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Bone and tissue graft logs

AORN Journal, Feb, 2008 by Denise Downing

QUESTION: I am responsible for maintaining our facitity's bone and tissue graft togs. The chapter on provision of care in the Joint Commission's 2007 Comprehensive Accreditation Process Guide for Hospitals and the series on tissue storage and issuance standards in the Joint Commission's 2007 Accreditation Process Guide for Laboratories require that a current copy of the US Food and Drug Administration (FDA) registration be maintained for each distribution company. If I have a copy of the American Association of Tissue Banks (AATB) accreditation certificate for the distributing company, is it necessary to have a copy of their FDA registration? Is it also necessary to have these same documents for bone graft substitutes?

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ANSWER: AORN's "Recommended practices for surgical tissue banking" offers guidance relating to requirements for health care organization tissue banking practices. (1) "Records should be developed and maintained according to the recommendations of the AATB and in compliance with FDA rules." (1(p608)) Documents pertaining to the AATB and FDA should include the following information:

* copies of the AATB accreditation of outside vendors from whom the tissue is obtained, (eg Eye Bank Association of America for ocular tissue or the AABB for stem cells);

* copies of the FDA registration; and

* listings of all tissue products ordered, stored, and used. (1)

At the end of each year, on or before December 31, every person in any state who owns or operates any establishment engaged in the manufacturing, preparation, propagation, compounding, or processing of a drug or drugs or a device or devices should register with the Secretary of Health and Human Services the person's name, places of business, and all such establishments. (2) This suggests that tissue banking documents, copies of certifications, licensure, and registration certificates should be reviewed and updated annually for possible changes to a tissue supplier's status.

The Joint Commission requires that all health care organizations maintain copies of the FDA registration and AATB accreditation certificate from each vendor supplying tissue to the organization. The Joint Commission's requirements can be reviewed in the chapter on provision of care in the 2007 Comprehensive Accreditation Process Guide for Hospitals. (3) A list of requirements also can be reviewed in the 2007 Accreditation Process Guide for Laboratories. (4) For more information, access the Joint Commission's frequently asked questions available at http://www.jointcommission.org/Accreditation Programs/LaboratoryServices/Standards/FAQs (5) and review the question that discusses what is considered tissue under the storage and issuance standard.

It is important to have copies of both FDA registration and AATB accreditation certificates because some tissue banks may not be registered with the FDA and not all tissue banks are accredited by the AATB. The FDA and AATB have different focuses relating to tissue banking. The FDA focuses on preventing transmission of communicable disease by requiring donor screening and testing. Since 1993, the FDA has inspected 118 tissue banks. (6) The FDA has identified 90 tissue suppliers that are not accredited. (6) The 2001 FDA Oversight Report is a useful report for information about the identified limitations in the FDA system relating to FDA registration requirements and the AATB accreditation process for tissue banking. The report can be found online at http://www.fda.gov/cber/tissue/ovrst010.pdf.

The AATB conducts a voluntary accreditation program. Not only does AATB accreditation require donor screening and testing practices similar to those of the FDA, they also focus on the operational and organizational aspects of an organization. The AATB reviews the qualifications of tissue bank personnel and the tissue bank's safety practices, equipment testing, facilities, labeling, and quality assurance programs. (6) The AATB currently accredits 58 tissue banks. The AATB provides updated information about institutional requirements and other useful information on its web site at http://www.aatb.org.

Many tissue banks are not licensed by their state nor accredited by the AATB. Currently, only five states (ie, New York, Florida, California, Georgia, Maryland) license tissue banks either as a tissue bank or a laboratory. (6) Those tissue banks not accredited by the AATB or inspected by their state do not have to meet any standards beyond the current FDA minimum requirements that mandate screening and testing of tissue donors for HIV and hepatitis. (6)

The requirements for bone graft substitutes are the same as those for human tissues, cellular products, and tissue-based products. Bone graft substitutes and certain tissue-based products also may be regulated under regulations for medical devices designed for human use. (7) Information about bone and bone substitutes can be found at http://www.fda.gov/cber /summarieskaiser080200.ppt.

Health Care Industry

Bone and tissue graft logs

AORN Journal, Feb, 2008 by Denise Downing

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