Tissue management system

• US 8,666,762 B2
• Filed: 10/20/2006
• Issued: 03/04/2014
• Est. Priority Date: 09/21/2006
• Status: Active Grant

• Current Assignee: Biomedical Synergies, Inc.
• Original Assignee: Biomedical Synergies, Inc.
• Inventors: Kozloski, Paul E., Kozloski, Susan A., Vercillo, Agnes, Winstead, Jeffrey K., Kasprisin, Duke O
• Primary Examiner(s): Fuelling, Michael
• Application Number:
  US11/584,357
• Publication Number:
  US 20080077433A1
• Time in Patent Office: 2,692 Days
• Field of Search: 705/2
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• 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 incorporating a database of information, processor, and software program containing an organized set of instructions 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 an inspection of the transplantable material upon its receipt from the supplier for an unsafe condition;

(c) a comprehensive set of standard operating procedures adopted by the medical establishment covering at least one step for login, handling, storage conditions, reconstitution, or surgical use of the transplantable material by staff members of the medical establishment in a manner compliant with prevailing safety regulations and industry mandates;

(d) means for entering into the database required data concerning how the at least one step for the login, handling, storage conditions, reconstitution or surgical use of the transplantable material by the staff member was carried out;

(e) means for processing such entered data by the software program which is built upon the standard operating procedures to ensure that the step for the login, handling, storage conditions, reconstitution, or surgical use of the transplantable material was conducted strictly in a manner compliant with the standard operating procedures before the next step for the login, handling, storage conditions, reconstitution, or surgical use of the transplantable material can be undertaken by the staff members;

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

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

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

(i) wherein the transplantable material is chosen from the group consisting of human cells, tissue, or organs intended for implantation, transplantation, infusion, or transfer to a patient, including, but not limited to;

musculoskeletal tissues like bone, tendons, fascia, ligaments, cartilage, and bioengineered bone products;

skin;

cardiovascular tissues like heart valves, arteries, veins, and pericardium;

reproductive cells like sperm, semen, oocytes, fertilized eggs, and embryos;

cellular therapies like stem cells, progenitor cells, cord blood, chondrocytes, bone marrow, and neural cells;

dura mater;

breast milk;

eyes, corneas;

organs;

islet cells;

parathyroids;

autologous tissue; and

synthetic and xenographic tissue used as replacements for human tissue;

as well as non-biologic implants, including but not limited to;

titanium screws;

titanium or carbon-fiber cages or resorbable cages, fixation systems, saline or silicone breast implants, synthetic polymers, prosthetic hips, knees and other joint combinations thereof;

as well as surgical instruments, equipment, reagents, and supplies associated with the transplanting or implanting of any transplant material into a patient; and

(j) wherein the medical establishment is an organization directed to the storage, research, transplantation, or implantation of transplantable materials chosen from the group consisting of hospitals, medical clinics, surgical centers, fertility clinics, tissue banks, organ banks, organ donor banks, university and research facilities, diagnostic laboratories, and willed body programs.

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 means for elements (a-b and d-h).

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 further comprising means for prompting an evaluation of any safety or health risks posed by transplantable materials supplied by the supplier against the benefits provided by such transplantable material.

5. The tissue tracking management system of claim 1 further comprising means for ensuring that a staff member of the medical establishment who performs any of the means for elements (a-b and d-h) possesses a relevant educational background for performing such step.

6. The tissue tracking management system of claim 1 further comprising means for ensuring that relevant training is provided to a staff member of the medical establishment who performs any of the means for elements (a-b and d-h).

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

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

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

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

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

12. A tissue management system incorporating a database of information, processor, and software program containing an organized set of instructions 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 into the database by a staff member data for the completion of each processing step comprising login, handling, storage conditions, reconstitution, or surgical use applied by staff members to the transplantable material;

(c) means for documenting in the database the present location of the transplantable material within the medical establishment;

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

(e) means for documenting in the database the date and time of each step applied to the transplantable material;

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

(g) means for documenting in the database the unique identification code of the transplantable material transplanted or implanted into the patient;

(h) a comprehensive set of standard operating procedures adopted by the medical establishment covering the data that must be recorded to adequately describe the steps for the login, handling, storage conditions, reconstitution, or surgical use of the transplantable material carried out by staff members of the medical establishment with respect to the transplantable material

(i) means for processing such entered data by the software program which is built upon the standard operating procedures to make sure that at least one of the documentation steps (b-g) complies with the documentation requirements under the standard operating procedures before the next step for the login, handling, storage conditions, reconstitution, or surgical use of the transplantable material can be undertaken by the staff members;

(j) means for tracing the transplantable material back to the supplier that supplied it to the medical establishment or to the specific login, handling, storage conditions, reconstitution, or surgical use processing step applied by a staff member of the medical establishment to the transplantable material;

(k) wherein the transplantable material is chosen from the group consisting of human cells, tissue, or organs intended for implantation, transplantation, infusion, or transfer to a patient, including, but not limited to;

musculoskeletal tissues like bone, tendons, fascia, ligaments, cartilage, and bioengineered bone products;

skin;

cardiovascular tissues like heart valves, arteries, veins, and pericardium;

reproductive cells like sperm, semen, oocytes, fertilized eggs, and embryos;

cellular therapies like stem cells, progenitor cells, cord blood, chondrocytes, bone marrow, and neural cells;

dura mater;

breast milk;

eyes;

corneas;

organs;

islet cells;

parathyroids;

autologous tissue; and

synthetic and xenographic tissue used as replacements for human tissue;

as well as non-biologic implants, including but not limited to;

titanium screws, titanium or carbon-fiber cages or resorbable cages, fixation systems, saline or silicone breast implants, synthetic polymers, prosthetic hips, knees and other joint combinations thereof;

as well as surgical instruments, equipment, reagents, and supplies associated with the transplanting or implanting of any transplant material into a patient; and

(l) wherein the medical establishment is an organization directed to the storage, research, transplantation, or implantation of transplantable materials chosen from the group consisting of hospitals, medical clinics, surgical centers, fertility clinics, tissue banks, organ donor banks, university and research facilities, diagnostic laboratories, and willed body programs.

13. The tissue tracing management system of claim 12 further comprising means for designating one or more staff members of the medical establishment with specific responsibility for conducting each of the means for elements (a-g and j).

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

15. The tissue tracing management system of claim 12, wherein the tracing means for element (j) is conducted in response to an adverse reaction detected in the patient into whom the transplantable material was transplanted or implanted.

16. The tissue tracing management system of claim 15 further comprising means for notifying the supplier that supplied the transplantable material to the medical establishment of the adverse reaction in the patient.

17. The tissue tracing management system of claim 12, wherein the tracing means for element (j) is conducted in response to a warning received from the supplier that supplied the transplantable material to the medical establishment.

18. The tissue tracing management system of claim 12 further comprising means for ensuring that a staff member of the medical establishment who performs any of the means for elements (a-g and j) possesses a relevant educational background for performing such step.

19. The tissue tracing management system of claim 12 further comprising means for ensuring that relevant training is provided to a staff member of the medical establishment who performs any of the means for elements (a-g and j).

20. The tissue tracing management system of claim 12, wherein the information contained within the database comprises data regarding the supplier.

21. The tissue tracing management system of claim 12, wherein the information contained within the database comprises the storage conditions of the transplantable material.

22. The tissue tracing management system of claim 12, wherein the information contained within the database comprises clinical data concerning the patient.

23. The tissue tracing management system of claim 12, wherein the information contained within the database comprises clinical data concerning the transplant or implant surgery.

24. The tissue tracing management system of claim 12 further comprising means for reporting a list of certified suppliers of transplantable material.

25. The tissue tracing management system of claim 12 further comprising means for reporting the certification credentials of a particular supplier.

26. The tissue tracing management system of claim 25, wherein such certification credential is selected from the group consisting of Food &

Drug Administration registration, American Association of Blood Banking accreditation, American Association of Tissue Banks (“

AATB”

) accreditation, Eye Bank Association of America (“

EBAA”

) accreditation, and licensure within a relevant geographic region.

27. The tissue tracing management system of claim 12 further comprising means for reporting results of an audit conducted by the medical establishment upon the supplier.

28. The tissue tracing management system of claim 12 further comprising means for reporting an order placed for the purchase of transplantable material.

29. The tissue tracing management system of claim 12 further comprising means for reporting a quality inspection assessment of transplantable material received from the supplier.

30. The tissue tracing management system of claim 12 further comprising means for reporting the present location of transplantable material within the medical establishment.

31. The tissue tracing management system of claim 12 further comprising means for reporting the storage history within the medical establishment of a piece of transplantable material.

32. The tissue tracing management system of claim 12 further comprising means for reporting results of the adverse reaction investigation with regard to a piece of transplanted material.