Swiss Medtech, a trade association for medical technology companies in Switzerland, and AdvaMed, a US medtech association, are jointly calling for reciprocal “zero for zero” tariffs between the two countries.

Additionally, they advocate for Switzerland to become the first European market to facilitate the acceptance of medical devices approved or cleared by the US Food and Drug Administration (FDA). This call reflects the role that medtech plays in both the US and Swiss health care systems and economies, as well as the critical need to avoid disruptions in patient care that tariffs could cause in both countries.

In a joint statement, Swiss Medtech and AdvaMed highlight the unique, highly regulated nature of the medtech industry and its fixed reimbursement environment. These characteristics restrict the ability of medtech companies to shift manufacturing sites or for hospital customers to absorb higher prices resulting from tariffs.

“Recent trade tensions and the threat of tariffs are posing a serious threat to our respective health technology industries and to the health systems, health care professionals, and patients who depend on us to ensure timely access to treatment,” the joint statement reads.

The joint statement also calls on the US and Switzerland to continue developing a regulatory framework in which private bodies will review the relevant conditions under a simplified conformity assessment procedure, taking into account elements already performed by the FDA. According to the trade associations, such a system would broaden access to innovation for Swiss patients and help ensure that Switzerland remains a strong global partner to the US in advancing medical technology research and innovation.

This announcement follows a similar joint effort earlier this month between AdvaMed and the Association of British HealthTech Industries, which called for reciprocal “zero-for-zero” tariffs and deeper regulatory alignment between the US and UK.

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Today, AdvaMed president and CEO Scott Whitaker testified before the US Senate Committee on Finance in its hearing focused on the impact of tariffs on US supply chains. AdvaMed was the only health care organization invited to discuss the medical technology supply chain. 

Below is Whitaker’s written testimony submitted to the committee: 

“Chairman Crapo and Ranking Member Wyden, thank you for inviting me to address the committee on this important topic.  

I am Scott Whitaker, president and CEO of AdvaMed, the MedTech Association. More than 600 medical technology companies are members of AdvaMed. These are the companies that invent, develop, distribute, and manufacture technologies and devices that fill every hospital, health clinic, and doctor’s office in America, and increasingly provide more products and technologies in home health care settings as well.   

“Medtech accounts for 3 million direct and indirect jobs in all 50 states across nearly 17,000 US manufacturing plants, with more than $600 billion in domestic economic output.  

“We are an American success story and the global superpower of medical innovation. Few people fully grasp the depth and breadth of our impact on the health care system. As we discuss trade and tariff policy, it is essential for policymakers to understand how this industry impacts health care, not only in the United States but around the world.   

“We are the industry that manufactures the laboratory equipment and diagnostic tests that detect virtually every form of disease. We are the companies that manufacture imaging equipment, from the X-ray machine to the CT scan and the MRI. We are the industry that manufactures the heart valves, pumps and cardiac monitors, the stents and pacemakers and defibrillators that help people stay alive.   

“We create the artificial hips, knees, and shoulders, and other implants that help patients stay healthy and mobile. We develop the surgical kits for the 77,000 procedures performed every day in America—and the surgical robots that deliver a more precise procedure that yields better outcomes for patients.  

“We manufacture insulin pumps and continuous glucose monitors that help millions of Type-1 diabetics manage their disease and live healthier lives. And now we are the industry developing the cutting-edge AI technology that is already diagnosing health problems early, saving our health care system money while saving lives. Just weeks ago, a groundbreaking study of breast cancer patients—the largest of its kind—found a 29% increase in breast cancer detection utilizing AI. And that’s only the beginning of medtech ushering in a new dimension of detection and prevention.   

“Simply put, we are the backbone of the health care system, the engine that makes hospitals run. Our industry is a critical component to keeping our health system functioning. Medtech products are not optional. They are, in many respects, mandatory. And because our technologies are often a matter of life or death, they are also highly regulated, as they should be. Even the facilities in which they are manufactured are FDA-regulated, as they should be.   

“Our industry has not historically faced tariffs. Because most countries have recognized the humanitarian nature of our work, they have collectively agreed to avoid placing tariffs on these lifesaving products. For example, prior to this year, the average tariff on medtech shipped to Europe was 1.3%, with Japan and Canada averaging around 1%.  

“To be clear, AdvaMed and our industry at large support the president’s goal to fix longstanding and unfair trade imbalances. We applaud the president for his efforts to bring more manufacturing across our economy back to the US, and many of our companies have done and are doing just that.  

“But the reality is that medtech is already a uniquely American success story. Upwards of 70% of the medtech that fills hospitals and clinics across the US is made in America. And that is growing: Just this year alone, more than a dozen medtech companies have announced expansions within the United States, and we expect that to continue.  

“The US is the largest medtech market in the world, accounting for 40% of global sales, and it is unquestionably the leader in innovation. If there is a breakthrough in medical technology that makes headlines, chances are it was developed right here in America.  

“Tariff policy, as proposed, puts this uniquely American success story at risk. And here is why:  

First, given that this is a highly regulated industry, shifting operations is a multi-year and incredibly expensive ordeal, bringing with it regulatory and safety concerns not seen in other industries. While the supply chains for smartphones or autos or toys are important to the economy, they simply do not have the same impact on lives.  

“Second, our companies operate in a mostly fixed-reimbursement environment: Medical technologies are purchased by hospitals through multi-year contracts, making cost spikes in the short term difficult to adjust to.   

“Third, and perhaps just as importantly, our biggest payors are funded by the federal taxpayer: Medicare, Medicaid, and the Veterans Health Administration. To the extent that tariffs on medtech products might generate federal revenue, much of those gains could be offset by the higher prices on these technologies. Any tariff policy that would force increased costs onto these federally funded programs would be counterproductive.  

“Our final concern is the impact these policies could have on the medical supply chain, which is highly complex. To illustrate, a diagnostic scanner and a medical infusion pump manufactured right here in the US can contain several hundred parts sourced from more than 20 countries across three continents. These are but two examples among hundreds of other technologies with similar makeups and needs.  

“Just recently, medtech supply chain leaders across the industry reported that procurement timelines have already slipped, especially for surgical kits, diagnostic components, and imaging devices.  

“For example, one company manufactures critical products for neonatal intensive care units, supplying 50% of the market for one product category and around 70% for another. If tariffs continue to be a threat, this will result in backorders, delays, and will ultimately impact NICU patient care. Currently, there are no competitors ready to immediately make up the capacity, and as a company executive told me, ‘We are talking about patients measured in ounces, not pounds.’ 

“Let me conclude by saying that we appreciate the president’s 90-day pause and are encouraged by the recent announcement with respect to China. Moving forward, we believe the best way for the medtech industry to continue delivering on its commitment to patients, both here at home and around the world, rests with maximum flexibility for our industry.    

“We ask this committee and the administration to treat medical products with a reciprocal ‘zero for zero’ model in these country-to-country negotiations. That means a mutual agreement in which countries eliminate tariffs on medical supplies and technologies between each other.   

“Given the unique lifesaving and humanitarian nature of our products and innovations, both the United States and its trading partners should respect that longstanding policy—a move that would prevent potential supply chain disruptions and cost increases that would negatively impact hospitals and patients around the world. There is precedent for this approach. In fact, during the first Trump Administration, many medtech products were exempt from the tariffs imposed.  

“We stand ready to work with this committee and the president on further strengthening industry’s already-vibrant and growing American presence. And we stand ready to work with him on alternative ways to restore fairness to trade policies that negatively impact the American medtech sector.   

“With that, thank you, and I look forward to your questions.”

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US-based AdvaMed, representing medtech innovators, and the Association of British HealthTech Industries (ABHI), a trade association for medical technology companies in the United Kingdom, are calling for reciprocal “zero-for-zero” tariffs between the two countries and greater regulatory convergence. They note the prominence of medtech in both the US and UK health care systems and economies and the need to avoid disruptions in patient care that tariffs could cause in both countries.

In a joint statement, AdvaMed and ABHI describe the unique, highly regulated nature of the medtech industry and its fixed reimbursement environment. They note that those characteristics restrict the ability of medtech companies to switch manufacturing sites or for hospital customers to adjust to higher prices resulting from tariffs.

“Recent trade tensions and the threat of tariffs are posing a serious threat to our respective health technology industries and to the health systems, health care professionals, and patients who depend on us to ensure timely access to treatment,” the joint statement reads. 

The joint statement also calls for the US and UK to continue developing a regulatory system in which the UK accepts regulatory approvals and clearance from the US Food and D ug Administration for medtech, a concept known as regulatory convergence. Such acceptance would expand access to innovation for UK patients and ensure the UK continues to be a strong global partner with the US in medical technology research and innovation. 

Tariff flexibility and regulatory convergence are the shared goals among the US and key trading partners to promote continued innovation and patient access to the medtech, according to a press release from AdvaMed. 

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The National Electrical Manufacturers Association (NEMA) has launched a new Make It American certification program to help the market identify products and manufacturing facilities that have implemented processes to meet Build America, Buy America Act domestic content requirements.

Make It American certification enables companies to demonstrate that their processes and supply chain management systems have undergone rigorous, third-party expert audits, providing greater certainty and confidence to manufacturers, government agencies, and procurement officials looking to source materials with enhanced levels of US-manufactured content.

Companies can certify their facilities to NEMA’s Make It American Process Standard, and additional product specifications which are currently available for low-voltage power distribution equipment  and wire and cable, with more specifications coming for other product lines in the coming months. Companies that successfully complete the certification audit are granted marks to showcase their rigorous supply chain processes, commitment to transparency, and enhanced domestic manufacturing footprint.

“The US electroindustry is the backbone of our nation’s energy system, investing over $185 billion in domestic electrical component manufacturing since 2018,” says Debra Phillips, president and CEO of NEMA, in a release. “NEMA’s Make It American program allows our nation’s manufacturers to showcase their commitment to US manufacturing, creating even more jobs, and strengthening the American manufacturing sector.”

NEMA Member Companies Gain Certification

Eaton, Schneider Electric, Siemens, Southwire, and TESCO Metering are the first NEMA member companies to achieve the NEMA Make It American Process Certification. In addition, Siemens, Southwire, and TESCO earned product certifications.

“Siemens is proud to support the Make It American program, which provides a robust framework for companies to document compliance with Buy America Preference requirements, ensuring transparency and accountability in the manufacturing process,” says Barry Powell, regional CEO of Siemens Electrical Products North America, in a release. “Siemens’ US manufacturing facilities are equipped to produce components and products that comply with the Buy America Preference requirements, reflecting our unwavering commitment to supporting American manufacturing and infrastructure while underscoring our commitment to manufacturing excellence.”

NEMA’s Make It American Program includes precedent-setting standards, certifications, and resources to help electrical manufacturers navigate domestic content requirements. Through these tools, NEMA aims to empower manufacturers to make informed decisions, strengthen critical supply chains, and support US infrastructure and economic growth.

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By Alyx Arnett

The Advanced Medical Technology Association (AdvaMed) has released its first artificial intelligence (AI) policy roadmap, offering lawmakers and regulators a framework for advancing the safe and effective use of AI-enabled medical devices. 

Developed by AdvaMed’s Digital Health Tech division, the roadmap outlines five key policy areas: privacy and data access, FDA AI regulatory framework, reimbursement and coverage, AI assurance labs, and generative AI.

“[A]ll of us in industry and medical devices are going after AI, and there’s such commonality that we could either play defense and wait for regulations, or we could partner with the FDA, legislators, CMS and help them understand the journey of something that sometimes is not very understandable,” says Robert Cohen, Digital Health Tech board member and president of digital, robotics, and enabling technology at Stryker, during a press call. 

AdvaMed’s roadmap, which draws input from a board that includes representatives from companies such as Siemens, Medtronics, Philips, Microsoft, Google, and Apple, arrives at a time when more than 1,000 AI-enabled medical devices have already received FDA authorization, and many more are in development. The organization hopes this roadmap will guide policymakers in ensuring that regulation, reimbursement, and infrastructure evolve alongside innovation.

“We wanted to cut through some of the noise and be able to put something in front of policymakers to get a better sense where medtech and big tech are coming together [and] where those primary issues are,” says Shaye Mandle, executive director of the Digital Health Tech division, during the press call.

1. Privacy and Data Access

AI-enabled medical devices rely on access to large, high-quality datasets to deliver accurate, personalized insights in diagnostics and treatment planning. However, fragmented data systems, inconsistent privacy standards, and siloed aggregation processes pose major barriers to innovation.

AdvaMed’s roadmap highlights the tension between protecting patient privacy and enabling developers to train robust, bias-mitigated algorithms. Current HIPAA regulations, while essential for safeguarding health information, were not designed for the scale and complexity of AI development. These limitations can make it difficult for companies to gather the longitudinal, demographically diverse data needed to meet FDA expectations and conduct meaningful bias analyses.

To address these challenges, AdvaMed calls for a modernized approach that supports responsible data use without weakening privacy protections.

Policy recommendations:

• Ensure data protection without stifling innovation.
• Evaluate the need to update HIPAA for the AI era and create clear guidelines specifically for data use in AI development.
• Develop appropriate guidelines around patient notice and authorization for the data used to develop AI. 

2. FDA AI Regulatory Framework

AdvaMed’s roadmap positions the FDA as the lead regulator for AI-enabled medical devices. The organization states that FDA’s risk-based framework—used to assess safety, effectiveness, and post-market performance—is already equipped to handle the unique challenges of AI in medical technology.

Rather than creating new oversight structures, AdvaMed recommends that FDA maintain its central role while continuing to adapt existing tools such as the Predetermined Change Control Plan (PCCP), which allows pre-approved software updates without requiring a full resubmission. The roadmap also calls for greater consistency in implementation and international alignment to avoid regulatory fragmentation.

Cohen notes during the call that “as long as we stick to some guiding principles and processes, I think we can work with the FDA to keep us moving at a pace that keeps us competitive, not just in the United States, but in the world.”

Board members also emphasized the need for global alignment on AI regulatory standards, warning that varying rules across countries—such as the US, EU, and Japan—could slow innovation and increase time to market. AdvaMed supports harmonized criteria for data validation, privacy, and bias mitigation to ensure consistent oversight without duplicative requirements.

“We could have a five-year regulatory process in Europe, an [eight]-year process in the United States, and a six-month [process] in Australia…It creates complexity with software, and we don’t have consistency,” Cohen says during the press call. 

Policy recommendations:

• FDA should remain the lead regulator responsible for overseeing the safety and effectiveness of AI-enabled medical devices.
• FDA should implement the existing PCCP authority to ensure it achieves its intended purpose of ensuring patients have timely access to positive product updates.
• FDA should issue timely and current AI guidance documents related to AI-enabled devices and to prioritize the development and recognition of voluntary international consensus.
• FDA should establish a globally harmonized approach to regulatory oversight of AI-enabled devices.

3. Reimbursement and Coverage

AdvaMed’s roadmap identifies reimbursement as a critical factor in determining whether patients can access the benefits of AI-enabled medical devices. Although FDA clearance establishes safety and effectiveness, many technologies face delays in adoption due to unclear or nonexistent payment pathways—especially within Medicare, which influences broader reimbursement policy across private insurers and Medicaid programs.

The roadmap states that CMS has the regulatory authority to expand access, but its current framework lacks the specificity needed to consistently support AI technologies and software-driven tools. AdvaMed urges legislative and regulatory action to ensure payment models evolve alongside innovation, particularly for emerging categories such as algorithm-based health care services (ABHS) and digital therapeutics.

Policy recommendations:

• Consider legislative solutions to address the impact of budget neutrality constraints on the coverage and adoption of AI technologies.
• CMS should develop a formalized payment pathway for algorithm-based health care services (ABHS) to ensure future innovation and to protect access to this subset of AI technologies for Medicare beneficiaries.
• To ensure future innovation and to protect access to ABHS for Medicare beneficiaries, we urge CMS to develop a formalized payment pathway for ABHS.
• Facilitate the adoption and reimbursement of digital therapeutics through legislation and regulation.
• CMS should leverage its model authority to test the ability of AI technologies to improve patient care and/or lower costs.

4. AI Assurance Labs

As AI-enabled medical devices evolve, some stakeholders have proposed the use of third-party quality assurance labs to manage ongoing performance evaluation. However, AdvaMed’s roadmap raises concerns about this approach, questioning whether these labs would add value beyond existing FDA oversight.

The organization warns that introducing external labs could create redundant regulatory layers, increase costs, and introduce new risks related to data security and intellectual property. The roadmap also notes that third-party evaluators may lack the clinical context or device-specific understanding needed for accurate performance assessments, which could affect reliability and transparency.

Instead of relying on third-party labs, AdvaMed recommends building on FDA’s existing risk-based framework and encouraging alignment around accredited, consensus-based standards.

Policy recommendation:

• Policymakers should encourage FDA to participate in the development of and timely recognition of accredited and consensus-based standards for quality assurance processes rather than rely on third-party assurance labs.

5. Generative AI

AdvaMed’s roadmap addresses the growing interest in generative AI (GenAI) and its potential role in medical technology. While no GenAI-enabled devices have yet been authorized by the FDA, early use cases—such as generating synthetic medical images for training or producing preliminary radiology reports—point to future clinical applications. Cohen says that generative AI may be best suited for improving efficiency in hospital operations, such as operating room scheduling or planning perioperative staffing—applications he describes as having a lower entry bar while the technology continues to evolve

Given the evolving nature of this technology, AdvaMed urges regulators to avoid premature or overly rigid frameworks. Instead, the organization recommends applying the FDA’s existing risk-based approach, which evaluates devices based on intended use, risk profile, and performance, rather than focusing solely on the underlying AI method.

The roadmap also stresses the importance of continued communication between the FDA and stakeholders to ensure thoughtful, transparent policy development as GenAI applications emerge.

Policy recommendations:

• Ensure FDA reviews and considers GenAI-enabled devices using the existing risk-based frameworks.
• Encourage FDA to maintain ongoing dialogue with stakeholders in the health care sector and regular information-sharing on generative AI applications in medical devices.

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ISPOR—The Professional Society for Health Economics and Outcomes Research published the insights from its first Global Health Technology Assessment (HTA) Roundtable in an article in the March/April issue of Value & Outcomes Spotlight.

The society has a history of convening experts for regional HTA Roundtables across the globe. This was ISPOR’s first globally focused HTA Roundtable. The virtual ISPOR Global HTA Roundtable convened 100 HTA professionals from 53 countries worldwide in Q4 2024 to connect, share best practices, and build consensus on global HTA standards. 

The roundtable participants focused on three key topics: 

• gene therapies and other advanced therapy medicinal products, 
• improving access to therapies while navigating budget constraints, and 
• digital health with a focus on artificial intelligence (AI).

The participants’ consensus was that there is a strong need for greater international collaboration, transparency, and information sharing to address the common challenges HTA bodies face. The discussions also underscored the importance of adapting HTA methodologies to assess emerging technologies/advanced therapy medicinal products; digital health (including AI); and access to treatments. 

ISPOR will be holding its next Global HTA Roundtable in 2026 in response to the experts’ strong agreement that more cross-regional collaboration and information sharing are greatly needed.

“ISPOR is committed to supporting events like the Global HTA Roundtable to foster collaboration, consensus, and the evolution of HTA methodologies,” says ISPOR CEO and executive director Rob Abbott in a release. “ISPOR’s Global HTA Roundtable ties directly to two objectives in the society’s new Strategic Plan 2030, including proactively horizon scanning to establish high-leverage health policy opportunities that the Society can contribute toward. It also engages broadly with stakeholders to increase the visibility and influence of health economics and outcomes research, which is vital to HTA.”

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The Radiotherapy Service Engineers Association (RSEA) will hold its 25th annual meeting July 25–26 at the Walter E. Washington Convention Center in Washington, DC. The event will take place in conjunction with the American Association of Physicists in Medicine conference and carries the theme “Back to Basics.”

Geared toward both newcomers and experienced professionals, the meeting is designed for those who service and support radiotherapy systems—particularly the linear accelerators, CT scanners, and MRI machines that keep cancer centers running. Attendees will have opportunities to reconnect with foundational concepts, strengthen their technical knowledge, and engage with others dedicated to the same mission.

“This event will be perfect for newcomers to the field of accelerator maintenance, aspiring accelerator maintenance engineers, and seasoned professionals looking to refresh their knowledge from their academic days,” says Samantha Bentley, executive administrative coordinator. “We encourage attendees who gain immense satisfaction from contributing to the success of cancer centers, aiding doctors, therapists, physicists, and most importantly, patients, to join us in celebrating the incredible work of maintenance engineers and their pivotal role in the fight against cancer.”

Uniting Radiotherapy Service Engineers

RSEA exists to create a single, collective voice to represent the interests of all radiotherapy service engineers across the globe. Critical to this objective is establishing an open source environment where the community has shared input and ownership of what we do and how we do it.  

“We’re at an exciting inflection point to drive real and lasting change, and we encourage all radiotherapy service engineers to join us and become active members in the community,” says Bentley. 

Registration is open now for the annul meeting, with more information available at information is available at linaceng.org and through RSEA’s global Discord community at discord.com/invite/RK65ahC.

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AdvaMed and nine other health care organizations are urging an exemption from tariffs for medical and dental supplies, equipment, and devices, citing concerns about increased costs resulting in supply chain disruptions.

In a letter addressed to US Trade Representative Jameison Greer, the organizations noted that increased costs tied to tariffs could disproportionately impact hospitals, particularly those serving rural and medically underserved communities. They cited data from the American Hospital Association showing that 136 rural hospitals closed between 2010 and 2021, and a separate report indicating that 700 more are currently at risk of closure due to financial problems.

“Given the important role of our work in making America healthy, we are concerned that tariffs placed on medical and dental equipment threaten to disrupt the supply chain and raise costs for these critical items. This ultimately places further financial pressure on providers, hospitals, and health systems, particularly those located in rural and medically underserved areas,” the groups wrote to US Trade Representative Jameison Greer.

Cost and Innovation Concerns

The groups also expressed concern that higher equipment costs could hinder innovation and lead to longer wait times and reduced access to treatment. They pointed to a Black Book Market Research survey in which 80% of 200 industry professionals said they expected hospital and health system costs to increase by at least 15% within six months due to higher import costs.

In addition to AdvaMed, the letter was signed by the American Dental Association, the American Association for Homecare, America’s Essential Hospitals, the Association of American Medical Colleges, Conquering CHD, Health Industry Distributors Association, the Preeclampsia Foundation, Prevent Cancer, and the Sepsis Alliance.  

The groups wrote that they welcome continued engagement with the administration to ensure policies support access to care and affordability across the US healthcare system.

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The White House on Wednesday announced sweeping new tariffs on imported goods, citing persistent trade deficits and a lack of reciprocity from global trading partners as a threat to US national and economic security. 

Under the executive order, a 10% baseline tariff will be imposed on all imports, unless explicitly exempted, starting April 5, 2025, with higher, country-specific tariffs scheduled to take effect April 9. The policy—framed as a “reciprocal tariff”—is positioned as an effort to rebalance global trade and boost domestic manufacturing across key sectors. While pharmaceuticals and certain other products, including semiconductors and energy goods, are exempt, industry groups are seeking clarity on how the tariffs may impact sectors like medical technology.

AdvaMed expressed concern that the broad application of these tariffs could harm the US medical technology industry. “If implemented as proposed, broad-based tariffs of this nature would act much as an excise tax,” says AdvaMed president and CEO Scott Whitaker in a statement. “It will have a negative impact on innovation, cost jobs, and increase overall costs to the health care system. Historically, industries with a meaningful humanitarian mission have been exempted from broad tariffs, and as a result, we have seen no to low tariffs on medtech from all key trading partners.”

AdvaMed says it remains committed to working with the administration to make the case for excluding medtech from the new import taxes. 

“While disappointed in this initial announcement, we look forward to continuing our conversations with the White House to help them understand the important role the medtech industry plays in our health care ecosystem, the value it provides to patients, and the importance of the industry to continued US economic growth. The medtech industry should be exempted from these tariffs,” says Whitaker in a statement.

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The US Food and Drug Administration (FDA) has amended its database of Recognized Consensus Standards, adding multiple Association for the Advancement of Medical Instrumentation (AAMI) documents in the agency’s latest round of updates in March. 

This includes one new addition and three revised versions of sterility assurance and sterilization documents previously recognized by the FDA in December of 2024.

The new entry to the FDA’s database of Recognized Consensus Standards is AAMI TIR106:2024: Microbiological methods—Understanding and use of product bioburden data. 

Three of AAMI’s most notable sterilization guidance documents were also superseded by newer versions that were recently revised and updated by AAMI. These documents are:

• ANSI/AAMI ST58:2024, Chemical sterilization and high-level disinfection in health care facilities
• ANSI/AAMI ST24:2024, General purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
• AAMI TIR17:2024, Compatibility of materials subject to sterilization

“FDA had previously included prior editions of AAMI ST58, ST24, and TIR17 in its database of Recognized Consensus Standards, but the recognition of the recently updated documents and the new recognition of TIR106 is a welcome validation of AAMI’s efforts to promote patient well-being through the production of regulatory-ready sterilization and sterility assurance standards and technical documents,” says AAMI vice president of sterilization Amanda Benedict says in a release.

The most recent edition of ANSI/AAMI ST58 was revised and reorganized in 2024. The document now includes information on new technologies and chemical sterilization modalities, including ethylene oxide. Prior to 2024, ST24 had not been updated in more than two decades, and the most recent edition features FDA-cleared ethylene oxide sterilization systems not included in the prior edition. Finally, the new edition of TIR17 includes completely overhauled materials compatibility tables per modality.

All four guidance documents can be found on AAMI ARRAY. 

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