactory sterilization and the red one indicates failure in the sterilization, thus eliminating a visual interpretation. With the use of this type of biological indicators, no subsequent incubation period is necessary. In addition, they offer the possibility of early detection of any equipment malfunction, validate repairs quickly and return the sterilizer to service. The level of quality assurance of sterilization obtained from biological indicators is 1 x 10"6. The Federal Dmg Administration (FDA), US regulatory agency requires that sterilization methods must document that the probability of finding a non-sterile item is less than one in a million. This is called SAL (for its acronym in English Sterility Assurance Level). This indicator is currently used to define that an article is sterile. (Russell 1993). The use of these indicators constitutes a confirmation of the conditions established by validation, and controls must be carried out periodically. In the described modality of the sterilization process that is followed for the Quiropaq® concept, a biological indicator (of the type of indicator that is not quick reading) per day of operation is used, as well as one for each cano (lot) that enters to the process of sterilization (witness package). Although of course the use of biological indicators of rapid reading is not ruled out. Biological control, once removed from the control package after the sterilization process, is triggered under corresponding conditions, as described in the quarantine section below. At the end of each cycle of the sterilizer, the door of the sterilizer is opened slightly (approximately 15 to 20 cm) giving a time of 10-15 minutes so that the temperature decreases a little and you can remove the canopy from inside. After the indicated time, the cartridge is removed from the sterilizer using asbestos gloves and the packages are moved to the Quiropaq® warehouse area for the quarantine period, which is indicated by placing a sign on the corresponding shelf. The sterilized record of each load is printed and the test package is removed. Then, the requested information is filled in a log of the sterilization process.

H) QUARANTINE. During the incubation process of the biological control, the surgical packages removed from the sterilizer must be kept in quarantine until the result of the biological control is verified. The quarantine time is established based on the incubation time required by the biological indicator to carry out the reading of the result. This time varies depending on the type of biological indicator. According to studies carried out, the biological indicators used in the described process require the following incubation time: 12 hours incubation: 95.6% reliability 24 hours incubation: 99.4% reliability 48 hours incubation: 99.9% reliability Interpretation of the Biological indicator: • A purple-colored amber color indicates that the sterilization process was not adequate.

• If it does not happen, turn on the purple color, the sterilization process is reliable.

Once the product is released from the quarantine (biological indicator, negative result) the packages are moved to their corresponding shelf for storage, taking the sterilized packages of the cano and verifying that they are not punctured, broken, imploded or wet. If defective packages are found, the wrapping is removed and placed inside the reprocessing container. Additionally, a record of Quiropaq® packages is produced.

I) STORAGE The finished and sterilized product is placed on the shelves that are identified by the type of package according to its content. The warehouse area is a hygienic, fresh area with low relative humidity.

Also, part of the process is to avoid unnecessary handling of all processed materials.

Shelf life: Sterile packages are marked with an expiration date of six months after they have been processed. However, if the package is not handled in excess, if the storage conditions are adequate in terms of humidity and temperature, and as long as the packaging is not damaged, the shelf life of the Quiropaq® packages can be extended by a year or even more. The information presented in the following Table is valid under the controlled environmental conditions of the Quiropaq® sterilization process warehouse.

J) ASSORTMENT The assortment of sterilized material must be made with great care, avoiding falls and unnecessary handling. The release of the material is documented in a register implemented for this purpose. Likewise, perfectly hygienic bags or containers are used to transport the sterilized material that is going to be distributed to the hospital centers.

The design of the package or package Quiropaq® produced by the process described above has been designed to allow easy use of its content and importantly important is that it can be opened aseptically. In addition, preferably the Quiropaq package must possess, without implying any limitation, the following characteristics: • Maximum size of the package: 30.5 cm x 30.5 cm x 50.8 cm • Maximum weight of the package 5.5 kg • Density factor: do not exceed 0.115 g / cm3 Likewise, with regard to the internal arrangement of the package, in the assembly phase of the latter, the textile garments must not be overloaded or compressed to allow the free circulation of the sterilizing agent in all its contents.

LIST OF TEAMS INVOLVED IN THE PROCESS: DRAWING CONVEYOR BANDS: (2) Model TL (Heavy Duty Horizontal Belt Conveyor) Reversible, Rugged finish band Band length: 30 ft Total length: 31 ft Band width: 30 inches • Belt width: 24 inches Capacity: 975 Ib Belt speed: constant 65 FPM Capacity: maximum load per linear foot = 100 lbs. Do not exceed capacity. • Engine: Í HP TUNNELS OF WASHING: TUNNEL MILNOR TOP TRANSFER CBW SYSTEM «11 modules • Countercurrent water flow system • Each module has a load capacity of 45 kg • Pendular washing movement, non-centrifugal. At the end of each transfer, it rotates 360 ° to transfer the clothes to the next module. • Internal basket made of stainless steel. • Drain in module 1 • Programmable • Automated system • Washing capacity: 1,100 kg / h • Two-step press: 31 bar pressure TUNNEL SENKING (JENSEN) CBW SYSTEM UNIVERSAL • 12 modules • Each module transfers water and clothes to the next module. • Internal basket made of stainless steel • Drain in module 4 • Each module has a load capacity of 90 kg • Pendular washing movement, not centrifugal. At the end of each transfer, it rotates 360 ° to transfer the clothes to the next module. • Three programmable variables • Automated system • Washing capacity: 2,400 kg / h • One-step press: 51 bar pressure EXTRACTOR WASHING MACHINES: MILNOR: OPEN POCKET WASHER-EXTRACTOR 64046 E6N (2 devices installed) • Maximum capacity: 250 kg • Cylinder volume 2,425 liters • Approximate washing speed: 33 rpm • Approximate draining speed: 42 rpm Extraction speed (low) 200 rpm Extraction speed (high) 575 rpm (decrease in drying time ) Centrifugal force 300 Gs Control Programmable Microprocessor 100 different washing formulas Separate motors Washed motor: 15 HP Drained motor / Distrib. 7.5 HP Engine extraction (low) 7.5HP Engine extraction (high) 20 HP MILNOR 95 LB WASHER EXTRACTOR: SYSTEM 7, E-P PLUS, AND MARK II MICROPROCESSOR MODELS 36026 Q6J Maximum capacity 95 Ib, 43 kg Cylinder diameter 914 mm Cylinder depth 660 mm Wash speed 31 rpm Final extraction speed 600 rpm G force during final extraction: 183 Motor wash / first part extraction: 1.5 HP Motor distribution / end extraction 2 HP 30 programmable formulas, includes 10 pre-established formulas, with programs specially designed for each type of Textile market.

MILNOR 50 LB WASHER EXTRACTOR: SYSTEM 7 E-PLUS AND MARK II MICROPROCESSOR MODELS 30022M5 J • Capacity: 25 kg • Cylinder diameter 762 • Cylinder depth 559 • Two 1.5HP motors • Washing speed 36 rpm • Final extraction speed 500 rpm • Force G during final extraction: 106 DRYERS The dryers have the following general characteristics: • Forced draft • They work with natural gas • They are reversible (impact on the reduction of drying time).

Its capacity depends on the equipment and is as follows: TUNNEL MILNOR DRYERS: "5 dryers of 90 kg capacity (2 loads of 45 kg)" Automated for loads and downloads "Programmable TENNEL SENKING DRYERS "35 dryers of 90 kg capacity 1 Automated for loading and unloading" Programmable CHALLENGE PACESETTER DRYER MODEL CPG-400-S GAS FIRED "Drying chamber capacity: 5.58 m3," 18-1 kg of dry weight. B Programmable CISSELL Model L44KD42G - Capacity: 110 1b (50 kg) "Programmable STERILIZERS: TWO AMSCO BRAND STERILIZING EQUIPMENT. One with a capacity of 1,000 liters. Another with a capacity of 2,000 liters.

EAGLE 3000 SERIES FLJ STEAM STERILIZER • Computerized automatic control "Stage 3" alphanumeric in Spanish, with an event recorder • With pre-vacuum capacity • Camera dimensions: 660 X 1574 X 1930 mm (for the model with a capacity of 2,000 liters) • Camera dimensions: 660 X 1574 X 1067 mm (for the model with 1,000 liter capacity) • Automatic operation, a manual and automatic folding door on the right. • Recessed to a wall and installed in a trench. • Powered by direct steam. • Powered by 208-240VAC, 60 Hz, 3 hp. Being conventional equipment for the process of sanitizing and sterilization of direct action items, the detailed description of the operation of the equipment previously mentioned has been omitted. Although the invention has been described in the context of a specific preferred embodiment, it will be apparent to those skilled in the art that the scope of the present invention extends beyond the specifically described embodiments to other alternative embodiments and / or uses of the invention. that are obvious and derivable from it. In addition, although the invention has been shown and described in detail, some other modifications or changes, which are within the scope of the present invention, will be clearly obvious to specialists in this particular subject based on the foregoing description. For example, other equipment than the aforementioned can be used to carry out the sanitization and sterilization process. Likewise, other types of biological indicators that lead to the same result can be used. The same applies to the type of packaging that is used to package clothes, since for this purpose other packaging may be used as long as the required sterility conditions are met. Likewise, the same interpretation should prevail for the use of other chemicals than those mentioned here or of surgical fabrics made of different materials. Accordingly, it will be understood that various combinations of the specific features and aspects of each described embodiment could be made that would undoubtedly fall within the scope of the invention. Also, it is clear that several features and aspects of the described modalities can be combined with others or substituted by others to form alternative modes of realization of both the Quiropaq® package and the process to produce it. In this way, it is intended that the scope of the present invention should not be limited by the particularly described modalities, but should be defined by a reasonable reading of the following claims.

REFERENCED BIBLIOGRAPHIES: Textile Laundering Technology, Charles L. Riggs, Ph.D., Joseph C. Sherrill, Ph.D., 1990, Textile Rental Services Association of America (TRSA), Hallandale, FL.

American National Standard, Association for the Advancement of Medical Instrumentation, ANSI / AAMI ST65: 2000 AMSCO Technical Manual, Guidelines for preparing and sterilizing wrapped packages, Edna K. Kirkwood, R.N., Nurse Consultant Sir, American Sterilizer Company., Pag. 16-18 Manual of Sterilization and Disinfection Standards, 1995, Ministry of Health Chile.

AORN Joumal: Recommended Practices for Sterilization in Perioperative Practice http: // www. Findarticles.eom / p / articles / mi_m0FSL / is_2_70 / ai_55525534 Microbiology (Outside), Bacteriology, http: //www.microbiologia. com. a ^ acteriologia / index.html Sterilization and Disinfection Manual. Ministry of Health of Colombia Infection Prevention Guidelines for Healthcare Facilities with Limited Resources, Chapter 11 and Appendix G, http://www.reproline.jhu.edu/english 4morerh / 4ip / IP_manual / ipmanual.htm Manual of Norms of Sterilization and Disinfection, 1995, Ministry of Health of Chile.

History of Biological Indicators, EU. Sandra Riveros C. http: //www.enfermeraspabellonyesterilizacion.d/trabajos/biologicos.pdf Technical Information provided by physical and biochemical indicators suppliers: Specialists in Sterilization and Packaging S.A. of C.V. and 3M ™

Claims (30)

1. - A package of sterile surgical articles, comprising: a) a medical-grade bag or wrapping, and b) a set of direct-acting articles for use in surgical procedures, which are contained in the packing bag that has been hermetically sealed; and c) a physicochemical indicator; said package has been previously subjected to a sterilization process of the surgical articles to fully guarantee their sterility conditions.

2. The package of claim 1, wherein the articles contained within the bag are textile materials for surgical use.

3. The package of claim 1, wherein the articles contained within the bag is pre-selected surgical clothing according to specific surgical procedures.

4. The package of claim 1, wherein the clothing has been previously subjected to a sanitizing process to provide adequate aseptic conditions before the process of packaging and sterilization.

5. The package of claim 1, wherein the clothing has been subjected to a sterilization process in which at least one mechanical, physicochemical and / or biological indicator, a combination thereof or each one has been used. of them, to validate the sterilization process.

6. The package of claim 1, which can last in sterile conditions for at least six months.

7. The package of claim 1, which can last in sterile conditions for more than one year.

8. The package of claim 1, wherein the clothing is reusable.

9. - The package of claim 1, wherein the laundry is accommodated inside the bag in such a way that it can be removed from it piece by piece.

10. The package of claim 1, wherein the wrap provides a tub to prevent bacterial contamination of the packages and allow their handling in aseptic form.

11. The package of claim 1, which contains the necessary amount of surgical clothing for a single procedure or provision.

12. The package of claim 1, wherein the bag or wrapper includes means that allow easy identification of its contents.

13.- The package of the claim, which also includes elements of identification or labeling for control purposes.

14. A process for the formation of packages or packages of sterile, reusable surgical clothing intended for hospital centers, comprising the following stages: classifying the surgical textile material by type of garment; to submit the textile material to a sanitizing process to leave it in adequate conditions of asepsis; inspect the sanitized garments to remove those that have defects and fold the rest of said garments; assemble packages or packages of surgical textiles by inserting them into medical grade bags or wrappings; sealing the wrappers of the packages or surgical packages by heat sealing; introducing the packages to a sterilization station for wet heat sterilization treatment at a temperature in the range of 121 ° C to 134 ° C, for a predetermined time; withdrawing the packages from the sterilizing station after a predetermined cooling time and passing the packages to a quarantine station; and verify that the packing conditions of the packages or packages of sterile surgical material are optimal before being stored and assorted.

15. The process of claim 14, wherein before introducing the packages to the sterilization equipment, biological control indicators are placed therein to verify that the packages are properly sterilized.

16. The process of claim 14, wherein the indicators consist of physical or mechanical, physicochemical and biological type indicators.

17. The process of claim 14, wherein the sterilization process is monitored by means of mechanical indicators, physicochemical and biological.

18. The process of claim 14, wherein the sanitizing process consists of the process of sorting or separating clothes by type of garment, washing and drying the surgical textile material.

19. The process of claim 14, which further includes the step of checking the different conditions of the sterilization process by means of the mechanical indicators.

20. The process of claim 14, wherein during the process of sterilization of packages or packages a biological indicator is used per day of operation, as well as one for each batch that enters the sterilization process.

21. The process of claim 14, wherein a package of praeba or control is used in each batch of packages that is subjected to the sterilization process.

22. - The process of claim 14, which further includes implementing a biological control process to verify the sterilization of surgical packages by incubating the biological indicator used in the sterilization process.

23. The process of claim 14, wherein the surgical packages removed from the sterilizer remain in quarantine until the result of the biological control is verified.

24. The process of claim 14, wherein sanitized garments are inspected during the bending stage to remove those that have defects.

25. The process of claim 14, wherein the garments detected with defects are classified by type of defect and type of garment to be re-processed or discarded.

26. The process of claim 14, wherein when assembling the package should not overload or compress the textile garments to allow free circulation of the sterilizing agent throughout its content.

27.- The process of claim 14, wherein before placing the packages into the sterilizer they are placed in the cart taking care that the textiles are arranged in such a way as to ensure the intimate contact of all its parts with the steam.

28. The process of claim 27, wherein the arrangement of the packages or packages in the sterilizer canopy must be continuous but not too close together to allow an adequate steam flow.

29. The process of claim 14, wherein the surgical packages are labeled for purposes of comparison.

30. The process of claim 14, wherein the time and temperature of sterilization of the packages depend on the type of selected sterilization cycle.