/ en Sat, 26 Apr 2025 02:35:40 -0500 Tue, 11 Mar 25 06:15:00 -0500 /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 Regulation /news/headline/2024-12-05-fda-finalizes-recommendations-simplifying-approval-process-medical-devices-use-ai <p>The Food and Drug Administration yesterday released <a href="https://www.fda.gov/media/166704/download" title="Med device recommendations">recommendations</a> for streamlining the approval process for medical devices that use artificial intelligence. The guidance recommends information to include in a predetermined change control plan as part of a marketing submission for a medical device using AI. The PCCP should include a description of the device's planned modifications; methods to develop, validate and implement the modifications; and an assessment of the modification's impacts. FDA will then review the PCCP within the submission to ensure the device's safety and effectiveness without needing additional marketing submissions for each modification. </p> Thu, 05 Dec 2024 13:45:43 -0600 Medical Device Regulation /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 Regulation /news/headline/2023-10-18-fda-webinar-oct-31-proposed-rule-laboratory-developed-tests <p>On Oct. 31 at 1 p.m. ET, the Food and Drug Administration will host a <a href="https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-proposed-rule-medical-devices-laboratory-developed-tests-10312023">webinar</a> to review its recent proposed <a href="/news/headline/2023-09-29-fda-proposes-enforcing-requirements-laboratory-developed-tests">rule</a> for laboratory developed tests, which would amend the agency’s regulations to require most laboratory developed tests to meet the same medical device requirements as other in vitro diagnostic products. Participants may email questions for consideration to <a href="http://CDRHWebinars@fda.hhs.gov">CDRHWebinars@fda.hhs.gov</a> until Oct. 23.</p> Wed, 18 Oct 2023 14:16:04 -0500 Medical Device Regulation /news/headline/2023-07-26-fda-updates-sterilization-standards-medical-device-makers <p>The Food and Drug Administration the week of July 24 updated its recognized consensus standards <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm?utm_medium=email&utm_source=govdelivery">database</a> for medical devices to advance innovation in medical device sterilization processes. The agency <a href="https://www.fda.gov/news-events/press-announcements/fda-roundup-july-25-2023">said</a> the changes support manufacturers’ use of low-temperature vaporized hydrogen peroxide and provides more options for device sponsors to consider for submission during the premarket review process.<br />  <br /> The Environmental Protection Agency in April <a href="/news/headline/2023-04-11-epa-proposes-new-standards-ethylene-oxide-sterilizing-facilities">proposed</a> requiring commercial sterilization facilities to comply within 18 months with stricter emission and control standards for ethylene oxide, a type of gas used to sterilize certain medical devices that cannot be sterilized using alternative methods.</p> Wed, 26 Jul 2023 15:33:44 -0500 Medical Device Regulation /news/headline/2023-03-24-fda-releases-transition-plans-medical-device-enforcement-authorization-after-covid-19-public-health <p>The Food and Drug Administration today released <a href="https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/faqs-emergency-use-authorizations-euas-medical-devices-related-covid-19">final guidance</a> for transitioning medical device enforcement policies and emergency use authorizations established during the COVID-19 public health emergency to normal operations. The Biden Administration plans to end the COVID-19 PHE declaration on May 11. The COVID-19 EUA declaration for COVID-19 diagnostics, personal protective equipment, other medical devices, and drug and biological products will <a href="/news/headline/2023-03-17-hhs-fda-covid-19-emergency-use-authorizations-remain-effect">remain in effect</a> until there is no longer a “significant potential” for a COVID-19 PHE or the authorized devices or products have been approved. </p> Fri, 24 Mar 2023 16:03:00 -0500 Medical Device Regulation /news/headline/2021-12-13-fda-seeks-input-future-guidance-3d-printing-point-care <p>The Food and Drug Administration Friday released a <a href="https://www.fda.gov/medical-devices/3d-printing-medical-devices/3d-printing-medical-devices-point-care-discussion-paper">discussion paper</a> on 3D printing of medical devices at the point of care to facilitate input from stakeholders and others to inform future guidance. The agency will accept comments on the paper for 60 days.<br />  <br /> “3D printing at hospitals and other patient-care settings enables health care professionals to quickly create patient-matched devices and anatomical models for surgical planning, as well as many other uses that can help health care facilities rapidly respond to patient needs,” FDA said. “The discussion paper we’re sharing today provides insight into our perspective of the benefits and challenges of 3D printing at hospitals and other points of care and presents a potential approach for regulatory oversight under various scenarios to inform future policy development.”</p> Mon, 13 Dec 2021 13:25:54 -0600 Medical Device Regulation /lettercomment/2021-09-22-aha-comments-remanufacturing-medical-devices-draft-guidance-industry-and-fda-staff <div class="container row"><div class="row"><div class="col-md-8"><p>September 22, 2021 </p><p>Janet Woodcock M.D.<br>Acting Commissioner of Food and Drugs - Food and Drug Administration <br>Food and Drug Administration<br>White Oak Campus <br>10903 New Hampshire Avenue<br>Silver Spring Maryland 20993</p><p>RE: Docket No. FDA-2018-N-3741, Remanufacturing of Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff</p><p>Dear Acting Commissioner Dr. Woodcock:</p><p>On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, and 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 submit comments on the Remanufacturing of Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff.</p><p>Within the draft guidance the FDA bases remanufacturing around the following definitions:</p><ul><li>Recondition/Refurbish/Rebuild: Restores a medical device to the OEM’s original specifications or to be “like new.” The device may be brought to current specifications if the change(s) made to the device do not significantly change the finished device’s performance or safety specifications, or intended use. These activities include repair of components, installation of OEM provided updates and upgrades, and replacement of worn parts.</li><li>Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.</li><li>Repair: A type of servicing that returns a component to original specifications, including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device.</li><li>Service: 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 OEM and to meet its original intended use. Servicing excludes activities that significantly change the finished device’s safety or performance specifications, or intended use.</li></ul><p>These definitions have an impact on what an organization or third party servicer can do to a medical device, thus influencing the organization’s right to repair. While the AHA agrees with the FDA that changing a finished device’s performance, or intended use would constitute remanufacturing, the AHA feels that the use of the word “significant[ly]” within several of these definitions adds ambiguity to the guidance. While the FDA attempts to define what “significant[ly] changing” is under Section VI to be:</p><p>“For purposes of this draft guidance, FDA generally considers a <em><strong>significant</strong></em> change to device performance or safety specifications to be one that, based on verification and validation testing and/or a risk-based assessment, results in a finished device that is outside the OEM’s performance or safety specifications or introduces new risks or <em><strong>significantly</strong></em> modifies existing risks.”</p><p>The AHA feels that the general consideration of this definition is subjective to interpretation as to what constitutes significantly changing the finished device’s safety or performance specifications or intended use and thus creates ambiguity to what is truly intended within the guidance.</p><p>Based on this understanding and in consultation with several of our health care leaders in the biomedical field the AHA recommends that the FDA change the definitions language to:</p><ul><li>Recondition/Refurbish/Rebuild: Restores a medical device to the OEM’s original specifications or to be “like new.” The device may be brought to current specifications if the change(s) made to the device do not change the finished device’s performance or degrade the devices safety specifications, or intended use. These activities include repair of components, installation of OEM provided updates and upgrades, and replacement of worn parts.</li><li>Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that changes the finished device’s performance or degrades the devices safety specifications, or intended use.</li><li>Repair: A type of servicing that returns a component to original specifications, including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device.</li><li>Service: 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 OEM and to meet its original intended use. Servicing excludes activities that change the finished device’s performance specifications, or degrade the devices safety specifications or intended use.</li></ul><p>These changes along with coordinated changes throughout the remainder of the guidance language will help to clarify the difference between service, repair, and reconditioning/refurbishing/rebuilding and remanufacturing and will eliminate any ambiguity from the guidance language.</p><p>We appreciate your consideration of these issues. Please contact me if you have questions or feel free to have a member of your team contact Jonathan Flannery, AHA’s senior associate director, advocacy, ASHE, at <a href="mailto:jflannery@aha.org" target="_blank" title="Email address">jflannery@aha.org</a>.</p><p>Sincerely,<br>Chad Beebe,<br>Deputy Executive Director<br>American Society for Health Care Engineering <br>(ASHE) of the ���������� Association</p></div></div></div> Wed, 22 Sep 2021 15:36:00 -0500 Medical Device Regulation /news/headline/2019-12-17-fda-approves-first-disposable-duodenoscope <p>The Food and Drug Administration Friday cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and access to the upper gastrointestinal tract to treat bile duct disorders and other upper GI problems.</p> <p>“The availability of a fully disposable duodenoscope represents another major step forward for improving the safety of these devices, which are used in more than 500,000 procedures in the U.S. each year,” <a href="https://www.fda.gov/news-events/press-announcements/fda-clears-first-fully-disposable-duodenoscope-eliminating-potential-infections-caused-ineffective">said</a> Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Unlike duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn’t need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing. Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients, and the FDA continues to encourage innovative ways to improve the safety and effectiveness of these devices.”</p> Tue, 17 Dec 2019 14:43:29 -0600 Medical Device Regulation /news/headline/2019-10-25-fda-sterilization-facility-closures-could-prompt-future-device-shortages <p>The Food and Drug Administration today <a href="https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-certain-sterilization-facility-closures">alerted</a> the public to growing concern about the potential for medical device shortages as facilities that sterilize devices using ethylene oxide close. “Since we first became aware of this issue earlier this year, we have continued to focus intently on addressing the immediate impacts of these closures and potential closures to help ensure patients can have access to the safe, effective, and high-quality medical devices they need today,” said Acting FDA Commissioner Ned Sharpless, M.D. “We continue to communicate directly with manufacturers and monitor the supply of devices sterilized in facilities that have closed or that may close, paying special attention to life-saving, life-sustaining, and other critical devices.” He urged health care providers and medical device makers to assess their supplies of affected devices and report anticipated shortages or distribution delays by email to <a href="mailto:deviceshortages@fda.hhs.gov">deviceshortages@fda.hhs.gov</a>.</p> Fri, 25 Oct 2019 14:54:57 -0500 Medical Device Regulation