BODi (BORN ON FOR DEVICES & IMPLANTS) PROCESS FOR TRACKING THE QUALITY ASSURANCE OF SURGICAL DEVICES

Abstract

BODI is an implant prescription and supply chain revolutionizing service. BODI is bringing accountability to the industry for surgical implants. It lowers both costs and risks for implant manufacturers, distributors, healthcare providers, insurers, and ultimately patients. The purpose of BODI is to provide transparency and safety when handling surgical devices and ultimately reduce costs for members, surgeons, and insurers. Medwell's BODI reduces the need for error-prone data entry and provides a solution that is completely automated throughout the chain of custody and beyond. By implementing our BODI tracking system, hospitals, surgery, and manufacturers will recognize annual savings while meeting strict compliance regulations and improving patient outcomes. By 2025, the current database system will encompass “blockchain” technologic capabilities to further enhance the system for all users.

Claims

1. A method including at least one feature depicted or described herein. provide inventory list of all implants per procedure and ensure the system is updated with the correct information. Information includes implant image, name, description, instructions for use (IFU), part # Implant package only contains necessary implants for specific procedure and physician.

2. A computer readable medium including at least one feature depicted or described herein. Name and contact information; Date the Device is was manufactured, shipped and provided. QR code reader

3. An element including at least one feature depicted or described herein.

4. A system that complies with FDA Code of Federal Regulation (CFR) for medical implant devices. CFR821.109 and CFR821.25

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] 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:

[0013] FIG. 1 is a simplified view showing the process of implant supply chain;

[0014] FIG. 2 is a fragmented view showing the process of implant supply chain in details.

[0015] FIG. 3.1 is the hospital/physician interface view on BODi—Prescription of required surgical devices

[0016] FIG. 3.2 is the hospital/physician requested order information—for tracking and updates.

[0017] FIG. 3.3 is the medical device manufacturers interface view on BODi—order request and shipping.

[0018] FIG. 3.4 is the case representatives interface view—confirmation of implants used during procedure.

DETAILED DESCRIPTION

[0019] 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. [0020] Step one: [0021] The provider enters the surgery information and implant prescription. The information is then sent to MedWell Solutions ‘BODI’ database. [0022] Step two: [0023] The system will query the inventory database of Trestige (Sterile processing center) to see if items are available before ordering from manufacture. [0024] A. If inventory is low, then system will notify mfg. of surgery date and requested implants. [0025] Manufacturer will scan implant information into database and ship order to Trestige. [0026] Orders should arrive five days before the surgery date. [0027] B. If order can be filled then information will be sent directly to Tresitge and not mfg. [0028] Step three: [0029] Orders are received and scanned in (time stamped). Trestige—sterile processing center—will then handle logistics [0030] Step four: [0031] Order arrives at hospital by delivery or pick-up by assigned representative. Representative will then time stamp start and completion of implants under radiation and sterilization cycles, then enter information into database, along with exact implants used during case if there were any additional outside of the original order kit.

[0032] 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.