Miller M J, Hammer G S
Med Instrum. 1975 Nov-Dec;9(6):278-80.
In summary, the AAMI approach enables the FDA to utilize all available resources needed to identify critical characteristics that should be subjected to standards; to develop rationale for those parameters that should not be subjected to standards; and to develop standards in those areas where standards should be developed. During the process, appropriate checks and balances are available because of AAMI's multidisciplinary approach, which is not available using other approaches. The AAMI approach is extremely participatory and, consequently, will result in the production of a standard that will be acceptable to the largest number of people without compromising critical safety and efficacy considerations.
总之，AAMI方法使美国食品药品监督管理局能够利用所有可用资源来确定应纳入标准的关键特性；为不应纳入标准的参数制定理由；并在应制定标准的领域制定标准。在此过程中，由于AAMI的多学科方法，能够进行适当的制衡，而其他方法则无法做到这一点。AAMI方法具有极强的参与性，因此将产生一个能被最多人接受的标准，同时又不损害关键的安全性和有效性考量。
