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Rationale and Justification for the Development of Standards

Reprinted with permission from Tissue Engineering , A Mary Ann Liebert publication, 1998, courtesy of Mary Ann Liebert, Inc. publishers, 2 Madison Avenue, Larchmont, NY 10538.

Tissue Engineered Medical Products Standards: The time is ripe!

by Grace Lee Picciolo1, Kiki B. Hellman1 and Peter C. Johnson2


1U. S. Food and Drug Administration, InterCenter Tissue Engineering Working Group, Rockville, MD 20850; 2Pittsburgh Tissue Engineering Initiative, Pittsburgh, PA 15219

By analogy, some fruits bear picking when still green, or at least a little on the flesh-colored side of red. Is this the case for the field of Tissue Engineering? It is important to formulate the basic science behind engineering tissue repair and replacement. However, as this process gallops along, early development of standards will begin to codify the field and establish firm guidelines for its development. Particularly where common components are used in various applications, formulating standards for both the biological and biomaterials components of these products could aid in their future successful applications.

It all began in St. Louis, MO in spring of 1997 with a "Workshop on Tissue Engineering: The Role of ASTM" sponsored by Committee F04 on Medical and Surgical Devices & Materials, where the needs for standards in this field were presented by experts in the field at the semi-annual meeting of the American Society for Testing and Materials (ASTM). This resulted in the chartering of Division IV of the Committee F04 on Medical and Surgical Materials and Devices at the ASTM semi-annual meeting in San Diego, Nov. 97. The Chair of Division IV, Peter C. Johnson, Pittsburgh Tissue Engineering Initiative, Vice Chair, Grace Lee Picciolo, FDA, and Executive Secretary, Kiki B. Hellman, FDA, were appointed. Prioritizing of areas in need of standards was accomplished. The following scope of work was approved:

The development of standards and promotion of related materials for tissue engineered medical products focusing on components of combination medical products intended to repair, replace or regenerate human tissue. These comprise the biological components such as the cells, tissue, cellular products, and/or biomolecules and biomaterials used in combination, including biologic, biomimetic and/or synthetic materials. This division will work with other committees within ASTM and other organizations having mutual interests.

ASTM , a not-for-profit corporation organized in 1898, is a management system for the development of standards and related technical information for materials, products, systems, and services. It provides a legal, administrative, and publications forum within which producers, users, ultimate consumers, and representatives of government and academia can meet on a common ground to develop standards that best meet the needs of all concerned. The ASTM procedures, based on due process, ensure that the standards produced are technically sound and rest on a solid legal foundation with appropriate concern for issues such as restraint of trade and volunteer liability. Using its consensus process with input from expert groups and all interested parties, several types of acceptable standards result, such as test methods, specifications, practices, guides, classifications, and terminology.

The application and use of standards for the medical community is important to developers, industry and regulators. Developers will have some guides against which to test their innovations. When achievement of certain performance levels are difficult, measures of comparison may assist in choosing appropriate courses of research. The industrial community needs to control process and production according to accepted methods comparable to other industrial applications. They also need to validate safety and efficacy for regulatory approval. Self certification against existing standards reduces the need for submission of selected data. Since this also reduces the amount of review for the regulatory process, the Food and Drug Administration is selecting and adapting standards for use in the review process. This is being implemented through the recently passed Modernization of FDA act of 1997.

At the Dec 16 meeting of ASTM F04 Committee Division 04 at the NIST, Gaithersburg, MD the effect was powerful. "I sense a great deal of energy here" was a comment by Dr. Jack Parr, Wright Medical, Inc. The 85 attendees began the effort to develop a number of consensus standards. The interest and interaction with several government agencies was described by Dr. Kiki Hellman. Programs in Tissue Engineering are being funded through the National Science Foundation, National Institutes of Health and the National Institute for Standards and Technology. The U.S. Federal Food and Drug Administration has developed a focus in Tissue Engineered Products since 1994 with the InterCenter FDA Tissue Engineering Working Group. Participants from these agencies were on hand and active in the task groups.

The presentation by Dr. Frank Gentile, Reprogenesis, Inc., offered a "straw man" document, being developed through the Society for Biomaterials Tissue Engineered Special Interest Group, Chair Dr. Robert Valentini, Brown University, for products containing living cells. Jennifer Colbert, NIST, described the Standard Reference Materials NIST program as "Possibilities for Reference Materials in Tissue Engineering".

Using the prioritized areas, approximately 10 task groups were established to further define the approach. These task groups elected their leaders and are proceeding to work toward drafts of their documents for presentation to the F04 Committee in Atlanta, May 1998. Online forums at the ASTM web site (http://www.ASTM.org) are being set up to be used to comment and redraft by the task groups members.

Categories of the task groups are as follows:


General: Liability
Normal Biologic Function
Components: Products with living cells
In vivo delivery systems
Cellular-based products and growth factors
Scaffolds: materials, soft tissues, hard tissues
In Vivo: Preclinical testing (animal models)
In vivo interactions
Clinical outcomes and end-points

The Task Group List gives the task group and the names of the subcommittee Chairs and their email addresses. Each subcommittee needs and welcomes your participation and please contact the individual sub Chairs if you would like to volunteer to participate in this effort. As this is a consensus effort, it is only through participation of knowledgeable scientists that this effort can be successful.

Need for additional task groups or the regrouping of task groups may result in changes in order to cover the necessary areas and comments are welcome regarding needed changes. Contact either the task group chairs or the Executive Committee (pcj@tissueinformatics.com; KXH@CDRH.FDA.GOV; PiccioloGrace@Mail-Me.com).

The semi-annual meeting of the ASTM, May 6-8, 1998 at the Hilton Hotel in Atlanta, GA will host the task groups as they present their drafts of the standards that have been developed this winter, and continue the consensus process. The meeting will highlight presentations on new technologies that promise to impact on Tissue Engineered products development, such as cellular responses to combinatorial biomaterials, and gene therapy. To register for this meeting (no registration fee), please contact Barbara Lake, 610 832-9713 or blake@ASTM.ORG. Additional information can be found on the ASTM web site: http://www.astm.org in the Technical Meetings section for F04.

The Tissue Engineering Society will host its biannual meeting in Orlando, FL, Dec. 1998 at which an update on the standards activities will be presented.

For comments on the Tissue Engineered Medical Products Standards contact the site coordinator: PiccioloGrace@mail-me.com