What are AAMI and ISO?
American Association for Medical Instrumentation (AAMI), a not for profit American organization, writes standards for medical devices and is a country (USA) member of the International Standards Organization (ISO).
Why are they important?
The Federal Food and Drug Administration (FDA) references AAMI standards for evaluation of perfusion products submitted by manufacturers for approval for clinical use. Approved perfusion products are mostly referenced to ISO standards designation. Example: oxygenators are referenced as ISO 7199 standard. Globalization of standards is a reality.
What is our recent accomplishment?
Establishment of an approved ISO “Perfusion Checklist” authored by AmSECT’s AAMI Liaison.
Why be involved?
The perfusionist should have a major impact on quality and safety of perfusion products. AAMI is the major force behind ISO documents. AmSECT is the only major perfusion organization involved.
AmSECT’s Liaison to the AAMI
Richard Chan CCP