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AAMI

The Association for the Advancement of Medical Instrumentation (AAMI) is a nonprofit organization founded in 1967 as a global leader in developing consensus-based standards to enhance the safety, efficacy, and management of medical devices and healthcare technologies.^[1] With nearly 15,000 individual and corporate members, including professionals from healthcare, industry, and government, AAMI serves as an alliance dedicated to advancing the development, safe use, and regulatory harmonization of medical instrumentation worldwide.^[2] Accredited by the American National Standards Institute (ANSI), AAMI's standards development processes follow rigorous, transparent procedures to produce documents that guide sterilization, biocompatibility, risk management, and human factors engineering in healthcare settings.^[3] Beyond standards, the organization hosts educational events, publishes resources, and fosters mentorship programs to support healthcare technology management (HTM) professionals in training the next generation of experts.^[4] AAMI's work influences international regulations, such as those from the FDA and ISO, ensuring that medical technologies meet high benchmarks for patient safety and innovation.^[5]

Overview

Mission and Purpose

The Association for the Advancement of Medical Instrumentation (AAMI) was established in 1967 as a nonprofit organization dedicated to advancing the development, management, and safe use of medical technology through the creation of standards, educational programs, and advocacy efforts.^[1] This founding mission emphasizes improving patient care by enhancing the safety and effectiveness of health technologies, serving as a foundational commitment to bridging innovation with reliability in the healthcare sector.^[1] Central to AAMI's purpose is the promotion of consensus-based standards for medical devices, health information technology, and related technologies, aimed at bolstering patient safety and ensuring regulatory compliance across global healthcare systems.^[1] By facilitating collaboration among diverse stakeholders, AAMI fosters a unified approach to addressing technical challenges, thereby reducing risks associated with medical equipment and supporting the integration of emerging technologies into clinical practice.^[6] AAMI unites a diverse community of over 15,000 healthcare professionals, manufacturers, and regulators from more than 70 countries (as of 2025), creating a platform for shared knowledge and collective problem-solving.^[2] Key goals include promoting interoperability among medical devices to enable seamless data exchange and system integration, implementing robust risk management practices for health technologies, and tackling emerging threats such as cybersecurity in medical systems to safeguard patient data and device functionality.^[6] These objectives reflect AAMI's ongoing evolution to meet contemporary challenges while upholding its core commitment to health technology safety.^[1]

Organizational Structure

The Association for the Advancement of Medical Instrumentation (AAMI) operates as a 501(c)(6) nonprofit organization headquartered at 901 N. Glebe Road, Suite 300, in Arlington, Virginia.^[7]^[8] This status enables AAMI to focus on advancing medical technology through collaborative efforts without profit motives, supporting its role in standards development and professional support for the healthcare sector. AAMI's organizational framework features key divisions that drive its core activities. The standards development division encompasses over 170 volunteer-led committees and working groups, which address specialized areas such as sterilization processes, biocompatible materials, and health technology management (HTM).^[9]^[10] Complementing this, the AAMI Credentials Institute (ACI) manages certification programs for professionals, including biomedical equipment technicians (CBET®) and clinical engineers (CCE®), ensuring competency in medical device maintenance and safety.^[11] Additionally, the AAMI Foundation, a separate 501(c)(3) entity, supports charitable initiatives like scholarships and professional development grants to advance health technology education and innovation.^[12] Central to AAMI's operations is its professional staff, led by President and CEO Pamela Arora, who oversees coordination of standards development, educational programs, certification services, and events like the annual AAMI eXchange conference.^[13] This leadership ensures seamless integration across divisions, aligning domestic efforts with global standards. AAMI maintains close ties with international bodies, including the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), by designating many of its committees as U.S. Technical Advisory Groups (TAGs) to ISO/IEC technical committees and subcommittees, such as IEC/SC 62 for medical equipment.^[10]^[14] This structure facilitates the harmonization of U.S. standards with global norms, enhancing the safety and efficacy of medical devices worldwide.

History

Founding and Early Development

The Association for the Advancement of Medical Instrumentation (AAMI) traces its origins to 1965, when entrepreneurs Robert D. Hall and Robert J. Allen, advertising professionals associated with high-tech companies in the Boston area, initiated efforts to create an organization dedicated to advancing medical instrumentation.^[15] Along with eight incorporators, including John Abele (later co-founder of Boston Scientific), they formally incorporated AAMI as a nonprofit entity that year to address the burgeoning field of biomedical engineering.^[15] This founding was spurred by the post-World War II explosion in medical electronics, as innovations in transistors, plastics, and computing enabled the rapid development of devices like electrocardiographs and defibrillators, which introduced new safety hazards requiring standardized approaches.^[16] A group of biomedical engineers, clinicians, physicians, inventors, and manufacturers recognized the need for collaboration to mitigate risks such as electrical shocks and device malfunctions in clinical settings.^[17] AAMI's early activities centered on fostering dialogue among hospitals, manufacturers, and government agencies to promote safe and effective medical technology. The organization's inaugural public event, MEDAC 66 (Medical Equipment Display and Conference), took place in Boston during the summer of 1966, featuring symposia, exhibitions, and discussions on standards for emerging technologies in fields like cardiac surgery and anesthesiology.^[15] By 1967, AAMI began formal operations following an internal organizational restructuring that solidified its nonprofit status and focus on consensus-building.^[15] This period marked the start of targeted efforts to tackle hazards from early electronic medical equipment, with the formation of the Electrical Safety Subcommittee in 1968 to evaluate risks in advanced diagnostic and therapeutic devices.^[18] In response to emerging regulatory pressures, including the FDA's increasing oversight of medical devices in the late 1960s—such as the 1968 Radiation Control for Health and Safety Act—AAMI established its first standards committees.^[19] One pivotal group, the Pacemaker Standards Committee chaired by John Abele, formed in the late 1960s to develop guidelines for cardiac devices, laying the groundwork for broader safety protocols.^[15] Early publications, including the launch of the journal Medical Instrumentation (which evolved into Biomedical Instrumentation & Technology), disseminated research and recommendations, while events like the 1969 National Conference on Medical Devices in Bethesda, MD, influenced federal policy through reports like the Cooper Report.^[15] These initiatives positioned AAMI as a key forum for interdisciplinary collaboration, directly addressing the safety challenges of the era's medical innovations.^[1]

Key Milestones and Growth

In the 1970s, AAMI achieved a significant milestone with the publication of its first comprehensive standard in 1971, focusing on the safe use of electrical medical devices to address emerging risks in healthcare technology.^[20] This effort marked the organization's shift toward establishing consensus-based guidelines that influenced device design and clinical practices. During this decade, AAMI's membership began to expand beyond its U.S. base, incorporating international participants to foster global dialogue on medical instrumentation safety.^[20] In 1977, AAMI was accredited by ANSI as a standards developing organization, enabling its documents to be recognized as American National Standards and enhancing their regulatory impact. The 1980s and 1990s saw AAMI further solidify its role in standards development through expanded activities.^[21] Concurrently, the organization launched key educational programs to train professionals in biomedical engineering and technology management, alongside the debut of its peer-reviewed journal, Biomedical Instrumentation & Technology, in the 1980s, which became a vital resource for disseminating research and best practices.^[15] These initiatives drove membership growth, reflecting AAMI's evolution from a nascent group to a cornerstone of the field. Entering the 2000s, AAMI expanded its scope to health information technology standards, emphasizing interoperability to integrate medical devices with electronic health records and broader IT systems.^[22] By the 2010s, this focus intensified with the development of cybersecurity standards, including AAMI TIR57 in 2016, which provided principles for risk management in medical device security to counter evolving digital threats.^[23] Membership surpassed 10,000 active professionals in 2021, underscoring the organization's growing influence.^[24] In 2025, AAMI released its first standard for healthcare technology management (HTM) college programs, ANSI/AAMI EQ110:2024, establishing minimum requirements for training biomedical equipment technicians and clinical engineers.^[25] This period also featured heightened emphasis on diversity, exemplified by the formalization of the Women in Leadership community in 2025 to support female professionals in HTM roles.^[26] By 2025, AAMI's membership had reached nearly 15,000 healthcare technology professionals, a substantial increase from around 6,000 in 2011, demonstrating robust growth driven by expanded services and global relevance.^[2] The organization's international stature is evident in collaborations, such as joint events with European standards bodies like BSI to harmonize regulations, and contributions to worldwide guidelines through partnerships with bodies influencing WHO and EU frameworks.^[27]

Standards and Publications

Standards Development Process

The Association for the Advancement of Medical Instrumentation (AAMI) employs a consensus-based approach to develop its standards and technical documents, ensuring broad participation from diverse stakeholders including manufacturers, end-users, regulators, clinicians, and academics. This process is managed through over 170 open committees and working groups comprising more than 3,000 volunteer technical experts who represent the full lifecycle of medical devices and healthcare technology. Balanced representation is maintained across interest categories to prevent dominance by any single group, fostering impartiality and comprehensive input.^[10]^[28] The development process begins with a needs assessment, where committees identify gaps in existing guidance through a New Work Item Proposal (NWIP) submitted for approval by the AAMI Standards Board. Once approved, a task group drafts a working draft (WD), which is reviewed and refined by the full committee into a committee draft (CD or CDV) over a period of about six weeks, incorporating comments and achieving substantial agreement—defined as more than a simple majority but less than full unanimity. This draft then undergoes public review, typically lasting at least 30 days, during which interested parties can submit comments via ANSI's platform; Technical Information Reports (TIRs) are exempt from this step. Following comment resolution, the document proceeds to electronic balloting by the consensus body using AAMI Connect, a collaborative platform that facilitates document management, voting, and communication. If approved, a final draft (FD) is submitted to the Standards Board for endorsement, potentially leading to ANSI approval as an American National Standard or harmonization with ISO/IEC documents.^[28]^[9]^[29] AAMI produces several types of documents through this methodology: standards that establish performance, safety, and quality requirements; TIRs that offer non-mandatory technical guidance; and consensus reports providing rapid, focused advice on emerging issues. All documents are evidence-based, drawing from peer-reviewed research and practical experience, while prioritizing performance-oriented criteria to support innovation without prescribing specific technologies. The process adheres to ANSI's Essential Requirements for due process, openness, and balance, with AAMI holding ANSI accreditation as a standards developer since 1977.^[30]^[31]^[3] To maintain relevance, AAMI mandates periodic reviews: standards every five years and TIRs every three years, during which committees assess the need for revisions, reaffirmations, or withdrawals based on new evidence or stakeholder feedback. Conflicts of interest are addressed through mandatory disclosure by participants, with cochairs—selected from varied sectors for three-year terms—ensuring transparency and recusal where necessary to uphold impartiality. In parallel, AAMI plays a key role in international harmonization by adopting, adapting, or serving as the U.S. Technical Advisory Group (TAG) for IEC and ISO standards, promoting global alignment to reduce trade barriers and enhance device safety and availability.^[28]^[3]^[20]^[31]

Notable Standards and Documents

The Association for the Advancement of Medical Instrumentation (AAMI) has developed numerous influential standards and technical documents that guide the safe design, production, and use of medical devices. Among these, ANSI/AAMI ST79:2017/(R)2022 serves as a comprehensive guide to steam sterilization and sterility assurance in healthcare facilities that use steam sterilizers, consolidating previous standards and providing detailed recommendations on equipment, processes, and quality control to promote sterility assurance and reduce infection risks; a revision process for this standard began in October 2025.^[32]^[33] ANSI/AAMI/ISO 14971:2019 outlines the application of risk management to medical devices, including software and in vitro diagnostics, specifying terminology, principles, and a process for identifying hazards, estimating risks, and implementing controls throughout the device lifecycle, harmonized with the international ISO 14971 standard to ensure global consistency.^[34] AAMI TIR57:2016/(R)2023 provides principles for medical device security risk management, offering guidance on integrating cybersecurity into the safety risk management process, including threat modeling, vulnerability assessment, and mitigation strategies to protect devices from cyber threats while maintaining patient safety.^[35] ANSI/AAMI ST108:2023 establishes requirements for water quality and steam purity in the processing of medical devices for patient use, detailing selection, treatment, testing, and maintenance of water systems to prevent contamination during reprocessing, with specific purity levels for critical applications like sterilization.^[36] Recent additions as of 2025 include AAMI TIR109:2025, which provides guidance for healthcare facilities and offsite reprocessing centers on the external transportation of processed medical devices, and a new standard on hospital equipment management programs released in April 2025, establishing guidance for stakeholders in medical equipment management. In March 2025, the U.S. Food and Drug Administration (FDA) updated its recognitions to include revised AAMI standards for sterilization and sterility assurance.^[37]^[38]^[39] AAMI's key publications include the peer-reviewed journal Biomedical Instrumentation & Technology (BI&T), a bimonthly resource offering practical guidance, research, and analysis on health technology management, clinical engineering, and device safety for professionals in the field.^[40] Additionally, the Standards Insider newsletter provides regular updates on standards development, committee activities, and regulatory news, supporting ongoing education and compliance efforts.^[41] Overall, AAMI maintains over 200 active standards and technical documents addressing critical areas such as biocompatibility evaluation, usability engineering for human factors, and healthcare technology management (HTM).^[3] These standards have significant impact, with many adopted or recognized by the U.S. Food and Drug Administration (FDA), influencing global regulations by providing consensus-based frameworks that enhance device safety, reduce adverse incidents, and streamline international harmonization.^[42] For instance, FDA recognition of documents like ST79 and TIR57 allows manufacturers to declare conformity, facilitating premarket approvals and postmarket surveillance while minimizing device-related risks worldwide.^[43]

Membership and Governance

Membership Categories

AAMI offers three primary membership categories designed to accommodate professionals, organizations, and companies involved in healthcare technology, ensuring broad accessibility for stakeholders across the medical device lifecycle.^[2] Individual membership is tailored for healthcare technology professionals, such as biomedical engineers, technicians, clinicians, students, and retirees seeking personal professional development. This category includes tiers like the Silver level at $250 annually for intermediate access with discounts on AAMI products and event registrations, plus $50 or more off ACI certification exams; and the premium Gold tier at $495 annually, which provides enhanced benefits including up to $250 in discounts on PDF purchases of AAMI standards or Technical Information Reports (TIRs), an additional $100 off member rates for events, and full access to member-exclusive resources such as webinars and publications. Student membership is free with proof of enrollment, while discounted options are available for new professionals to support early-career entry.^[44]^[45]^[46] Institutional membership targets healthcare delivery organizations, including hospitals, clinics, professional societies, colleges, universities, and technical schools, enabling team-based participation. Eligible entities designate representatives (minimum of three per institution) who gain individual-level access to resources, with benefits encompassing discounts on training, certification exams, and standards, as well as opportunities for committee involvement to influence standards development. Fees are structured on a per-person basis, scaling with the number of representatives—for example, $218 per person for 11-20 representatives or a flat $4,500 for unlimited access in larger systems—promoting cost efficiency for multi-user groups. Primary representatives manage rosters via an online tool to add or update members.^[47]^[48]^[49] Corporate membership serves medical device manufacturers, suppliers, consulting firms, and other entities in the health technology supply chain, fostering advocacy, standards input, and networking. Eligibility extends to organizations aligned with AAMI's mission, with up to 13 tiers based on the company's global revenue from health technology sales, ranging from $565 for smaller firms to over $100,000 for large multinationals. Key advantages include waived fees for standards committee participation, 40% discounts on job postings, and dedicated support for regulatory compliance and industry collaboration, allowing multiple employees to serve as representatives.^[50]^[51]^[49]^[52] All categories are open to global participants, reflecting AAMI's international scope, with memberships renewable annually via an online portal. As of 2025, AAMI's total membership comprises nearly 15,000 healthcare technology professionals, comprising a diverse balance of individuals, institutions, and corporations to represent varied perspectives from end-users to manufacturers. This structure is overseen by governance bodies to maintain equitable participation.^[2]^[1]

Governance and Leadership

The Association for the Advancement of Medical Instrumentation (AAMI) is governed by a Board of Directors comprising up to 20 elected representatives drawn from healthcare providers, medical device industry leaders, government regulators, clinicians, healthcare technology management (HTM) professionals, educators, and academia.^[53]^[13] These members are elected by the AAMI membership through an annual voting process managed by the Nominating Committee, which reviews nominations and recommends candidates to ensure broad stakeholder representation.^[53]^[54] Board members typically serve three-year terms, with opportunities for re-election, and the President and CEO serves as an ex-officio member.^[29]^[13] AAMI's governance extends to over 170 technical committees and working groups operating under the oversight of the Standards Board, a subset of the governance structure focused on standards development.^[55]^[10] These committees, comprising more than 3,000 volunteer experts, develop consensus-based standards through a process accredited by the American National Standards Institute (ANSI), ensuring due process, openness, and balance.^[29] Governance is guided by AAMI's policies and procedures, including a dedicated Conflict of Interest Policy that applies to directors, officers, management, and committee members to maintain impartiality and prevent undue influence in decision-making.^[56]^[29] Key leadership roles include the Board Chair, who presides over meetings and represents AAMI externally; the Chair-Elect and Treasurer, who support strategic oversight; and Vice Chairs for specific domains such as HTM, health IT, and industry.^[13] Annual elections fill officer positions, including President, to direct organizational priorities.^[57] The President and CEO, Pamela Arora—appointed in February 2022—oversees day-to-day operations, strategic planning, and alignment with AAMI's mission to advance health technology safety and innovation.^[58] As a 501(c)(3) nonprofit organization, AAMI ensures accountability through annual financial filings with the Internal Revenue Service (Form 990), which are publicly available and detail revenue, expenses, and governance practices. The Board reviews and approves annual reports and budgets, promoting transparency in operations and alignment with ANSI's essential requirements for standards governance.^[53]^[29] In 2025, AAMI's Board composition continued to emphasize diversity, with increased representation of women leaders—such as Chair-Elect Heidi E. Horn and Vice Chairs Cherie Pardue and Diane Wurzburger—and international perspectives among its members to reflect the global healthcare technology community.^[13]^[53]

Education and Training

Training Programs and eLearning

AAMI offers a variety of public training programs designed to enhance professional development in health technology management (HTM), including in-person and virtual instructor-led courses on regulatory compliance, risk management, and device maintenance.^[59] These programs cover topics such as the FDA's Quality Management System Regulation (QMSR), ISO 14971 risk management, and HTM leadership workshops, equipping participants with practical tools for compliance and operational efficiency.^[60] For example, the HTM Leadership Online Certificate program focuses on strategies for regulatory compliance and team management in healthcare settings.^[61] Courses are delivered by industry experts, including FDA training coordinators like Ed Bills, who provide insights aligned with regulatory requirements.^[62] Many sessions offer continuing education units (CEUs) pre-approved for AAMI certifications, supporting ongoing credential maintenance.^[63] In 2025, AAMI expanded its public training with virtual sessions on emerging topics, alongside core offerings like the QMSR course, available virtually from November 17–21.^[64]^[65] These programs emphasize hands-on application, with virtual formats allowing flexible participation for global professionals.^[66] AAMI's eLearning tools provide self-paced, interactive modules focused on mastering key standards and competencies, particularly for HTM professionals seeking practical skills in compliance and maintenance.^[67] Courses feature clause-by-clause breakdowns of standards like ISO 13485 (quality management systems) and ISO 14971 (risk management), delivered through videos, quizzes, and real-world examples to facilitate iterative self-assessment.^[67] This format integrates directly with AAMI's standards publications, enabling users to apply regulatory knowledge in daily operations without extensive prior expertise.^[68] Accessible via the AAMI Learning Management System, these modules support independent learning and preparation for broader professional challenges in health technology.^[67] For organizations, AAMI's private training delivers customized on-site programs tailored to specific business objectives, such as FDA regulatory preparation and quality system implementation.^[69] These sessions adapt standard curricula or develop new content based on client needs, conducted by the same expert faculty to ensure relevance and maximize team engagement.^[69] Benefits include cost savings on travel and member discounts, with AAMI handling logistics for seamless delivery.^[69] Overall, AAMI's training initiatives foster expertise in health technology through accessible, expert-led education.^[70]

Certifications and Apprenticeships

The AAMI Credentials Institute (ACI) administers certification programs that validate the expertise of healthcare technology management (HTM) professionals in areas such as medical device maintenance, management, and safety. Key offerings include the Certified Biomedical Equipment Technician (CBET), which requires demonstrated knowledge of electromechanical healthcare devices through a proctored exam and targets mid-level technicians with relevant experience; the Certified Associate in Biomedical Technology (CABT), an entry-level credential available to high school juniors or older without prior experience requirements; and the Certified Healthcare Technology Manager (CHTM), aimed at supervisory roles involving oversight of HTM operations, including budgeting and regulatory compliance.^[71]^[72]^[73] ACI previously offered the Certified Clinical Engineer (CCE) designation for professionals managing clinical engineering programs, with legacy holders eligible for renewal under specific conditions.^[73] No formal education is mandated for most exams, but candidates often prepare via AAMI's study courses or self-directed resources.^[73] To maintain certification, professionals must complete at least 30 Continuing Education Units (CEUs) every three years from pre-approved categories, such as professional development courses (minimum 15 CEUs required in this area), leadership activities, educational content creation, college coursework, or direct work experience in HTM.^[74]^[63] CEUs are tracked online, with submissions subject to audit, and renewal fees apply.^[73] AAMI's BMET Apprenticeship Program provides structured, paid entry-level training for aspiring biomedical equipment technicians, featuring a two-year hybrid format with over 2,000 hours of on-the-job experience, classroom instruction, and competency assessments.^[75] Launched in 2021 and registered with the U.S. Department of Labor, the program partners with healthcare employers to build skills in device repair, safety testing, and inventory management, addressing critical workforce gaps in HTM.^[76]^[77] The AAMI HTM Mentorship Program connects seasoned practitioners with at least five years of experience to early-career professionals, students, and newcomers, offering one-on-one guidance on career navigation, technical challenges, and industry networking.^[78] In October 2025, AAMI launched a recruitment drive for additional mentors to scale the initiative and mitigate persistent shortages in qualified HTM talent.^[79] Supporting these credentials, AAMI published ANSI/AAMI EQ110:2024 in January 2025, the inaugural standard defining minimum curricular requirements for HTM college programs, including core competencies in biomedical engineering, clinical engineering, and technology management to ensure consistent educational preparation.^[80]^[81] Through ACI, AAMI has issued over 5,000 certifications since 1967, empowering professionals to advance in HTM roles.^[82] The BMET Apprenticeship Program earned finalist status in the 2025 Anthem Community Voice Awards' Non-Profit Team & Internal Initiatives category for its innovative approach to talent development.^[83] AAMI's eLearning modules offer supplementary preparation for certification exams and CEU fulfillment.^[11]

Events and Community Initiatives

Conferences and Annual Events

The Association for the Advancement of Medical Instrumentation (AAMI) organizes several annual conferences and events that serve as key platforms for healthcare technology management (HTM) professionals, standards developers, and industry leaders to exchange knowledge on medical device safety, innovation, and regulatory compliance.^[84] These gatherings emphasize practical education, networking, and collaboration, often incorporating hybrid formats to enhance global accessibility following the shift to virtual elements during the COVID-19 pandemic in 2020.^[85] Attendees, including clinical engineers, sterile processing experts, and regulators, benefit from continuing education units (CEUs) that support professional certifications and career advancement.^[86] The flagship event, AAMI eXchange, is an annual four-day conference and expo dedicated to HTM, attracting nearly 2,000 participants from over 20 countries.^[86] Held in New Orleans from June 20–23, 2025, it featured more than 80 educational sessions across nine tracks, including sterilization, cybersecurity, artificial intelligence in HTM, and regulatory updates, with keynote speeches by experts like Aaron Horowitz on patient safety innovations.^[87] Formats included interactive workshops, an expo hall with over 150 exhibitors showcasing device technologies, and networking opportunities such as a career fair and charity golf tournament, all contributing up to 15 CEUs.^[87] The event fosters collaborations that influence new standards and best practices in equipment management and patient safety.^[86] Another prominent gathering is the Kilmer Conference, co-hosted with the Parenteral Drug Association (PDA), which focuses on advancements in medical device materials, sterilization, and sterility assurance to prevent infections.^[88] The 2025 edition, held in Orlando from February 3–6, included main stage talks, poster sessions, and exhibits on topics like terminal sterilization validation and aseptic processing innovations.^[89] With a theme of "Next Generation Microbiological Quality," it united global leaders from industry, academia, and government to shape standards through shared research and discussions.^[88] Proceedings from these conferences often inform AAMI's standards development, providing lasting impact on microbiological quality practices.^[90] AAMI also hosts specialized events like Sterilization Standards Week, conducted twice annually (spring and fall) to advance guidance on safe medical device preparation.^[91] The Fall 2025 session, from September 15–18, featured open working group meetings on topics such as moist heat sterilization and steam processes, available in hybrid format for broader participation.^[92] Complementing these are the HTMLive webinar series, offering virtual sessions on critical HTM issues like regulatory compliance and equipment reliability, ensuring ongoing knowledge-sharing beyond in-person events.^[93] These initiatives collectively promote interdisciplinary dialogue, leading to enhanced standards and innovations in healthcare technology.^[94]

Foundation and Professional Communities

The AAMI Foundation serves as the charitable arm of the Association for the Advancement of Medical Instrumentation, established in 1967 to advance patient safety by funding scholarships, awards, and grants for researchers, students, and healthcare technology management (HTM) professionals.^[95] It supports HTM workforce development through initiatives like the Michael J. Miller HTM Scholarship Program, launched in 2009, which provides annual academic scholarships to students pursuing careers as clinical engineers or biomedical equipment technicians (BMETs), with recipients selected based on academic merit and financial need.^[96] Additionally, the Foundation administers the John D. Hughes HTM Leadership Honors Award, sponsored by TRIMEDX, to recognize professionals demonstrating innovation, mentorship, and leadership in HTM.^[97] For 2026, nominations are open for AAMI Foundation Awards honoring innovation and contributions to the field, with a deadline of January 15, 2026, fostering philanthropy through a donor community that includes individuals, corporations, and grants totaling millions in support.^[98] AAMI's professional communities provide structured networking and collaboration platforms for members, emphasizing inclusivity and expertise sharing in HTM. The Standards Development Community, an official public group, enables volunteer participation in over 170 committees and working groups that shape global standards for medical devices and technologies, allowing experts to contribute input on consensus-building processes.^[99] Women in Leadership (WIL), formalized as an official AAMI community in January 2025, focuses on gender equity by enhancing recruitment, retention, and visibility of women in HTM leadership roles, offering free membership open to women and allies.^[100] WIL hosts activities such as webinars, including a February 12, 2025, event led by industry expert Andrea Bordenca on leadership strategies, providing continuing education units (CEUs) and promoting mentorship programs to build supportive networks.^[100] Other initiatives within these communities address talent shortages and underrepresented groups in HTM, including the BMET Apprenticeship program, a two-year hybrid model developed in partnership with the U.S. Department of Labor, which combines up to 6,000 hours of paid, competency-based on-the-job training with education to prepare entry-level technicians.^[75] The AAMI neXus platform facilitates discussions on emerging technologies, connecting industry, regulatory, and standards professionals for innovation and collaboration, with events like neXus 2026 focusing on medical device standards and regulatory science.^[101] These efforts, including awards recognizing "history makers" in HTM through programs like the Mary K. Logan Research Grant (up to $80,000 annually for health technology safety research), aim to promote inclusivity, expand access for diverse professionals, and mitigate workforce gaps projected in the field.^[97] Overall, the communities prioritize sustained engagement via online platforms and targeted support to drive equitable growth in HTM.^[102]

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[24]
https://pressroom.aami.org/posts/pressreleases/aami-exceeds-10000-members-a-milestone-for-he
[25]
AAMI Exceeds 10,000 Members, a Milestone for Health Technology
Nov 9, 2021 · The active membership of AAMI now exceeds 10,000 thanks to the commitment of the organization's many professionals and leaders—all united in ...Missing: history | Show results with:history
[26]
First-Ever Standard for HTM College Programs | AAMI News
Jan 21, 2025 · AAMI has published the first-ever standard that establishes minimum requirements for any college program that trains biomedical equipment technicians.
[27]
Women in Leadership (WIL) Becomes Official AAMI Community
Jan 6, 2025 · The Women in Leadership (WIL) Society seeks to promote and support female professionals in the HTM field. Now, as an official AAMI community, ...
[28]
What Is the BSI/AAMI International Standards & Regulation ...
Aug 21, 2023 · This virtual and in-person event is co-hosted by BSI and AAMI from October 17-18. It will address emerging issues related to medical devices.
[29]
[PDF] guide for - cochairs - AAMI
Standards Program Policies and Procedures Manual for detailed information on this procedure. AAMI Staff will provide guidance and structure for this procedure.
[30]
What Are Standards | AAMI
AAMI develops standards documents aimed at enhancing the safety, efficacy, safe use and management of medical devices and health technologies. A standard may ...
[31]
None
### Summary of AAMI Standards Philosophy (21 March 2025 Edition)
[32]
ANSI/AAMI ST79:2017/(R)2022; Comprehensive guide to steam ...
This recommended practice covers steam sterilization in health care facilities. The recommendations are intended to promote sterility assurance.
[33]
https://aami.org/news/below-the-hospital-st79-revision-starts/
[34]
Principles for medical device security—Risk management - AAMI Array
AAMI TIR57:2016/(R)2023; Principles for medical device security—Risk management · Copyright year: 2016 · Pages: 84 · Publisher: AAMI.Missing: history | Show results with:history
[35]
New AAMI Standard on Water Quality for Medical Device Processing
Aug 16, 2023 · AAMI has released ANSI/AAMI ST108:2023, a new national standard that establishes requirements for the quality of water used to process ...
[36]
Biomedical Instrumentation & Technology - AAMI Array
AAMI's award-winning peer-reviewed journal is the premier source of practical guidance, research, and analysis for those working in the health technology.
[37]
AAMI Standards Insider
In this edition of Standards Insiders, we discuss upcoming events, including sterilization standards week, and highlight education courses and AAMI committees.
[38]
New Standards to Support Innovation in Medical Device Sterilization
Jul 24, 2023 · When the FDA recognizes standards, it means the FDA finds them acceptable and a manufacturer can make a declaration of conformity to the ...
[39]
Recognized Consensus Standards: Medical Devices - FDA
Jun 7, 2021 · This recommended practice covers steam sterilization in health care facilities. The recommendations are intended to promote sterility ...
[40]
Individual Membership - AAMI
AAMI offers corporate and institutional membership options for teams of three or more which includes additional benefits for the organization. For more ...Missing: size | Show results with:size
[41]
Become a Member Today! | - AAMI
Individual membership is nontransferable and is renewed on an annual basis. Choose Your Tier Below. Gold Individual Membership - $495 per year. Deep discounts ...Missing: 2025 | Show results with:2025
[42]
AAMI Releases Guide for HTM Department Financials | AAMI News
Apr 12, 2024 · Priced at $100, this membership tier includes immediate access to a wealth of other AAMI HTM resources and BI&T publications such as guides on ...<|separator|>
[43]
Institutional Membership | AAMI
AAMI Institutional Membership is for healthcare delivery organizations, professional societies, colleges, universities and technical schools.Missing: categories | Show results with:categories
[44]
Institutional Membership | - AAMI
11-20 Reps, $218/Person; Unlimited Reps, $4,500 Flat Fee. AAMI also offers membership options for healthcare delivery systems with over 20 representatives.Missing: distribution individual
[45]
So, You're Joining AAMI… But What Kind of Member Should You Be?
Aug 4, 2023 · AAMI membership is good for one year from the time you join and there are three main categories from which to choose: Individual, Institutional, and Corporate.
[46]
Corporate Membership - AAMI
Membership · Join/Renew · Individual Membership · Institutional Membership · Corporate Membership. 2025 Corporate Membership Application ...Missing: size | Show results with:size
[47]
AAMI Membership Structure to Change in 2019 | AAMI News
Aug 23, 2018 · Starting in 2019, AAMI will consolidate corporate memberships from 19 to 13 tiers based on a company's total gross worldwide medical sales, ...
[48]
Association for the Advancement of Medical Instrumentation
Organization Type: National Trade or Professional Association. Acronym: AAMI. Tax Exempt Status: 501(c)(6) ; Address: 901 N Glebe Rd STE 300 Arlington, VA 22203.
[49]
AAMI 2025 Voting: Board Directors, Vice Chairs, and Re-elections
Mar 18, 2025 · The AAMI Board of Directors consists of up to 20 representatives who are responsible for reviewing, revising, and approving strategic plans and ...
[50]
2025 Nominees Sought for AAMI Board of Directors | AAMI News
Nov 25, 2024 · The current Nominating Committee will meet in February 2025 to review the submitted documents and make recommendations to the full AAMI ...
[51]
Join a Standards Committee - AAMI
Join a Standards Committee. The more than 170 committees and working groups of volunteer technical experts are the heart of AAMI's global standards ...
[52]
[PDF] AAMI Board Policy – Conflict Of Interest
This AAMI Conflict of Interest Policy is designed to help the directors, officers, management team, and members of committees of the Association for the ...Missing: terms | Show results with:terms
[53]
AAMI 2024 Voting: Board Officers, Director, Nominating Committee ...
Eligible AAMI members, submit a proxy to cast your vote online. The AAMI Board of Directors consists of up to 20 representatives who are responsible for ...<|separator|>
[54]
AAMI Announces Next President and CEO
Feb 3, 2022 · Following an eight-month search, the AAMI Board of Directors has announced Pamela Arora, a respected healthcare leader, as its next president ...
[55]
Public Training | AAMI
AAMI's interactive eLearning tools give you the flexibility to master key standards and professional competencies at your own pace. Explore clause-by-clause ...
[56]
Quality Systems & Risk Management - Public Training - AAMI
AAMI's quality systems and risk management training provides medical device design and manufacturing professionals the tools and knowledge to maintain ...
[57]
Final Word: Cultivating Leaders with the AAMI HTM Leadership ...
This article describes the program, why it is needed by the HTM professional community, and what it seeks to achieve. The HTM Leadership Online Certificate ...Missing: reach | Show results with:reach
[58]
Ed Bills' “Long and Circuitous Path” into MedTech Education
May 21, 2025 · An AAMI Faculty member since 2003, Bills has served as a Subject Matter Expert ... In addition to teaching, Bills works as an FDA Training ...<|control11|><|separator|>
[59]
ACI Continuing Education Pre-Approved Programs - AAMI
The courses listed below have been reviewed and pre-approved for continuing education CEUs for AAMI certification renewals. Navigate Focus Areas. ACI Continuing ...
[60]
Expert Insights - AAMI
AAMI Expert Insights are interactive, virtual presentations from leading industry experts on topics critical to your success. New Expert Insights are being ...
[61]
Software and Cybersecurity - Public Training - AAMI
If you oversee compliance activities related to software validation, regulatory affairs, or quality assurance, then this training is for you. ACCESS MY LEARNING.
[62]
eLearning Tools - AAMI
AAMI's interactive eLearning tools give you the flexibility to master key standards and professional competencies at your own pace. Each course combines expert ...Missing: programs | Show results with:programs
[63]
Using Brain Science, AAMI Will Change How Manufacturers ...
Nov 7, 2024 · The solution is rooted in the Association's two self-paced e-learning courses for ISO 14971 and ISO 13485. As online offerings, employees ...
[64]
AAMI Private Training
AAMI Private Training. Let us bring our expert industry faculty to your location and deliver a training experience based on your specific business goals and ...Missing: programs | Show results with:programs<|control11|><|separator|>
[65]
Report to the Membership…As 40 Year Career Winds Down, AAMI ...
In the education arena, AAMI's programs bring the association into contact with more than 9,000 people each year. Webinars have become a popular educational ...
[66]
Certified Biomedical Equipment Technician (CBET) - AAMI
Healthcare technology management professionals that desire a CBET certification are expected to have experience in a wide range of electromechanical devices ...Missing: CCE | Show results with:CCE
[67]
Certified Associate in Biomedical Technology (CABT) - AAMI
Individuals interested in earning the CABT designation must be a minimum junior in high school to sit for the exam. The CABT exam is monitored online and must ...Missing: CCE CEUs
[68]
[PDF] Certification Candidate Handbook | AAMI
Jun 2, 2025 · Those certified and on standard military assignments in the HTM field are expected to follow all recertification policies and procedures.
[69]
Maintain Your ACI Certification - AAMI
Maintaining your ACI certification is comprised of three main steps: · Earn at least 30 CEUs from the six approved categories within the 3-year reporting period.
[70]
BMET Apprenticeship - AAMI
The BMET Apprenticeship is a two-year hybrid program combining education and hours of paid, competency-based training to prepare future BMETS.
[71]
BMET Apprenticeship Employers - AAMI
The AAMI Registered BMET Apprenticeship program is the only nationwide apprenticeship program for BMETs that is approved by the US Department of Labor.
[72]
[PDF] AAMI BMET APPRENTICESHIP PROGRAM - TRIMEDX
Apprentices work for 24 months with an expert team of TRIMEDX Biomedical Equipment. Technicians (BMETs), gaining valuable on-the-job training and experience ...
[73]
Mentorship Program - AAMI
The goals of the program are to help protégés develop the skills and knowledge necessary to succeed and grow in the health technology field; ...
[74]
AAMI Seeks Mentors for HTM's Next Generation
AAMI HTM Mentorship Program pairs young professionals and students in the HTM field with experienced industry leaders who can provide advice, connections, and ...
[75]
HTM College Education: AAMI Sets New Standard - GlobeNewswire
Jan 22, 2025 · HTM College Education: AAMI Sets New Standard. First-ever standard for training biomedical, clinical engineers. January 22, 2025 08:51 ET ...
[76]
eXchange Archives - AAMI
AAMI's HTM mentorship program is seeking mentors to help train the next generation of HTM pros! Find out how you can get involved today!
[77]
[PDF] Membership Brochure - AAMI
Founded in 1967, AAMI membership is composed of a diverse group of over 11,000 healthcare technology professionals. Through standards, training, conferences, ...Missing: size | Show results with:size
[78]
Advancing Safety in Health Technology - AAMI
Oct 23, 2025 · We're finalists for the Anthem Community Voice Awards! Our BMET Apprenticeship program landed us in the Non-Profit Team & Internal Initiatives ...
[79]
Certifications - AAMI
Benefits of certification. ACI's well-respected certification program has set the bar for HTM professionals since the early 1970's. ACI has five certifications ...
[80]
Events - AAMI
The AAMI eXchange is a four-day conference and expo that is full of opportunities for learning, connecting with peers, and showcasing the latest innovations ...Missing: participants | Show results with:participants
[81]
AAMI eXchange 2024 – What You Need to Know | AAMI News
Mar 12, 2024 · With a schedule packed with education sessions, technical training, and expo hall events, AAMI eXchange24 is a must-attend event for anyone ...Missing: participants | Show results with:participants
[82]
AAMI eXchange 2026
four days of education, innovation, and networking that ...
[83]
AAMI eXchange Heads to New Orleans | AAMI News
Mar 19, 2025 · AAMI's biggest conference for healthcare technology management (HTM) professionals is coming to New Orleans! From June 20-23, the 2025 AAMI ...
[84]
Kilmer Conference - AAMI
The Kilmer Conference, co-hosted by AAMI and PDA, unites global leaders in sterility assurance to share innovations, shape standards, and advance infection ...
[85]
KILMER Conference 2025 – Call for Abstracts | AAMI News
Jul 23, 2024 · A call for abstracts for sessions and posters for the 2025 KILMER Conference, which will be held from February 3-6, 2025, in Orlando, Florida.
[86]
Kilmer Conference Proceedings - AAMI
The Kilmer Conference, co-hosted by AAMI and PDA, unites global leaders in sterility assurance to share innovations, shape standards, and advance infection ...
[87]
It's Sterilization Standards Week! What's It All About? | AAMI News
Sep 13, 2023 · Sterilization Standards Week (SSW) brings together experts to shape sterilization guidance, ensuring safe medical device preparation, and to ...
[88]
Fall 2025 Sterilization Standards Week | AAMI
Fall 2025 Sterilization Standards Week. Share. Fall 2025 Sterilization Standards Week. September 15 – 18, 2025. Register Now · AAMIFooter Logo. Address.
[89]
HTMLive Webinar Series | AAMI
HTMLive Webinar Series connects you with the healthcare technology management (HTM) topics most critical to your success!
[90]
Experts from AAMI Fall Sterilization Standards Week 2022 Reveal ...
Sep 14, 2022 · The week of September 12, 2022 has proven to be no different. Packaging, microbiological assurance, endoscope reprocessing, and medical device ...
[91]
AAMI Foundation
The AAMI Foundation is dedicated to advancing the professional development of health technology professionals and the safety of technology to improve health.
[92]
AAMI Foundation Michael J. Miller HTM Scholarship Program
The Michael J. Miller HTM Scholarship is designed to help fund the future of the HTM profession by awarding academic scholarships to students meeting the ...Missing: charitable workforce
[93]
AAMI Foundation Awards & Scholarships
AAMI and AAMI Foundation Awards · AAMI Foundation Laufman-Greatbatch Transformational Impact Award · AAMI Foundation John D. Hughes HTM Leadership Honors Award, ...Missing: profit | Show results with:profit
[94]
2026 AAMI Award Nominations Are Now Open!
Oct 29, 2025 · The prestigious 2026 AAMI and AAMI Foundation Awards and the AAMI Fellows Program are now open for nominations. From now until January 15th, we ...
[95]
Feed | Standards Development - AAMI
Group logo of Standards Development. Standards Development. Public Community. Public Community. Active 22 hours ago. Public Community. Organizers: Organized by.Missing: professional | Show results with:professional
[96]
Women in Leadership (WIL) Becomes Official AAMI Community
Jan 6, 2025 · Women in Leadership (WIL) is now an official community of AAMI, expanding its reach and mission to support women in HTM.Missing: gender equity input
[97]
AAMI neXus 2026
Join industry, regulatory, and standards leaders at AAMI neXus 2026 in Leesburg, VA, April 14–17, for four days of learning, collaboration, and innovation ...
[98]
https://aami.org/news/2026-aami-award-nominations-are-now-open/