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Integrator system and method for rapidly determining effectiveness of a germicidal treatment

A technology of effectiveness and integrator, applied in the field of integrator system, can solve the problem that medical equipment is not an effective use of resources

Inactive Publication Date: 2006-11-01
ETHICON INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Storing segregated medical equipment is not an efficient use of resources

Method used

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  • Integrator system and method for rapidly determining effectiveness of a germicidal treatment
  • Integrator system and method for rapidly determining effectiveness of a germicidal treatment
  • Integrator system and method for rapidly determining effectiveness of a germicidal treatment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] Results of hydrogen peroxide detection using an integrator containing arginine as an indicator chemical and using varying injection volumes

[0084] A series of integrators were prepared by contacting the paper disks with an aqueous solution of arginine. Place the integrator in the STERRAD with the instruments to be sterilized and some biological indicators  50 in the sterilizer. The paper disc is an absorbent substrate.

[0085] Vacuum the sterilizer to 0.8 torr. Plasma was generated in the chamber for 15 minutes to condition the load. The sterilizer was further evacuated to 0.4 torr and hydrogen peroxide was injected and left in contact with the load, integrator and biological indicator for 6 minutes.

[0086] Vent the sterilizer with air for 2 minutes. The sterilizer was again evacuated to 0.5 torr and the plasma was generated for an additional 2 minutes. The plasma power was 400 watts for both plasma exposures.

[0087] After the sterilization cycle, the pap...

Embodiment 2

[0095] Integrator response measured using a spectrophotometer

[0096] A non-absorbent fiberglass disc was impregnated with an aqueous solution of arginine. Fiberglass discs are non-absorbent substrates. Place the disc in the STERRAD  50 sterilizer, and the same conditions as in Example 1 were used for the treatment with varying injection volumes of hydrogen peroxide. The amount of hydrogen peroxide is shown in Table 2 below.

[0097]After the cycle is complete, contact the glass fiber disc with 50 μL of a 5% solution of OPA dye precursor in water. The optical absorption intensity of the disk was determined at about 470 nm, about 550 nm and about 610 nm (red, green and blue wavelengths) using a TAOS TCS230EVM evaluation module color sensor (Parallax, Rocklin, California).

[0098] Injection volumes of 50, 300, and 1000 μL of hydrogen peroxide were employed. at STERRAD  All BIs were negative when 300 μL of hydrogen peroxide was injected in a 50 sterilizer. Table 2 summ...

Embodiment 3

[0104] Integrator detection using histidine as indicator chemical and OPA as dye precursor

[0105] A series of integrators were formed in Example 3 using histidine instead of arginine as the primary amine indicator chemical. An aqueous histidine solution was placed on a series of fiberglass discs to form an integrator according to an alternative embodiment of the invention.

[0106] Place the integrator on a standard STERRAD  50 payload items, cycling was performed as described in Examples 1 and 2.

[0107] Cycle with 0 μL hydrogen peroxide and 300 μL hydrogen peroxide. At the end of the sterilization process, contact the integrator with 50 μL of 5 vol % OPA solution. The intensity of the third color of the third compound on the integrator was determined using the TAOS color sensor described in Example 2. A combination of red, green, and blue (RGB) wavelengths (470, 550, and 610 nm) was used to measure the response, since the reaction product of histidine with OPA is a d...

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PUM

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Abstract

The effectiveness of an oxidative sterilization process is determined by exposing a substrate having a known amount of a primary amine or aldehyde indicator chemical to an oxidative germicide. The oxidative germicide reacts with the indicator chemical. The amount of indicator chemical remaining after exposure to the germicide is determined by reacting the indicator chemical with a dye precursor chemical to form a colored product. The amount of indicator chemical remaining on the substrate is determined from the intensity of the color of the colored product. The amount of indicator chemical remaining on the substrate is a measure of the effectiveness of the germicidal treatment. The dye precursor is an aldehyde when the indicator chemical is a primary amine and a primary amine when the indicator chemical is an aldehyde. An integrator for determining the effectiveness of the germicidal process includes a substrate and an indicator chemical, where the indicator chemical is a primary amine or an aldehyde.

Description

technical field [0001] The present invention relates to an integrator system and method for rapidly determining the effectiveness of a sterilization process of a medical device. Background technique [0002] Medical devices are sterilized prior to use in hospitals, physician's offices, and other medical settings. Steam, heat, ethylene oxide, and hydrogen peroxide are commonly used as fungicides. [0003] It is common practice to include a sterilization indicator in the load of the sterilizer to be sterilized. The sterilization indicator provides a measure of whether the sterilization process was effective in the sterilization of a particular load of items. If the sterilization process is indicated by the sterilization indicator as ineffective, the loaded equipment cannot be used. [0004] Biological indicators are generally considered to be reliable indicators of sterilization. Biological indicators include vectors that have been inoculated with spores or other microorga...

Claims

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Application Information

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IPC IPC(8): A61L2/28C12Q1/22
CPCA61L2/28C12Q1/22G01N21/31G01N31/226Y10T436/101666Y10T436/13B23Q3/12B23Q3/16
Inventor B·弗赖尔P·C·朱
Owner ETHICON INC
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