SYSTEM AND METHOD FOR AN ORTHOPEDIC DYNAMIC DATA REPOSITORY AND REGISTRY FOR RECALL
At least one embodiment is directed to a system ( 1100 ) to generate an orthopedic dynamic data repository and registry ( 2214 ). The system ( 1100 ) can measure a parameter of the muscular-skeletal system and align at least one of the surfaces to a mechanical axis intra-operatively. The system ( 1100 ) comprises disposable sensors ( 1106 ), disposable targets ( 1110 ), lasers ( 1114 ), a processing unit ( 1122 ), a display ( 1124 ), a reader ( 1120 ), a receiver ( 1118 ), spacer blocks ( 1102 ), and a distractor 1104 . The sensors ( 1106 ) are in communication with the processing unit ( 1122 ) to display, process, store, and send data to dynamic data repository and registry ( 2214 ). Parameters can be measured pre-operatively, intra-operatively, post-operatively, and long term using sensor ( 1106 ). The measurement data is used to identify and provide clinical evidence of a health risk. A notification of the health risk is generated in electronic digital form and sent to at least one entity.
1 . A computer implemented method of notification of patient risk for an orthopedic device, procedure, or medicine comprising:
performing an analysis of a statistically significant sample of measured parameters from a data repository and registry where the analysis indicates a patient risk;
initiating an action if a patient risk is identified;
generating a notification of patient risk; and
sending at least one notification in electronic digital form to at least one entity.
2 . The method of claim 1 further including the steps of:
receiving measured parameters of the muscular-skeletal system in an electronic digital form from more than one entity; and
storing the measured parameters in the data repository and registry.
3 . The method of claim 2 further including the steps of:
collecting at least one of patient information, equipment information, procedure information, or component information in an operating room;
converting the at least one of patient information, equipment information, procedure information, component information to an electronic digital format;
generating at least one intra-operatively sensed parameter measurement in the operating room;
sending the at least one of patient information, equipment information, procedure information, or component information, and the at least one intra-operatively sensed parameter measurement to the data repository and registry.
4 . The method of claim 3 further including the steps of:
measuring parameters of the muscular-skeletal system of the patient post-operatively to generate post-operative measurements and long term measurements;
converting measured parameters of the muscular-skeletal system of the patient to an electronic digital form; and
sending measured parameters of the muscular-skeletal system of the patient to the data repository and registry.
5 . The method of claim 1 further including the steps of:
accessing pre-operative measurements related to the orthopedic device, procedure, or medicine from the data repository and registry; and
using pre-operative measurements as clinical evidence in the analysis of patient risk due to the orthopedic device, procedure, or medicine.
6 . The method of claim 1 further including the steps of:
accessing intra-operative measurements related to the orthopedic device, procedure, or medicine from the data repository and registry; and
using intra-operative measurements as clinical evidence in the analysis of patient risk due to the orthopedic device, procedure, or medicine.
7 . The method of claim 4 further including the steps of:
accessing post-operative measurements related to the orthopedic device, procedure, or medicine from the data repository and registry; and
using intra-operatively sensed parameter measurements as clinical evidence in the analysis of patient risk due to the orthopedic device, procedure, or medicine.
8 . The method of claim 4 further including the steps of:
accessing long term measurements related to the orthopedic device, procedure, or medicine from the data repository and registry; and
using intra-operatively sensed parameter measurements as clinical evidence in the analysis of patient risk due to the orthopedic device, procedure, or medicine.
9 . The method of claim 1 further including a step of sending the notification to one or more manufacturers.
10 . The method of claim 1 further including a step of sending the notification to one or more patients.
11 . A computer implemented method of notification of patient risk for an orthopedic device, procedure, or medicine comprising the steps of:
storing measured parameters of the muscular-skeletal system converted to an electronic digital form in a data repository and registry where the data repository and registry includes at least one of patient information, equipment information, procedure information, or component information;
identifying an orthopedic negative outcome where the negative outcome is supported by clinical evidence related to the measured parameters in the data repository and registry;
generating a notification in the electronic digital form; and
sending the notification to at least one at least one entity.
12 . The method of claim 11 further including a step of identifying the orthopedic device, procedure, or medicine related to the negative outcome from information in the data repository and registry.
13 . The method of claim 11 further including a step of performing an analysis of a statistically significant sample of measured parameters from the data repository and registry where the analysis indicates a patient risk.
14 . The method of claim 13 further including a step of using one or more of pre-operative measurements, intra-operative measurements, post-operative measurements, and long term measurements in the analysis from data repository and registry.
15 . The method of claim 11 further including the steps of:
identifying patients related to the negative outcome from information in the data repository and registry; and
sending notification related to the analysis to the patients.
16 . A computer implemented method of notification of patient risk for an orthopedic implant or procedure comprising the steps of:
performing an analysis of a statistically significant sample of measured parameters from a data repository and registry where the analysis indicates a patient risk from the procedure or orthopedic implant;
initiating an action if a patient risk is identified;
generating a notification in electronic digital form of patient risk; and
sending at least one notification in electronic digital form to at least one patient.
17 . The method of claim 16 further including the steps of:
identifying the orthopedic device or procedure from information in the data repository and registry; and
incorporating information related to the orthopedic device or procedure in the notification.
18 . The method of claim 16 further including the steps of:
identifying the patients at risk from information in the data repository and registry; and
incorporating information related to the patient in the notification.
19 . The method of claim 16 further including a step of using one or more of pre-operative measurements, intra-operative measurements, post-operative measurements, and long term measurements in the analysis from data repository and registry.
20 . The method of claim 16 further including the steps of:
receiving measured parameters of the muscular-skeletal system in an electronic digital form from more than one entity; and
storing the measured parameters in the data repository and registry.