Decontamination system including environmental control using a decontaminating substance

• US 9,017,607 B2
• Filed: 05/23/2012
• Issued: 04/28/2015
• Est. Priority Date: 05/27/2011
• Status: Active Grant

• Current Assignee: American Sterilizer Company (Steris Corporation)
• Original Assignee: Medivators, Inc. (Steris PLC)
• Inventors: Olson, Jonathan K., Schwartz, Mason
• Primary Examiner(s): Conley, Sean E
• Assistant Examiner(s): SPAMER, DONALD R
• Application Number:
  US13/478,837
• Publication Number:
  US 20120301356A1
• Time in Patent Office: 1,070 Days
• Field of Search: 422/33, 422/30, 422/28
• 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 2/22 Phase substances, e.g. smokes, aerosols or sprayed or atomised substances
• CPC Class Codes: A61L 2/24 Apparatus using programmed or automatic operation

Abstract

A system for decontaminating a medical device includes a decontamination chamber configured to retain the medical device and a chemical dispersion assembly configured to deliver a decontaminating fluid to the decontamination chamber. A pressure control assembly is connected to the decontamination chamber and configured to control the pressure in the decontamination chamber. The system also includes a system controller configured to control the decontamination chamber, chemical dispersion assembly, and pressure control assembly. A pressure in the decontamination chamber is reduced to within a sub-atmospheric pressure range in a first evacuation step and add a decontaminating fluid into the decontamination chamber at a first rate while increasing the pressure in the decontamination chamber. Adding the decontaminating fluid increases a relative humidity in the decontamination chamber to a level that improves the efficacy of the decontaminating fluid.

Claims

1. A system for decontaminating a medical device, the system comprising:

a decontamination chamber configured to retain the medical device;

a chemical dispersion assembly configured to deliver a decontaminating fluid containing peracetic acid to the decontamination chamber;

a pressure control assembly connected to the decontamination chamber and configured to control the pressure in the decontamination chamber; and

a system controller configured to control the decontamination chamber, chemical dispersion assembly, and pressure control assembly to;

reduce a pressure in the decontamination chamber to within a sub-atmospheric pressure range in a first evacuation step;

add a decontaminating fluid into the decontamination chamber at a first rate while increasing the pressure in the decontamination chamber, wherein adding the decontaminating fluid increases a relative humidity in the decontamination chamber to a level that improves the efficacy of the decontaminating fluid;

immediately following the addition of the decontaminating fluid at the first rate, add the decontaminating fluid into the decontamination chamber at a second rate higher than the first rate while increasing the pressure in the decontamination chamber to within a hold pressure range;

hold the decontaminating fluid in the decontamination chamber for a hold time within the hold pressure range;

reduce the pressure in the decontamination chamber after the hold time to within the sub-atmospheric pressure range in a second evacuation step; and

vent the decontamination chamber to atmospheric pressure, wherein after the addition of the decontaminating fluid at the first rate and before the addition of the decontaminating fluid at the second rate, the relative humidity in the decontamination chamber is between about 50% and about 90%.

2. The system of claim 1, wherein the chemical dispersion assembly adds the decontaminating fluid with forced air, and wherein the forced air increases the pressure in the decontaminating chamber.

3. The system of claim 1, wherein the chemical dispersion assembly comprises:

an atomizing assembly in fluid communication with the decontamination chamber.

4. The system of claim 3, wherein the atomizing assembly comprises:

an atomizing nozzle;

a chemical flow control system in fluid communication with the atomizing nozzle and a source of the decontaminating fluid; and

an air flow control system operatively connected to the atomizing nozzle, wherein the chemical flow control system is configured to deliver decontaminating fluid from the source of decontaminating fluid to the atomizing nozzle, and wherein the air flow control system is configured to force the decontaminating fluid through the atomizing nozzle.

5. The system of claim 1, and further comprising:

a neutralizing filter assembly coupled to the decontaminating chamber such that decontaminating fluid in the decontaminating chamber passes through the neutralizing filter assembly during the second evacuation step.

6. The system of claim 5, wherein the neutralizing filter assembly comprises:

a first filter configured to neutralize a first component of the decontaminating fluid; and

a second filter connected in series with the first filter and configured to neutralize a second component of the decontaminating fluid.

7. The system of claim 6, wherein the first filter is comprised of potassium permanganate and the second filter is comprised of sodium bicarbonate.

8. The system of claim 7, wherein the neutralizing filter assembly further comprises:

a third filter between the first and second filters, the third filter configured to remove particulate material generated by the first filter.

9. The system of claim 1, wherein the decontaminating fluid comprises hydrogen peroxide, peracetic acid, and/or acetic acid.

10. The system of claim 1, wherein the medical device is preconditioned to an ambient temperature, and wherein prior to the first evacuation step the relative humidity in the decontamination chamber is preconditioned to less than about 50%.

11. A method for decontaminating a medical device in a decontamination chamber, the method comprising:

reducing a pressure in the decontamination chamber to within a sub-atmospheric pressure range in a first evacuation step;

following the first evacuation step, adding a decontaminating fluid into the decontamination chamber at a first rate while increasing the pressure in the decontamination chamber to a first pressure, wherein adding the decontaminating fluid increases a relative humidity in the decontamination chamber to a level that improves the efficacy of the decontaminating fluid;

immediately following the addition of the decontaminating fluid at the first rate, adding the decontaminating fluid into the decontamination chamber at a second rate higher than the first rate while increasing the pressure in the decontamination chamber from the first pressure to within a hold pressure range;

holding the decontaminating fluid in the decontamination chamber for a hold time within the hold pressure range;

reducing the pressure in the decontamination chamber from the hold pressure range to within the sub-atmospheric pressure range in a second evacuation step; and

venting the decontamination chamber to atmospheric pressure following the second evacuation step, wherein after the addition of the decontaminating fluid at the first rate and before the addition of the decontaminating fluid at the second rate, the relative humidity in the decontamination chamber is between about 50% and about 90%.

12. The method of claim 11, wherein during the second evacuation step the decontaminating fluid in the decontamination chamber is forced through a neutralizing filter assembly.

13. The method of claim 12, wherein the neutralizing filter assembly comprises first and second serially coupled filters, the first filter configured to neutralize a first component of the decontaminating fluid and the second filter configured to neutralize a second component of the decontaminating fluid.

14. The method of claim 13, wherein the first filter is comprised of potassium permanganate and the second filter is comprised of sodium bicarbonate.

15. The method of claim 14, wherein the neutralizing filter assembly further comprises a third filter between the first and second filters, the third filter configured to remove particulate material generated by the first filter.

16. The method of claim 11, wherein prior to the first evacuation step, the method further comprises:

preconditioning the medical device to ambient temperature and the relative humidity in the decontamination chamber to less than about 50%.

17. A system for decontaminating a medical device, the system comprising:

a decontamination chamber configured to retain the medical device;

a chemical dispersion assembly configured to deliver a decontaminating fluid to the decontamination chamber, the chemical dispersion assembly comprising;

an atomizing nozzle;

a chemical flow control system in fluid communication with the atomizing nozzle and a source of the decontaminating fluid; and

an air flow control system operatively connected to the atomizing nozzle, wherein the chemical flow control system is configured to deliver decontaminating fluid from the source of decontaminating fluid to the atomizing nozzle, and wherein the air flow control system is configured to force the decontaminating fluid through the atomizing nozzle with forced air;

a pressure control assembly connected to the decontamination chamber and configured to control the pressure in the decontamination chamber; and

a system controller operably connected to the decontamination chamber, chemical dispersion assembly, and pressure control assembly, the system controller configured to;

control the pressure control assembly to reduce a pressure in the decontamination chamber to within a sub-atmospheric pressure range in a first evacuation step;

control the chemical dispersion assembly to add a decontaminating fluid into the decontamination chamber at a first rate, wherein the forced air from the air control assembly increases the pressure in the decontamination chamber and the decontaminating fluid increases a relative humidity in the decontamination chamber to a level that improves the efficacy of the decontaminating fluid;

immediately following the addition of the decontaminating fluid at the first rate, control the chemical dispersion assembly to add the decontaminating fluid into the decontamination chamber at a second rate higher than the first rate while increasing the pressure in the decontamination chamber to about within a hold pressure range;

control the pressure control assembly to reduce the pressure in the decontamination chamber after a hold time to within the sub-atmospheric pressure range in a second evacuation step; and

control the pressure control assembly to vent the decontamination chamber to atmospheric pressure, wherein after the addition of the decontaminating fluid at the first rate and before the addition of the decontaminating fluid at the second rate, the relative humidity in the decontamination chamber is between about 50% and about 90%.

18. The system of claim 17, and further comprising:

a neutralizing filter assembly coupled to the decontaminating chamber such that decontaminating fluid in the decontaminating chamber passes through the neutralizing filter assembly during the second evacuation step.

19. The system of claim 18, wherein the neutralizing filter assembly comprises:

a first filter configured to neutralize a first component of the decontaminating fluid; and

a second filter connected in series with the first filter and configured to neutralize a second component of the decontaminating fluid.

20. The system of claim 19, wherein the decontaminating fluid comprises hydrogen peroxide, peracetic acid, and acetic acid, and wherein the first filter is comprised of potassium permanganate and the second filter is comprised of sodium bicarbonate.

21. The system of claim 20, wherein the neutralizing filter assembly further comprises:

a third filter between the first and second filters, the third filter configured to remove particulate material generated by the first filter.

22. The system of claim 17, wherein the medical device is preconditioned to an ambient temperature, and wherein prior to the first evacuation step the relative humidity in the decontamination chamber is preconditioned to less than about 50%.