Cleaning evaluation filth for medical apparatus and contamination method for cleaning evaluation

• US 20080193631A1
• Filed: 06/27/2007
• Published: 08/14/2008
• Est. Priority Date: 12/27/2004
• Status: Abandoned Application

• Current Assignee: Olympus Corporation
• Original Assignee: Olympus Corporation
• Inventors: Obi, Kaori, Sato, Sawako, Kanamori, Yosuke, Nakao, Maiko, Nagai, Yuki
• Application Number:
  US11/823,204
• Publication Number:
  US 20080193631A1
• Time in Patent Office: Days
• US Class Current: 427/2.1
• CPC Class Codes: A61B 1/00057 provided with means for testing or calibration
• CPC Class Codes: A61B 1/121 provided with means for cleaning post-use
• CPC Class Codes: A61B 2017/00725 Calibration or performance testing
• CPC Class Codes: A61B 2090/701 for flexible tubular instruments, e.g. endoscopes
• CPC Class Codes: A61B 2090/702 Devices for testing the cleaning process, e.g. test soils
• CPC Class Codes: A61B 90/70 Cleaning devices specially adapted for surgical instruments
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00

Abstract

With respect to evaluation of the efficacy of cleaning of a medical apparatus, the present invention provides a cleaning evaluation filth for a medical apparatus, the filth simulating a body fluid in a human body cavity and exhibiting good reproducibility of evaluation of the efficacy of cleaning. With respect to the cleaning evaluation filth of the present invention, proteins and lipids having concentrations for forming at least bile and serum, which are primary components for constituting a human digestive juice, are produced by dispensing reagents of proteins and lipids.

Claims

1. A cleaning evaluation filth for a medical apparatus, the filth comprising an artificial filth prepared only from reagents configured to have components and concentrations simulating a human digestive juice.

2. The cleaning evaluation filth for a medical apparatus according to claim 1, wherein the artificial filth primarily simulates components and concentrations constituting bile and serum among the human digestive juice.

3. The cleaning evaluation filth for a medical apparatus according to claim 2, wherein reagents of proteins and lipids constituting the bile and serum are used in the artificial filth.

4. The cleaning evaluation filth for a medical apparatus according to claim 3, wherein reagents of serum protein and glycoprotein are used as the proteins and a reagent of phospholipid is used as the lipid in the artificial filth.

5. The cleaning evaluation filth for a medical apparatus according to claim 4, wherein 0.1 g/dl or more, and 8.0 g/dl or less of serum protein and 1.0 g/dl or more, and 4.0 g/dl or less of glycoprotein serving as the proteins and 0.5 g/dl or more, and 7.0 g/dl or less of phospholipid serving as the lipid are dispensed and included in the artificial filth.

6. The cleaning evaluation filth for a medical apparatus according to claim 5, wherein a reagent of serum albumin is used as the serum protein, a reagent of mucin is used as the glycoprotein, and a reagent of lecithin is used as the phospholipid in the artificial filth.

7. The cleaning evaluation filth for a medical apparatus according to claim 6, wherein 7.5 g/dl serum albumin serving as the serum protein, 4.0 g/dl of mucin serving as the glycoprotein, and 5.0 g/dl of lecithin serving as the phospholipid are dispensed in the artificial filth.

8. A cleaning evaluation filth for a medical apparatus, the filth comprising an artificial filth which includes a solution containing a substance serving as an index for evaluating the efficacy of cleaning of the medical apparatus and an adhesion-promoting substance contained in the solution in order to adhere the solution to a cleaning evaluation site of the medical apparatus and which is produced by dispensing commercially available reagents.

9. The cleaning evaluation filth for a medical apparatus according to claim 8, wherein the substance which is contained in the solution and which serves as the index for evaluating the efficacy of cleaning is a germ, a protein, e.g., serum albumin, or the like.

10. The cleaning evaluation filth for a medical apparatus according to claim 8, wherein a glycoprotein or the like is used as the adhesion-promoting substance.

11. The cleaning evaluation filth for a medical apparatus according to claim 10, wherein the glycoprotein serving as the adhesion-promoting substance includes a hyaluronate or sodium hyaluronate.

12. The cleaning evaluation filth for a medical apparatus according to claim 11, wherein the concentration of hyaluronate or sodium hyaluronate, which is the glycoprotein serving as the adhesion-promoting substance, is 10 mg/ml or less.

13. A contamination method for cleaning evaluation of a medical apparatus, the method comprising:

injecting filth into a channel of the medical apparatus; and

forming a contaminated layer on a channel inner surface by supplying air into or suctioning air from the inside of the channel, into which the filth has been injected.

14. The contamination method for cleaning evaluation of a medical apparatus according to claim 13, wherein the filth is injected from one end of the channel of the medical apparatus and the filth is filled in the channel in such a way that the filth outflows from the other end.

15. The contamination method for cleaning evaluation of a medical apparatus according to claim 13, the method further comprising clogging openings other than a filth injection inlet at one end of the channel of the medical apparatus and a filth outflow outlet at the other end before the filth is injected.

16. The contamination method for cleaning evaluation of a medical apparatus according to claim 13, wherein a uniform layer of the filth is formed on the channel inner surface by supplying air into or suctioning air from the channel, so as to form an air path penetrating the filth in the channel.