This patent application is assigned to
The following quote was obtained by the news editors from the background information supplied by the inventors: "Medical devices are used for diagnosis, monitoring, and prevention or treatment of diseases. Some medical devices are designed to be temporarily used at a remote location such as the home of a patient. When the medical device is no longer needed by the initial patient, the medical device is retrieved from the initial patient and re-used by a second patient typically at a second location. By re-using medical devices, an issuer and the patients can realize significant savings.
"Prior to re-use, the medical devices are refurbished. Refurbishment includes extensive testing of the device and excising data related to the previous user. In the event that any of the components of the medical device are not in an acceptable condition, the component is replaced or refurbished. After repair or replacement of components, the medical device is typically retested.
"In some instances, testing and refurbishment of a medical device is most economically achieved by servicing the device in the field. In these instances, a field technician tests/replaces components and performs any needed maintenance procedures. Field technicians may further repair medical devices for continued use by the original patient. In both instances, known systems rely upon the field technician to properly test, repair, and return to service the medical device.
"While the use of field technicians to test/replace components can be very cost effective, known approaches to using field technicians do not include sufficient safeguards against technician error. Consequently, it is possible for a device to be returned to service which is not operating at an optimal level.
"What is needed is a system which provides increased quality assurance of the refurbishment/repair of medical devices. It would be advantageous if such a system was integrated with field repair/refurbishment procedures for medical devices. It would be further advantageous if the system ensured proper refurbishment prior to allowing the medical device to be returned to service."
In addition to the background information obtained for this patent application, VerticalNews journalists also obtained the inventors' summary information for this patent application: "The embodiments herein provide a system and method which can be used to ensure that a medical device at a remote location, such as at the home of a patient, is properly refurbished/serviced.
"In one embodiment, a quality compliance system for a medical device includes at least one medical device configured to diagnose, monitor, or treat a medical condition, the at least one medical device configured to lockout operation of the at least one medical device, a refurbishment device configured to (i) establish a communication link with the at least one medical device, (ii) generate electronic documentation of a maintenance or service procedure on the at least one medical device, (iii) provide for associating a digital signature of an operator with the generated electronic documentation, (iv) transmit the digital signature and generated electronic documentation, and (v) unlock the at least one medical device with a received key, and a service application configured to receive the transmitted digital signature and generated electronic documentation, verify the transmitted digital signature and generated electronic documentation, and transmit the key to the refurbishment device upon verification of the transmitted digital signature and generated electronic documentation.
"In another embodiment, a method of ensuring quality compliance for a medical device includes providing a medical device configured to diagnose, monitor, or treat a medical condition, locking out operation of the medical device, providing a refurbishment device, establishing a communication link between the refurbishment device and the medical device, generating electronic documentation of a maintenance or service procedure on the medical device using the refurbishment device, associating a digital signature of an operator with the generated electronic documentation using the refurbishment device, transmitting the digital signature and generated electronic documentation to a service application using the refurbishment device, verifying the transmitted digital signature and generated electronic documentation with the service application, transmitting a key from the service application to the refurbishment device upon verification of the transmitted digital signature and generated electronic documentation, and unlocking the medical device with the key using the refurbishment device.
"Other features of the embodiments herein will be apparent from the drawings, and detailed description that follows below
BRIEF DESCRIPTION OF THE DRAWINGS
"FIG. 1 depicts a functional block diagram of a medical device quality compliance system;
"FIG. 2 depicts a functional block diagram of a medical device in the medical device quality compliance system of FIG. 1;
"FIG. 3 depicts a functional block diagram of a refurbishment device in the medical device quality compliance system of FIG. 1; and
"FIG. 4 depicts a method of ensuring quality compliance in refurbishment or servicing of a medical device."
URL and more information on this patent application, see: Brown, Stephen J.; Howells, Michael. Quality Compliance System for Refurbishment of Medical Device. Filed
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