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Introduction

The Guideline for Autologous Tissue Management has been approved by the AORN Guideline Advisory Board. It was presented as a proposed guideline for comments by members and others. The guideline is effective November 15, 2014. The recommendations in the guideline are intended to be achievable and represent what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice settings and/or clinical situations that determine the degree to which the guideline can be implemented. AORN recognizes the many diverse settings in which perioperative nurses practice; therefore, this guideline is adaptable to all areas where operative and other invasive procedures may be performed.

Purpose

This document provides guidance to perioperative personnel for managing autologous tissue in the perioperative setting, including avulsed teeth, cranial bone flaps, parathyroid glands, skin, veins, and dropped autografts. Guidance is provided for transferring tissue from the sterile field, packaging and labeling, transporting and storing, and handling autologous tissue for delayed replantation or autotransplantation within the same facility. Guidance for managing autologous adipose tissue is not provided. Currently, adipose aspirates can only be used for immediate autologous fat grafting at the time of recovery, and there is no reliable method for preserving and storing adipose tissue for delayed autotransplantation. 1,2  Recommendations related to processes for intraoperative storage and cryopreservation of autologous tissue are outside the scope of this document.

A facility that handles autologous tissue for delayed replantation or autotransplantation into the same patient and within the same facility is not required to register with the US Food and Drug Administration (FDA) as a tissue establishment (ie, tissue bank) that manufactures human cells, tissues, and cellular and tissue-based products, nor to follow requirements of 21 CFR Part 1271 (ie, the FDA regulations for these products). 3,4  Facilities or health care organizations 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 for errors. 3  Although the regulation defines manufacturing to include recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue, 3,5  the FDA considers most procedures related to autologous tissue to be a single procedure encompassed within the element of storage. The reader can refer to section 1271.15(b), in which storage of autologous tissue is exempt if replantation or autotransplantation will occur in the facility where the recovery took place. 4  Similarly, packaging and labeling of autologous tissue can be encompassed within the exception for storage. 4  Freezing autologous tissue as a method of storage does not, in itself, require registration and listing with the FDA as a tissue establishment. 4 

In addition, the FDA has interpreted the “same surgical procedure” language in its final rule to include recovery and storage before replantation or autotransplantation. 3  Retaining autologous tissue to be used in a subsequent application for the same patient is exempt from registration because the two applications are essentially a single, continuous procedure. 4 

The facility is required to register with the FDA if autologous tissue handling includes steps to process the autograft when any step requires specific manufacturing controls to decontaminate the tissue (ie, subjecting the autograft to a steam sterilization process). 4  If autologous tissue-handling functions are expanded to include distribution of the autograft to another facility located at a different address, registration and listing with the FDA using Form FDA 3356 is required. 3 

Whether or not facility registration is required, the federal regulations described in 21 CFR Part 1271 provide good practices for preventing the introduction, transmission, or spread of communicable disease and enhancing patient safety related to autologous tissue management. 3,5 

The reader can also refer to the standards of the American Association of Tissue Banks (AATB), which reflect the collective expertise and efforts of tissue bank professionals to provide a comprehensive foundation to support tissue banking activities, including practices for managing autologous tissue. 6 

Evidence Review

On January 24 and January 27, 2014, a medical librarian conducted a systematic search of the databases MEDLINE®, CINAHL®, and the Cochrane Database of Systematic Reviews for meta-analyses, systematic reviews, randomized controlled and non-randomized trials and studies, case reports, letters, reviews, and guidelines. The librarian also searched Scopus®, although not systematically. Search terms included autologous transplantation, tissue preservation, organ transplantation, preservation, storage, storage solution, saline solution, isotonic saline, potassium chloride, N-acetylhistidine, ice, cold temperature, bone flap, bone transplantation, skull, bone and bones, surgical flap, saphenous vein, radial artery, renal artery, mammary artery, and thoracic artery. During the development of this document, the lead author also requested supplementary searches on the topics of storage media, preservation of avulsed teeth, and the use of swab cultures.

The initial search was limited to literature published in English since January 2006; however, the time restriction was not considered in subsequent searches. At the time of the initial search, the librarian also established weekly alerts on the topics included in the initial search. The librarian later added terms from subsequent supplementary searches to the alerts and, until May 2014, presented relevant results to the lead author.

The lead author reviewed search results from the medical librarian’s literature search for the AORN Guideline for Specimen Management to identify literature specific to management of other tissues and the preservation of avulsed teeth. During the development of the document, the lead author requested additional articles and other literature that either did not fit the original search criteria or was discovered during the evidence appraisal process. Finally, the lead author and the medical librarian identified relevant guidelines from government agencies and standards-setting bodies. In total, 889 research and non-research sources of evidence were identified for possible inclusion, and of these, 182 were cited in the guidance document (Figure 1).

Figure 1.
Flow Diagram of Literature Search Results

Flow Diagram of Literature Search Results

Excluded were non-peer-reviewed or retracted publications; evidence specific to organ transplantations, processes for cryopreservation, and surgical techniques and treatment protocols; and some evidence related to allografts, intraoperative storage of autologous tissue, and educational needs surrounding traumatic dental injuries not specific to health care workers.

Articles identified in the search were provided to the lead author and the assigned evidence reviewer for review and critical appraisal using the AORN Research or Non-Research Evidence Appraisal Tools as appropriate. The literature was independently evaluated and appraised by the lead author and the evidence reviewer according to the strength and quality of the evidence. Each article was then assigned an appraisal score determined by consensus. The appraisal score is noted in brackets after each reference, as applicable. Various articles also were provided to an expert member of the project team for consideration regarding relevance and application of the evidence for determining practice guidelines.

The evidence supporting each intervention and activity statement within a specific recommendation was summarized, and the AORN Evidence-Rating Model was used to rate the strength of the collective evidence. Factors considered in the review of the collective evidence were the quality of the evidence, the quantity of similar evidence on a given topic, the consistency of evidence supporting a recommendation, and the potential benefits and harms. The assigned evidence rating is noted in brackets after each intervention and activity statement.

 

Note: The evidence summary table is available at http://www.aorn.org/evidencetables/.

 

Editor’s note: MEDLINE is a registered trademark of the US National Library of Medicine’s Medical Literature Analysis and Retrieval System, Bethesda, MD. CINAHL, Cumulative Index to Nursing and Allied Health Literature, is a registered trademark of EBSCO Industries, Birmingham, AL. Scopus is a registered trademark of Elsevier B.V., Amsterdam, The Netherlands.

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