Product Information / Package Insert

 

Summary of Records

 

RMTB grafts are "Donated Human Tissue" which have been prepared from a donor that has met the donor suitability criteria. Suitability is based on a documented Medical Director review of screening and testing records. These records include but are not limited to donor profile, informed consent, medical/social history, procurement documentation, microbiological testing, serology testing, hospital records (if applicable), autopsy report (if applicable), as well as all processing records.

All Donors have been screened and shown negative for the presence of active infectious disease, malignancies, degenerative neurological disease of unknown etiology, and diseases of unknown etiology. Blood samples have been tested for relevant communicable diseases and shown negative for HIV 1 & 2, Hepatitis B Surface Antigen, Hepatitis B core (total). Hepatitis C antibody, HTLV 1 & 2, syphilis (RPR), nucleic acid test (NAT) for HIV 1 & HCV. Communicable disease testing was performed by a laboratory registered with the FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvements Amendments of 1998 (CLIA) and 42 CFR part 493.

 

1. In the Rocky Mountain Tissue Bank processing, protocol, every effort is made to ensure the safety of our tissue. However, current technologies may not preclude the transmission of infectious agents.

2. The use of this tissue is limited to hospitals, physicians, dentists or other qualified medical professionals.

3. Allograft has been irradiated with betweeen 25 kGy and 38 kGy of irradiation.

4. Do Not Re-sterilize.

5. Store at Room Temperature.

6. It is the responsibility of the transplant facility and/or the clinician to maintain the allograft in the appropriate storage conditions prior to transplantation.

7. The Particulate grafts transport tube should be opened and inner sterilized vial placed in sterile surgical field; or the Bone Block outer pouch is opened and inner pouch is placed in sterile field.

8. Once the container seal has been compromised, the tissue shall be either transplanted or discarded.

9. No Special Handling is required.

10. No additional preparation is necessary for transplantation, such as diluting or reconstitution.

11. For Single Patient Use Only.

**ADVERSE OUTCOMES ATTRIBUTED TO THE TISSUE MUST BE REPORTED PROMPTLY TO ROCKY MOUNTAIN TISSUE BANK.

***A PATIENT TRACKING FORM ACCOMPANIES EVERY TISSUE GRAFT, COMPLETE AND RETURN IT TO ROCKY MOUNTAIN TISSUE BANK IMMEDIATELY AFTER TISSUE IS TRANSPLANTED.

****IT IS THE RESPONSIBILITY OF THE TRANSPLANT FACILITY AND THE CLINICIAN TO MAINTAIN RECIPIENT RECORDS FOR THE PURPOSE OF POST-TRANSPLANT TRACING.

 

 

 

 

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