Method and apparatus for enforced provisioning and compliant usage authorization of endoscope applications
An endoscope apparatus capable of ensuring safe and compliant use includes an endoscope, a means for identification of the endoscope, a means for determining whether the endoscope is suitable for a given medical act utilizing the identification of the endoscope, and a disablement means that prevents utilization of the endoscope when determined the endoscope is not suitable for the given medical act. The identification may be on a tag fixed to the endoscope and/or container. The information is checked for a match in a cloud database to ensure the endoscope is the right device for the medical act. If not the right device, the endoscope is deactivated. If the right device, the endoscope is activated and the cloud database is updated accordingly. The cloud database can also be updated at each point in the distribution chain to allow complete traceability.
1. An endoscope apparatus capable of ensuring safe and compliant use, the endoscope apparatus comprising:
an endoscope;
a means for identification of the endoscope;
a means for determining whether the endoscope is suitable for a given medical act utilizing the identification of the endoscope;
a disablement means that prevents utilization of the endoscope when determined the endoscope is not suitable for the given medical act; and
a cloud stored activation database comprising fields or information about software, product ID, and serial number utilized for determining whether the endoscope or a container of endoscope is suitable for a given medical act utilizing the at least one of a product ID and a serial number.
2. The endoscope apparatus of claim 1 , wherein the means for identification of the endoscope comprises a tag fixed to the endoscope, the tag comprising at least one of a product ID or a serial number.
3. The endoscope apparatus of claim 1 , further comprising a container encompassing the endoscope and the means for identification of the endoscope comprises a tag fixed to the container encompassing endoscope, the tag comprising at least one of a product ID or a serial number.
4. The endoscope apparatus of claim 1 , wherein the endoscope comprises an internal non-volatile memory and the means for identification of the endoscope comprises the internal non-volatile memory comprising at least one of a product ID or a serial number.
5. The endoscope apparatus of claim 4 , further comprising a container encompassing the endoscope and the means for identification of the endoscope comprises a tag fixed to the container encompassing endoscope, the tag comprising at least one of a product ID or a serial number.
6. The endoscope apparatus of claim 1 , further comprising means for authorizing the use of the endoscope when determined the endoscope is suitable for a given medical act.
7. The endoscope apparatus of claim 6 , further comprising a device provisioning scanner utilized for scanning a tag attached to the endoscope or attached to a container for the endoscope and inputting the at least one of a product ID and a serial number comprised by the tag into the means for determining whether the endoscope is suitable for a given medical act utilizing the identification of the endoscope.
8. The endoscope apparatus of claim 1 , wherein the cloud stored activation database further comprises a hash algorithm applied to the fields or information to increase security and expedite activation database searches.
9. The endoscope apparatus of claim 1 , further comprising a local activation database replica synchronized with the cloud stored activation database and utilized for determining whether the endoscope is suitable for a given medical act utilizing the at least one of a product ID and a serial number when the cloud stored activation database is inaccessible.
10. The endoscope apparatus of claim 1 , further comprising updating the cloud database with information about which device was activated and information about the intended medical act, viewing and activation software, or containers used when determined the endoscope is suitable for the given medical act.
11. The endoscope apparatus of claim 1 , wherein determining whether the endoscope is suitable for a given medical act includes at least one of whether a unit was previously used and should not be reused, expiration of the unit, recall of the unit, invalid authorization software license, improper unit for the given medical procedure, or invalid firmware version.
12. The endoscope apparatus of claim 1 , wherein the disablement means includes at least one of preventing an image sensor from sending any images or sequences of images, transmitting an electric current to electrically burn a fuse or components, blocking a connection between a cannula and a handle, either mechanically or electrically, so that the cannula will not be able to be mounted to the handle, blockage of electro-mechanical contacts within the cannula or endoscope via proximity detection of the cannula using a Radio-frequency identification (RFID) transceiver, a Near Field Communication (NFC) transceiver, or Radio Frequency Choke (RFC) antenna, and electrically triggering magnets utilized between the cannula and the handle to shutter-off or repulse electronic or mechanical connections.
13. A method of ensuring compliant utilization of an endoscope, the method comprising:
provisioning an endoscope with a means for identification of the endoscope;
determining whether the endoscope is suitable for a given medical act utilizing the identification of the endoscope, wherein the determining includes accessing a cloud stored activation database comprising fields or information about software, product ID, and serial number for determining whether the endoscope or a container of endoscope is suitable for the given medical act utilizing the at least one of a product ID and a serial number; and
disabling utilization of the endoscope when determined the endoscope is not suitable for the given medical act.
14. The method of claim 13 , wherein the means for identification of the endoscope comprises a tag fixed to the endoscope or to a container encompassing the endoscope, the tag comprising at least one of a product ID or a serial number.
15. The method of claim 13 , further comprising updating the cloud stored activation database with information about which device was activated and information about the intended medical act, viewing and activation software, or containers used when determined the endoscope is suitable for the given medical act.
16. The method of claim 13 , wherein each of the endoscope and the container is provisioned with a tag, and the method further comprises matching the container tag with the endoscope tag to ensure the proper endoscope goes back into the proper container when sending the endoscope back after the endoscope and/or exam is authorized and completed.
17. The method of claim 13 , further comprising utilizing the means of identification to update the cloud stored activation database at each stage of the distribution and/or return of the endoscope to provide complete traceability.
18. A method of ensuring compliant utilization of an endoscope, the method comprising:
identifying an intended type of medical exam;
determining a product ID and/or a serial number of an endoscope;
determining whether the endoscope is of a correct class of endoscopes for the intended type of medical exam utilizing the product ID and/or the serial number of the endoscope;
activating the endoscope for the intended type of medical exam when determined that the endoscope is of the correct class for the intended type of medical exam; and
disabling the endoscope when determined the endoscope is not of the correct class for the intended type of medical exam.
19. The method of ensuring compliant utilization of an endoscope of claim 18 , further comprising determining whether the endoscope is of the correct class for the intended type of medical exam utilizing the product ID and/or the serial number of the endoscope includes searching a database for a matching serial number and/or product ID and activating the endoscope when a match is found that indicates the endoscope is of the correct class for the intended type of medical exam and disabling the endoscope when no match is found that indicates the endoscope is of the correct class for the intended type of medical exam.
20. The method of ensuring compliant utilization of an endoscope of claim 19 , wherein the database is a cloud stored activation database comprising fields or information about software, product ID, and serial number utilized for determining whether the endoscope or a container of endoscope is the endoscope is of the correct class for the intended type of medical exam.
21. The method of ensuring compliant utilization of an endoscope of claim 18 , further comprising provisioning the endoscope, wherein provisioning the endoscope comprises fixing a tag to the endoscope with the tag comprising at least one of the product ID or the serial number, fixing a tag comprising at least one of the product ID or the serial number to a container encompassing the endoscope, and/or storing at least one of the product ID or the serial number to an internal non-volatile memory of the endoscope.