AAMI News February 2018

Colleagues Mourn the Loss of Two AAMI Founders

Two respected leaders critical to AAMI’s creation and success, W. Gerald Rainer and David Link, died at the end of 2017. Both men, who were good friends, were praised by colleagues for their leadership in the development of early medical device regulations.

W. Gerald Rainer

Gerald Rainer
Gerald Rainer

Rainer, a renowned Denver heart surgeon, died suddenly of natural causes on Nov. 14, the day after his 90th birthday.

Rainer was a dedicated AAMI member, attending many of the association’s earliest meetings and joining the Board of Directors in 1969. He later went on to serve as Board chair from 1972–1973, was the first chair of the AAMI Standards Board, and chaired the Harken Memorial Awards Committee well into the 21st century.

“Dr. Gerald Rainer was one of the many early leaders at AAMI who would take on any important responsibility that the association asked of him,” said Mike Miller, AAMI’s first president and CEO. “There were many times when we asked him to take on important responsibilities that were critically important to AAMI’s development and success in its very early years.”

Rainer also was “one of the most active AAMI supporters of efforts leading to the passage of the Medical Device Amendments of 1976,” according to attorney and consultant Larry Pilot, an expert on Food and Drug Administration (FDA) regulations and a longtime member of AAMI.

Rainer testified before a Senate subcommittee about this initial medical device legislation and worked tirelessly to make it relevant to the industry and patients. He was instrumental in the success of the 1969 Bethesda Conference, which served as the foundation for the Cooper report and an approach to regulation that did not unnecessarily restrict medical device innovation and use, according to former colleagues.

“He was one of a small number of prominent surgeons from the cardiovascular and orthopedic community who devoted their time and resources to ensure that the recommendations of the Cooper Committee were successfully codified into law and regulation,” Pilot said.

David Link
David Link

David Link

Following his death on Dec. 23 at the age of 87, Link was hailed by colleagues for his “common-sense” approach to regulation at the FDA and for his pioneering role in developing strong ties between the agency and AAMI.

In the early 1970s, Link set the tone for medical device regulation at the FDA as the first director of the agency’s Bureau of Medical Devices, which would eventually become the Center for Devices and Radiological Health. From 1974–1980, Link ushered critical amendments through Congress and provided essential guidance in the areas of quality control and validation.

During his time at the FDA, Link forged a strong partnership between the agency and AAMI. Link was a member of AAMI’s Board of Directors for many years, played an active role in AAMI’s standards program, and chaired AAMI’s government relations committee.

“One of the most important contributions that David made to AAMI was his and the FDA’s support for AAMI assuming the national and international secretariats for medical device sterilization activities,” Miller said. “This activity, in my opinion, was one of the most pivotal achievements in AAMI’s history, leading to new areas of membership, major new educational programs and publications, important new areas of standards development, and an impressive new presence in national and international arenas.”

After leaving the FDA, Link went on to manage the regulatory affairs, quality assurance, sales, and manufacturing functions at Cordis, Millipore, and Expertech, and served as an industry consultant for Boston Healthcar Associates.