/ en Mon, 28 Apr 2025 04:59:32 -0500 Thu, 20 Mar 25 14:39:52 -0500 /news/headline/2025-03-20-fda-alerts-risk-calyxo-aspiration-systems <p>The Food and Drug Administration today issued an <a href="https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-aspiration-system-issue-calyxo" target="_blank">alert</a> on a potentially high-risk issue with Calyxo CVAC Aspiration Systems. In patients who have thick fluid in their kidneys at the start of the procedure, the system can cause reduced fluid overflow, potentially leading to excessive pressure in the kidneys. Serious death or injury could occur if the increased pressure is not addressed. Calyxo has reported one death associated with the issue. </p> Thu, 20 Mar 2025 14:39:52 -0500 Patient Safety Risk /news/headline/2025-02-19-aha-podcast-tiered-system-safety-committing-zero-harm-wellspan-health <p>In this conversation, Carlos Roberts, M.D., urogynecologist, vice president and chief medical officer of the Women and Children service line at WellSpan Health, discusses the organization's commitment to zero harm, its innovative tier structure for daily safety huddles, and its fostered culture of continuous improvement and celebration of patient safety. <a href="/advancing-health-podcast/2025-02-19-tiered-system-safety-committing-zero-harm-wellspan-health" title="POD LINK"><strong>LISTEN NOW</strong></a><strong> </strong></p><div></div> Wed, 19 Feb 2025 14:48:56 -0600 Patient Safety Risk /news/headline/2024-12-04-aha-podcast-mitigate-and-prevent-commonspirit-healths-transparent-culture-and-error-reporting-toolkit <p>In this “Safety Speaks” conversation, CommonSpirit Health's Beth Miller, system director, patient safety-performance improvement, and Austin Peterson, system director, patient harm prevention, discuss how safety transparency benefits both patients and providers, and how a CommonSpirit Health toolkit can help organizations lead the way in error reporting and patient safety. <a href="/advancing-health-podcast/2024-12-04-mitigate-and-prevent-commonspirit-healths-transparent-culture-and-error-reporting-toolkit"><strong>LISTEN NOW</strong></a></p><div></div> Wed, 04 Dec 2024 16:06:58 -0600 Patient Safety Risk /member-report-quality-trends-and-aha-patient-safety-initiative <div class="row"><div class="col-md-5"><img src="/sites/default/files/2024-03/Quality-as-defined-by-members-700-532.jpg" alt="Quality as Defined by Members Report" width="700" height="532"></div><ul><li>The ���������� Association (AHA) presents insights from the Quality Collective (QC), a collaborative platform addressing health care quality improvement challenges amid the COVID-19 pandemic.</li><li>QC members note a dynamic shift in the definition of quality, with 60% experiencing changes over the past three years.</li><li>Clinical strengths include patient safety, infection prevention and emergency preparedness, while areas for improvement include population health management and health equity.</li><li>QC outlines priorities for the future, emphasizing a commitment to safe, timely, effective, equitable, patient-centered and affordable care.</li><li>Anticipating the increasing role of technology, members foresee the prevalence of artificial intelligence in disinfection practices.</li></ul><p>The AHA introduces the Patient Safety Initiative, building on QC success, to empower hospitals in national health care safety discussions. The initiative aims to enhance engagement, public trust and data accuracy while reducing preventable harms and inequities. AHA, with extensive membership, leads the initiative through research, collaboration and data sharing, reinforcing its commitment and leadership in the health care field.</p><p>The AHA acknowledges hospitals' commitment to providing safe, high-quality care amid the expanded definition of quality post-COVID-19. The QC, launched as a collaborative platform, engaged leaders in quality improvement over three months. Members focused on co-designing strategies to address current needs and shape the future trajectory of quality standards. The report highlights successes, innovative solutions and a redefined culture rooted in quality and performance. The AHA expresses gratitude to participants for their contributions in fostering a just society of healthy communities.</p></div> Wed, 10 Jul 2024 12:45:00 -0500 Patient Safety Risk /news/headline/2024-02-26-fda-withdraws-accelerated-approval-myeloma-drug <p>The Food and Drug Administration Feb. 23 withdrew <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-final-decision-withdraw-approval-pepaxto-melphalan-flufenamide" target="_blank">approval</a> of Pepaxto (melphalan flufenamide), a drug once used with dexamethasone to treat certain U.S. patients with multiple myeloma, because a post-approval trial did not show it safe or effective. This is the first time the agency has used procedures amended under the Food and Drug Omnibus Report Act of 2022 to withdraw accelerated approval of a drug. The drug is not currently marketed in the U.S., FDA said.</p> Mon, 26 Feb 2024 14:15:24 -0600 Patient Safety Risk /center/cybersecurity-and-risk-advisory-services/preferred-cybersecurity/bringing-value/ep2-strategies-using-cybersecurity-prot Fri, 01 Sep 2023 11:00:00 -0500 Patient Safety Risk /news/news/2023-01-26-aha-comments-proposed-ahrq-initiative-advance-patient-safety <p>AHA today submitted <a href="/lettercomment/2023-01-26-aha-comments-ahrqs-request-information-creating-nation-al-health-care-system-action-alliance-advance">comments</a> on how the Agency for Healthcare Research and Quality can best support the field in advancing patient safety through an action alliance, which the agency is launching in partnership with health care systems and patient safety advocates. AHA recommends the agency align the alliance’s work with other federal efforts to accelerate patient safety; prioritize resources on addressing the most preventable adverse safety events; engage patients and providers along the full care continuum; and back the alliance with robust logistical support to capture and broadly share important learnings and evidence-based care improvement tools. <br />  </p> Thu, 26 Jan 2023 16:03:00 -0600 Patient Safety Risk /news/headline/2022-05-26-fda-announces-recall-abbott-imaging-catheter <p>Abbott has recalled certain lots of its Dragonfly OpStar imaging catheter because a marker band may separate from the catheter and remain in the patient after use, potentially causing injury, the Food and Drug Administration <a href="https://www.fda.gov/medical-devices/medical-device-recalls/abbott-medical-recalls-dragonfly-opstar-imaging-catheter-potential-loose-catheter-marker-band-may">announced</a> today. The catheter is used for optical coherence tomography of coronary arteries. Five related incidents and one injury have been reported. Health care providers should immediately stop using devices in the affected lots and report any product performance issues to Abbott, FDA said.<br />  </p> Thu, 26 May 2022 16:28:37 -0500 Patient Safety Risk /news/headline/2022-05-24-aha-urges-ftc-investigate-certain-pharmacy-benefit-manager-practices <p>AHA today urged the Federal Trade Commission to scrutinize commercial health plans that steer patients to third-party specialty pharmacies in which they have a financial interest. These practices, commonly referred to as “white bagging,” disallow health care providers from procuring and managing the drugs they administer to patients, resulting in significant patient safety concerns, frequent delays in care, and a tremendous administrative burden on hospitals to reconcile these policies on behalf of their patients, AHA <a href="/lettercomment/2022-05-24-aha-ftc-re-request-public-comment-impact-pharmacy-benefit-managers">wrote</a>, responding to a request for public comments on PBM business practices. <br />  <br /> “As large health plans engage in broad vertical integration efforts, including the acquisition of PBMs and specialty pharmacies, the practice of mandated white bagging has increased dramatically,” forcing hospitals and health systems “to navigate substantial supply chain and logistical challenges in order to continue to provide safe and effective care to the patients they treat,” the letter notes.<br />  <br /> AHA also urged the agency to scrutinize “the impact of PBM-negotiated rebates and other business practices on the 340B drug discount pricing program and overall drug prices and drug price increases.”</p> <p>Learn more about AHA’s concerns with white bagging policies in this <a href="/advancing-health-podcast/2022-05-24-special-edition-insurers-white-bagging-drug-policy-threatens">AHA podcast</a> and <a href="/system/files/media/file/2022/05/aha-white-bagging-infographic.pdf">infographic</a>. </p> Tue, 24 May 2022 14:40:43 -0500 Patient Safety Risk /news/headline/2022-05-09-fda-issues-update-covid-19-treatments-hemodialysis-machine-risk <p>The Food and Drug Administration last week <a href="https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Pages/important-update-04May2022.aspx">extended</a> to 24 months the shelf life for certain lots of refrigerated bamlanivimab. The combination monoclonal antibody therapy bamlanivimab and etesevimab is currently not authorized to treat or prevent COVID-19 in any U.S. region because it is not effective against the omicron variant. However, the Department of Health and Human Services and FDA recommend retaining both products in case future COVID-19 variants are susceptible to them, and are evaluating whether to extend the shelf life for etesevimab in the future.</p> <p>In other news, FDA last week released a <a href="https://www.fda.gov/media/158165/download">screening checklist and drug interaction tool</a> to help prescribers identify patients eligible for the Pfizer COVID-19 antiviral pill Paxlovid; and a <a href="https://www.fda.gov/food/whole-genome-sequencing-wgs-program/wastewater-surveillance-sars-cov-2-variants">dashboard</a> summarizing data from its project to track SARS-CoV-2 variants from wastewater samples. </p> <p>The agency also <a href="https://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-exposure-toxic-compounds-when-using-certain-hemodialysis-machines-manufactured">alerted</a> health care providers that certain hemodialysis machines made by Fresenius Medical Care may expose patients to toxic chemicals, and recommended certain actions to ensure patients continue to receive needed care.</p> Mon, 09 May 2022 15:45:26 -0500 Patient Safety Risk