SYSTEM AND METHOD FOR MEDICAL DEVICE SECURITY, DATA TRACKING AND OUTCOMES ANALYSIS

• US 20170068792A1
• Filed: 09/06/2016
• Published: 03/09/2017
• Est. Priority Date: 09/03/2015
• Status: Abandoned Application

• Current Assignee: Bruce Reiner
• Original Assignee: Bruce Reiner
• Inventors: REINER, Bruce
• Application Number:
  US15/257,208
• Publication Number:
  US 20170068792A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2090/0812 indicating loosening or shifting of parts of an instrument, signaling maladjustment of parts
• CPC Class Codes: A61B 2560/0266 for monitoring or limiting apparatus function
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: G16H 40/63 for local operation

Abstract

The present invention creates an objective methodology of quantitative accountability for medical device manufacturers, vendors, clinical providers, patients, and payers. In one embodiment, the standardized data received and stored in the medical device database can in turn be used for a variety of applications related to decision support (e.g., medical device selection), education and training (e.g., procedural performance), cost efficacy, evidence based medicine and best practice guidelines, personalized medicine, and comparative performance/safety analytics.

Claims

1. A computer-implemented method of providing ensuring medical device position and functionality, comprising:

providing a medical device for internal use within a patient during a medical procedure, said medical device having sensors or biomarkers disposed therein for providing data on said medical device and said patient;

confirming said medical device data integrity and device functionality by receiving said data from said medical device into a database of a computer system and performing an analysis of said data using a processor of said computer system; and

confirming, using said processor, a position of said medical device within said patient using an imaging device or a positional analysis of positional data from said data from said medical device;

wherein predetermined changes in said position of said medical device are monitored for indication of an adverse event.

2. The method of claim 1, wherein said medical device includes electronic tags which contain medical device information that can be scanned by a scanner and saved in said database.

3. The method of claim 2, wherein when a data outlier is detected during said analysis, performing a data reconciliation process using said processor, to identify erroneous, insufficient or abnormal data relative to best practice guidelines.

4. The method of claim 3, wherein when said data outlier is determined as abnormal, using said processor, generating an escalation pathway to analyze a cause and a severity of said data, in order to determine whether an intervention should be performed.

5. The method of claim 4, further comprising:

generating an alert by electronic means when a contraindication is identified during said analysis by said processor.

6. The method of claim 5, wherein said sensors or biomarkers provide continuous data after completion of said medical procedure.

7. The method of claim 6, wherein an appropriateness of said medical procedure and said medical device are included in said analysis.

8. The method of claim 7, wherein a standardized model for training, education, and proof of clinical competency with respect to medical devices is determined during said analysis.

9. The method of claim 6, wherein a GPS in said medical device provides anatomic real-time position and continuous data.

10. The method of claim 9, comparing data on said position of said medical device within said patient with comparable patients and medical devices using said processor.

11. The method of claim 10, wherein said analysis includes clinical outcomes analysis and analysis of providers to generate customized medical device decision-making relative to peer and community wide standards.

12. The method of claim 11, further comprising:

continuously monitoring quality and safety metrics of at least patients, providers, and said medical devices.

13. The method of claim 12, further comprising:

generating best practices guidelines using said processor, based on said compared data, for use of said medical device with patients