The present invention relates generally to the process of tracking and handling of implantable surgical devices used in surgeries. More particularly, the invention relates to real-time tracking and quality assurance of surgical implants from manufacture to the moment devices are implanted in the patient's body.
For most medical implants, no clinical trials are undertaken. Instead, most medical 15 implants are approved on the basis of “substantial equivalence”. In other words, if a new implant is substantially equivalent to an implant already on the market, then it likely gets approved. The US Food & Drug Administration (FDA) requires manufacturers to submit a 510(k), which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally 20 marketed device (21 CFR 807.92(a)(3)). This excludes the clinical trials, which US drugs are tested and approved upon-through clinical trials and placebos.
Example of similar concept being implemented is TrackCore Operating Room. TrackCore Operating Room is a tissue tracking and implant management software 5 eliminating the need for arduous manual processes. TrackCore does not provide time-stamped tracking of all the processes that surgical devices undergo such as washing, sterilization, radiation exposure, storage, and remaining life cycle of the devices.
The prior art has taught us that healthcare workers are required to ensure that all surgical instruments and implants are appropriately cleaned and sterilized according to the 10 nature of the item as instructed by the manufacturer. However, there is no standard process in place that handles the tracking of surgical implants at all times and research has shown that the repetitive exposure to radiation and the over sterilization of implants increase risks of complications to patients.
The prior art also teaches the importance of tracking surgical devices using a software 15 that records every step that implant undergoes with real time-updates incase a complication or a need for revision surgery occurs, we can easily determine the reason for such action. For instance, there was reporting of multiple adverse events occurring post orthopedic surgeries where surgical implants were used in the surgery. One case reported to the FDA (Food and Drug Administration) showed evidence of injury in patient due to rods breaking at both sides 20 of the patient's spine requiring removal of the implants and replacement through revision surgery.
There was no reason stated for the occurrence of the implant's breakage and unfortunately, the patient had to undergo spinal surgery for the second time after 5 years of the occurrence given the patient's age and health status.
Accordingly, BODI invention is an improvement over other products and technology because there is no product that tracks and records the cycles of sterilization for each 5 customized surgical implants. BODI offers that improvement and ensures that each surgical implant is customized to that specific case and patient and provides the exact history of that implant since it was manufactured.
BODI, a revolutionary tool developed by MedWell Consultants, LLC. dba MedWell 10 Solutions, tracks surgical implants from manufacture throughout use, reducing risk for hospitals, costs for manufacturers, and provides verification and accountability for medical device distributors.
The BODI system follows medical implants from the moment they enter circulation and through surgical procedures. The software acts as database system, tracking a medical 15 implant's cycle throughout its useful life, from the time manufactured, through procedures where it may be sterilized and re-sterilized, from the operating room to storage, and ultimately to use. By determining the amount of time that an implant has been under
radiation, we also reduce the risk to patients and cost to insurers of a less durable product.
BODI ensures an “implant integrity model” by collecting data and using safeguarded 20 procedures to identify why implants fail. The software process provides real time access to surgical implants shipment status, expiration dates and activity alerts, tracks implants by lot, serial, or QR codes in seconds, reduces waste, and offers a standardized process for handling all devices.
These and other features and advantages of the present invention will become more readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:
Referring to the figures, wherein the numbers and letters represent the order and flow of each process in relation to the parties involved. The key members in this supply chain include; healthcare provider (physician or surgeon), MedWell Solutions employee, implant manufacturers (MFGs), Trestige (outsourced sterile processing/order fulfillment center), and surgical case representative.
By tracking the cycle of medical implants, BODI can manage risk in a unique way that drives collaboration between the healthcare providers, manufacturers, and insurers to safeguard patients. The system ensures a standardization process of cleaning, sterilization, and handling of these surgical implants. Each cycle of sterilization and radiation will be recorded and tracked via BODI technology. Once the standard limit of sterilization and radiation has been reached, the product will be eliminated, and a newly customizable surgical implant will replace it to ensure quality and safety of the surgical implant has been met. Currently, there is no existing system to determine the amount of time an implant has been under radiation, which may have a significant impact on the durability of the implant; higher amounts of radiation might equal higher risk for patients. A supply chain method of tracking a medical implant's cycle—from time manufactured, sterilized, re-sterilized, from the operating room to storage, etc.—can improve this system.
Provisional patent application No. 62/804,635