1984 — The Medical Device Reporting regulation was published, requiring manufacturers to report device-related incidents to the FDA.
1986 — Lt. Col. Burt Dodson, Jr. received the first AAMI Leadership Award.
1990 — The Safe Medical Devices Act required user facilities to report device incidents to the FDA.
1991 — The first annual clinical engineering management seminars were held.
1992 — The AAMI certification program introduced a three-year renewal process to add value to and increase the credibility of the CBET, CRES, CLES and CCE programs.
1993 — AAMI was named secretariat for a new ISO committee on quality management.
1996 — AAMI was assigned secretariat duties for IEC/SC 62A, Common Aspects of Electrical Equipment Used in Medical Practice.
1997 — The FDA Modernization Act was signed into law, and a new quality system regulation took effect.
1998 — AAMI was assigned secretariat duties for the new ISO/TC 150/SC 6, focusing on active implants.
1999 — The AAMI/FDA Conference on the Reuse of Single-Use Devices and New Industrial Sterilization Course was held.
2000 — The Institute of Medicine published the seminal report “To Err is Human,” which linked medical errors to as many as 98,000 deaths each year.
2001 — AAMI began offering standards and other technical documents in electronic formats.
2002 — AAMI introduced three new courses: Industrial Sterilization for Medical Devices; Risk Management for Medical Devices; and Corrective and Preventive Action Requirements and Industry Practice.
2003 — AAMI launched its Technology Management Council (TMC).
2005 — AAMI’s TMC initiated a benchmarking project for clnical engineering departments.
2006 — AAMI launched an online community for members to get Joint Commission-related news and resources and to share their experiences.
Mary Logan
2009 — Mary Logan became AAMI’s second president/CEO in April.
2010 — The Infusion Device Summit, a joint venture of AAMI and the FDA, was held Oct. 5–6.
2011 — AAMI coined the term “health care technology management” (HTM) at the Future Forum in April.
2011 — On Oct. 11–12, leaders from industry, regulatory bodies, and associations, as well as clinicians, patient safety officers, researchers and others attended the AAMI/ FDA Medical Devices Reprocessing Summit.