/ en Fri, 25 Apr 2025 22:49:40 -0500 Fri, 25 Apr 25 13:40:12 -0500 /news/headline/2025-04-25-fda-announces-recall-certain-iv-bags <p>The Food and Drug Administration published a <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-ropivacaine-hydrochloride-injection-usp" target="_blank">notice</a> from Amneal Pharmaceutical that said the company is recalling two lots of its Ropivacaine Hydrochloride Injection 500mg/100mL Infusion bags due to the products potentially containing inert polypropylene fibers. As of April 18, Amneal Pharmaceuticals said it received no reports of adverse events or injuries related to the recall. The recalled IV bags were distributed nationwide to wholesalers and distributors from April 23-Nov. 8, 2024.</p> Fri, 25 Apr 2025 13:40:12 -0500 Medical Device Safety /news/headline/2025-04-24-recall-issued-aspiration-system-qapel-medical <p>The Food and Drug Administration has identified a <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-classifies-qapel-medical-incs-worldwide-medical-device-recall-and-discontinuation-its-072" target="_blank">Class I recall</a> of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports that included a tip detachment, a vessel rupture and a vasospasm.</p> Thu, 24 Apr 2025 15:59:59 -0500 Medical Device Safety /news/headline/2025-04-21-fda-issues-alerts-certain-catheters-produced-bd-conavi <p>The Food and Drug Administration has issued alerts for issues with certain catheters made by <a href="https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-intravascular-picc-catheter-issue-bd">BD</a> and <a href="https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-diagnostic-intravascular-catheter-issue-conavi">Conavi</a>. <br><br>BD identified an increase in material fatigue leaks associated with certain PowerPICC Intravascular Catheters. The FDA sent a letter to affected consumers recommending unused catheters be removed from where they are used or sold, and in-use catheters have updated instructions.</p><p>Conavi reported an incident where the sheath of its Novasight Hybrid catheter detached during use. Conavi sent all affected providers a recall notice recommending they return the product to the company.</p> Mon, 21 Apr 2025 15:14:20 -0500 Medical Device Safety /news/headline/2025-03-31-fda-recalls-medtronic-aortic-root-cannulas <p>The Food and Drug Administration has identified a Class I recall of <a href="https://www.fda.gov/medical-devices/medical-device-recalls/vascular-cannula-recall-medtronic-removes-aortic-root-cannula-due-unexpected-loose-material-male">Medtronic Aortic Root Cannulas</a> due to a risk of unexpected loose material in the male luer used in the cannula. The loose material could become dislodged and cause serious injuries or death. The FDA said there have been no reports of injuries or death from the issue. </p> Mon, 31 Mar 2025 15:12:08 -0500 Medical Device Safety /news/blog/2025-03-28-can-collaborative-efforts-improve-device-design-improve-safety <p>During World War II, the U.S. Army Air Corps depended on its B-17 bombers to inflict incredible damage against the Axis powers in Europe. These “Flying Fortresses” were deemed essential to winning the war in the European theater, but they had one big problem. Despite the plane’s technically advanced design and the provision of effective training for the young pilots responsible for steering them through war zones, too many crashed on landing, destroying the machines and often killing the pilots and crew.</p><p>Initial investigations into B-17 crashes concluded that the accidents resulted from pilot error, and the Army invested in training and retraining pilots. Yet, the crashes continued. Then Alphonse Chapanis, a young psychologist who joined the Army Air Corps’ aeromedical lab in 1942, noticed that the switches for the plane’s flaps and the landing gear were adjacent on the dash and identical in appearance — but radically different in function.</p><p>It was far too easy for pilots — stressed and weary after hours of combat flying — to flip the wrong switch when trying to land the B-17. The plane’s design had failed to account for the likelihood of normal human error. Chapanis suggested changing the knobs so that one was triangular and the other was spherical, making it easy for pilots to differentiate. This small change in design led to an immediate and substantial decrease in the number of B-17 crashes. (<a href="https://uxmag.com/articles/pilot-error-chapanis-and-the-shape-of-things-to-come" target="_blank">Read more about Chapanis</a> and his influence on device design).</p><p>While most health care isn’t delivered in war zones, health care and device company leaders recognize that care is often delivered in high-stress, high-risk situations. Despite elegant efforts to design for safe use, rigorous standards and regulatory requirements from the Food and Drug Administration and standards bodies, and lots of training of health care professionals, many acknowledge that there is still room to ensure clinicians are “flipping the right switch” when using medical devices.</p><h2>AHA and AAMI Meeting</h2><p>Earlier this year, the ���������� Association (AHA) and the Association for Advancement of Medical Instrumentation (AAMI) 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. Their energy and commitment were palpable. Participants were invigorated and challenged by the shared goal of creating devices that could be used more easily, effectively and safely.</p><p>The meeting began with table-setting presentations to make sure all attendees understood each other’s perspectives. Clinical leaders described the stresses and distractions of the busy hospital environment that make it difficult for staff to use devices as the designers had envisioned, including their personal experiences of devices being implicated in near misses or safety events. Manufacturers discussed their rigorous processes for designing, testing and providing instructions to ensure safe use. An AAMI leader described the role of standards in promoting safety, and a former FDA official spoke about the role of regulation, oversight and post-market surveillance in promoting safety. The group then broke into multidisciplinary groups with direction to identify practical, actionable pathways that augment or replace current activities and lead to better safety by design.</p><h2>3 Key Takeaways from the Conversations</h2><ul><li><strong>Users and manufacturers need better information.</strong> Engineers and users need to be able to exchange the right information to make design improvements that address usability issues. Right now, they are not connecting well. Health care providers often discover a design challenge with a piece of equipment when conducting a root cause analysis and then report that information to their patient safety organization, but that information is not readily available to manufacturers. Manufacturers get information from FDA databases, but these may not have sufficient information to understand exactly how the device design may have contributed to the occurrence of patient harm or inform design alterations that could prevent it in the future. Finally, post market surveillance reporting is often slow to reach the manufacturer, limiting their ability to alter design in a timely fashion.</li><li><strong>Work as imagined differs from work as done.</strong> In designing each particular product, engineers imagine the clinical environment in which it will be placed, plan for a rigorous training of the health care professionals who will be operating it and create comprehensive instruction manuals. Health care professionals use an expanding and rotating panoply of devices every day, and their ability to be trained on each and every one of those, remember that training and use it in a moment of emergent patient need is radically different from what the designer imagined. Better communication between users and designers is the only way to help designers anticipate how their devices will actually be used.</li><li><strong>There is a natural tension between innovation and the experience that promotes safe use of a device.</strong> In a busy clinical environment, it is challenging for clinicians to keep up with all they must learn, but device makers may want to make routine improvements to the software or user interface of their devices to refresh perceptions of the device. Honest discussions about the kind of innovation device manufacturers intend and how the alteration will work in a busy clinical environment are needed to ensure innovation better contributes to safety and ideally decreases the draw on clinicians’ already-stretched mental capacity. Further, the regulatory framework needs to support this balance between innovation and safety by recognizing and creating safe tables and sandboxes within which to drive progress.</li></ul><p>One actionable item that drew keen interest was creating an opportunity for the manufacturers’ engineers to participate in a hospital’s response to a patient safety event. Stakeholders across the spectrum agreed that open sharing of how design may have contributed to an event is vital to generating changes needed to promote safer use and reduce patient harm. AHA and AAMI are committed to working to make these conversations a reality as part of our ongoing efforts to make care safer.</p><p><em>Nancy Foster is the AHA’s vice president of quality and safety policy.</em></p> Fri, 28 Mar 2025 11:56:05 -0500 Medical Device Safety /aha-center-health-innovation-market-scan/2025-03-11-4-steps-improve-medical-device-recall-tracking <div class="container"><div class="row"><div class="col-md-8"><img src="/sites/default/files/inline-images/4-Steps-to-Improve-Medical-Device-Recall-Tracking.png" data-entity-uuid="3cebf36b-682b-4704-8fcd-80ff48d369f1" data-entity-type="file" alt="4 Steps to Improve Medical Device Recall Tracking. A large Recall button in front of medical devices." width="100%" height="100%"><p>The need to build an effective recall management team in health care is becoming increasingly clear. Consider the recent news that medical device recalls by the Food and Drug Administration reached a four-year high in 2024.</p><p>With nearly 11% of these events involving Class 1 recalls, which signals a reasonable probability that using the product could cause harm or death, the data underscore the seriousness of this issue. And early results for 2025 indicate that the rise in Class 1 medical device recalls is continuing.</p><p>As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a <a href="https://www.modernhealthcare.com/digital-health/medical-device-recalls-fda-2024" target="_blank" title="Modern Healthcare: Medical device recalls hit a four-year high in 2024. Here’s why">Modern Healthcare report</a>.</p><h2>Medical Device Recalls by the Numbers</h2><p>Highlights from the <a href="https://marketing.sedgwick.com/acton/media/4952/US-SOTN-2025-Recall-Index-Report-Download-eu-cross-promo" target="_blank" title="Sedgwick: 2025 Product Safety and Regulation: Recall Index Report United States Edition">2025 Product and Safety Regulation Recall Index report</a> from Sedgwick, which offers best practices in product recall and remediation solutions, include:</p><img src="/sites/default/files/inline-images/2025-Product-and-Safety-Regulation-Recall-Index-report-statistics.png" data-entity-uuid="05d228ee-3fd9-4603-a7ff-faba90e92770" data-entity-type="file" alt="2025 Product and Safety Regulation Recall Index report statistics. 4-year high: In 2024, 1,059 medical device recall events were recorded--a four-year high that reflects an 8.6% increase over 2023. Device failure: Device failure accounted for 11.1% of medical device recalls, the highest rate in more than five years and the first time it has been the leading cause of recalls. Leading cause: Quality, software, mislabeling and parts issues were other leading causes of medical device recalls." width="805" height="313" class="align-center"><p>Reasons for the rising number of medical device recalls vary. A large portion of the increase is due to a higher number of recalls from a small number of manufacturers subject to inspections and/or other actions, an FDA spokesperson told Modern Healthcare. Additionally, manufacturers increasingly are reporting problems and fixing them due to a continued, concerted effort by the FDA to drive greater device safety.</p><p>Recalls, whether involving medical devices, pharmaceuticals, food, equipment, vehicles or other defective products, demand prompt, coordinated action to prevent harm to patients and staff, notes Aaron Weinbaum, Vizient’s physical environment adviser for regulatory and accreditation services, in a <a href="https://www.vizientinc.com/newsroom/blogs/2025/building-effective-recall-teams-a-blueprint-for-hospital-safety" target="_blank" title="Vizient: Building effective recall teams: A blueprint for hospital safety">recent blog</a>.</p><h2>4 Steps to Build or Improve an Effective Recall Management Team</h2><h3><span>1</span> <span>|</span> Establish a formal recall policy.</h3><p>A comprehensive recall policy is important for standardizing response procedures and ensuring compliance with regulatory guidelines, Weinbaum notes. This policy should include clearly documented protocols that define the steps to be taken during a recall. It also should establish escalation criteria, identifying triggers for various levels of recalls, such as high-risk or routine, and outlining the necessary actions for prompt response.</p><h3><span>2</span> <span>|</span> Define the recall team’s purpose and scope.</h3><p>The team's primary role is managing the hospital's response to product recalls and vendor notifications. This includes identifying, communicating, removing and replacing recalled items. The team oversees all stages of recall management, from initial notification to final handling. A well-structured recall team ensures compliance with regulations, maintains clear communication with patients and staff and minimizes financial and operational impacts.</p><h3><span>3</span> <span>|</span> Collaborate with external stakeholders.</h3><p>This is important for effective recall management. Open communication with vendors ensures timely recall alerts and necessary support. Staying up to date on regulatory trends helps providers stay compliant and adapt to changing standards. This proactive approach strengthens recall efforts and reduces risks.</p><h3><span>4</span> <span>|</span> Develop tracking and documentation metrics.</h3><p>Effective recall management requires systematic tracking and reporting. Providers should document alerts received, resolution times and impacts on patients, staff or inventory, Weinbaum writes. These metrics ensure accountability and identify areas for improvement. Recall management tools streamline efforts by automating notifications, tracking responses and maintaining records for audits. Adopting these practices enhances efficiency and reduces risks.</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" width="721" height="130" 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 width="360" height="300"></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; } h2 { color: #9d2235; } Tue, 11 Mar 2025 06:15:00 -0500 Medical Device Safety /news/headline/2025-02-19-icu-medical-recalls-certain-lots-potassium-chloride-injection-bags-due-mislabeling <p>The Food and Drug Administration Feb. 18 <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-nationwide-recall-potassium-chloride-injection-20-meq-and-potassium-chloride" title="nationwide recall">announced</a> that ICU Medical is voluntarily recalling certain lots of its potassium chloride injection bags with overwrap labels displaying 10 mEq that are packaged in 20 mEq cases. The FDA said the company learned of the issue from a customer complaint. The notice said the 20 mEq label printed on the bag is not visible or easily visible without manipulation when the 10 mEq overwrap is in place.</p> Wed, 19 Feb 2025 14:52:37 -0600 Medical Device Safety /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 Safety /news/headline/2025-01-06-baxter-alerts-providers-potential-high-risk-issues-devices <p>The Food and Drug Administration Dec. 31 released an <a href="https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-solution-set-issue-baxter-healthcare-corporation">alert</a> highlighting a Baxter letter that recommended health care providers not use certain lots of Solution Sets with Duo-Vent Spikes due to a potentially high-risk issue. Baxter reported that some affected products were incorrectly assembled with inverted slide clamps.  <br><br>The affected products include:  <br>•    Solution Set with Duo-Vent Spike, lot DR24C22079, expiration March 24, 2026, and lot DR24H23086, expiration Aug. 26, 2026. <br>•    Clearlink System Solution Set with Duo-Vent Spike, lot DR24C15109, expiration March 16, 2026. <br>•    Continu-Flo Solution Set with Duo-Vent Spike, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, lot DR24B21017, expiration Feb. 28, 2026. </p> Mon, 06 Jan 2025 14:32:27 -0600 Medical Device Safety /news/headline/2024-05-24-fda-announces-firm-distributing-chinese-made-plastic-syringes-us-initiates-recall <p>The Food and Drug Administration May 23 <a href="https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication">announced</a> that Medline Industries, a firm marketing and distributing Chinese-manufactured plastic syringes within the U.S., initiated a recall to stop using affected products, including unauthorized plastic syringes made in China. On Tuesday, Chinese manufacturer Jiangsu Shenli Medical Production Co. initiated a recall to stop using its unauthorized syringes. The FDA last week <a href="/news/headline/2024-05-17-fda-issues-import-alert-additional-recommendations-against-using-plastic-syringes-made-china">recommended</a> users immediately transition away from plastic syringes made by Jiangsu Shenli Medical Production Co., along with those made by Jiangsu Caina Medical Co., Zhejiang Longde Pharmaceutical Co. and Shanghai Kindly Enterprise Development Group Co.</p> Fri, 24 May 2024 10:38:34 -0500 Medical Device Safety