Part 4: Managing the Risks From Medical Product Use
Parts 2 and 3 of this report describe the Agency's premarketing and postmarketing risk assessment activities for medical products. These programs serve to identify the risks of the product. Once risks are identified, the highest level of safety can be achieved only if those risks are managed appropriately. Part 4 of the report takes a look at the existing system for managing medical product risks. The Commissioner asked the Task Force to look into how the Agency relates to the other groups involved in these activities. As already mentioned, many groups involved in healthcare delivery are active in medical product risk management.
The discussion in Part 4 explores the need for a new systems framework for medical use risk management that integrates the efforts of all involved parties. Recommendations and some options are listed at the end to provide a basis for future discussions with stakeholders on the design and implementation of such a new framework.