Autologous Tissue

Get clinical answers to frequently asked questions about autologous tissue.
  • How should autologous bone autografts be stored?

    There are gaps in the literature related to best practices for storage of autologous bone and further research is warranted. The American Association of Tissue Banks and the AORN “Guideline for autologous tissue management” recommend that autologous bone autografts be stored at -4° F (-20° C) or colder for six months or less. Autologous bone may be stored at -40° F (-40° C) for up to five years; however, this is considered long-term storage and may require registering with the US Food and Drug Administration as a tissue establishment.

    Storage at -40° F (-40° C) or colder is preferred because tissue enzymes may be active at temperatures warmer than -40° F (-40° C) and may negatively affect tissue if it is stored for an extended time. Temperatures of -94° F (-70° C) or colder may prevent enzymatic destruction of tissue. Maintaining the storage temperature below -40° F (-40° C) may also be a “buffer” that provides additional time before critical temperatures are reached in the event of a freezer malfunction.

    Resources:

    • Standards for Tissue Banking. McLean, VA: American Association of Tissue Banks; 2012.
    • Guideline for autologous tissue management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.
    • Sample Procedure: Handling Autologous Bone Skull Flaps. Version 14. McLean, VA: American Association of Tissue Banks; 2012.

    Updated November 6, 2014.

  • Can autologous bone be subjected to the steam sterilization process?

    Autologous bone should not be subjected to the steam sterilization process unless there is a clinical indication to do so. The steam sterilization process may denature bone protein, severely damage the bone structure, and increase the potential for bone resorption and infection; however, steam sterilization may also destroy and prevent recurrence of tumor cells.

    There are gaps in the literature related to best practices for management of autologous cranial bone flaps removed for treatment of brain tumors and subjected to steam or other sterilization processes. Further research is warranted. Subjecting the bone flap to the steam sterilization process is considered manufacturing and would require that the facility register with the FDA as a tissue bank.

    Resources:

    • Guideline for autologous tissue management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc. 
    • Schultke E, Hampl JA, Jatzwauk L, Krex D, Schackert G. An easy and safe method to store and disinfect explanted skull bone. Acta Neurochir (Wien). 1999;141(5):525-528. 
    • Vanaclocha V, Saiz-Sapena N, Garcia-Casasola C, De Alava E. Cranioplasty with autogenous autoclaved calvarial bone flap in the cases of tumoural invasion. Acta Neurochir (Wien). 1997;139(10):970-976. 
    • Wester K. Cranioplasty with an autoclaved bone flap, with special reference to tumour infiltration of the flap. Acta Neurochir (Wien). 1994;131(3-4):223-225. 
    • §21 CFR 1271: Human cells, tissues, and cellular and tissue-based products. April;2013. US Food and Drug Administration. 
    • Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps). Silver Spring, MD: US Food and Drug Administration; 2012.

    Updated November 6, 2014.

  • Can allografts and autografts be stored in the same refrigerator or freezer?

    Allografts and autografts may be stored in the same refrigerator or freezer if they are separated, packaged using appropriate materials, and prominently labeled, and if the correct storage conditions exist for all items in the refrigerator or freezer. Allografts can be separated from autografts in the same refrigerator or freezer by placing the tissue in separate storage bins and storing the allografts on the upper shelves and the autografts on the lower shelves to avoid accidental contamination of the allografts.

    Bins or shelves used for storing allografts and autografts should contain prominent, easily identifiable labels to help perioperative personal distinguish between the containers. Perioperative team members storing allografts and autografts in the same refrigerator or freezer should ensure the appropriate storage conditions are maintained.

    Resources:

    • Guideline for autologous tissue management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.

    Updated November 6, 2014.

  • What actions should be taken when an autograft intended for replantation or autotransplantation is contaminated or dropped on the OR floor?

    A multidisciplinary team should first conduct a risk assessment to consider the benefits and potential harms associated with replantation or autotransplantation of a contaminated autograft. If a decision is made to replant or autotransplant the contaminated autograft, the following steps should be taken:

    • Rinse the contaminated graft in sterile normal saline solution to remove surface debris and contaminants. Rinsing the dropped autograft in normal saline solution may be sufficient to remove surface debris and contaminants.
    • Use a separate sterile field for decontaminating the dropped graft and exercise care to prevent splashing onto the primary sterile field.
    • Implement corrective actions as necessary to maintain the sterility of the primary sterile field (eg, changing gowns and gloves after pulsatile lavage of the contaminated graft).
    • Change the wound classification to Class III, Contaminated. According to the Centers for Disease Control and Prevention surgical wound classification system, a surgical wound with a major break in sterile technique is classified as Class III, Contaminated.
    • Document the event in a variance report.
    • Conduct a debriefing session and a root cause analysis with members of the surgical team and other individuals who may be helpful in providing a critical analysis to help determine the factors that contributed to the event and methods to prevent its recurrence.

    Resources:

    • Guideline for autologous tissue management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc. 
    • Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999;27(2):97-132; quiz 133-4; discussion 96.

    Updated November 6, 2014.

  • How should autologous human skin autografts be stored?

    There are gaps in the literature related to best practices for storage of autologous skin and further research is warranted. The American Association of Tissue Banks and the AORN “Guideline for autologous tissue management” recommend that autologous skin autografts be stored between 32° F to 50° F (0° C to 10° C) for no longer than 14 days. Refrigerated skin should be submerged in a storage medium, and the storage medium should be changed every 72 hours. Refrigeration retards autolysis and helps prevent bacterial proliferation, and keeping the skin submerged helps prevent dehydration of the tissue. Changing the storage medium every 72 hours may help prevent microbial growth and improve skin autograft viability.

    Resources:

    • Standards for Tissue Banking. McLean, VA: American Association of Tissue Banks 2012.
    • Guideline for autologous tissue management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.
    • Robb EC, Bechmann N, Plessinger RT, Boyce ST, Warden GD, Kagan RJ. Storage media and temperature maintain normal anatomy of cadaveric human skin for transplantation to full-thickness skin wounds. J Burn Care Rehabil. 2001;22(6):393-396.
    • Titley OG, Cooper M, Thomas A, Hancock K. Stored skin—stored trouble? Br J Plast Surg. 1994;47(1):24-29.
    • Cram AE, Domayer MA. Short-term preservation of human autografts. J Trauma. 1983;23(10):872-873.

    Updated November 6, 2014.

  • How should autologous human vein autografts be stored?

    There are gaps in the literature related to best practices for storage of autologous veins and further research is warranted. The American Association of Tissue Banks and the AORN “Guideline for autologous tissue management” recommend that autologous vein autografts be stored between 32° F to 50° F (0° C to 10° C) for no longer than 14 days. Refrigerated veins should be submerged in a storage medium, and the storage medium should be changed every 72 hours. Refrigeration retards autolysis and helps prevent bacterial proliferation, and keeping the vein submerged helps prevent dehydration of the tissue. Changing the storage medium every 72 hours may help prevent microbial growth and improve vein autograft viability

    Resources:

    • Standards for Tissue Banking. McLean, VA: American Association of Tissue Banks; 2012.
    • Guideline for autologous tissue management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc. 
    • Robb EC, Bechmann N, Plessinger RT, Boyce ST, Warden GD, Kagan RJ. Storage media and temperature maintain normal anatomy of cadaveric human skin for transplantation to full-thickness skin wounds. J Burn Care Rehabil. 2001;22(6):393-396. 
    • Titley OG, Cooper M, Thomas A, Hancock K. Stored skin—stored trouble? Br J Plast Surg. 1994;47(1):24-29. 
    • Cram AE, Domayer MA. Short-term preservation of human autografts. J Trauma. 1983;23(10):872-873.

    Updated November 6, 2014.

  • Does storing autologous tissue require registration with the US Food and Drug Administration as a tissue bank?

    Facilities that handle autologous tissue for delayed replantation or autotransplantation into the same patient and within the same facility are not required to register with the US Food and Drug Administration (FDA) as tissue banks. Facilities that handle autologous tissue are required to recover, process, package, label, store, track, and replant or autotransplant the tissue in a manner that minimizes microbial growth, prevents mix-ups, and reduces the risk of errors.

    Storing autologous tissue to be used in a subsequent replantation or autotransplantation procedure for the same patient in the same facility is exempt from registration because the FDA considers the two applications to be a single continuous procedure.

    Resources:

    • 21 CFR 1271: Human cells, tissues, and cellular and tissue-based products. April;2013. US Food and Drug Administration. 
    • Human ells, Tissues, and Cellular and Tissue- Based Products; Establishment Registration and Listing. Fed Regist. 2001;66(13):5447-5469.

    Updated November 6, 2014.

  • What are the AORN recommendations for temperature monitoring of refrigerators and freezers used to store autologous tissue?

    Freezers and refrigerators used for storage of autologous tissue should:

    • Provide continuous temperature monitoring and should be monitored regularly with daily temperature checks recorded;

    • Have an alert or alarm system that notifies personnel when the temperature is not within the acceptable range; and

    • Have an emergency power system.
    The alert or alarm should sound in an area where an individual is present at all times to initiate corrective action or notify personnel who are available to respond. Processes should be established for maintaining the temperature and integrity of stored autologous tissue in the event of a refrigerator or freezer malfunction and for responding to a malfunction of the refrigerator or freezer that occurs when the facility is closed or when the area where the tissue is stored is unoccupied.

    Resources:

    • Joint Commission. Transplant safety. In: Comprehensive Accreditation Manual for Hospitals E-dition. Washington, DC: The Joint Commission; March 2014. 

    • Joint Commission. Transplant safety. In: Comprehensive Accreditation Manual for Ambulatory Care E-dition. Washington, DC: The Joint Commission; March 2014.

    • Guideline for autologous tissue management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc. 

    • Sample Procedure: Handling Autologous Bone Skull Flaps. Version 14. McLean, VA: American Association of Tissue Banks; 2012.

    • Standards for Tissue Banking. McLean, VA: American Association of Tissue Banks; 2012.

    Updated November 6, 2014.