/ en Fri, 25 Apr 2025 20:18:35 -0500 Wed, 05 Feb 25 09:22:30 -0600 <div class="container"><div class="row"><div class="col-md-8"><p>The AHA late yesterday told the administration that its current and proposed tariffs on Canada, Mexico and China may jeopardize the availability of vital medications and essential health care devices.</p><p>“We ask that you consider granting exceptions to the current and proposed tariffs for medical devices and pharmaceuticals made in Mexico, Canada and China that are essential to the provision of safe, effective care in America's hospitals, clinics, and other settings,” AHA President and CEO Rick Pollack wrote in a <a href="/lettercomment/2025-02-05-aha-urges-administration-grant-exceptions-tariffs-medications-and-medical-supplies" target="_blank">letter</a> to President Trump. “It is especially critical to have these exceptions for products already in shortage and for which production in the countries subject to increased tariffs supply a significant part of the U.S. market.”</p><p>Since the announcement of the potential tariffs, conversations with the leaders of Canada and Mexico led to a delay in the imposition of tariffs on products made in those countries, but AHA said, “We believe the principle still prevails.”</p><p>Specifically, AHA expressed concern about dangers for patients associated with the disruption in the supply of cardiac drugs, oncology drugs and others made in China, as well as the supply of active pharmaceutical ingredients — the U.S. gets nearly 30% of its APIs from China — “meaning that these tariffs may also limit the availability of U.S. drug manufacturers to produce critical drugs here in the U.S.”</p><p>The AHA also expressed concern about the potential impact of tariffs on medical devices designed to protect patients from infection, such as single-use blood pressure cuffs, stethoscope covers and sterile drapes, as well as supplies that health care workers need to care for patients, including gowns, gloves, face masks, respirators and other equipment, “much of which is manufactured in China and cannot be easily replaced by domestic manufacturers.”</p><p>The AHA Feb. 3 issued a <a href="/advisory/2025-02-03-tariffs-canada-china-and-mexico" target="_blank" title="Member Advisory PDF">Member Advisory</a> with additional information about the tariffs. The AHA will continue to monitor this issue and provide additional updates as needed.</p><h2>ADDITIONAL INFORMATION ON EXECUTIVE ACTIONS</h2><p>The Trump administration continues to issue executive orders and administrative actions that reinforce the administration’s priorities. The AHA has compiled a <a href="/system/files/media/file/2025/01/2025-New-Executive-Orders-20250127.pdf" target="_blank" title="AHA tracker ">tracker</a> of the actions the administration has taken that may be of interest to hospitals and health systems. The tracker will be updated regularly as new actions are released.</p><h2>FURTHER QUESTIONS</h2><p>If you have further questions, please contact Nancy Foster, AHA vice president of quality and patient safety policy, at <a href="mailto:nfoster@aha.org">nfoster@aha.org</a>. </p></div><div class="col-md-4"><a href="/system/files/media/file/2025/02/aha-urges-administration-to-grant-exceptions-for-current-and-proposed-tariffs-for-medications-and-medical-supplies-advisory-2-5-2025.pdf"><img src="/sites/default/files/inline-images/cover-aha-urges-administration-to-grant-exceptions-for-current-and-proposed-tariffs-for-medications-and-medical-supplies-advisory-2-5-2025.png" data-entity-uuid="29876587-0bcc-48ec-8b34-dcc8529a1acd" data-entity-type="file" alt="Cover of the Member Advisory" width="640" height="834"></a></div></div></div> Wed, 05 Feb 2025 09:22:30 -0600 Medical Device Purchasing /lettercomment/2025-02-05-aha-urges-administration-grant-exceptions-tariffs-medications-and-medical-supplies <div class="container"><div class="row"><div class="col-md-8"><p>February 4, 2025</p><p>The Honorable Donald J. Trump<br>President of the United States of America<br>White House<br>1600 Pennsylvania Avenue<br>Washington, D.C. 20500</p><p>Dear President Trump:</p><p>America's hospitals stand with you in seeking ways to prevent the ravages of illicit drug use in this country. Every day, the doctors, nurses and other caregivers in our hospitals and health systems treat those suffering from addiction. They work tirelessly to prevent deaths from overdoses of fentanyl and other addictive drugs. We commend your focus on this issue in the first few days of your second term. We are, however, concerned that the approach of using tariffs may inadvertently put others' lives at risk by jeopardizing the availability of vital medications and essential health care devices.</p><p>We ask that you consider granting exceptions to the current and proposed tariffs for medical devices and pharmaceuticals made in Mexico, Canada and China that are essential to the provision of safe, effective care in America's hospitals, clinics, and other settings. It is especially critical to have these exceptions for products already in shortage and for which production in the countries subject to increased tariffs supply a significant part of the U.S. market. We are aware, since the announcement of the potential tariffs, conversations with the leaders of Canada and Mexico led to a delay in the imposition of tariffs on products made in those countries, but we believe the principle still prevails.</p><p>Despite ongoing efforts to build the domestic supply chain, the U.S. health care system relies significantly on international sources for many drugs and devices needed to both care for patients and protect our health care workers. Tariffs, as well as any reaction of the countries on whom such tariffs are imposed, could reduce the availability of these life-saving medications and supplies in the U.S. For example, U.S. providers import many cancer and cardiovascular medications, immunosuppressives, antibiotics and combination antibiotics from China. For many patients, even a temporary disruption in their access to these needed medications could put them at significant risk of harm, including death. Carefully planned chemotherapy treatments and antibiotic schedules are essential to giving patients the best chance of overcoming their disease. Similarly, the provision of necessary cardiovascular medications must be continuous to preserve their cardiovascular health.</p><p>Beyond the use of these finished products, many raw ingredients for pharmaceuticals come from China. These are commonly known as active pharmaceutical ingredients (APls). These chemicals are the most important components of any pharmaceutical manufacturer's supply chain. The U.S. gets nearly 30% of its APls from China, meaning that these tariffs may also limit the availability of U.S. drug manufacturers to produce critical drugs here in the U.S.<a href="#fn1"><sup>1</sup></a></p><p>China is also the source of many medical devices. Some of these devices are single­ use devices designed to protect the patient from infection, such as single-use blood pressure cuffs, stethoscope covers and sterile drapes. Others are small devices used ubiquitously in hospitals, such as anesthesia instruments, cautery pencils, needles and syringes, pulse oximeters and blood pressure cuffs. Disruption in the availability of these instruments would curtail hospitals' ability to perform life-saving surgeries and keep patients safe from contagion and greatly reduce our ability to effectively diagnose and monitor patient conditions.</p><p>Finally, the protection of our health care workers from infectious diseases is vital to their health and the ability of the health care system to continue caring for patients. Health care workers need gowns, gloves, face masks, respirators and other equipment, much of which is manufactured in China and cannot be easily replaced by domestic manufacturers. In 2023, Chinese manufacturers provided the majority of the N95 and other respirators used in health care. Additionally, China was the source for one-third of the disposable face masks, two-thirds of the non-disposable face masks, and 94% of the plastic gloves used in health care.<a href="#fn2"><sup>2</sup></a> The lack of this essential equipment will not only put patients at risk but also threaten our health care delivery personnel.</p><p>Thank you for your consideration of our concerns on this important matter. We welcome the opportunity to discuss how to preserve access to essential pharmaceuticals and devices with your team. Please feel free to have your designee contact me or Nancy Foster, AHA vice president for quality and patient safety policy, at 202-626-2337 or nfoster@aha.org.</p><p>Sincerely,</p><p>/s/</p><p>Richard J. Pollack<br>President and Chief Executive Officer</p><hr><ol><li id="fn1">Neils Graham, Atlantic Council, April 19, 2023; The US is relying more on China for pharmaceuticals and vice versa.</li><li id="fn2">AdvaMed presentation 2023</li></ol></div><div class="col-md-4"><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/system/files/media/file/2025/02/AHA-Urges-Administration-to-Grant-Exceptions-for-Tariffs-for-Medications-and-Medical-Supplies.pdf" target="_blank" title="Click here to download the AHA Urges Administration to Grant Exceptions for Tariffs for Medications and Medical Supplies letter PDF.">Download the letter PDF</a></div><p><a href="/system/files/media/file/2025/02/AHA-Urges-Administration-to-Grant-Exceptions-for-Tariffs-for-Medications-and-Medical-Supplies.pdf" target="_blank" title="Click here to download the AHA Urges Administration to Grant Exceptions for Tariffs for Medications and Medical Supplies letter PDF."><img src="/sites/default/files/inline-images/Page-1-AHA-Urges-Administration-to-Grant-Exceptions-for-Tariffs-for-Medications-and-Medical-Supplies-letter.png" data-entity-uuid="7b65288a-4404-46df-a4d2-2055dbbc12b4" data-entity-type="file" alt="AHA Urges Administration to Grant Exceptions for Tariffs for Medications and Medical Supplies letter page 1." width="695" height="900"></a></p></div></div></div> Wed, 05 Feb 2025 07:54:44 -0600 Medical Device Purchasing /news/headline/2020-02-18-fda-india-collaborate-stop-unapproved-medical-products <p>The Food and Drug Administration, in its first enforcement operation with the government of India, recently stopped about 500 shipments of unapproved prescription drugs and combination medical devices from reaching U.S. consumers, the agency <a href="https://www.fda.gov/news-events/press-announcements/fda-takes-action-indian-government-protect-consumers-illicit-medical-products">announced</a> today. The shipments, many sent through third-party countries to conceal their origin, included about 50 FDA-regulated products, including cancer and HIV medications and opioid products, FDA said. “Consumers and physicians purchasing medicines cannot be assured the products they are receiving are legitimate, safe or effective if they are obtained from outside of the FDA-regulated pharmaceutical supply chain,” said FDA Commissioner Stephen Hahn, M.D.  </p> Tue, 18 Feb 2020 14:58:12 -0600 Medical Device Purchasing /news/headline/2019-04-15-fda-alerts-providers-temporary-shortage-breathing-tube <p>The Food and Drug Administration Friday <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635925.htm">alerted</a> hospitals and others to a temporary shortage of a tracheostomy tube used to help adult and pediatric patients breathe in health care facilities and at home. Made by Smiths Medical, the Bivona tracheostomy tubes are sterilized with ethylene oxide before they are marketed in the U.S. FDA last month <a href="/news/headline/2019-03-27-fda-closure-medical-device-sterilization-facility-could-prompt-shortages">announced</a> the potential for medical device shortages due to the closure of a large ethylene oxide sterilization facility in Willowbrook, Ill., and the future planned closure of a similar facility in Michigan. The temporary shortage is more likely to impact pediatric patients because the supply of alternative tubes for pediatric patients is limited, FDA said. “We recognize the challenges this shortage imposes for these pediatric patients who need access to new tubes now, and are working to limit the impact to patients as much as possible by helping the company quickly move their sterilization to another facility,” the agency said. Health care professionals who have patients urgently in need of a new Bivona tube should contact Smiths Medical directly to inquire about current inventory, FDA said.</p> Mon, 15 Apr 2019 14:37:16 -0500 Medical Device Purchasing /news/headline/2019-03-12-cms-outlines-planned-changes-competitive-bidding-program-2021 <p>The Centers for Medicare & Medicaid Services last week <a href="https://www.cms.gov/newsroom/fact-sheets/dmepos-competitive-bidding-round-2021">announced</a> planned changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program for 2021. Under the program, DMEPOS suppliers compete to become Medicare contract suppliers to furnish 16 product categories in 130 competitive bidding areas. The program’s last contracts expired in December. In May, CMS will announce bidder registration and bidding dates for the 2021 program.</p> Tue, 12 Mar 2019 15:12:55 -0500 Medical Device Purchasing