40 Years of People, Progress,

and Patient Safety

Jill Schlabig Williams

I
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 pro-
cesses 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 pro-
duced by the bypass pump.
e
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 ser-
viced 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
later it saw its first clinical application. Earl E. Bakken

Biomedical Instrumentation & Technology 27

 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 manu-
facturing industry that would build safe devices and de-
liver 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 medi-
cal 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, manage-
ment, use, and regulation of medical devices.
From these early efforts, through four decades of chang-
es 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.
28
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. Physician-
inventors 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 medi-
cal 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-mak-
ing scheme that involved the creation of a new organiza-
tion 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
January/February 2007
 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 (Ameri-
can 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 ea-
ger 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 ap-
plied earlier,” says Abele.
Physicians were also interested in the new organization. Many
were also inventors and were concerned that regulation, educa-
tion, 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 regu-
lation 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 medi-
cine 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 ar-
tificial 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.

Biomedical Instrumentation & Technology 29

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

All of us—Government, Science and Industry—have a vital stake in

A Message From the President
the health and vitality of America’s citizens and the world’s. If men
This telegram (image recreat-
are to enjoy longer, healthier lives, we must ensure that advances
ed, right) was received from
in the medical technology are applied quickly and effectively
the President of the United
in hospitals and clinics. Your efforts to broaden knowledge and
States at the opening of
establish high standards in medical instrumentation are immensely
MEDAC ’66:
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 dispropor-
tionate impact for its size.”
With so many huge names in medicine on its side, the
fledgling organization got off the ground quickly. Mer-
rill chaired AAMI’s medical advisory board, and Abele
chaired the manufacturers’ advisory board. A 1967 mem-
bership directory lists nearly 600 individual members and
nearly 100 corporate members.
1967: The Doctors Take Over
Through this early period, the marketing men who found-
ed 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 organiza-
tion, and decided to take over AAMI. In 1967, the doc-
tors 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
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 execu-
tive 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. Pub-
lication 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 Medi-
cine. 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 organiza-
tion. 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 for-
given,” 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.

30 January/February 2007

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 Wash-
ington, 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 inexperi-
enced 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 im-
pact 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 ensur-
ing 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
Biomedical Instrumentation & Technology
COVER STORY
Jill Schlabig Williams
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 bureau-
crats writing it.”
AAMI, under Harken’s leadership, organized a con-
ference in Bethesda, MD, in 1969 to address these con-
cerns. 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 mem-
bership and the industry outlining the importance of the
event, and raised an additional $100,000. Manufactur-
ers 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 confer-
ence—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
31
 COVER STORY
40 Years of People, Progress, and Patient Safety
event,” says Abele. “It was the first time that the presi-
dents 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 regula-
tion 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 pub-
lications. Following the conference, the Department
of Health, Education and Welfare organized the Study
Group on Medical Devices, chaired by Theodore Coo-
per, 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 founda-
tion 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 neu-
trality, playing a nonpartisan role as the facilitator of
discussions and not advocating for any one position. By
32
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 founda-
tion 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 is-
sued a new Good Manufacturing Practice (GMP) regula-
tion, 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
January/February 2007
 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 pa-
tient monitors, infant incubators, and ECG recorders
transitioning from vacuum tube technology to inte-
grated 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 or-
ganized 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 train-
ing programs for biomedical equipment technicians
(BMETs). In 1967, the Technical Education Research
Center (TERC), an independent, nonprofit research or-
ganization 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 cur-
riculum, 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 Dod-
son, who was running a successful medical equipment
support operation for the U.S. Air Force, to help them

Left: Bob Stiefel

Right: Burt Dodson

Biomedical Instrumentation & Technology 33

 COVER STORY
40 Years of People, Progress, and Patient Safety
develop training programs for biomedical equipment
technicians and eventually institute a certification pro-
gram 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, educa-
tion, or government, not hospitals. “Caceres felt that the
hospital needed the judgment and experience that clini-
cal 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 biomedi-
cal equipment technician. Hargest earned the first cer-
tification 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 certifica-
tions. “The title Certified Biomedical Equipment Tech-
nician (CBET) has long been the single most recognized
and universally accepted credential by which BMETs
can publicly demonstrate both their commitment and
Left: Herman D. Hubbard
Right: Thomas Hargest
34
achievement in their chosen profession,” says Michael E.
Carver of Premier Inc., himself a CBET who has partici-
pated 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 electri-
cal 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 pa-
tients were being accidentally electrocuted in U.S. hospi-
tals each year. In 1971 Ralph Nader published an exposé
on the issue in the Ladies Home Journal, and national at-
tention 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 ex-
hibit 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, some-
thing we all take for granted today.” In 1971, AAMI’s first
published standard focused on electrical safety.
The BMET profession has flourished. Today, the Bu-
reau 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
January/February 2007

equipment technicians and clinical engineers. They in
turn rapidly made up a large portion of AAMI’s mem-
bership.
Over the years, AAMI’s annual meeting content has
shifted to focus on the needs of the engineering commu-
nity, 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, Bio-
medical 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
COVER STORY
Jill Schlabig Williams
An early sterilization standards committee meeting.
made pacemakers, along with the giants of cardiac sur-
gery. He recounts this story as a measure of the power
of the people in that room: “When a manufacturer ex-
pressed concern about antitrust regulations, we put the
meeting on hold and someone called the Attorney Gen-
eral, 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 Interna-
tional 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 indus-
try 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 docu-
ments. “Suddenly, it was to industry’s advantage to par-
ticipate 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 stan-
dards development efforts.
35
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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. Na-
tional Standards. AAMI’s first recognized American Na-
tional Standard, “Safe Current Limits for Electromedical
Apparatus,” was published in 1978. The first AAMI stan-
dards 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 cardio-
vascular 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 equip-
ment, 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 work-
ing 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 in-
ternational 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 instru-
mentation. 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
36
changed as growth in the engineer and technician seg-
ments outpaced growth in physician membership. AAMI’s
consensus orientation led to the rise of other, more par-
tisan 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 organi-
zation 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 standards-
based education programs has added to AAMI’s stability,
and given the association the opportunity to consider
new initiatives like those by the Technology Manage-
ment 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 re-
mained 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 work-
ing together,” says Miller. “AAMI has made diversity
work for itself and others.”
This diversity will continue to serve AAMI, its mem-
bers, 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.
January/February 2007
 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 AAMI’s
the medical technology arena, reflect back on four de- 40th Anniversary
cades of achievements and changes in medical technol-
ogy, and explore the future direction of the field. Task Force
AAMI is seeking ideas from members on particular in-
dustry leaders, milestones, and key developments of the A 17-member 40th
last 40 years that deserve acknowledgement. anniversary task force
“Our upcoming anniversary provides an ideal oppor- has been formed to
tunity to reflect back on the advancements in medical help plan AAMI’s
instrumentation that have changed our world for the anniversary events.
better,” says Michael J. Miller, JD, president of AAMI. The members include:
“From those who develop medical devices to those who
keep them functioning safely and effectively, AAMI is John Abele
proud to serve as a unique resource for members who Bill Betts
represent a wide range of device-related interests.”
Burt Dodson
As part of its year-long celebration, AAMI will present
an “Evolution of Technology” museum in the expo hall at
Bob Flink
the AAMI 2007 Conference in Boston, June 16–18. The Thomas Hargest
museum will include photos, artifacts, and information Adrian Kantrowitz
about AAMI’s and the industry’s history. It will also in- Fran Koch
clude historical technologies on loan from AAMI 2007 Ray Laxton
exhibitors. David Link
Fittingly, the AAMI 2007 Conference returns to Bos-
ton, the scene of the first-ever AAMI annual meeting.
Mike Miller
That inaugural meeting was held in 1966, the year before Marcy Petrini
AAMI was officially established. John Post
Other highlights of the celebration will include a Gerry Rainer
publication that will reflect upon advancements in AAMI Bill Short
and the medical technology field in the last 40 years; sev- Chuck Sidebottom
eral profiles of device innovators throughout the year in
Bob Stiefel
AAMI News, and much more. Plans for other events and
recognitions are under way.
Larry Tanner
AAMI members who wish to submit information
about innovators, technology professionals, and mile-
stone events of the past 40 years for AAMI’s consider-
ation are encouraged to contact AAMI’s senior writer,
Jill Williams, at jwilliams@aami.org; or by calling (703)
525-4890, ext. 267.

Biomedical Instrumentation & Technology 37