Approved by the AAMI Board of Directors, June 2007
The Association for the Advancement of Medical Instrumentation (AAMI) is a unique alliance of professionals and organizations dedicated to the understanding and beneficial use of medical device technology. AAMI members include health care institutions, research and teaching facilities, government agencies, manufacturers, test houses, trade associations and individual health care professionals.
AAMI and its members have assumed an important leadership responsibility in medical device standards worldwide. Over more than 40 years of developing medical device standards, the following have evolved as the guiding principles of the AAMI Standards Program:
1. Requirements should be performance-based; design standards should be avoided as they can limit innovation and restrict competition. Requirements should include a corresponding rationale to assist standards users in understanding the requirement, and to help avoid gratuitous requirements. Standards should allow for technology changes/innovation. As appropriate, proven test methods should be provided that standards users can follow to determine compliance with the requirements.
2. There should be “at most one globally applied standard and one globally accepted test, with conformity assessment processes appropriate to the needs of the parties, for each characteristic of a product, process or service.”1
3. National standards developing organizations (SDO) should not purport to be consensus international standards bodies. All interests should work through accepted international bodies such as ISO, IEC and ITU whenever possible to avoid duplication of effort and standards.
4. Standards are not the basis of competition; they are the basis of “good practices” in terms of patient safety and the basis of harmonizing marketplace, regulatory and other requirements to enhance the use of technology for the welfare of patients. Standards should enhance competition, commerce and the availability of devices and not be barriers to trade.
5. Standards are not the basis of competition; they are the basis of “good practices” in terms of patient safety and the basis of harmonizing marketplace, regulatory and other requirements to enhance the use of technology for the welfare of patients. Standards should enhance competition, commerce and the availability of devices and not be barriers to trade.
6. Standards should be based on current technology and consensus; they should not generally lead the state of technology, although exceptions may be necessary e.g. in cases where a standard is needed in order to introduce a system-wide technological innovation. To the extent possible, standards requirements should be based on published, peer-reviewed studies combined with practical experience from the user community.
7. Standards should be developed only where there is a clear need – validated e.g. by a risk assessment – and should address only essential requirements. Resources are limited and must be used wisely. A corollary of this statement is that standards are an important reference to responsible decision-making, but should never replace responsible decision-making by medical device manufacturers and users.
8. Governments should participate with other stakeholders in the setting of priorities for standards, in standards development and in funding standards activities. Governments should utilize voluntary standards in the regulatory process, but government should not be the exclusive or dominant agent in developing standards unless there are compelling circumstances.
9. Governments rarely have the resources to effectively and efficiently develop standards and keep them up to date (which is critical in a regulatory context). To be effective, such standards require strong input from industry and the professions, i.e., the developers and the users of technology. For these reasons, the voluntary consensus standards system should be seen by governments as a viable alternative to developing their own technical standards. A corollary of this statement is that SDOs have a major responsibility to assure that their standards are relevant to the current state of technology.
10. As standards in the health care field, regardless of how they are developed, rarely lead technology, their adoption as regulation may inappropriately preclude cutting edge technology, and become a barrier to innovation. Such barriers do not serve the best interest of patients, manufacturers or governments. Therefore, governments should view voluntary consensus standards as a way, but only one way, to demonstrate compliance with relevant regulatory requirements. However, when public health concerns mandate the adoption of standards, they should be incorporated by reference in regulation.
11. Duplication of effort should be avoided at both the national and international level. The concept of giving “choices” of conflicting standards to users of standards is a burdensome concept in a regulatory context. In addition, unnecessary duplication adds cost to the system and dilutes the consensus process by encouraging “forum shopping.”
12. A fundamental premise underlying effective voluntary standards in the health care technology field is that the user of the standard is a trained and experienced professional who knows when and how a standard should be used and understands the limitations, in general, of voluntary standards.
13. There are many instances where a standard is not the appropriate solution for a safety or performance issue and, in these instances, other means of resolution should be employed.
14. Technical reports are useful when there is insufficient basis or consensus for a standard. Documents that do not allow for full participation and consensus development (e.g., workshop agreements, fast-track adoptions, consortia documents), while of possible use to some industries, should be avoided in the medical area given the safety, regulatory and trade issues involved that require a high level of public due process and consensus.
Reference: National Standards Strategy for the United States; 2000, ANSI