Tissue management system

• US 20080215363A1
• Filed: 10/19/2007
• Published: 09/04/2008
• Est. Priority Date: 09/21/2006
• Status: Active Grant

• Current Assignee: Biomedical Synergies, Inc.
• Original Assignee: Biomedical Synergies, Inc.
• Inventors: Winstead, Jeffrey K., Vercillo, Agnes, Kozloski, Susan A., Kasprisin, Duke O., Kozloski, Paul E.
• Granted Patent: US 10,671,706 B2
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/08 Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

The present invention provides a comprehensive tissue management system for transplantable materials like tissues and organs. The tracking portion of the system prompts and verifies that staff members of a medical establishment like a hospital have handled, stored, transported, reconstituted, and used the tissue or organ materials in a safe and regulatory-compliant manner from the point of receipt to the point of issuance or surgical use throughout the hospital'"'"'s organization. The tracing portion of the system creates an integral record that documents which hospital staff members have provided which processing steps to the tissue or organ, any associated materials used in conjunction with such tissue or organ, and an identification of the tissue or organ that was transplanted or implanted inside a patient. Such a system will enable adverse reaction investigations for transplant patients, and recalls of transplantable materials.

Claims

1. A tissue management system having a database of information for tracking the internal processing by a medical establishment of a piece of transplantable material provided by a supplier for subsequent transplantation or implantation into a patient, such system comprising:

(a) means for assigning a unique identification code to the transplantable material upon its receipt by the medical establishment from the supplier;

(b) means for prompting the inspection of the transplantable material upon its receipt from the supplier for an unsafe condition.

(c) means for prompting the staff members of the medical establishment to conduct each processing step comprising handling, storage, reconstitution or surgical use of the transplantable material strictly in a manner compliant with prevailing regulations and industry standards;

(d) means for documenting each processing step comprising login, handling, storage, reconstitution, or surgical use applied by staff members to the transplantable material;

(e) means for documenting the identity of each staff member who comes into contact with the transplantable material;

(f) means for documenting all materials used to prepare and process the transplantable material;

(g) means for prompting the assessment of the patient after transplantation or implantation of the transplantable material for evidence of an adverse effect;

(h) means for prompting the investigation of any such adverse effect discovered in the patient to determine whether it constitutes an adverse reaction; and

(i) means for reporting any such adverse reaction to the supplier that supplied the transplant material to the medical establishment;

(j) wherein information relevant to any of the foregoing steps (a-f) is provided by the system to a user of the system to facilitate such user'"'"'s conduct of the step with regard to the transplantable material.

2. The tissue tracking management system of claim 1 further comprising means for designating one or more staff members of the medical establishment with specific responsibility for conducting each of the steps (a-j).

3. The tissue tracking management system of claim 1 further comprising means for prompting a certification verification that the supplier currently possesses all required regulatory certifications and licenses to supply the transplantable material.

4. The tissue tracking management system of claim 1, wherein the information contained within the database comprises data regarding the supplier.

5. The tissue tracking management system of claim 1, wherein the information contained within the database comprises the storage conditions of the transplantable material.

6. The tissue tracking management system of claim 1, wherein the information contained within the database comprises clinical data concerning the patient.

7. The tissue tracking management system of claim 1, wherein the information contained within the database comprises clinical data concerning the transplant or implant surgery.

8. The tissue tracking management system of claim 1 further comprising means for placing an order with the supplier for a piece of transplantable material.

9. The tissue tracing management system of claim 1 further comprising means for reporting the results of the adverse reaction investigation with regard to a piece of transplanted material.

10. A tissue management system having a database of information for tracing a piece of transplantable material received by a medical establishment from a supplier throughout the internal life of the transplantable material within the medical establishment until it is transplanted or implanted into a patient, such system comprising:

(a) means for assigning a unique identification code for the transplantable material upon its receipt by the medical establishment from the supplier;

(b) means for documenting the present location of the transplantable material within the medical establishment;

(c) means for documenting the unique identification code of the transplantable material transplanted or implanted into the patient; and

(d) means for tracing the transplantable material back to the supplier that supplied it to the medical establishment or to the specific processing step applied by a staff member of the medical establishment to the transplantable material.

11. The tissue tracing management system of claim 10 further comprising means for designating one or more staff members of the medical establishment with specific responsibility for conducting each of the steps (a-d).

12. The tissue tracing management system of claim 10 further comprising means for sending to the supplier a tissue utilization information card for the transplantable material transplanted or implanted to the patient.

13. The tissue tracing management system of claim 10, wherein the tracing step is conducted in response to an adverse reaction detected in the patient into whom the transplantable material was transplanted or implanted.

14. The tissue tracing management system of claim 13 further comprising means for notifying the supplier that supplied the transplantable material to the medical establishment of the adverse reaction in the patient.

15. The tissue tracing management system of claim 10, wherein the tracing step is conducted in response to a recall received from the supplier or regulatory authority for transplantable material.

16. The tissue tracing management system of claim 10, wherein the information contained within the database comprises data regarding the supplier.

17. The tissue tracing management system of claim 10, wherein the information contained within the database comprises clinical data concerning the transplant or implant surgery.

18. The tissue tracing management system of claim 10 further comprising means for reporting a list of certified suppliers of transplantable material.

19. The tissue tracing management system of claim 10 further comprising means for reporting the quality inspection assessment of transplantable material received from the supplier.

20. The tissue tracing management system of claim 10 further comprising means for reporting the present location of transplantable material within the medical establishment.

21. The tissue tracing management system of claim 10 further comprising means for reporting the storage history within the medical establishment of a piece of transplantable material.