AHA Responds to Department of Commerce’s RFI on PPE and Medical Equipment

October 17, 2025

Stephen Astle
Director, Defense Industrial Base Division
Office of Strategic Industries and Economic Security
U.S. Department of Commerce
1401 Constitution Ave, NW
Washington, DC 20230 

RE: Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Personal Protective Equipment, Medical Consumables, and Medical Equipment, Including Devices (XRIN 0694-XC134), Sept. 26, 2025

Dear Director Astle: 

On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, the American Hospital Association (AHA) appreciates the opportunity to comment on the Department of Commerce’s request for public comment on its Section 232 national security investigation on personal protective equipment (PPE), medical consumables and medical equipment. The investigation could form the basis for future tariffs or other trade restrictions on these products.

Each day in America’s hospitals and health systems, the expertise of care teams comes together with a dizzying array of PPE, medical consumables and state-of-the-art medical technologies to deliver safe and effective care. The supply chains for these goods are highly complex, bringing together both domestic and international sources. In 2024 alone, the U.S. imported over $75 billion in medical devices and supplies, according to AHA analysis of Census Bureau data. Estimates of the proportion of medical devices used in the U.S. that are imported vary. According to the Food and Drug Administration, about 62% of medical devices used in the U.S. are imported, while another recent analysis showed that nearly 70% of medical devices marketed in the U.S. are manufactured exclusively overseas.^1,2 The degree of dependence on international sources also varies by type of PPE, device and equipment. For example, around 30% of the medical technology market in the U.S. is imported, while much higher percentages of PPE are sourced internationally.^3,4

The AHA shares the administration’s long-term goal of strengthening domestic manufacturing for medical devices, PPE and other equipment while reducing our nation’s reliance on international sources. At the same time, achieving this goal will require a significant amount of time, given the logistical complexity and resources involved in shifting the supply chain. In the short term, we are concerned that tariffs on these critical goods — and any retaliatory action from the countries on which tariffs are imposed — could inadvertently disrupt the availability of diagnostic and treatment tools and hinder access to PPE that is essential to protecting the workforce and patients. Tariffs and retaliatory actions from other nations also could significantly raise hospital costs.

As the administration continues its Section 232 investigation and considers potential future policy approaches, we urge a balanced approach that advances America’s interests while ensuring dependable, affordable access to the PPE, medical consumables, medical devices and other equipment hospitals need to deliver care. We believe part of this approach could include a tariff exception process for certain products — especially those in shortage and for which production in the countries subject to tariffs supply a significant part of the U.S. market.  We also encourage continued engagement with multiple stakeholders — hospitals and health systems, medical device manufacturers, suppliers, group purchasing organizations and others — to explore approaches to making the supply chain for these goods more resilient and, when feasible, less dependent on international sources, especially from America’s adversaries

Patients’ lives often depend on the ready availability of medical devices and consumables to diagnose, monitor and treat patients. These imports include many low-margin, high-use essentials in hospital settings. Some devices are used only once to protect patients from infection, such as single-use blood pressure cuffs, stethoscope covers and sterile drapes. Others are small devices used ubiquitously in hospitals, such as surgical and anesthesia instruments, cautery pencils, needles, syringes and pulse oximeters. The low-margin nature of these products makes them difficult to produce sustainably within the U.S. At the same time, disruption in the availability of these devices would curtail hospitals’ ability to perform life-saving surgeries and keep patients safe from contagion, as well as hinder providers’ ability to effectively diagnose, monitor and treat patients.

Hospitals are especially reliant on international sources for PPE to protect both caregivers and patients. In 2023, Chinese manufacturers supplied the majority of N95 and other respirators used in health care. Additionally, China was the source for one-third of disposable face masks, two-thirds of non-disposable face masks and 94% of the plastic gloves used in health care settings.⁵

While these data underscore the importance of bolstering domestic manufacturing capacity for essential medical goods to protect America’s interests, reshoring alone cannot provide the supply chain stability needed to ensure unrestricted access to necessary devices and equipment for patient care. Indeed, medical devices and other technologies produced in the U.S. often still include significant international content. For example, a typical U.S.-made infusion pump can contain parts from more than 20 countries, while a single magnetic resonance imaging machine can include parts from 15 countries.⁶ Furthermore, even domestic medical supply chains are prone to disruption, as illustrated by the lingering shortages of intravenous (IV) fluids stemming from the impacts of Hurricane Helene on a large North Carolina production facility in 2024. The disruption lasted 11 months and was declared resolved in August 2025 despite that facility being located on American soil.⁷

The AHA also urges the administration to preserve the Nairobi Protocol. This policy helps ensure access to imported medical devices that deliver better outcomes and a higher quality of life for millions of Americans with chronic conditions and disabilities. Among other devices that have qualified for Nairobi Protocol exemptions, hospitals rely on pacemakers to treat patients with heart conditions, and insulin pumps to treat patients with diabetes. They also provide patients with prosthetic limbs to restore function to patients with mobility and physical impairments and use cochlear implants for patients with permanent or chronic hearing loss. The duty-free treatment available for qualifying products is vital for ensuring affordable access to these devices for patients and their families.

Lastly, the AHA is concerned about the potential for tariffs to raise the costs of delivering care in hospitals and health systems. Tariffs could have a particularly significant impact on complex medical devices that are higher cost and lower volume, in part due to requiring specialized parts and customization to meet the needs of health care providers. A recent survey found that 82% of health care experts expect tariff-related expenses to raise hospital costs by at least 15%, and 90% of supply chain  professionals expect procurement disruptions.⁸ Given that hospital payments are set by government and private payer contracts, the costs would be borne by hospitals directly. As underscored by the AHA’s recent Cost of Caring report, such cost increases could further compound the broader financial headwinds challenging hospitals’ ability to provide care to patients and communities.⁹

Thank you for the opportunity to provide feedback on this notice. The AHA welcomes the opportunity to discuss with your team how to preserve access to PPE, medical devices and other equipment that help hospitals deliver on their mission of healing and hope. Please contact me if you have questions at ademehin@aha.org.

Sincerely,

/s/

Akinluwa (Akin) A. Demehin
Vice President
Quality and Safety Policy

__________

¹  https://www.fda.gov/international-programs/fda-globalization
²  https://www.medicaldevice-network.com/analyst-comment/trump-tariffs-us-medical-device-market/?cf-view
³  https://www.advamed.org/wp-content/uploads/2025/07/7.16.25-Medtech-manufacturing-fact-sheet.pdf
4 https://www.healthcare-brew.com/stories/2025/08/12/pandemic-efforts-us-mostly-imports-ppe
5 AdvaMed presentation, 2023
6  https://www.ft.com/content/31402296-753c-4fa9-b5bb-0c8c25ccff04
7 https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-announcing-resolution-iv-saline-solutions-shortage
⁸ https://www.beckershospitalreview.com/supply-chain/hospital-finance-supply-leaders-predict-15-increase-in-tariff-related-costs/
⁹ https://www.aha.org/costsofcaring