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Guideline Update: Autologous Tissue Management 2026

These slides are adapted from the webinar Autologous Tissue Management Guideline 2026. To listen to the webinar, visit https://www.aorn.org/education/education-for-individuals/recorded-webinars

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AORN Perioperative Practice Specialist
Lead author of the Guideline for Autologous Tissue Management
Contributing author to Clinical Issues (AORN Journal)
Clinical consultant to members via the AORN Consult Line

Developed and originally presented by

Tammy Hanks, DNP, APRN, PCNS-BC, NEA-BC, EBP-C, CNOR

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Autologous Tissue Management

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Why Is this Important?

Decrease risk for infection
Decrease risk for tissue identification error
Decrease the risk for exposure
Preserve the clinical viability of the tissue

Preserving and replanting or autotransplanting autologous tissue may improve the patient’s long-term outcomes. Some types of autologous tissue (eg, cranial bone flaps, parathyroid glands) are preserved because the patient’s clinical symptoms (eg, swelling, hormone levels, infection) prevent the tissue from being replanted or autotransplanted during the same procedure in which it was removed. Other types of autologous tissue (eg, veins, skin, adipose tissue) are preserved because the tissue was harvested but was not all used during the original procedure and may be needed for a future procedure (eg, cardiovascular bypass graft, skin graft, fat graft). In addition, the use of autologous tissue may be preferred over the use of allograft tissue or synthetic tissue implants in certain situations.

Following good tissue practices described in 21 Code of Federal Regulations (CFR) Part 1271 Subpart D and evidenced-based guidance for autologous tissue management can

decrease the patient’s risk for infection;
decrease the risk for a packaging, labeling, or tissue identification error;
decrease the risk to perioperative personnel of exposure to blood and other potentially infectious materials; and
preserve the clinical viability of the tissue.

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Autologous

Removed from a person

Used on the same person

Allograft

Removed from a person

Used on a different person

There are generally two different human tissue types. The first is autologous. Autologous tissue is cells or tissue that are taken out of a person and then used again in that same individual. One example of this is a cranial bone flap. Allograft tissue is different; this is human tissue removed from one person and placed into a different individual. Most people commonly think of organ or tissue transplantation when thinking of allograft tissue. This distinction is important because the Code of Federal Regulations regarding tissue generally applies more to allograft tissue in order to prevent disease transmission between individuals. Additionally, the recommendations made by the American Association of Tissue Banks mostly apply to allograft tissue as well.

Autologous: Cells or tissues obtained from the same individual. To be used exclusively for that individual.

Allograft: A graft taken from a living or nonliving donor for transplantation to a different individual.

This is an important distinction due to the scope of this document. The scope of this document is very clear. To be included in AORN Guideline for Autologous Tissue Management, the tissue needs to be both autologous and preserved. This scope helped exclude items like organ transplantation or autologous tissue that is removed and replanted during the same procedure, meaning there was no tissue preservation.

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Guideline Process

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What Is New?

Interdisciplinary Team Approach

Limbs

Reproductive Tissue

Education

Quality

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What Has Changed?

New Sections

Re-organization of content

Updated recommendations and rationale

Section Name Changes

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Guideline Revision Crosswalk

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Tissue Establishment �Registration

Human cells

Human tissues

Human cellular or tissue-based products

Exception

Remove and replant same individual, same surgery

Section 1 covers Tissue Establishment Registration. This section has not changed but includes important regulatory considerations for perioperative teams to be aware of.

The FDA requires establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/Ps) to register and list their HCT/Ps. The FDA defines manufacture as any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue, and the screening or testing of the cell or tissue donor.

The FDA provides the following exceptions from registration as a tissue establishment: [CLICK]

facilities that use HCT/Ps solely for nonclinical scientific or educational purposes;
facilities that remove HCT/Ps from an individual and implant such HCT/Ps into the same individual during the same surgical procedure;
facilities that only receive or store HCT/Ps for implantation, transplantation, infusion, or transfer within the facility; and
facilities that recover reproductive cells or tissue and immediately transfer them into a sexually intimate partner of the cell or tissue donor.

The FDA has clarified that the only processing steps that can be completed for the autologous tissue to be considered to be still in its original form are cleaning, rinsing, sizing, and shaping. Surgical removal and subsequent replantation or autotransplantation of autologous tissue that occur a number of days apart may be considered the same surgical procedure under the 21 CFR Part 1271.15(b) exception. Refer to the FDA for information regarding tissue establishment registration and exceptions.

Though this section’s recommendations did not change, there are some language changes to clarify registration requirements and direct organizations to the FDA for any questions related to registration requirements and exemptions. It is also important to note that all facilities that handle tissue are required to follow current good tissue practices.

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2. Interdisciplinary Team Approach

Informatics professionals

Clinical laboratory professionals

The first new section of the revised guideline is Section 2, titled Interdisciplinary Team Approach. In many sections of the guideline, we refer to the work of the interdisciplinary team in establishing and maintaining standardized tissue-specific methods for safe handling of autologous tissue. We felt it was important to identify the interdisciplinary team and highlight the importance of an interdisciplinary collaborative approach to promote optimal tissue handling and patient outcomes.

Convene an interdisciplinary team to provide oversight of managing autologous tissue practices in the organization. The team should include

perioperative RNs,
surgeons,
perioperative leaders,
surgical technologists,
risk management professionals,
infection preventionists,
Informatics professionals,
clinical laboratory professionals, and
others identified by the health care organization.

[Recommendation]

An interdisciplinary, collaborative approach to determining standardized methods for autologous tissue handling can facilitate implementation of comprehensive protocols in the organization. These standardized methods serve as the basis for clear policies and procedures and team education for specific recommendations relevant to each tissue type.

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Standardized Methods

Education

Policies

Procedures

Competency Verification

Tissue Types

Storage Conditions

Preparation Methods

QA/PI Measures

The interdisciplinary team should establish and maintain standardized tissue-specific methods for the safe handling of autologous tissue that include

types of autologous tissue that will be handled in the organization;
preparation for preservation such as

storage medium or solution(s) and
the addition of antiseptics or antibiotics to storage solution(s);

storage conditions such as

temperature range for refrigerating, freezing, and cryopreserving and
maximum storage duration;

preparation for autotransplantation;
quality assurance and performance improvement measures such as

microbial culturing (eg, swab, liquid, sponge) and technique;
practices to minimize the risk of contamination, dropping, or accidental disposal;
transfer of autologous tissue on and off the sterile field;
management of tissue that is nearing the maximum storage duration or expiration date for packaging;
sequestering of compromised tissue packages for investigation; and
contingency planning for equipment failure or outages;

release of tissue to the patient or family when it is not autotransplanted; and
education and competency verification for perioperative personnel.

[Recommendation]

One of the major limitations for synthesizing the existing evidence on autologous tissue is the lack of standardized handling methods or even lack of description in studies on the handling methods used. This is one of the reasons why it is so important for organizations to convene an interdisciplinary team to create standardized methods for the tissue handled in their specific organization, so we can track outcomes and identify optimal handling methods with data. Determining standardized methods also set the foundation necessary for education, competency verification, policies, and procedures within the organization.

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Cranial Bone Flaps

Cranial bone flaps may be frozen, cryopreserved, or stored in a subcutaneous pocket for delayed cranioplasty. This recommendation has not changed from the last revision; however, we did add a recommendation for determining the preservation method in collaboration with the interdisciplinary team and in consideration of patient-specific factors. The evidence supports that several factors are considered when selecting the optimal preservation method, including patient-specific considerations such as age, health, previous infections, costs considerations, surgical complexity, cosmetic and functional outcomes, patient preference, and storage availability. Some additional considerations discussed in the literature include primary decompressive craniectomy etiology, history of previous cranial surgeries, patient age, body mass index, and comorbidities, presence of hydrocephalus shunts, the quality of the scalp tissue, the size of the skull defect, the number of cranial flap fragments, and the patient’s smoking history. What is important is that the interdisciplinary team is determining the best method of preservation for the patient in consideration of all relevant factors.

The team also needs to consider how long it is anticipated that the flap will be stored and the availability of a freezer with ultra-low temperature capabilities.

This is a recurring recommendation for each tissue type in the guideline. The interdisciplinary team should design and implement standardized methods for preserving each autologous tissue type that will be used in the organization. Several researchers reported how autologous tissue was handled and prepared for storage as part of the study methodology; however, no studies were identified that compared the effects of a specific cranial bone flap preparation technique on patient outcomes, such as infection and resorption. Additional research is needed to determine the effect of autologous bone flap preparation on patient outcomes.

What we wanted to emphasize, however, is the importance of standardization of methods at an organization level.

The interdisciplinary team should also determine a standardized method for preparing autologous tissue for replantation following preservation as well as safe handling practices to minimize the risk of contamination.

And in the event of contamination or “dropping” a bone flap, AORN maintains the recommendation that sterilization not be used to decontaminate cranial bone flaps.

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*New: Limbs

No recommendation can be made for preserving amputated limbs by ectopic banking for future replantation

The balance between the potential benefits and harms of preserving amputated limbs by ectopic banking for future replantation is unclear. The potential benefits include allowing for delayed replantation when immediate replantation is not feasible and avoiding the need for a prosthetic. The potential harms include replantation failures related to complications at the ectopic banking site (ie, infection, tissue necrosis) and the need for multiple surgeries for initial debridement, temporary implantation, and final replantation.

The evidence supporting the preservation of amputated limbs by ectopic banking is considered to be of low quality because it is limited to two case reports and a literature review describing ectopic banking of amputated upper extremity limbs for later replantation. In the two cases reported, ectopic banking resulted in successful replantation and function in the replanted limb. However, because of variability in the way ectopic banking is described in the literature, the small numbers of patients having these procedures, and lack of long-term follow-up, no conclusion can be drawn as to how ectopic banking affects long-term limb viability and function. Additional research is needed.

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*New: Reproductive Tissue

Ovarian Tissue

Testicular Tissue

11.1. Ovarian tissue may be cryopreserved and autotransplanted 11.6. No recommendation can be made for the cryopreservation and autotransplantation of testicular tissue

Ovarian tissue may be cryopreserved and autotransplanted. [Conditional Recommendation]

Moderate-quality evidence supports cryopreservation of ovarian tissue as an option for fertility preservation in some patients, including those who are prepubertal and those who have malignant and nonmalignant conditions (ie, diseases that cause premature limitation of ovarian reserve).

The benefits of cryopreserving ovarian tissue may outweigh the harms. Benefits described in the literature include

an immediate fertility preservation option;
the ability to immediately initiate cancer treatment;
no requirement for prior ovarian stimulation, thus reducing risks for estrogen-sensitive cancers;
the restoration of both endocrine and reproductive ovarian function;
delayed menopause and extension of fertility; and
restored fertility.

Potential harms described in the literature include

risks associated with its experimental status in some countries outside of the United States,
reintroduction of malignant cells in cancer patients,
ischemic injuries related to poor revascularization after transplantation, and
decreased viability and graft survival.

A standardized method for cryopreservation is vital to support the best outcomes for ovarian tissue preservation and delayed autotransplantation. There is no consensus on the optimal method of preparation of ovarian tissue in the OR for cryopreservation. No evidence was found comparing different preparation methods with patient outcomes, although several studies described handling and preparation as part of the study protocol. Additional research is needed.

No recommendation can be made for the cryopreservation and autotransplantation of testicular tissue. [No Recommendation]

Low-quality evidence exists regarding the viability of testicular tissue cryopreservation and autotransplantation as an option for fertility preservation in prepubertal male patients, including those requiring gonadotoxic therapies or bone marrow transplantation or those diagnosed with Klinefelter syndrome. Testicular tissue cryopreservation and autotransplantation is currently considered an experimental therapy in humans.

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Revised: Tissue Tracking

Documentation

Tissue Tracking

Tissue Records

Corrective Actions

Equipment Logs

Patient Information

Storage Methods

Surgical Information

Document and maintain records for tissue tracking. [Regulatory Requirement]

The FDA requires any establishment or facility that performs any step in the manufacture of tissue (eg, recovery, processing, storage, labeling, packaging, distribution) to track each tissue item to facilitate the investigation of actual or suspected transmission of communicable disease.

Establish and maintain a records management system relating the core current good tissue practice requirements. [Regulatory Requirement]

Records pertinent to the manufacture of tissue (eg, labeling and packaging procedures, equipment logs) must be maintained and organized under the records management system. This requirement is meant to support prompt identification, location, and retrieval of all tissue-related records.

Recording tissue tracking information is an FDA current good tissue practice regulatory requirement and an accreditation standard. Accurate recording of autologous tissue information is important for tissue tracking, quality monitoring, and investigations. It is the responsibility of the organization or facility to determine a specific method for recording and tracking tissue and organizing the information within a records management system.

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New: Education & Quality

Education

Quality

P&P

Initial & ongoing

Competency verification

Protocols

QA/PI activities

Audits

Corrective actions

Personnel training

Labeling

Storage

Records

Tracking

Provide initial and ongoing education and verify competency of personnel responsible for any step of autologous tissue management. [Recommendation]

Initial and ongoing education of perioperative personnel facilitates the development of knowledge, skills, and attitudes that affect safe patient care. The health care organization is responsible for providing initial and ongoing education and verifying the competency of its personnel; however, the primary responsibility for maintaining ongoing competency remains with the individual. Perioperative personnel education on autologous tissue management promotes consistency in practice and helps ensure compliance with regulations and best practices.

Verify the competency of perioperative personnel and their compliance with core current good tissue practice requirements. [Regulatory Requirement]

Include the following in education and competency verification activities related to autologous tissue management:

policies and procedures,
factors that contribute to contaminated or lost tissue,
personnel roles and responsibilities specific to

organization and tissue type–specific standardized methods,
preservation methods,
handling methods,
storage methods (eg, temperature range, duration, temporary),
transportation methods (eg, on ice),
decontamination methods for contaminated tissue intended for replantation or autotransplantation,
preparation methods (eg, thawing),
tissue culture techniques,
team communication components,
disposal protocols, and
tissue tracking documentation requirements.

[Recommendation]

Team communication, collaboration, and consistent autologous tissue management techniques can improve patient outcomes and reduce complications. Ongoing education and competency verification activities for the surgical team foster a culture of safety and are crucial for maintaining high standards of care and achieving optimal results in complex procedures involving autologous tissue preservation and autotransplantation. See the AORN Guideline for Specimen Management² for additional guidance and recommendations for education that are relevant to autologous tissue management.

Before perioperative personnel are assigned to procedures involving research, provide education about the research protocols for autologous tissue collection. [Recommendation]

The benefits of providing education for personnel on the collection process for research include an understanding of the processes used for research tissue collection in the facility, less time spent during the patient assessment and collection process, and assurances of tissue viability for research purposes.

It is an FDA requirement for facilities that handle tissue to establish and maintain a quality program for the specific type of tissue (eg, cranial bone flap, parathyroid tissue, vessels) and the manufacturing steps performed (eg, recovery, storage, labeling, packaging, distribution). A quality assurance/performance improvement (QA/PI) program can facilitate the identification of problem areas and assist perioperative personnel in analyzing data and evaluating patient outcomes related to autologous tissue management. A QA/PI program provides a mechanism to evaluate the effectiveness of processes and adherence to established policies and procedures for autologous tissue management.

The QA/PI activities related to autologous tissue management should include

audits of tissue tracking documentation;
audits of compliance with autologous tissue management policies and procedures);
identification, documentation, implementation, and evaluation of corrective actions related to autologous tissue management; and
personnel training and education in activities related to core current good tissue practices.

[Recommendation]

Review and evaluation of QA/PI activities facilitates identification of opportunities to improve autologous tissue management practices and ensure compliance with core current good tissue practices. The FDA describes current good tissue practice requirements and quality audit activities in 21 CFR Part 1271. See the AORN Guideline for a Safe Environment of Care116 for additional information and guidance on QA/PI program activities related to the environment of care. See the AORN Guideline for Specimen Management for additional information and guidance on QA/PI program activities related to specimen management.

Establish and maintain procedures for autologous tissue to meet the core current good tissue practice requirements (eg, labeling, storage, records, tracking) for all steps performed in tissue management. [Regulatory Requirement]

Maintaining procedures for tissue management is a regulatory requirement according to 21 CFR Part 1271.180(a). It is also a Joint Commission accreditation standard specific to autologous tissue to have policies and procedures that clarify tissue management practices including identifying, tracking, storing, and handling tissue and adverse event management. The AATB recommends that facilities maintain policies and procedures, including a written policy for discarding autologous tissue.

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References

Guideline for autologous tissue management. In: Guidelines for Perioperative Practice. AORN Inc; 2025.

21 CFR 1271: Human cells, tissues, and cellular and tissue-based products. Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271

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