Sterilization/disinfection cycle control

• US 7,452,504 B2
• Filed: 05/28/2004
• Issued: 11/18/2008
• Est. Priority Date: 05/28/2004
• Status: Active Grant

• Current Assignee: ASP Global Manufacturing GmbH (Fortive Corp.)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Williams, Harold R., Kohler, James P., Wu, Su-Syin S.
• Primary Examiner(s): Griffin; Walter D.
• Assistant Examiner(s): EDWARDS, LYDIA E
• Application Number:
  US10/856,664
• Publication Number:
  US 20050265889A1
• Time in Patent Office: 1,635 Days
• Field of Search: 422/33
• US Class Current: 422/33
• CPC Class Codes: A61L 2/20 Gaseous substances, e.g. vapours
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2/24 Apparatus using programmed or automatic operation
• CPC Class Codes: A61L 2202/122 Chambers for sterilisation
• CPC Class Codes: A61L 2202/14 Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs

Abstract

A sterilizer includes a vacuum chamber, a source of vaporizable sterilant, a vacuum pump, and a control system. The control system is programmed to take one or more data inputs regarding the nature of the load, such as lumen length and diameter, and determine one or more parameters of the sterilization cycle based upon the inputs.

Claims

1. A method of sterilizing a load of instruments in a sterilizer comprising the steps of:

entering data regarding the nature of the load into a control system of the sterilizer;

placing the load into a vacuum chamber in the sterilizer;

based upon the data regarding the nature of the load entered into the control system, determining one or more parameters of the cycle before running the sterilizer;

running the sterilizer in accordance with the determined one or more parameters, including the step of running the sterilizer comprising;

drawing a vacuum upon the vacuum chamber with a vacuum pump;

admitting a sterilant into the vacuum chamber, the sterilant being substantially in its vapor phase within the vacuum chamber, and contacting the load with the sterilant.

2. The method according to claim 1 the data comprises a material of one or more instruments in the load.

3. The method according to claim 1 wherein the one or more parameters comprises an amount of sterilant input to the vacuum chamber.

4. The method according to claim 1 wherein the sterilant is hydrogen peroxide and further comprising the step of increasing the amount of sterilant input to the vacuum chamber from the sterilant source in response to the input of one or more of the following materials:

a polyamide, a polyurethane, a silicone rubber, a polyvinyl chloride, a polymethyl methyacrylate or a polysulfone.

5. The method according to claim 1 wherein the one or more data inputs comprise a length and internal diameter of a lumen.

6. The method according to claim 1 wherein the one or more data inputs comprise a weight of the load.

7. The method according to claim 1 wherein the one or more parameters of the sterilization cycle comprises the concentration of sterilant.

8. The method according to claim 1 wherein the one or more parameters of the cycle comprises time of exposure to the sterilant.

9. The method according to claim 1 wherein a user manually enters the data regarding the nature of the load.

10. The method according to claim 1 wherein at least a portion of the data regarding the nature of the load is read automatically from at least one of the instruments.

11. The method according to claim 10 wherein the data is read from a bar code on the instrument.

12. The method according to claim 10 wherein the data is read from an RFID tag on the instrument.

13. The method according to claim 1 further comprising the step of measuring one of the parameters of the sterilization cycle and employing a feedback control loop to adjust one or more of the sterilization cycle parameters.

14. The method according to claim 1 and further comprising verifying efficacy of sterilization with a biological indicator.

15. The method according to claim 1 and further comprising verifying efficacy of sterilization by measuring exposure level and integrating this over time to ensure that at least a minimum integrated exposure of the load to the sterilant is achieved.

16. The method according to claim 1 and further comprising saving a cycle outline for future use with a similar load.