Methods for disinfection and tracking of soiled items
Methods for single-step and rapid high-level or better disinfection utilizing a push/pull reprocessing apparatus and a predetermined mixture of detergent and sterilant. The accessible surfaces (including any lumens) of the soiled item or items to be disinfected are contacted with a mixture of detergent and sterilant or with detergent alone for a predetermined period followed by the addition of a sterilant. High-level disinfection or better is achieved within a 5 to 20 minute washing cycle period. A tracking function is also provided whereby the disinfection history of the item being reprocessed, the status of the reprocessing apparatus, whether the item is read-to-use, and the inventory of both items being reprocessed and the consumables used by the apparatus may be tracked.
1 . A method for achieving at least high-level disinfection of a soiled item, comprising the steps of:
a. securing said soiled item within a push/pull reprocessing system;
b. flowing a predetermined mixture including a fluid, a detergent, and a sterilant over accessible surfaces of the soiled item, wherein the item is reprocessed to a biological endpoint of 10 −5 CFU/ml to 10 −6 CFU/ml; and
c. flowing ozonated sterile water over said accessible surfaces after step (b).
2 . The method of claim 1 , wherein said biological endpoint of 10 −5 CFU/ml to 10 −6 CFU/ml is achieved within 5 to 20 minutes.
3 . The method of claim 1 , wherein the fluid of step (b) is between 50° F. to 100° F.
4 . The method of claim 1 , wherein step (b) is performed for a duration and with a mixture of detergent and sterilant such that less than 6.4 ug/cm 2 of a test protein remains upon said item.
5 . The method of claim 4 , wherein said mixture comprises about 50vol/50vol of detergent to sterilant and said duration is between 5 and 10 minutes.
6 . The method of claim 1 , wherein step (b) is performed with said detergent alone for a predetermined period, and said sterilant is subsequently added to said mixture before step (b) has ended.
7 . The method of claim 1 , further including a step of tracking information associated with said soiled item.
8 . The method of claim 7 , wherein said information is selected from the group consisting of one or more of: a number of times said item has been processed for cleaning, confirmation that a process for cleaning has been completed, whether said item is ready-to-use, and inventory tracking of said item, said detergent, or said sterilant used in cleaning said item.
9 . The method of claim 1 , wherein said soiled item comprises a lumened instrument.
10 . A method for high-level disinfection or better of a soiled item, comprising the steps of:
a. providing a push/pull reprocessing system;
b. securing said item within said reprocessing system;
c. flowing a mixture including a fluid, a detergent, and a sterilant back-and-forth upon accessible surfaces of said soiled item for at least 5 minutes, wherein the item is reprocessed to a biological endpoint of 10 −5 CFU/ml to 10 −6 CFU/ml; and
d. flowing ozonated sterile water over said accessible surfaces after step (c).
11 . The method of claim 10 , wherein said biological endpoint of 10 −5 CFU/ml to 10 −6 CFU/ml is achieved within 5 to 20 minutes.
12 . The method of claim 10 , wherein the fluid of step (c) is between 50° F. to 100° F.
13 . The method of claim 10 , wherein step (c) is performed for a duration and with a mixture of detergent and sterilant such that less than 6.4 ug/cm 2 of a test protein remains upon said item.
14 . The method of claim 13 , wherein said mixture comprises about 50vol/50vol of detergent to sterilant and said duration is between 5 and 10 minutes.
15 . The method of claim 10 , wherein step (c) is performed with said detergent alone for a predetermined period, and said sterilant is subsequently added to said mixture before step (b) has ended.
16 . The method of claim 10 , further including a step of tracking information associated with said soiled item.
17 . The method of claim 16 , wherein said information is selected from the group consisting of one or more of: a number of times said item has been processed for cleaning, confirmation that a process for cleaning has been completed, whether said item is ready-to-use, and inventory tracking of said item, said detergent, or said sterilant used in cleaning said item.
18 . The method of claim 10 , wherein said item comprises a lumened instrument.
19 . A method for high-level disinfection or better of a soiled item secured within a push/pull reprocessing apparatus, comprising the step of:
a. contacting accessible surfaces of said soiled item with a predetermined mixture including a fluid, a detergent, and a sterilant to a biological endpoint of 10 −5 CFU/ml to 10 −6 CFU/ml in a single washing cycle of 20 minutes or less.
20 . The method of claim 19 , further including the step of:
b. flowing ozonated sterile water over said accessible surfaces after step (a).
21 . The method of claim 19 , wherein the fluid of step (a) is between 50° F. to 100° F.
22 . The method of claim 19 , wherein step (a) is performed for a duration and with a mixture of detergent and sterilant such that less than 6.4 ug/cm 2 of a test protein remains upon said item.
23 . The method of claim 22 , wherein said mixture comprises about 50vol/50vol of detergent to sterilant and said duration is between 5 and 10 minutes.
24 . The method of claim 19 , wherein step (a) is performed with said detergent alone for a predetermined period, and said sterilant is subsequently added to said mixture before step (a) has ended.
25 . The method of claim 19 , further including a step of tracking information associated with said soiled item.
26 . The method of claim 19 , wherein said information is selected from the group consisting of one or more of: a number of times said item has been processed for cleaning, confirmation that a process for cleaning has been completed, whether said item is ready-to-use, and inventory tracking of said item, said detergent, or said sterilant used in cleaning said item.
27 . The method of claim 19 , wherein said item comprises a lumened instrument.