Patent Application
20230024180
The present application relates to medical instrument reprocessing, in particular to systems and methods for tracking medical instruments reprocessing.
A typical medical instrument reprocessing system consists of ultrasonic washers, washers or washer disinfectors and sterilization equipment. Once medical instruments, such as dental or surgical instruments, were used for procedures, personnel use the reprocessing system to wash and sterilize the medical instruments to allow reuse.
To record the completion of medical instrument reprocessing steps, the personnel may manually record or track, such as on a paper or electronic log, the steps performed on a medical instrument and reprocessing states of the medical instrument, including the status of the class 4 and 5 chemical indicators, to record successful completion of the sterilization cycle and sterile status of the medical instrument.
However, manual recording or tracking of medical instrument reprocessing steps is prone to human errors, and may be inaccurate due to missing or inaccurate information. As well, the records of reprocessing a medical instrument may also be tampered.
The present application provides a tracking system for medical instrument reprocessing. The system allows batch or wrapped medical instruments tracking across all infection control steps, including washing, disinfection, and sterilization.
The systems and methods of the present application may use RFID and barcode for medical instrument tracking, and use traceable chemical indicator for sterilization that allows machine readable status of sterilization.
As well, the systems and methods use asymmetric encryption and blockchain to authenticate and file successful sterilization cycles with trusted third parties.
In an aspect, there is provided a method for tracking an cassette housing one or more instruments in an instrument reprocessing, comprising: sterilizing, at a sterilizer, the cassette; receiving, at a server, a chemical indicator identification encrypted by a private key after the cassette is sterilized; decrypting, at the server, the chemical indicator identification with a corresponding public key; and in response to decryption of the chemical indicator identification, authenticating, at the server, the chemical indicator identification.
Reference will now be made, by way of example, to the accompanying drawings which show example embodiments of the present application, and in which:
Similar reference numerals may have been used in different figures to denote similar components.
The tracking systems and methods of the present application provide capability of tracking of all the steps of reprocessing medical instruments. The tracking systems and methods substantially or entirely eliminate potential error due to user assessment of the chemical indicator, substantially increase accuracy of records or documentation for tracking reprocessing medical instruments as each chemical indicator used in the reprocessing has a unique identification (ID) authenticated via a trusted third party. Finally, records produced at each step of medical instrument reprocessing are securely stored in a blockchain. Each block has a time stamp and the blockchain makes the records safe against modifications.
It is important or even mandatory in some regulatory domains to keep records or documentation accurately tracking each steps of infection reprocessing of a medical instrument. The instrument reprocessing system may be used to (1) clean and sterilize the instruments for reuse and (2) to provide evidence to support successful completion of the reprocessing activity.
As illustrated in
After an instrument is used, the instrument reprocessing system 100 may be used to wash and sterilize the instrument. One or more used instruments may be placed in a cassette 101 for cleaning and sterilizing. As illustrated in the example of
The washer 102 may be used to wash used instruments in the cassette 101, for example by ultrasonic cleaning or washing. Before the cassette 101 is loaded into the washer 102, the cassette ID is checked in the server 106. As illustrated in
In the example of
A class 4 chemical indicator is accessible to the user once the wrap of the cassette 101 is removed prior to instruments being used.
In some examples, the wrapped cassette 101 may be checked into the computer 106 or sterilizer 104 with the cassette ID. In response, the computer 106 may generate a tracking label with an load ID. A tracking label displays human and machine readable information, such as the load ID, to create options for information access during integration with a patient/treatment file. Load ID tracks the cassette 101 throughout the sterilization reprocessing session. The load ID of the tracking label may be associated with the cassette ID for a sterilization reprocessing session. Generation of the tracking label indicates that the instruments in the cassette 101 have been washed and that a class 4 chemical indicator is attached to the cassette 101. The tracking label with an load ID may be attached to the wrapped cassette 101. The wrapped cassette 101 may be checked in the computer 106 by scanning the load ID on the tracking label before the cassette 101 is sterilized in the sterilization equipment 104.
Next, the wrapped cassette 101 is placed within the chamber of the sterilizer 104. As illustrated in
Each chemical indicator 4 and 5 has a unique identification (ID) authenticated via a trusted third party, for example at the server 120. As illustrated in
At the end of the sterilization cycle, the sterilizer 104 provides an indication whether the sterilization process ended successfully based on the measurements of internal temperature and pressure sensors of the sterilizer 104. The class 4 indicator and class 5 indicator changes state and become readable when the sterilization cycle met the required sterilization parameters, such as internal temperature and pressure. The class 4 indicator and class 5 chemical indicator functions fully independent of the machine control and sensors of the sterilizer 104 and provides an additional confirmation when the sterilization parameters have been satisfied as measured by the class 4 indicator and class 5 indicator.
As illustrated in
A scanning device 108 may scan the revealed code of class 5 chemical indicator and check in the cassette 101 in the computer 106 or sterilizer 104 with scanned class 5 chemical indicator code. The class 5 chemical indicator code in the local computer 106 or sterilizer 104 indicates that the instruments in the cassette 101 are successfully sterilized.
As the class 4 chemical indicator is placed inside the wrapped cassette 101, the result for the cassette 101 is available only when the cassette 101 is unwrapped prior to using the instruments in the cassette 101.
As illustrated in the example of
A class 4 indicator ID may be similarly encrypted or decrypted as a class 5 indicator ID as provided in the example in Table 1 above. Class 4 or 5 indicator ID may include identification of the class 4 or 5 indicator, time stamps and serial number information. As illustrated in
In an example, for Block 0, the hash of the previous block [n−1] may be set to 0, while the hash for current block, Hash n, may be is calculated over the content of Timestamp, Indicator ID, Status, Sterilization log and previous Hash fields. For block 1, the previous hash field Hash [n−1] is initialized to 0 calculated for block 0. Current hash for block 1 is calculated over the content of Timestamp, Indicator ID, Status, Sterilization log and previous Hash field Hash [n−1]. For block n, the previous hash filed is initialized to the hash value as calculated for Block n−1. Current hash for block n is calculated over the content of Timestamp, Indicator ID, Status, Sterilization log and previous Hash field Hash [n−1].
In
As illustrated in
After the class 5 indicator ID is authenticated at the server 120 or computer 106, the local computer 106 or sterilizer 104 may send the encrypted class 5 indicator ID to the remote server 120. The remote server 120 or the computer 106 may use a public key from the trusted third party to decrypt the ID. The remote server 120 may compare the decrypted ID with the indicator ID store in the block n against the immutable blockchain record when the indicator ID is initially created to validate the decrypted ID. In some examples, the remote server 120 may create a new block, such as block n in
To simplify the process, the original encrypted information with a private key may be sent to the remote server 120 for authentication. With encrypted information, the server 120 can authenticate the encrypted information using a public key to decrypt the encrypted information. After the indicator ID is authenticated, when an instrument associated with the indicator ID is used in a procedure for treatment, the server 120 may update the blockchain related to the instrument by adding a new block with a new block m, which comprises a timestamp when the block m is generated, hash m−1, hash m, unencrypted indicator ID, and a status set as used. A confirmation may be sent back to the local computer 106 regarding the change of status of the indicator to used. An error may be reported, by the server 120, to the local office computer 106 if the record of the indicator ID is not found in the blockchain or if the status of the block with the indicator ID is found to be marked as used. The authentication mechanism and the blockchain therefore may protect against malicious actors trying to abuse the reprocessing tracing system.
If a load has an unsuccessful sterilization cycle, the code of class 4 or 5 medical indicator is not revealed and thus cannot be scanned, therefore the load with the Load ID cannot be safely released, and the instruments in the cassette 101 require repackaging and reprocessing at least for the sterilization step.
The system 100 uses reprocessing equipment 102 and 104 and associates each of the cassette ID, the load ID, and the class 4 or chemical indicator code with each instrument in the cassette 101. This allows tracking of instruments in the cassette 101 throughout the infection reprocessing process. As such, a specific instrument used in treatment of a patient or a patient file is associated with a specific cassette 101, a specific washing cycle, and a specific sterilization step. As well, a machine readable chemical indicator (class 4 and 5) becomes readable only on sterilization process success.
As well, the revealed code of class 4 or 5 chemical indicator may be read and automatically authenticated through the use of asymmetric encryption by using public key and private key, and finally use of blockchain technology to document and file chemical indicator (CI) and biological indicator (BI) to successful sterilization cycles with trusted third parties.
As illustrated in
Pairing of the private or public key with the blockchain allows for the records to be authenticated as well as identifying if successfully used and when. The blockchain 700 may store, in the server 120, in each of the blocks class 4 and/or 5 chemical indicator ID, indicator Class, time stamp and optionally the sterilization log for successful cycles. The instruments in a cassette 101 have the same class 4 or 5 indicator ID, same load ID and cassette ID.
As illustrated in the example of
As well, the new ID can be linked to or associated with an ultrasonic cycle ID and/or a washer cycle ID prior to washing of one or more instruments. The new ID may be associated with both ultrasonic cycle ID and the washer cycle ID and therefore is a “1” to “n” relationship with the ultrasonic cycle ID and the washer cycle ID. The ultrasonic cycle ID is a unique identification for an ultrasonic cleaning cycle of a washer. The washer cycle ID is a unique identification for a washing cycle of a washer. Linking or associating the new ID with the ultrasonic cycle ID or washer cycle ID indicates that the one or more instruments in the cassette are washed at an ultrasonic cleaning cycle or a washing cycle of a washer with the ultrasonic cycle ID or washer cycle ID. As such, the ultrasonic cycle ID also indicates an ultrasonic cycle or wash record of the one or more instruments in a cassette at a specific ultrasonic cycle of an ultrasonic cleaning cycle or a washing cycle of a washer. As such, the new ID may also reflect the ultrasonic washing cycle or a washer cycle.
As well, a class 4 and/or 5 indicator may be associated with a unique sterilization ID and record. The sterilization ID may be associated with both class 4 indicator ID and the class 5 indicator ID and therefore is a “1” to “n” relationship with the class 4 indicator ID and the class 5 indicator ID. As described above, a lass 4 and/or 5 indicator is revealed for reading or scanning only after a sterilization of instruments in a cassette is successfully performed. The sterilization ID may include information of specific sterilization equipment and sterilization cycle information. Association of a class 4 and/or 5 indicator with the unique sterilization ID indicates that the one or more instruments in the cassette are successfully sterilized at a specific sterilization cycle of a sterilization equipment. As such, the sterilization ID also indicate a sterilization record of the one or more instruments in a cassette at a specific sterilization cycle of a sterilization equipment.
After a unique sterilization ID and record is associated with a class 4 and/or 5 indicator, the sterilization ID may be associated with a unique Load ID of an instrument.
As such, the Load ID is associated with an ultrasonic cycle or wash record of the instrument a sterilization record of the instrument, and a class 4 and 5 indicator of the instrument. The Load ID indicates a full reprocessing cycle of an instrument.
As well, the Load ID may be associated with a treatment ID with which the instrument associated with the Load ID may be used to treat a patient. As illustrated in
As illustrated in
Certain adaptations and modifications of the described embodiments can be made. Therefore, the above discussed embodiments are considered to be illustrative and not restrictive.
This application claims the benefits of priority to U.S. Provisional Patent Application No. 63/188,895, filed May 14, 2021, titled SYSTEMS AND METHODS FOR TRACKING MEDICAL INSTRUMENTS CLEANING AND STERILIZATION, the contents of which are hereby expressly incorporated into the present application by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63188895 | May 2021 | US |
