Tissue management system

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.

We claim: 
     
         1 . A method 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, wherein a computer database, processor, and software program containing an organized set of instructions in coded language are provided for storing and processing information, such method comprising the steps of:
 (a) assigning a unique identification code to the transplantable material upon its receipt by the medical establishment from the supplier;   (b) inspecting the transplantable material upon its receipt from the supplier for an unsafe condition;   (c) providing a comprehensive set of standard operating procedures adopted by the medical establishment covering at least one step for the 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) 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) 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) assessing the patient after transplantation or implantation of the transplantable material for evidence of an adverse effect;   (g) investigating any such adverse effect discovered in the patient to determine whether it constitutes an adverse reaction;   (h) 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 donor banks, university and research facilities, diagnostic laboratories, and willed body programs.   
     
     
         2 . The transplantable material tracking method of  claim 1  further comprising designating one or more staff members of the medical establishment with specific responsibility for conducting each of the steps (a-f). 
     
     
         3 . The transplantable material tracking method of  claim 1  further comprising the step of certifying that the supplier currently possesses all required regulatory certifications and licenses to supply the transplantable material. 
     
     
         4 . The transplantable material tracking method of  claim 1  further comprising evaluating the safety or health risks posed by transplantable materials supplied by the supplier against the benefits provided by such transplantable materials. 
     
     
         5 . The transplantable material tracking method of  claim 4 , wherein input from a transplant surgeon is obtained when conducting the risk-benefit analysis. 
     
     
         6 . The transplantable material tracking method of  claim 1  further comprising ensuring that a staff member of the medical establishment who performs any of the steps (a-f) possesses a relevant educational background for performing such step. 
     
     
         7 . The transplantable material tracking method of  claim 1  further comprising providing relevant training to a staff member of the medical establishment who performs any of the steps (a-h). 
     
     
         8 . The transplantable material tracking method of  claim 1  further comprising providing relevant policies or procedures to the staff members in support of the reliable conduct of any of the steps (a-h). 
     
     
         9 . The transplantable material tracking method of  claim 1  further comprising periodic auditing of the medical establishment to ensure that each step (a-h) is being conducted properly. 
     
     
         10 . A method 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, wherein a computer database, processor, and software program containing an organized set of instructions in coded language are provided for storing and processing information, such method comprising:
 (a) assigning a unique identification code for the transplantable material upon its receipt by the medical establishment from the supplier;   (b) providing a comprehensive set of standard operating procedures adopted by the medical establishment covering the data that must be recorded to adequately describe at least one step 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;   (c) documenting into the database by a staff member data for the completion of at least one step for the login, handling, storage conditions, reconstitution, or surgical use applied by staff members to the transplantable material;   (d) documenting in the database the identity of each staff member who comes into contact with the transplantable material;   (e) documenting in the database the date and time of each processing step applied to the transplantable material;   (f) documenting in the database all materials used to prepare and process the transplantable material;   (g) documenting in the database the unique identification code of the transplantable material transplanted or implanted into the patient;   (h) 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 (c-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;   (i) 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 upon request;   (j) 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   (k) 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.   
     
     
         11 . The transplantable material tracing method of  claim 10  further comprising designating one or more staff members of the medical establishment with specific responsibility for conducting each of the steps (a-g or i). 
     
     
         12 . The transplantable material tracing method of  claim 10  further comprising sending to the supplier a tissue utilization information card for the transplantable material transplanted or implanted in the patient. 
     
     
         13 . The transplantable material tracing method 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 transplantable material tracing method of  claim 13 , wherein the supplier that supplied the transplantable material to the medical establishment is notified of the adverse reaction in the patient. 
     
     
         15 . The transplantable material tracing method of  claim 10 , wherein the tracing step is conducted in response to a warning received from the supplier that supplied the transplantable material to the medical establishment. 
     
     
         16 . The transplantable material tracing method of  claim 13 , wherein the adverse reaction investigation is conducted utilizing medical cladistics to identify risk clades. 
     
     
         17 . The transplantable material tracing method of  claim 10  further comprising ensuring that a staff member of the medical establishment who performs any of the steps (a-g or i) possesses a relevant educational background for performing such step. 
     
     
         18 . The transplantable material tracing method of  claim 10  further comprising providing relevant training to a staff member of the medical establishment who performs any of the steps (a-g or i). 
     
     
         19 . The transplantable material tracing method of  claim 10  further comprising providing relevant policies or procedures in support of the reliable conduct of any of the steps (a-g or i). 
     
     
         20 . The transplantable material tracing method of  claim 10  further comprising periodic auditing of the medical establishment to ensure that each step (a-g or i) is being conducted properly. 
     
     
         21 . The transplantable material tracking method of  claim 1  further comprising sending a tissue utilization card to the supplier documenting the transplantation or implantation of the transplantable material into the patient after the surgery. 
     
     
         22 . The transplantable material tracing method of  claim 10  further comprising sending a tissue utilization card to the supplier documenting the transplantation or implantation of the transplantable material into the patient after the surgery.