RU207243U1 - Sterilization bag with biochemical indicator - Google Patents

Abstract

The utility model relates to the field of sterilization of products, mainly for medical purposes (surgical instruments, dental instruments), as well as for sterilization of instruments for manicure, pedicure, piercing (forceps, nippers, scissors, needles, etc.). The package has a closing valve 1 with an applied adhesive strip, which is covered with a protective tape 2, which allows it to be hermetically sealed after placing tools in it. On the front side of the package there is an indicator mark 3, made with the use of a heat-sensitive composition, which irreversibly changes its color after a sterilization cycle. The spores of the test microorganisms are pre-distributed in the volume of the thermosensitive composition, and an indicator label is formed from this composition with spores. Next to the indicator mark, a reference mark 4 is made, clearly demonstrating what color the indicator mark should acquire after sterilization. Also on the front side there is a QR code or any other barcode in which the personal identification information on the package is encrypted, which allows it to be read by a mobile phone with a built-in barcode scanner, while the said information allows in a mobile phone equipped with a barcode recognition application code and its processing, generate an electronic version of the sterilization cycle log. The package also contains its individual batch number. The achieved technical result is to ensure the versatility of the sterilization control method, that is, to ensure the possibility of both chemical and biological control of sterilization of instruments.

Description

The utility model relates to the field of sterilization of products, mainly for medical purposes (surgical instruments, dental instruments), as well as for sterilization of instruments for manicure, pedicure, piercing (forceps, nippers, scissors, needles, etc.).

Instruments used for manipulations in which damage to the skin or mucous membranes is possible are subject to mandatory sterilization and storage in sterilization bags (see clause 2. 29. SP 2.1.3678-20).

Known package for sterilization of medical products, described in patent RU 2452514, made in the form of a rectangular envelope glued on the sides and in the lower part of the perimeter, in the upper and lower parts of the package has valves. The lower flap is folded and glued to the bag from the back side, a double-sided adhesive tape is placed on the upper flap, a creasing or notch-perforation is applied to the bag at the bend of the upper flap. On the outside of the bag there is an indicator mark to indicate the end of the sterilization process.

The package for sterilization of medical devices described in patent RU 166580 U1 was chosen as a prototype. The package is made of paper in the form of a rectangular envelope glued on the sides and at the bottom. The package has a closing flap in the upper part with an applied adhesive strip, covered with a protective tape. A chemical indicator is applied to one side of the bag to monitor the sterilization process.

In the above and other known sterilization bags, the sterilization process is monitored by a change in the color of a chemical indicator containing pigments that irreversibly change their color under the influence of sterilization parameters. The color of the label changed during the sterilization process is compared with the color indicated on the package next to the label in the form of a verbal notation: "Color of the final state (air) gray" or "Color of the final state (steam) brown" (https://www.medtest.ltd /gold-land-fixed.html). The color depends on the chemical composition of the tag and the sterilization conditions (steam or air). This control is superimposed on the individual peculiarity of the perception of the wording of the name, since the colors of both "gray" and "brown" or, for example, "dark pink" have many shades. The supervisor must have sufficient experience to determine that the sterilization process produces the same "gray" or "dark pink". That is, the reliability of the control of the sterilization process is significantly influenced by the subjectivity of the assessment.

In addition, in known sterilization bags, control is carried out only on the change in the color of the chemical indicator.

Known biological indicators based on the use of standardized preparations of certain microorganisms used to assess the effectiveness of the sterilization process. A biological indicator is usually a composition with bacterial spores (test microorganisms) applied to an inert carrier. Inoculated carriers are prepared by applying a suspension of test mycoorganisms to the base, followed by drying under controlled conditions [GOST R ISO 11138-1-2000 sterilization of medical products. Biological indicators. Part 1 Technical requirements]. The inoculated carrier is isolated so as to prevent damage or contamination and, at the same time, allow contact of the sterilizing agent with microorganisms. Spore suspensions can be kept in hermetically sealed ampoules.

From the prior art, a sterilization package is known, in which the spores of microorganisms are applied to a paper strip placed inside the package [Biotest-P1-Vinar, TU 9398-090-11764404-2011]. After control, the sterilization package is opened under aseptic conditions, and the carrier in the form of a strip of paper is placed in a vial with a sterile nutrient indicator solution for subsequent incubation. The main disadvantage of this design is the need to open the package under sterile conditions and then determine the degree of sterilization. In addition, biological indicators cannot be used as a means of operational control. In terms of the information content of the result, biological control surpasses the known methods of chemical control, since it is a means of direct control and gives an unambiguous answer about the death of microorganisms during sterilization.

Thus, chemical indicators show whether sterilization treatment has taken place under specified conditions, while biological indicators determine the effectiveness of the sterilization process.

The author is not aware of sterilization bags that provide both chemical and biological control of sterilization of the instruments placed in them.

The utility model is based on the task of expanding the arsenal of tools and creating a new package for sterilization of instruments, equipped with a sterilization control device. The achieved technical result is to ensure the universality of the sterilization control method, that is, to ensure the possibility of both chemical and biological control of sterilization of instruments.

The inventive package for sterilization has a closable valve with an applied adhesive strip, which is closed with a protective tape. On one side of the package, an indicator mark is applied, made using a heat-sensitive composition, which irreversibly changes its color after a sterilization cycle. It differs from the prototype in that the indicator label contains spores of test microorganisms, the fixation of which was carried out using the mentioned thermosensitive composition. Spores of test microorganisms can be introduced into the indicator label in two ways:

- spores are applied to the carrier and covered with a layer of heat-sensitive composition on top,

- the spores of the test microorganisms are distributed in the volume of the thermosensitive composition and an indicator mark is formed from this composition.

The bag can be provided with a reference mark to showcase the color of the indicator mark after sterilization. Replacing the verbal description of the color of the label after sterilization with a colored spot reduces the subjectivity of the perception of the achieved result during sterilization.

The package can be made with an expanding inner volume and have expanding folds on the sides, but it can also be made in the form of a flat envelope.

The bag can be made of heat-resistant and moisture-resistant paper material. Another implementation is possible - from two sheets connected on the sides and one of the ends by hermetic heat-resistant seams, while one of the sheets is made of heat-resistant and moisture-resistant paper material, and the other sheet is made of a transparent polymer film. The material of the package itself, the adhesive must withstand the temperature of air and steam sterilization.

According to Appendix 5 to the Order of the Ministry of Health of the USSR of 10.10.1991 N 287 "On the introduction of industry guidelines for WMD 42-21-35-91" Operating rules and safety requirements when working on steam sterilizers "the sterilization process is monitored and recorded in the cycles (https://www.centrmag.ru/catalog/product/zhumal_ucheta_sterilizatsionnykh_tsiklov/_).

In order to ensure the possibility of maintaining the above-mentioned journal in electronic form, it is proposed to place a QR code on the package, in which the information necessary for creating an electronic version of the Journal of Sterilization Cycles is encrypted. In particular, such a technical means can be a QR code.

In order to better demonstrate the distinctive features of the utility model, a preferred embodiment is described below by way of an example without any limitation. The sterilization bag itself is shown in the Figure.

The package is made of two sheets, connected on the sides and one of the ends by hermetic heat-resistant seams. One of the sheets is made of heat-resistant and moisture-resistant paper material, and the other sheet is made of transparent plastic film. The material of the package itself, the adhesive composition, withstands the temperature of air and steam sterilization. The package has a closable valve 1 with an applied adhesive strip, which is covered with a protective tape 2, which allows it to be hermetically sealed after placing the instruments in it. On the front side of the package there is an indicator mark 3, made with the use of a heat-sensitive composition, which irreversibly changes its color after a sterilization cycle. The spores of the test microorganisms are pre-distributed in the volume of the thermosensitive composition, and an indicator label is formed from this composition with spores. Next to the indicator mark, a reference mark 4 is made, clearly demonstrating what color the indicator mark should acquire after sterilization. Also on the front side there is a QR code 5, or any other barcode in which personal identification information on the package is encrypted, which allows it to be read by a mobile phone with a built-in barcode scanner, while the said information allows in a mobile phone equipped with a recognition application barcode and its processing, generate an electronic version of the Journal of Sterilization Cycles. The package also contains its individual batch number.

Most smartphones come with a built-in QR code scanner. Some recent smartphones, such as the Google Pixel or iPhone, have a QR scanner built into the camera. Older models may require a dedicated QR code reader app - these can be found in the Apple App Store and Google Play.

The sterilization package is equipped with markings that provide protection against falsification and protection against entering an incorrect (duplicate) result when maintaining an electronic Journal of sterilization cycles using specialized software.

The QR code is applied to the package, including for the purpose of identifying information about the manufacturer, batch number and production date of the batch of packages. In combination with the applied coded designation of the individual package number, the QR code forms a counterfeit protection system. When maintaining an electronic Register of sterilization cycles, the combination of the batch number and the individual QR code should not be repeated for different sterilization cycles. Protection is implemented when reading information encrypted in a QR code and processing it with special software.

The sterilization bag is used as follows. After sterilization of the instruments placed in the bag, the inspector checks the color of the indicator mark and the color of the reference mark. If the color matches, then the sterilization was carried out correctly. In biological control, after visual control of the color change of the indicator mark, the mark is separated, placed in a test tube with a nutrient medium, which is included in the kit, and the studies used for biological control are carried out. After the end of the incubation, it is assessed whether the culture medium has changed its color or not. If the culture medium changes its color, it means that there is an increase in the number of microorganisms and the sterilization cycle was not completed correctly. All medical devices sterilized in this cycle are considered non-sterile. The sterilization process is repeated and controlled again.

After monitoring the state of the indicator tag, the QR code is scanned with a mobile phone scanner and the software allows you to make another entry in the electronic Journal of Sterilization Cycles.Thus, the declared sterilization package provides the ability to carry out both chemical and biological control of sterilization of instruments. The package is equipped with additional options to increase the reliability of control, to maintain an electronic Register of sterilization cycles and to exclude the possibility of reuse, disposable packaging.

Claims (4)

1. A package for sterilization, which has a closable valve with an adhesive strip applied, closed with a protective tape, on one side of the package there is an indicator mark made using a temperature-sensitive composition that irreversibly changes its color after a sterilization cycle, characterized in that the indicator mark contains test spores -microorganisms, the fixation of which is carried out using the above-mentioned thermosensitive composition. 2. A package for sterilization according to claim 1, characterized in that the spores of the test microorganisms are fixed by a covering layer formed from a thermosensitive composition of an indicator tag. 3. A package for sterilization according to claim 1, characterized in that the spores of the test microorganisms are distributed in the volume of the thermosensitive composition, from which the indicator label is formed. 4. A package for sterilization according to claim 1, characterized in that the package is made of two sheets connected on the sides and one end with hermetic heat-resistant seams, while one of the sheets is made of heat-resistant and moisture-resistant paper material, and the other sheet is made of transparent polymer film.

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