Wash monitor composition, device, and method of use

Patent metadata

Field	Value
Publication number	US-10287618-B2
Application number	US-201515129442-A
Country	US
Kind code	B2
Filing date	Mar 24, 2015
Priority date	Mar 28, 2014
Publication date	May 14, 2019
Grant date	May 14, 2019

Abstract

A composition for monitoring the efficacy of a decontamination process is provided, the composition comprising a cellulose polymer and a predetermined quantity of an adenine nucleotide. A monitoring device comprising a test element with the composition disposed thereon is also provided. The composition and/or monitoring device can be used in a method. The method includes exposing the monitoring device to a decontamination process and subsequently measuring the residual tracer analyte on the monitoring device.

First claim

The invention claimed is:

1. A monitoring device, comprising:
a container comprising a first end with an opening dimensioned to receive a test element;
the test element disposed in the container, the test element comprising a test portion;
a dried composition releasably adhered to the test portion, the dried composition comprising a cellulose polymer, sugar, and a predetermined quantity of an adenine nucleotide, wherein the sugar and the cellulose polymer are present in the composition at a sugar:cellulose polymer mass ratio of about 9:1 to about 60:1, inclusive; and
a reagent for detecting the adenine nucleotide, the reagent disposed in the container.

2. The monitoring device of claim 1 , wherein the cellulose polymer comprises a water-soluble cellulose derivative.

3. The monitoring device of claim 1 , further comprising a secural element.

4. A kit, comprising the monitoring device of claim 1 .

5. The kit of claim 4 , further comprising a means to secure the test element.

6. The kit of claim 4 , further comprising an article comprising a receiver dimensioned to receive the test element and to restrict fluidic accessibility to the test portion.

7. A system, comprising:
a monitoring device, comprising:
a container comprising a first end with an opening dimensioned to receive a test element;
the test element disposed in the container, the test element comprising a test portion;
a dried composition releasably adhered to the test portion, the dried composition comprising a cellulose polymer, sugar, and a predetermined quantity of an adenine nucleotide, wherein the sugar and the cellulose polymer are present in the composition at a sugar:cellulose polymer mass ratio of about 9:1 to about 60:1, inclusive;
a reagent for detecting the adenine nucleotide, the reagent disposed in the container;

an analytical instrument for detecting a reaction between the adenine nucleotide and the reagent; and
a processor configured to receive electronic data from the analytical instrument.

8. A method of assessing the efficacy of a decontamination process, comprising:
exposing a test portion of a monitoring device to a decontamination process;
wherein the test portion includes a dried composition removably adhered thereto;
wherein the dried composition comprises a cellulose polymer, a sugar, and

a predetermined first quantity of an adenine nucleotide, wherein the sugar and the cellulose polymer are present in the composition at a sugar:cellulose polymer mass ratio of about 9:1 to about 60:1, inclusive;
after exposing the test portion to the decontamination process, contacting the test portion with a reagent for detecting the adenine nucleotide;
using the detection reagent to measure a second quantity of the adenine nucleotide remaining on the test portion; and
comparing the second quantity to a predetermined first threshold quantity.

9. The method of claim 8 , wherein comparing the second quantity to a predetermined threshold quantity further comprises comparing the second quantity to a plurality of predetermined threshold quantities.

10. The method of claim 9 , further comprising the steps of comparing the second quantity of adenine nucleotide to a second threshold quantity and reporting an outcome of an assessment of the efficacy:
wherein, when the second quantity is less than or equal to the first threshold quantity, the outcome of the decontamination process is reported to indicate the process was efficacious;
wherein, when the second quantity is greater than the first threshold quantity but less than or equal to a second threshold quantity, the outcome of the decontamination process is reported to indicate the process had a deficiency associated with a first predetermined parameter of the decontamination process.

11. The method of claim 8 , further comprising the step of placing the test portion of the monitoring device into a receiver configured to restrict fluidic accessibility to the test portion.

Assignees

• 3M Innovative Properties Co

Inventors

• Ahimou Francois
• Duda Ruthann R
• Bommarito G Marco
• Nies Timothy J
• Qiu Kai

Classifications

• A61L2103/15

  Laboratory, medical or dentistry appliances, e.g. catheters or sharps · CPC title

• A61B90/70

  Cleaning devices specially adapted for surgical instruments · CPC title

• C12Q1/22 Primary

  Testing for sterility conditions · CPC title

• A61L2/04 Primary

  Heat (radiation A61L2/08) · CPC title

• A61L2202/17

  Combination with washing or cleaning means · CPC title