The AAMI Standards & Recommended Practices

AAMI standards come from a lengthy process.

According to the Association for the Advancement of Medical Instrumentation, its Standards and Recommended Practices provide guidelines for medical settings and the proper packaging, handling and sterilization of medical devices and instruments in the United States. Over 100 groups of technical experts design the SRPs, and many national and international agencies adhere to them. Though voluntary, the AAMI standards greatly influence the health care community and medical devices industry.

Philosophy

When creating standards, developers should focus on enhancing patient safety and welfare. The AAMI discourages competition in developing standards, but it can serve to improve technology for the benefit of the patient, and to increase the availability of medical devices. Standards should address only the essential requirements of a need that has received clear validation, such as through a risk assessment. Standards can serve as an important source for decision-making by manufacturers and end-users, but should not replace responsible decision-making.

Design and Development

The AAMI organizations that develop standards to work through the accepted international standards organizations already in place, such as the ISO, IEC and ITU, to avoid duplication. The AAMI encourages sector-based development and the use of a bottom-up strategy for collaboration and consensus among health care professionals, regulatory bodies and industry.

Each separate aspect of a product or service should involve only one internationally applied standard and one internationally accepted test. The test--appropriate to the setting and needs of the user--should indicate that the user's actions comply with the standard. The AAMI strongly discourages the practice of giving conflicting standard choices at any level.

In the case of insufficient basis or lack of consensus, technical reports can help. However, a fast-track approach or using consortia documents would negate the need for a high level of public due process and consensus, and ignore the complex safety, trade and regulatory issues involved. Also, government agencies should use voluntary standards and shouldn't be the dominant or exclusive participant in developing standards, funding standards activities and setting standards priorities.

Technology Considerations

AAMI standards require that organizations continually revise the standards for relevancy and to fully integrate technological advances. The basis of all standards should be consensus and the practical experience of end-users combined with published, peer-reviewed studies. Standards require input from the industry, and end-users in the medical professions. Governments should view standards as just one way to comply with regulatory requirements to encourage advances in technology, and standards should never undermine the best interest of patients or the intentions of manufacturers.

Limitations

The AAMI standards system has general limitations to consider. Standards assume end-users have experience and appropriate training as professionals, and know the proper time, manner and circumstances to use them. Standards should present the rationale behind a requirement, so users can understand why the requirement matters. When another means of resolution for a safety or performance issue seems more appropriate, professionals should use it.

References

• Association for the Advancement of Medical Instrumentation: About the Standards Program
• AORN Journal: Top 10 Things OR Nurses Should Know About the AAMI Standards
• American National Standards Institute: National Standards Strategy for the United States (First Edition--Approved August 2000)
• Association for the Advancement of Medical Instrumentation: Standards Philosophy and Strategy--Key Elements

Resources

• Association for the Advancement of Medical Instrumentation: Search AAMI Database