Medical consensus is a public statement on a particular aspect of medical knowledge available at the time it was written, and that is generally agreed upon as the evidence-based, state-of-the-art (or state-of-science) knowledge by a representative group of experts in that area. Its main objective is to counsel physicians on the best possible and acceptable way to diagnose and treat certain diseases or how to address a particular decision-making area. Therefore, it can be considered an authoritative, community-based consensus decision-making and publication process.
There are many ways of producing medical consensus, but the most usual way is to convene an independent panel of experts, either by a medical association or by a governmental authority. In the United States, for example, the National Institutes of Health promotes about five to six consensus panels per year, and organizes this knowledge by means of a special Consensus Development Program, managed by its NIH Office of Medical Applications of Research (OMAR). The statements are available in printed form as well as for downloading from the Internet (see link below).
Since consensus statements provide a "snapshot in time" of the state of knowledge in a particular topic, it must periodically be re-evaluated and published again, substituting the previous consensus statement.
Consensus statements differ from medical guidelines, another form of state-of-science public statements. According to the NIH, "Consensus statements synthesize new information, largely from recent or ongoing medical research, that has implications for reevaluation of routine medical practices. They do not give specific algorithms or guidelines for practice. Such policy decisions often depend on cost, available expertise and technology, and local practice circumstances."
Although FDA recognizes that many of the currently available biomaterials have vast utility in the fabrication of medical devices, the properties and safety of these materials must be carefully assessed with respect to the specific application in question and its degree of patient contact.
An important principle in the safety assessment of medical devices is that a material that was found to be safe for one intended use in a device might not be safe in a device intended for a different use.
Medical devices designated as Class II are devices for which general controls alone are not sufficient to ensure safety and effectiveness, but for which there is sufficient information to establish special controls to provide this assurance.
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