Sterilization system with automated sterilization data processing and related methods

Abstract

A sterilization system with automated sterilization data processing and related methods. In one aspect, the sterilization system receives mechanical indicator values and chemical indicator values for the sterilization cycle. The system determines whether the mechanical indicator values and chemical indicator values for the sterilization cycle match predetermined criteria. In response to the mechanical indicator and chemical indicator values for the sterilization cycle matching predetermined criteria, the system automatically generates a sterilization record in accordance with the first sterilization cycle data and second sterilization cycle data, stores the sterilization record in a sterilization database, and prints a sterilization label for each sterilized item in the sterilization cycle. Each sterilization label includes a Quick Response (QR) code encoding information for sterilization cycle.

1 . A sterilization system, comprising:
 a computer comprising a processor and a memory coupled to the processor;   a sterilizer coupled to the processor, the sterilizer comprising one or more sensors configured to detect sterilization cycle data for a sterilization cycle, the sterilization data comprising one or more mechanical indicator values for the sterilization cycle;   a printer coupled to the processor;   wherein the processor is configured to:
 receive from the sterilizer first sterilization cycle data for a sterilization cycle, the first sterilization cycle data comprising the one or more mechanical indicator values for the sterilization cycle that are detected by the one or more sensors in the sterilizer; 
 receive second sterilization cycle data for the sterilization cycle, the second sterilization cycle data comprising one or more chemical indicator values for the sterilization cycle; 
 determine whether the mechanical indicator values and chemical indicator values for the sterilization cycle match predetermined criteria; 
 in response to the mechanical indicator and chemical indicator values for the sterilization cycle matching predetermined criteria:
 automatically generate a sterilization record in accordance with the first sterilization cycle data and second sterilization cycle data, the sterilization record comprising a number of fields, the fields comprising a date of sterilization identifying a date upon which a sterilization cycle was performed, a sterilizer identifier (ID) identifying a sterilizer used in the sterilization cycle, a load type, a number of items sterilized in the load for which all of the chemical indicators matched predetermined criteria and which passed a visual inspection, an ID of a staff member who inspected and verified the mechanical indicators, an ID of a staff member who inspected and verified the chemical indicators as being passed, and an ID of a staff member who inspected and verified the integrity of any pouch or wrapping containing the respective item; 
 automatically store the sterilization record in a sterilization database; and 
 automatically cause, by the printer, printing of a sterilization label for each sterilized item in the sterilization cycle, each sterilization label having printed information for the sterilization cycle, wherein the printed information comprises text and a Quick Response (QR) code encoding information regarding the load type, the number of items sterilized in the load for which all of the chemical indicators matched predetermined criteria and which passed a visual inspection, and the load number and/or cycle number. 
 
   
     
     
         2 . The sterilization system of  claim 1 , wherein the mechanical indicator values comprise a minimum temperature within the sterilizer during the sterilization cycle, a maximum temperature within the sterilizer during the sterilization cycle, a minimum pressure within the sterilizer during the sterilization cycle, a maximum pressure within the sterilizer during the sterilization cycle, and the duration of the sterilization cycle. 
     
     
         3 . The sterilization system of  claim 1 , wherein the chemical indicator values comprise a Class 1 chemical indicator pass/fail, Class 4 chemical indicator pass/fail/N/A and Class 5 chemical indicator pass/fail. 
     
     
         4 . The sterilization system of  claim 1 , wherein the sterilization record further comprises one or more of a load number and/or cycle number. 
     
     
         5 . The sterilization system of  claim 1 , wherein the sterilization record further comprises mechanical indicator values and chemical indicator values. 
     
     
         6 . The sterilization system of  claim 1 , wherein the processor is further configured to:
 automatically generate the QR code encoding information regarding the load type, the number of items sterilized in the load for which all of the chemical indicators matched predetermined criteria and which passed a visual inspection, and the load number and/or cycle number.   
     
     
         7 . The sterilization system of  claim 1 , wherein the processor is configured to:
 receive for each of one or more patients, a patient name identifying a patient for whom a sterilized item was used and a date of use identifying a date upon which the sterilized item was used;   receive for each of one or more sterilized items used to treat each of the one or more patients, a sterilizer ID and a sterilization date for a sterilization cycle in which the respective sterilized item was last sterilized, wherein the sterilizer ID and sterilization date are received via a scanner coupled to the processor, the scanner having extracted the sterilizer ID and sterilization date from the QR code associated with the sterilized item; and   automatically generate and store an instrument usage record in an instrument usage database, the instrument usage record comprising a number of fields, the fields comprising the patient name, the date of use, the sterilizer ID, sterilization date, a load number identifying a load on the sterilization date and/or a cycle number identifying the sterilization cycle relative to a reference date, a number of items sterilized in the load for which all of the chemical indicators matched predetermined criteria and which passed a visual inspection, and an item type.   
     
     
         8 . The sterilization system of  claim 7 , wherein the processor is configured to:
 perform an instrument recall routine for a recalled sterilization cycle in response to the determination that the sterilization cycle has failed and in dependence on sterilization cycle parameters for the recalled sterilization cycle in which the processor is configured to:
 identify one or more patients for whom an item in the recalled sterilization cycle was used by comparing the sterilization cycle parameters for the recalled sterilization cycle to a plurality of records of the instrument usage database, wherein the fields of the instrument usage database are linked to corresponding fields in the sterilization database; and 
 initiate a patient notification routine comprising at least one of outputting identifying information of the one or more patients for whom an item in the recalled sterilization cycle was used and notifying the one or more patients for whom an item in the recalled sterilization cycle was used about the recalled sterilization cycle. 
   
     
     
         9 . The sterilization system of  claim 8 , wherein the processor is configured to:
 determine the failed sterilization cycle of the sterilizer in response to failure of a biological indicator test for the sterilizer; and   identify sterilization cycles to be recalled based on the failed sterilization cycle.   
     
     
         10 . The sterilization system of  claim 9 , wherein the processor is configured to identify sterilization cycles to be recalled based on the failed sterilization cycle by identifying sterilization cycles performed via the sterilizer since a last successful biological indicator test was obtained for the sterilizer. 
     
     
         11 . The sterilization system of  claim 9 , wherein the processor is configured to automatically, without user intervention, determine the failed sterilization cycle and identify sterilization cycles to be recalled. 
     
     
         12 . The sterilization system of  claim 8 , wherein the processor is configured to, when performing the instrument recall routine for a recalled sterilization cycle:
 identify unused items from the recalled sterilization cycle by comparing sterilization cycle parameters for the recalled sterilization cycle to a plurality of records of the sterilization database.   
     
     
         13 . The sterilization system of  claim 8 , wherein the sterilization cycle parameters for the recalled sterilization cycle comprise the sterilizer ID and the sterilization date. 
     
     
         14 . The sterilization system of  claim 8 , further comprising:
 an incubator coupled to the processor;   wherein the processor is configured to:
 receive, from the incubator, incubation cycle results for incubation cycles performed by the incubator; 
 determine, from the incubation cycle results, whether an incubation cycles has passed or failed; 
 determine, from an incubation cycle result, that a sterilization cycle has failed in response to a determination that an incubation cycle for a biological indicator has failed. 
   
     
     
         15 . The sterilization system of  claim 14 , wherein the processor is configured to automatically perform the instrument recall routine for the recalled sterilization cycle in response to the determination that the sterilization cycle has failed. 
     
     
         16 . The sterilization system of  claim 8 , wherein the processor is configured to notify the one or more patients for whom an item in the recalled sterilization cycle was used about the recalled sterilization cycle by:
 generating an electronic message about recalled sterilization cycle for each patient for whom an item in the recalled sterilization cycle was used;   automatically populating each electronic message with a contact address for the respective patient, the contact address being determined from a patient database using the patient name; and   sending, via communication module of the processor, each electronic message to the respective contact address.   
     
     
         17 . The sterilization system of  claim 16 , wherein the electronic message includes information about the recalled sterilization cycle and patient instructions. 
     
     
         18 . The sterilization system of  claim 1 , wherein the processor is configured to determine whether the mechanical indicator values and chemical indicator values for the sterilization cycle match predetermined criteria by comparing the mechanical indicator values and chemical indicator values for the sterilization cycle to the predetermined criteria, and determining whether the mechanical indicator values and chemical indicator values for the sterilization cycle match the predetermined criteria. 
     
     
         19 . A computer-implemented method of automated processing of sterilization data, the method performed by a computer comprising a processor and a memory coupled to the processor, the computer coupled to a sterilizer and a printer, the sterilizer comprising one or more sensors configured to detect sterilization cycle data for a sterilization cycle, the sterilization data comprising one or more mechanical indicator values for the sterilization cycle, the method comprising:
 receiving from the sterilizer first sterilization cycle data for a sterilization cycle, the first sterilization cycle data comprising the one or more mechanical indicator values for the sterilization cycle that are detected by the one or more sensors in the sterilizer;   receiving second sterilization cycle data for the sterilization cycle, the second sterilization cycle data comprising one or more chemical indicator values for the sterilization cycle;   determining whether the mechanical indicator values and chemical indicator values for the sterilization cycle match predetermined criteria;   in response to the mechanical indicator and chemical indicator values for the sterilization cycle matching predetermined criteria:
 automatically generating a sterilization record in accordance with the first sterilization cycle data and second sterilization cycle data, the sterilization record comprising a number of fields, the fields comprising a date of sterilization identifying a date upon which a sterilization cycle was performed, a sterilizer identifier (ID) identifying a sterilizer used in the sterilization cycle, a load type, a number of items sterilized in the load for which all of the chemical indicators matched predetermined criteria and which passed a visual inspection, an ID of a staff member who inspected and verified the mechanical indicators, an ID of a staff member who inspected and verified the chemical indicators as being passed, and an ID of a staff member who inspected and verified the integrity of any pouch or wrapping containing the respective item; 
 automatically storing the sterilization record in a sterilization database; and 
 automatically causing, by the printer, printing of a sterilization label for each sterilized item in the sterilization cycle, each sterilization label having printed information for the sterilization cycle, wherein the printed information comprises text and a Quick Response (QR) code encoding information regarding the load type, the number of items sterilized in the load for which all of the chemical indicators matched predetermined criteria and which passed a visual inspection, and the load number and/or cycle number. 
   
     
     
         20 . A non-transitory machine-readable medium having tangibly stored thereon executable instructions that, in response to execution by a processor of a computer, cause the processor to perform a method of automated processing of sterilization data, the computer comprising a processor and a memory coupled to the processor, the computer coupled to a sterilizer and a printer, the sterilizer comprising one or more sensors configured to detect sterilization cycle data for a sterilization cycle, the sterilization data comprising one or more mechanical indicator values for the sterilization cycle, wherein the executable instructions, in response to execution by the processor, cause the processor to:
 receive from the sterilizer first sterilization cycle data for a sterilization cycle, the first sterilization cycle data comprising the one or more mechanical indicator values for the sterilization cycle that are detected by the one or more sensors in the sterilizer;   receive second sterilization cycle data for the sterilization cycle, the second sterilization cycle data comprising one or more chemical indicator values for the sterilization cycle;   determine whether the mechanical indicator values and chemical indicator values for the sterilization cycle match predetermined criteria;   in response to the mechanical indicator and chemical indicator values for the sterilization cycle matching predetermined criteria:
 automatically generate a sterilization record in accordance with the first sterilization cycle data and second sterilization cycle data, the sterilization record comprising a number of fields, the fields comprising a date of sterilization identifying a date upon which a sterilization cycle was performed, a sterilizer identifier (ID) identifying a sterilizer used in the sterilization cycle, a load type, a number of items sterilized in the load for which all of the chemical indicators matched predetermined criteria and which passed a visual inspection, an ID of a staff member who inspected and verified the mechanical indicators, an ID of a staff member who inspected and verified the chemical indicators as being passed, and an ID of a staff member who inspected and verified the integrity of any pouch or wrapping containing the respective item; 
 automatically store the sterilization record in a sterilization database; and 
 automatically cause, by the printer, printing of a sterilization label for each sterilized item in the sterilization cycle, each sterilization label having printed information for the sterilization cycle, wherein the printed information comprises text and a Quick Response (QR) code encoding information regarding the load type, the number of items sterilized in the load for which all of the chemical indicators matched predetermined criteria and which passed a visual inspection, and the load number and/or cycle number.