The search for standards.

Abstract

The International Organization for Standardization (ISO) assigned the responsibility for developing valve standards to its technical committee on surgical implants. A sub-committee on cardiovascular implants and the working group for heart valves were formed more than 20 years ago. The working group has learned a great deal, not only from its experience with ISO, but most of all from the collaboration of its international experts representing science, engineering and manufacturing. The first valve standard was published in 1984, revised in 1989, and the next revision will probably be published in 1995. After the formation of this ISO working group in 1972, the U.S. Food and Drug Administration (FDA) developed regulations for the premarket approval of heart valves in the United States. The European Committee for Standardization (CEN) was subsequently formed and appointed a working group to develop heart valve standards for Europe. It rapidly became apparent that the lack of co-ordination and communication of three separate organizations writing documents with different requirements and tests would lead to inconsistent and conflicting requirements. The ultimate outcome could have been a threat to public welfare by limiting the availability of medical devices. The commitment to the harmonization of standards by CEN and ISO, and the recent FDA policy to participate actively in standards development, have greatly improved this situation. Past errors, omissions and inappropriate attitudes have often slowed the standards process or have resulted in incomplete standards. This learning experience, while painful, should point the way to more timely and complete standards development in the future.