/ en Sun, 15 Jun 2025 02:40:33 -0500 Fri, 16 May 25 11:55:19 -0500 /lettercomment/2025-05-16-aha-responds-commerce-department-investigation-critical-minerals <p>May 16, 2025</p><p>Stephen Astle<br>Director, Defense Industrial Base Division<br>Office of Strategic Industries and Economic Security<br>U.S. Department of Commerce<br>1401 Constitution Ave, NW<br>Washington, DC 20230</p><p><em><strong>RE: Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Processed Critical Minerals and Derivative Products (XRIN 0694-XC124), April 25, 2025</strong></em></p><p>Dear Director Astle: </p><p>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 ���������� 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 processed critical minerals and derivative products. The investigation could form the basis for future tariffs or other trade restrictions on these products.</p><p>Critical minerals — including certain rare earth materials — are essential to the manufacture and operation of many medical devices that hospitals and health systems use to diagnose and treat patients every day. For example, magnetic resonance imaging (MRI), computerized tomography (CT), positron emission tomography (PET), radiopharmaceuticals and radiation therapy equipment all require the ready availability of critical minerals to function as intended. A substantial proportion of the critical minerals used in medical devices and therapies are either extracted or processed internationally, even when the device or therapy is manufactured in the U.S.</p><p>The AHA shares the administration’s long-term goal of securing reliable sources for critical minerals, including by strengthening domestic capabilities for mining and processing such minerals where possible. 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 for critical minerals. In the short term, we are concerned that tariffs on critical minerals used in health care — and any retaliatory action from the countries on which tariffs are imposed — could inadvertently disrupt the availability of critical diagnostic and treatment tools on which effective patient care relies. Tariffs and retaliatory actions from other nations also could significantly raise hospital costs.</p><p><strong>The AHA urges the administration to consider tariff exceptions for critical minerals and derivative products that are used for medical purposes. </strong>These exceptions could be coupled with continued engagement with multiple stakeholders —hospitals and health systems, device and drug manufacturers, mining and mineral processors and others — to explore approaches to making the supply chain for critical minerals used in medical devices and therapies more resilient and, when feasible, less dependent on international sources.</p><p>Multiple minerals on the critical minerals list are essential to aiding diagnosis and delivering treatments, and are heavily dependent on international sources, especially China. For diagnostic imaging, gadolinium is a rare earth material used in contrast fluid, which improve MRI precision. Contrast fluid can help identify vascular aneurysms and blockages, spinal cord injuries and brain tumors. Lutetium, another rare earth material, is used to produce very high-resolution PET/CT scans that help physicians determine how aggressive a tumor is and inform treatment plans. The U.S. is 80% reliant on international sources for rare earth materials.<sup>i</sup> Lutetium along with yttrium are also critical components of radiopharmaceuticals that are used to help shrink certain kinds of tumors. All of the yttrium used in the U.S. is imported, with 93% of it coming from China.<sup>ii</sup> Tungsten is also an essential component used to make certain linear accelerators that deliver radiation therapy treatment, with over half of the U.S. supply coming from China.<sup>iii</sup> Tariffs on these and other critical minerals used in health care could lead to disruptions in the availability of these critical patient care tools.</p><p>Lastly, the AHA is concerned about the potential for tariffs to raise the costs of delivering care to hospitals and health systems. Tariffs on critical minerals 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.<sup>iv </sup>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.<sup>v</sup></p><p>Thank you for the opportunity to provide feedback on this notice. We welcome the opportunity to discuss with your team how to preserve access to medical devices and technologies that depend on critical minerals and ensure that hospitals can continue delivering safe and effective care. Please contact me if you have questions at <a href="mailto:ademehin@aha.org">ademehin@aha.org</a>.</p><p>Sincerely,</p><p>/s/</p><p>Akinluwa (Akin) A. Demehin<br>Vice President<br>Quality and Safety Policy<br>______</p><div><div id="edn1"><p><small class="sm"><sup>i</sup> United States Geologic Services (USGS) Mineral Commodities Summaries. </small><a href="https://pubs.usgs.gov/periodicals/mcs2025/mcs2025-rare-earths.pdf"><small class="sm">https://pubs.usgs.gov/periodicals/mcs2025/mcs2025-rare-earths.pdf</small></a></p></div><div id="edn2"><p><small class="sm"><sup>ii</sup> USGS Mineral Commodities Summaries. </small><a href="https://pubs.usgs.gov/periodicals/mcs2025/mcs2025-yttrium.pdf"><small class="sm">https://pubs.usgs.gov/periodicals/mcs2025/mcs2025-yttrium.pdf</small></a></p></div><div id="edn3"><p><small class="sm"><sup>iii</sup> USGS Mineral Commodities Summaries. </small><a href="https://pubs.usgs.gov/periodicals/mcs2025/mcs2025-tungsten.pdf"><small class="sm">https://pubs.usgs.gov/periodicals/mcs2025/mcs2025-tungsten.pdf</small></a></p></div><div id="edn4"><p><small class="sm"><sup>iv</sup> </small><a href="https://www.beckershospitalreview.com/supply-chain/hospital-finance-supply-leaders-predict-15-increase-in-tariff-related-costs/"><small class="sm">https://www.beckershospitalreview.com/supply-chain/hospital-finance-supply-leaders-predict-15-increase-in-tariff-related-costs/</small></a></p></div><div id="edn5"><p><small class="sm"><sup>v </sup></small><a href="/costsofcaring"><small class="sm">/costsofcaring</small></a><small class="sm"> </small></p></div></div> Fri, 16 May 2025 11:55:19 -0500 Medical Device Technology /news/headline/2025-03-28-aha-blog-can-collaborative-efforts-improve-device-design-improve-safety <p>Despite elegant efforts to design for safe use, rigorous standards and regulatory requirements, and lots of training of health care professionals, there’s still room to ensure clinicians are using medical devices correctly — especially in high-stress, high-risk situations. Earlier this year, AHA and the Association for Advancement of Medical Instrumentation brought together a small group composed of hospital and health system leaders, device manufacturers and policy leaders to explore how to make devices safer by design. <a href="/news/blog/2025-03-28-can-collaborative-efforts-improve-device-design-improve-safety"><strong>READ MORE</strong></a></p> Fri, 28 Mar 2025 14:24:35 -0500 Medical Device Technology /news/headline/2025-02-11-white-house-announces-tariffs-steel-and-aluminum-imports <p>The Trump administration yesterday <a href="https://www.whitehouse.gov/fact-sheets/2025/02/fact-sheet-president-donald-j-trump-restores-section-232-tariffs/" title="tariffs">announced</a> it issued executive orders authorizing 25% tariffs on all steel and aluminum imports. Importantly, both steel and aluminum are used broadly for medical devices such as surgical instruments, prosthetics, implants, crutches, wheelchairs, plates and screws, among many others.</p><p> </p> Tue, 11 Feb 2025 16:31:53 -0600 Medical Device Technology /news/headline/2025-02-07-fda-warns-potential-miss-notifications-smartphone-compatible-diabetes-devices <p>The Food and Drug Administration Feb. 5 released an <a href="https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-potential-miss-critical-safety-alerts-due-phone-settings-when-using-smartphone" title="fda alert">alert</a> notifying patients of a safety concern using diabetes devices such as continuous glucose monitors, insulin pumps and automated insulin dosing systems that rely on a smartphone for delivering alerts. The agency said it received medical device reports in which users reported alerts were not being delivered or heard in situations where the users thought they configured the alerts to be delivered. Some instances may have contributed to serious harm, including severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis and death.   </p><p>The FDA issued recommendations for users and said it is working with diabetes-related medical device manufacturers to ensure that smartphone alert configurations are evaluated prior to use. It is also working with manufacturers to ensure settings for smartphones and mobile medical applications are continuously tested and that updates are communicated quickly and clearly to users.</p> Fri, 07 Feb 2025 14:44:30 -0600 Medical Device Technology /role-hospitals-intermountain-utah-medical-center-first-nation-use-game-changing-device-treat-aortic-aneurysms <div class="container"><div class="row"><div class="col-md-9"><div class="col-md-6"><p><img src="/sites/default/files/2024-11/ths-internountain-aorta-replacement-700x532.jpg" data-entity-uuid data-entity-type="file" alt="Intermountain Medical Center. Illustration and microscopicscan of aortic valve" width="700" height="532"></p></div><p>Patients with complex aneurysms in the visceral aorta, which supplies blood to vital abdominal organs, had limited treatment options, often requiring highly invasive open surgery with long recovery times and high risks of complications.</p><p>Intermountain Medical Center in Murray, Utah, has become the first hospital in the United States to use the newly FDA-approved Gore EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) device to treat this form of aortic aneurysm. This minimally invasive procedure, performed by vascular surgeon Dr. Evan Brownie, marks a significant advancement in treatment by eliminating the need for major surgery, offering a safer and less invasive option for patients.</p><p>The TAMBE device allows for the repair of these aneurysms through small punctures in the femoral arteries and beneath the collarbone, significantly reducing recovery time and improving patient outcomes. Dr. Brownie highlights the device as a game-changer, providing new hope for patients not only in Utah but across the country.</p><p>“This device was designed specifically for these complex cases, and the difference it makes is already clear,” said Dr. Brownie. “We’re at the forefront of something truly significant, and it’s exciting to be part of a new era in treating these complex and dangerous aneurysms.”</p><p><a class="btn btn-primary" href="https://news.intermountainhealth.org/intermountain-medical-center-first-in-nation-to-use-fda-approved-device-to-treat-life-threatening-aortic-aneurysms-providing-new-hope-for-patients/">LEARN MORE</a></p></div><div class="col-md-3"><div><h4>Resources on the Role of Hospitals</h4><ul><li><a href="/topics/innovation">Innovation, Research and Quality Improvement</a></li><li><a href="/roleofhospitals">All Case Studies</a></li></ul></div></div></div></div> Mon, 18 Nov 2024 11:46:28 -0600 Medical Device Technology /news/headline/2024-10-02-hhs-says-impacts-medical-products-should-be-limited-strike-us-ports-begins <p>The Department of Health and Human Services Sept. 30 released a <a href="https://www.hhs.gov/about/news/2024/10/01/statement-by-us-department-health-human-services-strike-east-coast-gulf-coast-ports.html">statement</a> on the dockworker strike at ports along the East and Gulf coasts, saying that immediate impacts to medicines, medical devices and other goods should be limited. HHS, the Food and Drug Administration and the Administration for Strategic Preparedness and Response are working with trade associations, distributors and manufacturers to limit impacts on consumers and assess vulnerabilities. The AHA is monitoring the situation.  </p><p>According to <a href="https://39932089.hs-sites.com/port-strikes-threat-assessment">Healthcare Ready</a>, a nonprofit organization that works with the government, providers, and supply chain organizations to enhance the resiliency of communities before, during and after disasters, a substantial number of pharmaceuticals commonly used in the care of patients come through the ports every day. Given the shortages that already exist for many medications, and the disruption in the supply of IV solutions caused by the flooding of the Baxter plant in North Carolina, AHA will be alert for potential shortages of vital pharmaceuticals related to the strike.</p> Wed, 02 Oct 2024 14:30:08 -0500 Medical Device Technology /role-hospitals-monmouth-medical-center-new-robotic-platform-technologies-are-helping-transform-early-lung-cancer-diagnoses <div class="container"><div class="row"><div class="col-md-9"><div class="col-md-5"><p><img src="/sites/default/files/2024-09/ths-monmouth-surgery-tech-700x532.jpg" data-entity-uuid data-entity-type="file" alt="Monmouth Medical Center. Surgeons operate on unseen patient in this surgical innovation concept image" width="700" height="532"></p></div><p>A triple-whammy of advanced new diagnostic and treatment options holds the promise for better outcomes for New Jersey lung cancer patients.</p><p>Monmouth Medical Center (MMC), an RWJBarnabas Health facility, has introduced three new highly precise technologies used to both diagnose and treat lung cancer.</p><p>The centerpiece is Ion, a robot-assisted platform designed to enable minimally invasive lung biopsies that may become a key part of early diagnosis. Ion’s ability to navigate small nodules via an ultrathin catheter, aided by a GPS-like guide system, enhances reach, precision, and stability for lung biopsies and affords doctors access to all segments of the lung.</p><p>“[This] can help patients with suspicious lung nodules get answers sooner, potentially enabling more time to consider treatment options,” said Richard Lazzaro, M.D., chief of Thoracic Surgery for the RWJBarnabas Health Southern Region.</p><p>Monmouth Medical Center’s Ion system is used in conjunction with the Aliya PEF System, which delivers high-voltage, high-frequency electrical currents through a single monopolar electrode designed to ablate the targeted cancer cells.</p><p>Completing its triad of lung cancer fighting tools, MMC became the first hospital in New Jersey to introduce intraoperative AI-driven CT imaging for use with the Ion. Benefits to patients include less radiation exposure and less time spent in surgery.</p><p>“We are proud to be able to introduce these amazing new technologies as a part of our commitment to delivering the highest level of thoracic care to our patients,” said Monmouth Medical Center President and CEO Eric Carney. “In pioneering these firsts, our team has a singular focus – that is on the best patient outcomes.”</p><p><a class="btn btn-primary" href="https://www.rwjbh.org/blog/2024/july/monmouth-medical-center-introduces-three-innovat/">LEARN MORE</a>.</p></div><div class="col-md-3"><div><h4>Resources on the Role of Hospitals</h4><ul><li><a href="/topics/innovation">Innovation, Research and Quality Improvement</a></li><li><a href="/roleofhospitals">All Case Studies</a></li></ul></div></div></div></div> Mon, 16 Sep 2024 14:29:12 -0500 Medical Device Technology /role-hospitals-petersburg-medical-center-delivers-gentler-more-effective-breast-cancer-screenings <div class="container"><div class="row"><div class="col-md-9"><div class="col-md-5"><p><img src="/sites/default/files/2024-09/ths-petersburg-mammography-700x532.jpg" data-entity-uuid data-entity-type="file" alt="Petersburg Medical Center. Female clinician stands with new 3d mammography device" width="700" height="532"></p></div><p>Petersburg Medical Center in Petersburg, Alaska, has ushered in a new era of breast cancer detection with the arrival of its advanced 3D mammography machine. This leading-edge technology provides earlier and more accurate diagnosis of abnormalities and aims to alleviate the discomfort often associated with breast exams.</p><p>While mammograms may be uncomfortable, they should never be a source of pain. The new machine's design incorporates features intended to enhance patient comfort, such as a flexible compression paddle and rounded corners. By making the experience more tolerable, the hospital hopes to remove obstacles that prevent patients from seeking essential preventive care.</p><p>“Many women who are here year after year say it’s not the same mammogram that women have always [spoken] of,” Radiology Manager Sonja Paul said. “…Breast exams and mammograms, they’re uncomfortable, but they shouldn’t hurt! I don’t want that to be a barrier between women receiving their exams.”</p><p>Beyond the comfort factor, the 3D mammography machine offers a significant advantage in detecting breast cancer at its earliest stages. The detailed images produced by the technology provide radiologists with a clearer view of breast tissue, increasing the likelihood of identifying potential issues. Early detection is crucial for successful treatment outcomes, making this technological advancement a game-changer in the fight against breast cancer.</p><p><a class="btn btn-primary" href="https://www.kfsk.org/2024/04/30/petersburg-medical-center-brings-in-new-mammography-machine-that-could-catch-abnormalities-earlier/" target="_blank">LEARN MORE</a></p></div><div class="col-md-3"><div><h4>Resources on the Role of Hospitals</h4><ul><li><a href="/topics/innovation">Innovation, Research and Quality Improvement</a></li><li><a href="/roleofhospitals">All Case Studies</a></li></ul></div></div></div></div> Tue, 03 Sep 2024 14:30:10 -0500 Medical Device Technology /role-hospitals-sharp-memorial-hospital <div class="container"><div class="row"><div class="col-md-9"><div class="col-md-5"><p><img src="/sites/default/files/2024-05/ths-Sharp-Memorial-Hospital-700x532.jpg" data-entity-uuid data-entity-type="file" alt="Sharp Memorial Hospital exterior" width="700" height="532"></p></div><p>Every 40 seconds, someone in the U.S. experiences a stroke; every four minutes, someone doesn’t survive one. Strokes occur when blood flow to the brain is blocked or disrupted, and recovering can mean undergoing intensive rehabilitative therapy to restore speech, movement and the ability to conduct daily activities.</p><p>About 87% of strokes are ischemic, caused when blood flow to the brain is blocked by a clot or fatty plaque. For some people, there is no apparent cause. But for others, the answer lies in a different organ: the culprit may be a hole, located in the upper chambers of the heart, that doesn’t close properly. This hole, called a patent foramen ovale (PFO), incorrectly remains open in 30% of people with a PFO. And a PFO not closing can lead to a blood clot forming, which can eventually reach the brain and cause a stroke.</p><p>Knowing whose heart has a PFO and whether it’s open or closed can go a long way in helping doctors understand which patients are at higher risk. At Sharp Memorial Hospital in San Diego, health care providers use a technology called robotic transcranial Doppler (TCD), to identify PFOs in the heart and determine a patient’s likelihood of ischemic stroke.</p><p>Though a number of hospitals also use TCD in critical care settings, Sharp Memorial Hospital in October 2022 became the first in southern California to use TCD to find PFOs. Prior to then, the available technology was limited to traditional ultrasounds.</p><p>“With the latest advancements in robotic TCD technology, PFOs are three times more likely to be found, and the risk of stroke is better determined,” said Ajay Yadlapati, M.D., a cardiologist affiliated with Sharp Memorial Hospital.</p><p>The TCD test to find PFOs involves injecting microbubbles of an air and saline mix into a patient’s vein, and using a Doppler signal to measure blood flow through vessels. People with symptomatic or large PFOs may benefit from an additional procedure to close the hole, which is often paired with medication, to minimize their risk of stroke.</p><p><a href="https://www.sharp.com/health-news/new-technology-detects-a-persons-risk-of-stroke"><strong>LEARN MORE</strong></a></p></div><div class="col-md-3"><div><h4>Resources on the Role of Hospitals</h4><ul><li><a href="/topics/innovation">Innovation, Research and Quality Improvement</a></li><li><a href="/roleofhospitals">All Case Studies</a></li></ul></div></div></div></div> Thu, 16 May 2024 13:36:26 -0500 Medical Device Technology /news/headline/2024-05-09-fda-clarifies-definition-remanufacturing-medical-devices-needing-maintenance <p>The Food and Drug Administration May 9 released <a href="https://www.fda.gov/media/150141/download">final guidance</a> clarifying the definition of “remanufacturing” for reusable medical devices needing maintenance or repair, advising that manufacturers include instructions necessary for proper servicing and provide examples of activities that constitute remanufacturing. The final guidance is in response to public comments, including from the <a href="/lettercomment/2021-09-22-aha-comments-remanufacturing-medical-devices-draft-guidance-industry-and-fda-staff">AHA</a>, which highlighted the need for clarity, considering the different regulatory implications between “servicing” and “remanufacturing” of a medical device. The FDA <a href="https://www.fda.gov/news-events/press-announcements/fda-issues-final-guidance-clarify-remanufacturing-devices-need-maintenance-or-repair">defines</a> remanufacturing as “the processing, conditioning, renovating, repackaging, restoring or any other act done to a finished device that significantly changes the finished device’s performance, safety specifications or intended use." The agency also defines servicing as “the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the original equipment manufacturer (OEM) and to meet its original intended use.” The agency also recommends certain information be included in the labeling of such devices regarding preventive maintenance and repair, including instructions on how to adequately return a device to its performance and safety specifications established by the OEM. </p> Thu, 09 May 2024 15:15:56 -0500 Medical Device Technology