American Institute of Medical and Biological Engineering - AIMBE

Editor’s note: There has not been much news from the USA in IFMBE News recently. Below, however, is an excerpted presentation made by AIMBE Executive Director Kevin O’Connor at the AIMBE Council of Societies Summit Meeting, 7 November, 1998. It provides a look into the business of the AIMBE and describes its efforts to become a unified voice for the biomedical engineering community in the USA. Included in this issue there is an announcement for the Second BECON conference of NIH.

Welcome to the Third Summit Meeting of the AIMBE’s Council of Societies. I will say a few words about the AIMBE, highlight some of the public policy issues that are of interest to us and the Society members, and highlight why this summit is important to the AIMBE.

The AIMBE was established in its present form in 1991, and opened its Washington Office in January 1995. Our bylaws tell us what our mission is: to promote public awareness of medical and biological engineering; to establish liaison with government agencies and other professional groups; to improve intersociety relations; to promote the national interest in science, education, and engineering; and to recognise individual and group achievements. In addition to the Council of Societies, our membership consists of the College of Fellows, now more than 400 top individuals in the field; the Academic Council, numbering 60 university-based graduate programs; and the Industry Council, made up of individuals and companies in the field.

Since the opening of the Washington Office, the AIMBE Board of Directors has addressed many topics. Of these, three public issues have been predominant: (1) Food and Drug Administration (FDA) reform of medical device regulation; (2) biomaterials availability; and (3) bioengineering at the National Institutes of Health (NIH). In all three areas, thanks to the concerted efforts of AIMBE members, we have had a lot of impact.

The topic of FDA reform was on the front burner when we opened the office in 1995. The AIMBE Annual Event that year focused on medical device regulation, and the laborious and lengthy processing of device applications. At that meeting, we heard from former vice president Dan Quayle, Rep. David McIntosh, and a number of FDA officials. Following that meeting, the AIMBE, under the leadership of the late and much-missed Pierre Galletti, developed two white papers addressing medical device regulation. The AIMBE was later invited to testify at a hearing of the House Government Operations Committee. When legislation finally made its way through Congress, AIMBE members and constituent societies were involved in letter-writing campaigns advocating what later became the FDA Modernization Act, which was passed by Congress and signed into law in 1997.

The issue of biomaterials availability has been with us the past two Congresses. In the 104th Congress, legislation to provide tort relief to the suppliers of raw materials used in the construction of medical devices passed both houses of Congress, but was vetoed by President Clinton. For the 105th Congress, the AIMBE, along with the Health Industries Manufacturers Association and the Center for Patient Advocacy, chaired PROJECT ACCESS, a coalition of 41 organisations representing consumers, researchers, and industry. A number of our Societies, notably the Society for Biomaterials and the American Society for Artificial Internal Organs, were very active in this very successful coalition effort. The AIMBE, through the coalition, arranged two meetings with House Speaker Newt Gingrich and chaired a presentation to the staff of Senate Majority Leader Trent Lott. Our message: Keep the biomaterials bill separate from other product liability legislation, and schedule the bill for a floor vote. Our efforts succeeded when the House and Senate both passed the Biomaterials Access Assurance Act in late July, which was signed into law by President Clinton on 12 August, 1998.

Bioengineering at NIH has been a long and continuing issue for the AIMBE. We have come such a long way but have much more work to do. Following the passage of legislation in 1993 that required the Department of Health and Human Services (HHS) to provide a report to Congress on federal programs in bioengineering, an External Consultants Group (including AIMBE Fellows Robert Nerem as chair, Peter Katona, and Shu Chien) developed a report that to this day guides the AIMBE policy in this area. The report recommended that NIH establish a central focus for basic bioengineering research, and that NIH should expand representation of medical and biological engineers on advisory groups and study sections. One of my first tasks as AIMBE’s Executive Director was to encourage HHS to release its final report to the requesting congressional committees. With the report in hand, Senator Bill Frist (R-TN) gave a memorable keynote address at AIMBE’s 1997 Annual Event, where he pledged to introduce legislation addressing bioengineering at NIH. He did so in July, and invited AIMBE testimony at a Senate hearing addressing co-ordination of research at NIH. In 1997, NIH established a Bioengineering Consortium (BECON), which has served as a good in-house champion for bioengineering at NIH. Earlier this year, BECON held a two-day Symposium on bioengineering attended by more than 700 people. Efforts are underway now for BECON’s next symposium, to be held in 1999 on the topic of biomedical engineering, and I am happy to report that NIH has invited the AIMBE to cosponsor this meeting. This past Congress, we have seen the introduction of four bills that address the conduct and organisation of bioengineering at NIH, and several of our societies (notably ASAIO and the American Society for Mechanical Engineering’s bioengineering division) have developed public policy positions on the subject. This issue will be with us again in the 106th Congress.

So why is this, the third Summit of the Council of Societies (CoS) an important one for the AIMBE? One need only review the brief history of CoS to see that this section of the AIMBE is maturing. The first summit, held in Virginia in 1994, occurred before the opening of the AIMBE Washington Office and focused on AIMBE’s organisation. The second summit, held here in Minneapolis in 1996, focused on the structure, function, and communications between the Societies and AIMBE. This summit looks at these past issues, but also adds a layer of policy items for the Societies to address and focuses on building a public policy agenda with the AIMBE.

Since I was not here at the time, it is easy for me to tout the genius you all had in forming this organisation. Each of the four membership groups brings a particular strength to our operations. In the case of the Council of Societies, your strength is both in sheer numbers (15 Societies representing 30,000 researchers and engineers) and in the breath of experience you bring from the many technical perspectives found in our many Societies.

The CoS also represents a still largely untapped resource, given the size and numbers we represent. Since the AIMBE is staffed by only two individuals, we rely greatly on liaisons on coalitions to obtain information, develop expertise, and to do the work that it embodies in our mission statement. The issues we have addressed to date, and the increasing need to provide information tomorrow, makes the CoS an invaluable resource to AIMBE.

For more information see:

AIMBE website: http://fairway.ecn.purdue.edu/BME/societies/AIMBE/