Current Risk Management For Medical Products
Although marketed medical products are required to be safe, safety does not mean zero risk. A safe product is one that has reasonable risks, given the magnitude of the benefit expected and the alternatives available. All parts of the health care delivery chain try to maintain this benefit-risk balance by making sure that products are developed, tested, manufactured, labeled, prescribed, dispensed, and used in a way that maximizes benefit and minimizes risk. The roles of each part of the healthcare system in product safety have evolved independently. Although each participant has a role in managing risks, no participant can be successful alone. Optimal safety can be accomplished only by an integrated system in which the roles and responsibilities, as well as capabilities and limitations, of each participant are known to all. Given the complexity of today's healthcare, our understanding of risk management must evolve from emphasis on the functions and responsibilities of freestanding groups (e.g., FDA, hospitals) to an understanding of product safety as a systems issue.
As discussed already in Part 1 and illustrated again below, recent concerns about the safety of medical products have focused on several types of risks, but often without distinguishing among the different types and their sources. Not all risks are the same. To effectively manage risks, it is necessary to identify the type of risk, the source, and the appropriate intervention. Each of the risks shown in the figure below needs to be managed differently, and by different components in an overall system.
A conceptual framework for risk management activities is needed to focus discussion. As explained below, a specific framework has been developed for other health and safety issues within the Federal Government. This part of the report analyzes FDA's safety efforts within this risk management framework, and also points out the role of other participants, although their roles are not extensively explored. This benchmarking approach helps identify potential weaknesses in the overall system and areas for improvements or changes to FDA's approach. The discussion also sets the stage for the possible creation of an overall systems model of medical product risk management that incorporates the roles of all components.