/ en Fri, 25 Apr 2025 20:18:42 -0500 Fri, 28 Mar 25 14:24:35 -0500 /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 /aha-center-health-innovation-market-scan/2024-03-12-nebraska-medicine-targets-earlier-diabetic-retinopathy-detection-ai <div class="container"><div class="row"><div class="col-md-8"><p><img src="/sites/default/files/inline-images/Nebraska-Medicine-Targets-Earlier-Diabetic-Retinopathy-Detection-with-AI.png" data-entity-uuid="a9ff0a0b-8210-454c-853d-f5d907a4e3a3" data-entity-type="file" alt="Nebraska Medicine Targets Earlier Diabetic Retinopathy Detection with AI. A closeup on a man's face with a focus on his left eye, which is being digitally scanned for diabetic retinopathy and evaluated by AI." width="100%" height="679"></p><p>The potential for using artificial intelligence (AI) to bring greater diagnostic precision in health care has been growing, with hundreds of FDA approvals issued specifically for radiology.</p><p>Yet many AI applications are in their earliest stages of use. Nebraska Medicine, based in Omaha, Nebraska, however, has <a href="https://www.modernhealthcare.com/digital-health/nebraska-medicine-ai-artificial-intelligence-diabetic-retinopathy" target="_blank" title="Modern Healthcare: How one system is using AI to diagnose patients">begun testing an AI tool</a> in two of its primary care clinics to detect diabetic retinopathy in patients — a condition that can lead to blindness.</p><p>Using a system called <a href="https://www.eyenuk.com/us-en/products/eyeart/" target="_blank" title="Eyenuk: EyeArt Immediate, Fully-automated, On-site Diabetic Retinopathy Screening">EyeArt</a> from AI company <a href="https://www.eyenuk.com/us-en/" target="_blank" title="Eyenuk homepage">Eyenuk</a>, primary care nurses or assistants capture images of their patients’ retinas using a fundus camera that photographs the back of the eye. The images are securely transmitted to the system’s cloud-based platform, which looks for signs of disease or lesions and then returns a report in less than 60 seconds.</p><p>The results are integrated into Nebraska Medicine’s electronic health record system, and primary care physicians can refer patients to an ophthalmologist if needed. The system enables physicians to identify patients who may be at risk for serious visual complications so they can be referred to a specialist earlier.</p><p>“Early detection and timely intervention can reduce the risk of vision loss and are essential, given that late-stage disease can be more difficult to treat,” Steven Yeh, M.D., a board-certified ophthalmologist at Nebraska Medicine, said in a statement.</p><p>Early results at Nebraska Medicine appear to be promising, with clinicians referring 28% of patients who have been screened with the system to an ophthalmologist, notes a Modern Healthcare report.</p><p>EyeArt is the first and only FDA-cleared technology for the autonomous detection of vision-threatening diabetic retinopathy caused by high blood sugar, according to the company’s website. The company reports that the system has been tested on more than 500,000 patients globally with more than 2 million images collected in real-world clinical settings.</p><p>EyeArt reports a 91.3% sensitivity rate for referrable diabetic retinopathy and a 98.5% sensitivity for vision-threatening diabetic retinopathy in a study of more than 100,000 consecutive patient visits to more than 400 primary care clinics, the company states.</p><p>The platform also may detect age-related macular degeneration and glaucoma, but it’s not intended to replace a thorough eye exam, which can detect other things like the need for glasses.</p></div><div class="col-md-4"><p><a href="/center" title="Visit the AHA Center for Health Innovation landing page."><img src="/sites/default/files/inline-images/logo-aha-innovation-center-color-sm.jpg" data-entity-uuid="7ade6b12-de98-4d0b-965f-a7c99d9463c5" alt="AHA Center for Health Innovation logo" data-entity- type="file" class="align-center"></a></p><p><a href="/center/form/innovation-subscription"><img src="/sites/default/files/2019-04/Market_Scan_Call_Out_360x300.png" data-entity-uuid data-entity-type alt></a></p></div></div></div>.field_featured_image { position: absolute; overflow: hidden; clip: rect(0 0 0 0); height: 1px; width: 1px; margin: -1px; padding: 0; border: 0; } .featured-image{ position: absolute; overflow: hidden; clip: rect(0 0 0 0); height: 1px; width: 1px; margin: -1px; padding: 0; border: 0; } Tue, 12 Mar 2024 06:00:00 -0500 Medical Device Technology