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FDA Basics: Tissue Safety

Ellen F. Lazarus, M.D.CAPT, USPHSDirector, Division of Human Tissues OCTGT, CBER, FDA

September 20, 2012

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Human Tissues in the US Tissues for transplantation are

recovered from over 30,000 volunteer donors annually*

The recovered tissues are processed and distributed to hospitals, surgery centers, and dental offices for treatment of patients. Recovery, processing and distribution of tissues are regulated by the FDA

Tissues from a single donor can be used to treat as many as 100 patients, or more

*2007 American Association of Tissue Banks (AATB) Annual Survey of Accredited Tissue Banks in the United States. McLean, VA: AATB, 2010.

giftoflifemichigan.org

giftoflife.on.ca

giftoflifemichigan.org

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Human tissue is an important source of medical treatment

Over 1 million people in the US receive tissue transplants every year.

• Donated skin used in healing burn victims and for reconstructive surgery

• Bone implanted to replace tissue destroyed by cancer, trauma or infection; or processed into powder used in dental surgery

• Donated heart valves transplanted in young children with heart defects

• Cornea transplants commonly done to treat people with vision loss

donorrecovery.org

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Tissue donors may also be organ donors

• Both organ procurement organizations (OPOs) and tissue banks may approach families to discuss donation– OPO representative consults state donor registry– States’ Uniform Anatomical Gift Acts address the

manner in which OPOs and tissue banks obtain authorization

• Organs from a single donor go to up to 8 recipients and are in short supply

• Tissues from a single donor can go to as many as 100 recipients, and alternative materials usually exist

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Regulations and Standards for Tissues

• Federal government– FDA regulations cover practices and procedures to prevent the

transmission and spread of communicable diseases by tissues• Tissue recovery, donor screening and testing, processing,

packaging, storage, distribution• Mandatory and enforceable by law

– Interaction with other government agencies: CDC, HRSA

• State and local health authorities• Industry associations and professional organizations

– American Association of Tissue Banks (AATB) and Eye Bank Association of America (EBAA) issue voluntary standards and have active accreditation programs

– The Joint Commission (TJC) has standards for tissue storage, tracking, and adverse reaction investigation in hospitals they accredit

The Joint Commission

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Layers of Tissue Safety• Donor screening for risk of communicable

disease– Medical history questionnaire and medical records– Physical examination

• Testing donor samples for infectious agents• Tissue processing procedures and product testing• Quarantining tissues until they are determined to

be suitable for use• Tissue tracking and traceability• Communicating among clinicians, recovery

partners, and tissue manufacturers• Taking corrective actions to address errors• Performing communicable disease surveillance

and research

ehow.com

Manufacturers, healthcare systems, regulators and public health personnel, professional organizations, and academic researchers work together to apply layers of safety in the tissue supply

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FDA Tissue Regulations

• Section 361 of the Public Health Service Act (PHS Act)– Authorizes FDA to make and enforce regulations necessary to

prevent the introduction, transmission, or spread of communicable diseases

• Regulations published in the Code of Federal Regulations (CFR) after public notice and comment– Tissue regulations located in 21 CFR Part 1271

• 3 “rules”

• More complex cellular and tissue-based products may also be regulated as biologic drugs or devices under the Federal Food, Drug, and Cosmetic Act and/or Section 351 of the PHS Act

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21 CFR Part 1271

Rule Issues Addressed

Establishment Registration and Listing

Applicability: types and uses of products that will be regulated by these rules; requirements for registering and listing products

Donor Eligibility Requirements for donor screening and testing for “relevant communicable disease agents and diseases”

Current Good Tissue Practice (CGTP)

Manufacturing practices to ensure that HCT/Ps do not contain communicable disease agents, are not contaminated, and do not become contaminated; also labeling, records, tracking, and complaint file requirements

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Other Parts of the Regulations

• Tissue banks must conduct an investigation and report to the FDA when – a communicable disease transmission event has

occurred or is suspected– a problem or error occurred during recovery,

processing, or other step in tissue manufacturing that may relate to infectious disease risk

• Tissue banks must label the tissues with clear and distinct identification codes, warnings, and instructions

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Inspection and Enforcement of the Regulations

• Tissue banks and other entities involved in recovering, processing, or distributing tissues for transplantation are inspected periodically to determine whether they are complying with the regulations

• If it is found that tissues were not manufactured in accordance with regulations, a range of compliance actions may be taken, including orders for tissue product recall or destruction, or orders to cease operations

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How are tissues tracked and traced?

• Manufacturers must track tissues from the donor to the receiving facility, and back; FDA regulations do not require tissue establishments to track tissues to individual recipients

• Tissue products must be labeled with a unique identifier• Variety of methods and technologies are used for

tracking• Healthcare providers use the unique identifiers when

reporting problems to the supplier or FDA• If tissues need to be recalled, the tissue bank reviews

tracking records and contacts the receiving facilities; the tracking system indicates which other tissues may be affected (e.g., other tissues recovered from the donor)

• TJC standards for hospitals include requirements for recording and tracking the tissues that each patient receives; these do not apply to other types of facilities where tissues may be implanted

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Additional elements of tissue safety

• Hospital tissue management– Centralized and non-centralized systems for tissue inventory

management– Barcode labeling technologies to track tissues in hospitals and clinics– Other types of healthcare facilities where tissues are implanted need to

develop their own systems for tracking tissues to the individual recipients

• Future directions in tissue transplantation science and research– Pathogen reduction technologies to minimize the risk of communicable

disease transmission– Uniform organ and tissue donor history questionnaire– New infectious disease testing technologies– Basic research on risks of tissue transplantation and transplant

outcomes– Surveillance systems for emerging infectious diseases

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Summary

• Tissue donation is an important source of treatments for a wide range of medical conditions

• The FDA tissue regulations and other government and industry standards apply multiple layers of safety to the supply of human tissues

• Additional elements of tissue safety include good tissue management practices at the hospital and clinic level, and advances in tissue transplantation science and technology

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Questions about today’s webinar?

• Phone: Toll-free 1-800-835-4709 or (301-827-1800)

• E-mail: ocod@fda.hhs.gov• On the web:

http://www.fda.gov/BiologicsBloodVaccines/default.htm

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