Originally Published MDDI
August 2004
Industry Perspectives
AAMI: A Historical Perspective on Standards and Education
With an increasing focus on global standards, AAMI has helped the industry understand and participate in the standards-making process.
Michael J. Miller
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| Michael J. Miller, JD, is CEO of AAMI (Arlington, VA). |
During the 35 years I’ve been CEO at the Association for the Advancement of Medical Instrumentation (AAMI), the medical device field has experienced extraordinary changes as well as extraordinary challenges, opportunities, and innovations. One of those was the launch of
MD&DI in 1979. Throughout the last 25 years, it has played an important part in educating the medical device industry about AAMI standards and its programs.
As I examine both the past and the future of the device industry, I will address the following three perspectives:
• The changing environment and the challenges that have been resolved.
• How AAMI’s membership and programs have changed in response to the specific challenges and needs of the field.
• From the vantage point of some
recent research, how AAMI’s members perceive future challenges.
AAMI’s Mission
It is helpful first to understand AAMI’s purpose and the diverse membership that created and supported the
organization.
AAMI’s stated mission is to “provide global multidisciplinary leadership and programs that will enhance the ability of the professions, healthcare institutions, and industry to develop and effectively manage and use medical instrumentation and related technologies.”
Its membership currently consists of more than 3000 individual members from all healthcare fields; some 120 institutional members (hospitals, government agencies, trade associations, academic
institutions, and professional societies); and another 160 corporate members (mostly from the manufacturing industry). AAMI’s individual membership (which also includes representatives from organizational members) totals nearly 6000 professionals worldwide.
AAMI, a nonprofit, tax-exempt organization, serves this membership through a number of programs including publications, education, career guidance, certification, national and international standards, and other consensus and collaborative
activities.
Early Challenges
During the 1960s and through the 1970s, AAMI members faced a number of challenges, including the
imminent advent of medical device legislation and regulation in the United States. Designing legislation that would protect public safety and welfare without placing a stranglehold on continuing innovation often resulted in heated and divisive debates.
AAMI’s leadership saw an opportunity to bring all parties to a consensus on legislation through a forum where all interests would be heard with one common goal: fostering the best and safest medical technology. Consequently, in 1969, an AAMI conference, supported through funding from the National Institutes of Health, was convened with leaders from many fields.
This conference covered several topics, including education, hazards, research and development, standards, and the key elements of effective legislation. The outcome of this conference was a report issued by NIH director Theodore Cooper, MD, which outlined a practical context and framework for legislation that was ultimately approved in the 1976 medical device law.
The basic elements of this U.S. legislation exist today in a clear recognition of the significant differences between drugs and devices; provisions for general controls, standards, and premarket clearance; and a public policy of parity between the need for safety controls and advancing innovation in medical technology.
International Standardization
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Since then, a major aspect of AAMI’s membership and program emphasis has shifted from creating U.S. legislative concepts to developing international standards and educational and other programs that help members with national and global regulation. This global outlook has affected all of AAMI’s members.
In the 1980s, the association’s technical consensus and standards program became much more of a global activity as the vision of an integrated market in Western Europe moved closer to becoming a reality. A cornerstone of this
vision was the contemplated use of standards by the European Community. The principle of one standard, one test method (and uniform or convergent
regulations) adopted by all countries
became a new vision and, to some extent, a necessity. It’s not difficult to imagine the adverse effect on commerce
and patient safety if every country (and market) adopted conflicting standards and regulations. Words such as harmonization and convergence became
important to regulators, the device manufacturing industry, professionals, and patients.
In addition, as FDA contemplated an increasing use of voluntary standards, industry’s emphasis transitioned from national voluntary safety standards to standards that have a global effect on safety, regulation, and commerce. Because voluntary standards that are developed and used in a regulatory context have a much different significance than those developed and used in an unregulated field, it became clear that new goals, additional
resources, and a new national and international framework were needed for standards. (Important principles underlying AAMI’s standards program and the development and use of standards in a regulatory context are
outlined on AAMI’s Web site at www.aami.org/standards/philosophy.html.)
AAMI’s members believed that the foundation the organization had established in its national standards program could and should play a
significant role in the development of global uniform standards and related regulations. Through cooperative ventures worldwide, AAMI now administers important international-standards activities that have a major effect on commerce, regulation, and safety.
AAMI members have the opportunity to participate in and benefit from various standards-development activities, consensus mediums, education, publications, and other forms of communications in the following areas:
• Electromedical devices.
• Sterilization technology.
• Quality systems and risk
management.
• Cardiovascular implants.
• Active implantable medical devices.
• Biological evaluation of medical devices.
• Technical information reports, technology conference reports, and position statements on a wide range of issues of concern to the healthcare community.
• Networking among AAMI experts from many fields.
In a relatively short period of time, the world standards community has developed a comprehensive body of international medical device standards used worldwide as an important context for markets and regulation. (The AAMI Web site provides a reference source for these standards at
www.aami.org/standards.)
Regulation, standards, and the rapid pace of technology innovation, closely related to the developments in legislation, presented the need for increased focus on various types of education. AAMI now provides a diverse array of educational programs for government, industry, and other healthcare professionals related to important aspects of technology, standards, and regulation.
Education and More
Increasingly, regulatory issues (or quasi-regulatory issues, such as those arising from joint commission
guidelines used for accrediting U.S. hospitals) are as important to AAMI’s members in hospitals and other healthcare facilities as they are to the association’s manufacturing members. The regulation of insurance eligibility and level of coverage for new technologies, for example, affect hospital members as much as manufacturing members. In another context, FDA’s regulation of the reprocessing of medical devices is of concern to all AAMI members.
The number and complexity of medical technologies require an increasing amount of sophistication from technology managers in hospitals, industry, and government. This need has
resulted in the creation in 2004 of an AAMI Technology Management Council that represents all segments and fields involved with medical
technology management. The work of this new council encompasses technology management benchmarking,
career guidance, standards, certification, education, publications, and a host of other activities.
Strategic Direction
Recently, AAMI conducted a strategic assessment by asking leaders from all membership segments basic questions about AAMI’s strategic direction and about issues members felt were important over the next 5 years. Members also were asked how AAMI should respond to these issues. Several aspects of this survey are worth noting.
Members’ primary concerns relate to accessing and using new technologies and to increasing cost constraints. Many members feel strongly that technology management must improve to keep pace with the increasing benefits medical technology provides patients. There is strong support for AAMI’s vision, mission, and consensus and collaborative approach to challenges in the field. AAMI’s ability to bring together government agencies such as FDA and the Centers for Medicare Services, manufacturers, and the healthcare professions with an objective and cooperative intent provides a major service to all members and to the healthcare-delivery system.
AAMI will, of course, continue to evaluate and respond to the concerns of its members about the need to
advance technology management and respond to the challenges of new technologies and cost constraints.
While the challenges of the past have turned into the opportunities of today, new challenges are constantly emerging. One such challenge is the pace at which the U.S. standards system is moving in response to global standards needs and technology innovation. In a recent communication, AAMI has expressed its concern to the American National Standards Institute (ANSI, the organization that coordinates aspects of the U.S. voluntary standardization system) that a major revision of the national standards strategy is required. Basically, AAMI has stated that ANSI needs to provide more support to U.S. standards bodies that participate in and fund international standards development.
New technologies require new educational media. New educational technologies or media are offering delivery mechanisms that will bring program content to the healthcare professional rather than the professional traveling to the content. The new technologies present key opportunities to convey information and knowledge in a field where information and knowledge can mean a significant improvement in the quality of life of many patients.
A global regulatory framework is also evolving. Cooperative ventures between a number of national and
international organizations show great promise in making sure that harmonized or convergent regulations (and related standards and guidance documents) serve as an international sieve to screen unsafe products, rather than a dam blocking exciting new technologies.
Much progress has been made in this highly regulated field during the last 30 years. There were major incentives to advance safe and effective medical technology through such activities as education, standards, information, regulation, and interdisciplinary
collaboration 30 years ago. The incentives are even greater today. As a result, we all can be confident that over the next 35 years, patients will continue to benefit from extraordinary advancements and innovations in medical devices.
Copyright ©2004 Medical Device & Diagnostic Industry
