History Of Aami Bit Story

40 Years of People, Progress, and Patient Safety Jill Schlabig Williams

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n the mid-1960s, a group of pioneering physicians looked into the future and saw possibility. They realized that breakthroughs with transistors, plastics, and synthetic materials and modernized manufacturing processes had the potential to launch a Golden Age for medical devices, opening the door to treatments that only a few years earlier would not have been possible. They also knew that without vision and leadership, the doors to this promising future might never be fully opened. Without effective standards, appropriate regulation, and better coordination of the chaotic medical device Dwight Harken industry—then a plethora of small companies—brilliant medical devices might never achieve their full potential to save lives.

e Dwight Harken had already pushed the envelope to create new lifesaving devices. As a captain in the U.S. Army stationed in France, he performed successful cardiac operations by removing shrapnel and other projectiles in and around the hearts of soldiers injured in combat. In 1948, he carried out one of the first mitral valvuloplasties. In the 1960s, Harken developed and implanted a device to assist the heart’s pumping and an internal pacemaker, and was among the first to implant artificial valves.

e At Baylor University in Houston, TX, Arthur C. Beall, Jr., was developing an international reputation for his work. His efforts led to the creation of prosthetic heart valves, including the Beall valve that went on to become one Arthur C. Beall, Jr. of the most widely used prosthetic valves from 1965 until 1970. He was also a driving force behind the concept of using cardiopulmonary bypass during cardiac surgery, and developed filters that removed dangerous debris produced by the bypass pump.

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In Minnesota, a struggling electrical engineer named Earl E. Bakken was on the brink of throwing in the towel on his 10-year old company that serviced medical electronic equipment when a power outage in the Twin Cities changed the medical device industry forever. C. Walton Lillehei, MD, of the University of Minnesota had achieved success in treating infants suffering heart block by relying on AC-driven pacemakers, but the blackout rendered the machines useless and a baby died. The next day, Lillehei called Bakken and asked if Bakken’s struggling company, called Medtronic, could come up with something better. Four weeks later the world’s first wearable, external, battery-powered, transistorized pacemaker was handed to Lillehei. A day Earl E. Bakken later it saw its first clinical application. Biomedical Instrumentation & Technology

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COVER STORY 40 Years of People, Progress, and Patient Safety

These individuals, and others like them, realized that in order to bring new technologies and new treatments to patients, they would need to generate industrywide cooperation and interdisciplinary communication among those who would be able to help usher in this Golden Age. They would need the help of the physicians who inspired, invented, and used medical devices; the manufacturing industry that would build safe devices and deliver them to the point of care; engineering personnel who would maintain the devices; and a government eager to bring medical devices under its regulatory watch. Harken, Beall, Bakken, and other giants in the medical device industry would find themselves partners in 1967 in an effort to launch a fledgling organization that promised to help realize these goals. This organization, named the Association for the Advancement of Medical Instrumentation, would bring together a unique alliance of stakeholders involved with the development, management, use, and regulation of medical devices. From these early efforts, through four decades of changes and challenges, AAMI has used its resources to foster collaboration, education, communication, and consensus building, offering a forum where issues that threaten the advancement of medical instrumentation can be discussed and, in many cases, resolved so that patients can receive the best care possible. Hundreds of initiatives have been launched; thousands of professionals have been helped; and millions of patients around the globe have benefited from the work of AAMI and its members. In 2007, as AAMI celebrates its 40th anniversary, we find ourselves looking back. How and why did AAMI’s early leaders come together? What goals did they have, and how did they plant the seeds for the many programs that would sprout from their efforts? Please join us as we take a look back and see just how far AAMI has come.

1965: An Idea Catches On By 1965 the use of medical devices in patient care was expanding rapidly. Medical devices were having a major impact on patient outcomes, and many physicians had a very personal relationship with devices. Physicianinventors like Beall and Harken were struggling to find engineers to translate their ideas into lifesaving medical devices. At the same time, businessmen-engineers like Bakken and John Abele, who went on to found Boston Scientific, needed doctors to help their fledging medical device companies refine and market their products. Technicians in the armed services like Burt Dodson and Herman Hubbard were running organized medical equipment programs, but the concept hadn’t yet made its way into the private sector. Rumblings of problems with equipment safety in hospitals were laying the foundation for the full-blown electrical safety scare of the early 1970s. The FDA was looking closely at medical devices, trying to figure out how to regulate the technologies that were having such an impact on patient care. And, in Boston, MA, a group of marketers were hatching a money-making scheme that involved the creation of a new organization they named the Association for the Advancement of Medical Instrumentation. Robert D. Hall, Robert J. Allen, and their colleagues were in the advertising business and worked for small high-tech companies in the Boston area, recalls John Post, who served as AAMI’s first executive director. “They had an idea to start an expo and a journal with advertising, hoping to attract manufacturers of medical devices and make money,” says Post. They approached Abele, who was then working for a small medical device company, with their idea. The men realized that they needed to create a structure to attract physicians who could lend legitimacy to their efforts, so

Left: Robert J. Allen Center: AAMI’s first membership ad Right: An early board meeting

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COVER STORY Jill Schlabig Williams

in 1965 they filed the articles of organization to create AAMI and began recruiting physicians to serve on its board of directors. “Bob Hall came up with the name AAMI as a riff on the AAAS (American Association for the Advancement of Science),” says Abele. The men plied a green, pocket-sized pamphlet that described what AAMI was about, and succeeded in getting an article about the new organization in the New York Times. Companies were eager to attend AAMI’s first meeting. “Businessmen (and they were all men then) saw an opportunity for visibility, an opportunity to influence the practice of medicine and get their technologies applied earlier,” says Abele. Physicians were also interested in the new organization. Many were also inventors and were concerned that regulation, education, standards, and communications were not as they needed to be to perpetuate the flourishing development of exciting new technologies. They worried about how pending government regulation would affect innovation and development. And they saw the need for interaction between the stakeholders—doctors, industry, government, researchers, and engineers. AAMI was perceived as a vehicle through which diverse groups could achieve consensus on a number of issues that were defining the field. The first trade show, called MEDAC ’66, was a huge success. The meeting—and AAMI—attracted a great deal of attention. It was attended by then-FDA commissioner James L. Goddard, MD. President Lyndon B. Johnson sent a congratulatory telegram extending best wishes for a successful meeting. “It was a dynamite meeting,” says Abele. “The giants in medicine attended. Those were the people who changed the world.” Renowned surgeon Michael DeBakey, who developed the Mobile Army Surgical Hospital (MASH) concept and pioneered the artificial heart, debated possible artificial heart designs with Adrian Kantrowitz, MD. Other leading surgeons like Beall, Harken, John Merrill (the kidney transplant pioneer), and Warren Zeph Lane (a cardiac surgeon and inventor) took part in the meeting.

Michael DeBakey and Adrian Kantrowitz debated artificial heart designs. Shots from the first two MEDAC meetings, held in 1966 and 1967.

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COVER STORY 40 Years of People, Progress, and Patient Safety

A Message From the President This telegram (image recreated, right) was received from the President of the United States at the opening of MEDAC ’66:

All of us—Government, Science and Industry—have a vital stake in the health and vitality of America’s citizens and the world’s. If men are to enjoy longer, healthier lives, we must ensure that advances in

the

medical

technology

are

applied

quickly

and

effectively

in hospitals and clinics. Your efforts to broaden knowledge and establish high standards in medical instrumentation are immensely valuable to the nation. You have earned my thanks—and the gratitude of all whose lives will be lengthened by your work. I am delighted to extend greetings to the Association for the Advancement of Medical Instrumentation—and my best wishes for a successful and productive meeting.

—Lyndon B. Johnson

Fortunately for AAMI, these and other leaders in the field came on board to help the organization get started, taking positions as officers or directors. “These men were very skillful at manipulating the worlds of medicine and politics,” says Abele. “As a result, AAMI had a disproportionate impact for its size.” With so many huge names in medicine on its side, the fledgling organization got off the ground quickly. Merrill chaired AAMI’s medical advisory board, and Abele chaired the manufacturers’ advisory board. A 1967 membership directory lists nearly 600 individual members and nearly 100 corporate members.

1967: The Doctors Take Over Through this early period, the marketing men who founded AAMI were running the show behind the scenes, with help from executive director Post (on loan from Abele’s company) and his secretary. The organization, based in Boston, ran one more trade show—MEDAC ’67—and published several issues of the bimonthly journal Medical Instrumentation, which premiered in July 1966. Quickly, though, the physicians became more involved and more committed to the ideals behind the organization, and decided to take over AAMI. In 1967, the doctors reorganized the association and changed its by-laws to consolidate the power of the board. “The people who started AAMI rapidly lost control,” says Post. “I was hired by them, but then Art Beall and the others came on board. I remember a confrontation 30

with Bob Hall in his office. Bob said, ‘I want you to do this,’ and I said ‘I don’t work for you anymore. I work for AAMI.’ He backed away, and the organization went on.” “The real AAMI was created in 1967, despite the founding of the shell that existed prior to that time,” says Mike Miller, who came on board as AAMI’s chief executive officer in 1969 and still holds that post today. “It’s a real tribute to the strength and foresight of those early founders, who cared enough and valued the idea of AAMI enough to wrest the organization away and raise the money to keep it going.” The transition shook up the young organization. Publication of AAMI’s journal, Medical Instrumentation, was halted while the board found a new publisher—Williams & Wilkins of Baltimore—and a new editor—Harry S. Lipscomb, MD, of the Baylor University College of Medicine. The revamped journal reappeared in January 1969. AAMI’s third annual meeting—no longer called MEDAC— took place in Houston, TX, under Beall’s leadership. Significant financial problems plagued the organization. A 1967 financial review showed that AAMI carried a $58,000 debt, which the board rallied to eliminate. Beall and John Kimbell (from Baxter Labs) became AAMI’s chief fundraisers. “AAMI borrowed some money from individuals, and in many cases, those debts were forgiven,” recalls Abele. “Art Beall squeezed the arms of his corporate friends, and Medtronic and its founder, Earl Bakken, stepped in and saved AAMI many times.” By the end of 1969, they had erased the debt. January/February 2007

COVER STORY Jill Schlabig Williams

The board also moved to position AAMI for success in the new legislative climate that was emerging as FDA regulation of medical devices became inevitable. In 1969, they relocated the association’s headquarters to the Washington, DC, area and began a search for a permanent executive director. They found Mike Miller, who had a law degree and an association management background, with experience in lobbying and legislation. In hiring Miller, the board found an executive who would lead AAMI through the next four decades. “When we interviewed Mike, we could see that he got it, that he was able to see the horizon. Mike understood how to deal with all the constituencies of AAMI and their unique concerns and emotional biases,” says Abele. “During my early years, volunteer leaders were always there to provide guidance to a very young and inexperienced CEO,” says Miller. He describes those early days as ones of great challenge. “When I arrived at AAMI, two organizational lawsuits were pending. We had no money, we had no staff. Officers had to sign personal notes to make sure payrolls were met. In a sense, AAMI existed in the offices of its leaders.” Over the next four decades, AAMI—with its volunteer leaders and growing staff—managed to have a huge impact on the medical device field. Building on the efforts of its early leaders, the organization would go on to play key roles in regulation of medical devices, the emergence of the biomedical equipment technician and clinical engineering professions, and the creation of consensus standards that have taken on global importance in ensuring the safety of medical devices.

First Up: Medical Device Regulation AAMI’s board first turned its attention to the pending medical device regulation. In the 1960s, the specter of

government regulation of medical devices was looming over the community and was a key driver in AAMI’s formation. While the FDA was actively regulating drugs, it had not yet expanded its authority to medical devices. By the late 1960s, though, concern about device safety was prompting Congressional leaders to introduce bills on device regulation. The FDA was trying two legal cases, the “AMP Case” and the “DIFCO Case,” in which it was seeking authority to regulate medical devices the way it did drugs. A 1969 consumer protection message from President Nixon to Congress called for regulation of medical devices. “We doctors knew that regulation was inevitable,” says W. Gerald Rainer, MD, a heart surgeon and early AAMI board member. “We wanted to get in there and help write the regulation to ensure that it was sensible, that it did not hamstring physicians, and that it spoke to the issue of safety. We didn’t want politicians or bureaucrats writing it.” AAMI, under Harken’s leadership, organized a conference in Bethesda, MD, in 1969 to address these concerns. The National Institutes of Health (NIH) offered start-up funding for the conference, giving AAMI a grant of $20,000. Harken authored a letter to the AAMI membership and the industry outlining the importance of the event, and raised an additional $100,000. Manufacturers saw AAMI and its physician members as a means of helping to secure constructive legislation, and were eager to sign on to support the conference. Doctors, heavily dependent on devices and afraid that their promise could be throttled by government regulation, were also eager to participate. Leaders from all sectors were pulled into the conference—people from the highest levels of government, industry, and medicine. “This conference was a huge

Left: John Kimble Center: Warren Zeph Lane Right: Mike Miller

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event,” says Abele. “It was the first time that the presidents of every American Medical Association-recognized society were present in one room.” Virginia Knauer, special assistant to President Nixon for consumer affairs, opened the meeting with remarks that highlighted the government’s concerns over device safety. “To put the subject in perspective,” she said, “it has been pointed out that toilet valves must undergo several preclearances before they can be used. Yet a pacemaker inserted in the body to regulate the heart need not be tested or examined at all.” The 1969 conference had an impact on device regulation like no other meeting before or since. The report from AAMI’s conference, which included task force recommendations on device regulation, was published simultaneously in many major engineering, medical, industrial, nursing, and other journals and trade publications. Following the conference, the Department of Health, Education and Welfare organized the Study Group on Medical Devices, chaired by Theodore Cooper, MD, director of the National Heart and Lung Institute. The group’s report—the Cooper Committee Report—built on the AAMI report and laid the foundation for the ultimate regulation. Beall, Rainer, and other AAMI leaders literally wrote sections of the legislation. They pulled in experts like David Link, who would eventually become director of the FDA’s Center for Devices and Radiological Health, and Larry Pilot, a leading attorney, to continue AAMI’s efforts to track the legislation as it moved forward and eventually was enacted into law as the Medical Device Amendments of 1976. Throughout this period, AAMI maintained its neutrality, playing a nonpartisan role as the facilitator of discussions and not advocating for any one position. By

capitalizing on its unique membership mix—an alliance of physicians, manufacturers, engineers, and others with an interest in medical devices—AAMI was able to bring different factions together to advance the field. AAMI would play this role again and again, laying the foundation for its success on future government programs. In 1990, when the Safe Medical Devices Act required user facilities to begin reporting adverse events to the FDA, AAMI commented extensively on the regulation and, after its passage, sponsored a series of seminars to educate the user community about the new requirements. Similarly, AAMI held a series of seminars on reuse of single-use devices when the user community was affected in the late 1990s by new FDA requirements. The 1990s would also bring a new role for AAMI in the realm of government regulation. When the FDA issued a new Good Manufacturing Practice (GMP) regulation, which lays out strict requirements for medical device manufacturers, the agency turned to AAMI to help with its implementation. In this groundbreaking effort, AAMI and others created a process where FDA and industry learned together what meeting the new regulation would require. AAMI’s government education program grew out of this effort and is now a mainstay of the association.

The Next Step: Who’s Watching the Devices? AAMI’s early physician leaders knew that the engineering community was a hugely important partner in the effort to ensure the safety of medical instrumentation. Their services were badly needed in hospitals to manage the rapidly growing number of devices that were becoming so central to patient outcomes. “Our concern was that we had a lot of people using this complex instrumentation, but nobody was maintaining it,” says Abele.

Left: Larry Pilot Center: David Link Right: W. Gerald Rainer (left) and William Mallette

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COVER STORY Jill Schlabig Williams

Bob Stiefel, now a prominent clinical engineer, shared those concerns. In the mid-1960s Stiefel was an engineering student and held his first job in a hospital handling centrally distributed medical equipment. “I had a nagging feeling that somebody in the hospital ought to be keeping a closer eye on that equipment,” he says. He was seeing first-generation devices like patient monitors, infant incubators, and ECG recorders transitioning from vacuum tube technology to integrated circuits. Equipment service was provided almost exclusively by manufacturers, and hospitals struggled to get their hands on service manuals and spare parts. Few hospitals had engineers on staff, and even fewer had organized medical equipment maintenance programs. “The hospitals had no idea how much it cost them to maintain instruments or how to do it,” says Abele. “So AAMI told them.” AAMI’s early leaders helped develop the first training programs for biomedical equipment technicians (BMETs). In 1967, the Technical Education Research Center (TERC), an independent, nonprofit research organization based in Cambridge, MA and funded by the U.S. Office of Education, developed a two-year post high school curriculum for BMETs. AAMI helped the center conduct a study of the need for biomedical equipment technicians in the health fields, improve the BMET curriculum, and set up pilot teaching programs. “The program was developed under an Office of Education grant, but nobody checked to see if there was a market need,” says Abele. “As a consultant to TERC, I convinced them to redirect some of that funding to AAMI to do some research and selling of hospitals on the need for BMETs.” In the early 1970s, Abele and others recruited Dodson, who was running a successful medical equipment support operation for the U.S. Air Force, to help them

Left: Bob Stiefel Right: Burt Dodson

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COVER STORY 40 Years of People, Progress, and Patient Safety

develop training programs for biomedical equipment technicians and eventually institute a certification program to solidify the growth of this new profession. “The defining factor in AAMI’s relationship with and programming for BMETs was the development of the BMET certification exam by Col. Burt Dodson in the early 1970s,” says Mike Miller. “He had a major role in training Air Force BMETs and took his knowledge and developed and tested the first BMET exam for AAMI.” AAMI was also a leader in advancing the role of clinical engineers in hospitals. Another early AAMI leader, Cesar Caceres, MD, coined the term “clinical engineer.” “He realized that the term ‘biomedical engineer’ did not truly describe what clinical engineers were doing in hospitals,” says Thomas Hargest, who would eventually become the first clinical engineer certified under AAMI’s program. Biomedical engineers typically work in industry, education, or government, not hospitals. “Caceres felt that the hospital needed the judgment and experience that clinical engineers provided.” AAMI launched the BMET certification program in 1971, and the clinical engineering certification program followed closely behind in 1973. In 1972 Herman D. Hubbard of Fitzsimons Army Hospital in Aurora, CO, became the first person designated a certified biomedical equipment technician. Hargest earned the first certification as a clinical engineer in 1974. A certification program for radiation equipment specialists was added in 1979, and another for laboratory equipment specialists in 1981. Today, more than 6,000 people hold AAMI certifications. “The title Certified Biomedical Equipment Technician (CBET) has long been the single most recognized and universally accepted credential by which BMETs can publicly demonstrate both their commitment and

achievement in their chosen profession,” says Michael E. Carver of Premier Inc., himself a CBET who has participated in the certification process for more than 20 years. “In the credential-oriented U.S. healthcare environment, the letters CBET engender confidence, mutual respect, and acceptance by other healthcare professionals.” The electrical safety scare of the early 1970s helped to solidify the importance of the BMET and clinical engineering professions. While concerns about electrical safety in hospitals had been prevalent throughout the 1960s, it was not until 1969 that the concerns began to gain public attention. “In 1969, the electrical safety scare was promulgated by Dr. Carl Walter in a series of major articles and television broadcasts,” says Abele. Walter, a well-known surgeon at the time, asserted that 1,200 patients were being accidentally electrocuted in U.S. hospitals each year. In 1971 Ralph Nader published an exposé on the issue in the Ladies Home Journal, and national attention focused on the issue. Many hospitals developed in-house medical equipment management programs for the first time in response to these concerns. AAMI played a leading role in responding to the scare. Leaders launched a series of electrical safety education programs and created a traveling electrical safety exhibit to educate medical audiences about the issue. “The exhibit was taken to many medical meetings to educate the doctors,” recalls Post. “The message was as basic as the importance of using a three-prong, grounded plug, something we all take for granted today.” In 1971, AAMI’s first published standard focused on electrical safety. The BMET profession has flourished. Today, the Bureau of Labor Statistics estimates that 29,000 people are employed as BMETs. With its early efforts to develop the profession and the growing importance of its certification program, AAMI provided an early home for biomedical

Left: Herman D. Hubbard Right: Thomas Hargest

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COVER STORY Jill Schlabig Williams

equipment technicians and clinical engineers. They in turn rapidly made up a large portion of AAMI’s membership. Over the years, AAMI’s annual meeting content has shifted to focus on the needs of the engineering community, as have many of its publications. The research-based journal Medical Instrumentation was at first supplemented by the engineering-focused Biomedical Technology Today. They eventually merged to form today’s journal, Biomedical Instrumentation & Technology. Numerous regional meetings and stand-alone educational courses have also served the engineering community, as have dozens of targeted books and other publications. In 2004, AAMI launched the Technology Management Council to develop new services to meet the needs of its BMET and clinical engineering members, including a project currently in development that would create benchmarks to help clinical engineering departments evaluate their performance, procedures, and policies.

Focus on Patient Safety Leads to Standards Work Concern about patient safety was also a driver in AAMI’s medical device standards development program. In the mid-1960s, many new devices were being introduced into the hospital environment. While most of these were well-designed and reliable, some were not. Hospital infrastructures were sometimes unable to support these devices, with inadequate electrical systems and facilities. Hospital personnel needed significant training to use the devices, and even much of the test equipment for devices that we take for granted today had not yet been designed. The association’s early standards work featured forums of doctors, engineers, and company representatives who met to discuss the basic parameters of device safety and efficacy. That first MEDAC meeting had several sessions on standards development led by neurosurgeon Charles D. Ray. These standards efforts were very different from what we know today. Early on, the groups were hesitant to commit their ideas to paper out of concern of legal liability. There were also concerns that the government would take up the standards development effort, issuing requirements that would hamper device development. Industry leaders were heavily involved in these early standards committees. Abele, who chaired the first standards meeting on pacemakers in 1966, recalls it as a gathering of all the presidents of the companies that Biomedical Instrumentation & Technology

An early sterilization standards committee meeting.

made pacemakers, along with the giants of cardiac surgery. He recounts this story as a measure of the power of the people in that room: “When a manufacturer expressed concern about antitrust regulations, we put the meeting on hold and someone called the Attorney General, Bobby Kennedy, for an opinion on the issue.” They avoided antitrust concerns by focusing their discussions on device performance rather than design, a distinction that has proven fundamental to standards work. Rainer was also active in early standards efforts. He attended the first European Congress on standards in Lausanne, Switzerland, in 1972, and an early International Organization for Standardization meeting in London. “I remember when ANSI [American National Standards Institute] decided to take on medical devices,” he says. “They put the pacemakers in between ‘screws’ and ‘concrete.’ It took some time for us to persuade them to let AAMI handle those items.” It took many years for the standards program to evolve. “In the early years, companies were reluctant to support the publication of standards,” says Miller. “The FDA tried to write standards, contracting with private agencies like ECRI, but most of those standards did not work well. It is very hard to write standards unless industry is at the table helping to write them.” Standards development got a huge boost in the 1980s when the European Community declared its reliance on standards as a form of regulation in its organizing documents. “Suddenly, it was to industry’s advantage to participate in these efforts and harmonize standards across different markets,” says Miller. The FDA also came to acknowledge that standards were an inexpensive form of regulation and began strongly supporting private standards development efforts. 35

COVER STORY 40 Years of People, Progress, and Patient Safety

AAMI, with its existing standards program, strong reputation as a consensus-building organization, and diverse membership, was ideally positioned to develop medical device standards. The association was accredited by ANSI in 1977 as a standards developing organization and quickly became a leader in the creation of U.S. National Standards. AAMI’s first recognized American National Standard, “Safe Current Limits for Electromedical Apparatus,” was published in 1978. The first AAMI standards book, published in 1985, contained 21 standards and recommended practices. As the importance of international harmonization of standards grew, AAMI expanded its efforts into the global arena. A formal decision by AAMI’s board in 1989 to expand the international standards program laid the groundwork for this effort. By the mid-1990s, AAMI had assumed international secretariats in the areas of cardiovascular implants, sterilization, electromedical devices, and quality systems and had solidified the international reputation of its standards development program. AAMI’s standards work has had a huge impact on patient safety in such areas as sterilization, electromedical equipment, dialysis, biological evaluation of medical devices, and cardiovascular implants. AAMI today also plays a leading role in the promulgation of quality systems standards for the manufacture and development of medical devices. AAMI now administers 110 committees and working groups that develop U.S. positions on international standards and develop/approve American National Standards. AAMI also administers secretariats for five international committees or subcommittees and 85 international working groups.

AAMI Today: Looking to the Future From 1967 to 2007, AAMI as an organization has come a long way. From its early beginnings operating out of the offices of its volunteers with a skeleton staff and a large debt, AAMI has grown into a stable association with a bright future. It is now a unique alliance of more than 6,000 members united by the common goal of increasing the understanding and beneficial use of medical instrumentation. It relies on a staff of 35 professionals and has annual revenues in excess of $10 million. Over the years, AAMI’s membership makeup has

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changed as growth in the engineer and technician segments outpaced growth in physician membership. AAMI’s consensus orientation led to the rise of other, more partisan groups that splintered off to represent the interests of particular membership segments in the 1970s, but also positioned AAMI for success in key areas like standards and government programs. The success of its standards program put the organization on a firm financial footing for the first time in the mid-1980s, and a reorganization in 1991 helped refocus AAMI’s priorities and position it for major growth. The success of its more recent regulation- and standardsbased education programs has added to AAMI’s stability, and given the association the opportunity to consider new initiatives like those by the Technology Management Council and a possible role in cost reimbursement for medical devices. Rainer, one of those early physicians, says that AAMI has followed a perfectly natural evolution to what it is today. “Its key focus was always to promote safety,” he says, “First through regulations, then through standards and education. By creating forums through the years in which people could get together and talk, AAMI has remained true to its mission.” Abele, another founder, agrees. “AAMI has provided an amazing way of connecting people who usually don’t connect,” he says. “There are many services that can only be created by engineers, industry, and the healthcare professions working together,” says Miller. “AAMI has made diversity work for itself and others.” This diversity will continue to serve AAMI, its members, and the medical device field in the future, says Miller. As AAMI and its members look forward to the next 40 years, they can continue to rely on the principles that have guided the organization through its first 40. “The importance of medical technology in healthcare is growing, and the need for AAMI members is greater than ever,” says Miller. “This need will take different forms in the future, but the need for interaction between the stakeholders to ensure that resources are in place to guide and avoid restricting technology will remain.” n Jill Schlabig Williams is AAMI’s senior writer.

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COVER STORY Jill Schlabig Williams

Special Events to Mark AAMI 40th in 2007 AAMI is celebrating its 40th anniversary this year with a series of special events and recognitions throughout 2007. Through a commemorative pictorial publication, articles in AAMI publications, and special events, AAMI will honor the historical achievements of individuals in the medical technology arena, reflect back on four decades of achievements and changes in medical technology, and explore the future direction of the field. AAMI is seeking ideas from members on particular industry leaders, milestones, and key developments of the last 40 years that deserve acknowledgement. “Our upcoming anniversary provides an ideal opportunity to reflect back on the advancements in medical instrumentation that have changed our world for the better,” says Michael J. Miller, JD, president of AAMI. “From those who develop medical devices to those who keep them functioning safely and effectively, AAMI is proud to serve as a unique resource for members who represent a wide range of device-related interests.” As part of its year-long celebration, AAMI will present an “Evolution of Technology” museum in the expo hall at the AAMI 2007 Conference in Boston, June 16–18. The museum will include photos, artifacts, and information about AAMI’s and the industry’s history. It will also include historical technologies on loan from AAMI 2007 exhibitors. Fittingly, the AAMI 2007 Conference returns to Boston, the scene of the first-ever AAMI annual meeting. That inaugural meeting was held in 1966, the year before AAMI was officially established. Other highlights of the celebration will include a publication that will reflect upon advancements in AAMI and the medical technology field in the last 40 years; several profiles of device innovators throughout the year in AAMI News, and much more. Plans for other events and recognitions are under way. AAMI members who wish to submit information about innovators, technology professionals, and milestone events of the past 40 years for AAMI’s consideration are encouraged to contact AAMI’s senior writer, Jill Williams, at [email protected]; or by calling (703) 525-4890, ext. 267.

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AAMI’s 40th Anniversary Task Force A 17-member 40th anniversary task force has been formed to help plan AAMI’s anniversary events. The members include: John Abele Bill Betts Burt Dodson Bob Flink Thomas Hargest Adrian Kantrowitz Fran Koch Ray Laxton David Link Mike Miller Marcy Petrini John Post Gerry Rainer Bill Short Chuck Sidebottom Bob Stiefel Larry Tanner

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