Ethics of technology introduction

In the United States, the Food and Drug Administration has been charged with the job of determining the safety and effectiveness of new drugs and devices. It is a thankless task because there is no reward for taking a balanced risk approach, only criticism for taking too long or approving a product that subsequently has a problem. And making decisions in Washington D.C. that influence the physician's ability to 'do the right thing' for his or her patient regardless of local circumstances doesn't seem to be the socially responsible or ethical thing to do. Devices, of course, are very different from drugs. Their performance is strongly influenced by physician level of skill. A great deal of learning can be accomplished with models. Their mode-of-action can generally be tested before, during and after use. Imaging and accessory tools can significantly reduce risk and trauma as well as enhance their function. Advances in design and performance occur much more rapidly than with drugs. These and other factors suggest that a very different approach is warranted to evaluate their safety and efficacy, as well as to determine when it is ethical to use them on patients. There are many different categories of devices: complex or simple; high inherent risk or low; procedure specific or generic function; etc. Guidelines exist for regulatory approvals in these categories, but the 'bar has been raised' for approval to such an extent that physician, industry and patients groups are questioning the ethics of withholding or delaying the availability of technology and/or adding significantly to its cost without correspondingly significant benefits in reduction of risk.© (1995) COPYRIGHT SPIE--The International Society for Optical Engineering. Downloading of the abstract is permitted for personal use only.