Such calls for action have been heard over the past few years inside and outside Congress. We suggest a voluntary group com-posed of members of the public, medical doctors, manufacturers, and hospital administrators. ASTM is a voluntary group that develops standards manufacturers follow voluntarily. The acceptance of such voluntary standards created by members of the public, industry, and government is so widespread that FDA routinely refers to them. What is ideal about this group is that there is no cost to the public, the group has the knowledge to review new technologies, and it reaches effective decisions.
Members are experts in their fields and represent some of the best medical minds.
This group has established itself as an effective nongovernment organization, through which testing, materials, and performance standards are established for all products. Perhaps FDA should be assigned to assist such an organization on compliance issues and to leave the establishment of standards alone. Post them in our Regulatory Discussion Forum .