/ en Wed, 30 Apr 2025 19:09:33 -0500 Mon, 03 Feb 25 15:40:32 -0600 /news/headline/2025-02-03-tariff <p>The White House Feb. 1 <a href="https://www.whitehouse.gov/fact-sheets/2025/02/fact-sheet-president-donald-j-trump-imposes-tariffs-on-imports-from-canada-mexico-and-china/" target="_blank">announced</a> it placed tariffs on imported goods from Canada, Mexico and China. The tariffs for Mexico and Canada have since been delayed for 30 days, while tariffs for China are scheduled to begin Feb. 4.</p> Mon, 03 Feb 2025 15:40:32 -0600 Products /news/headline/2023-12-04-fda-evaluating-certain-plastic-syringes-made-china <p>The Food and Drug Administration is <a href="https://www.fda.gov/medical-devices/safety-communications/evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication">evaluating</a> Chinese-made plastic syringes used to inject or withdraw fluids from the body, citing concern that they may not provide adequate quality and performance, including their ability to deliver the correct dose of medication when used alone or with other medical devices, such as infusion pumps. Meanwhile, health care facilities should use other plastic syringes or closely monitor their use, the agency said. The concern does not currently apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes, FDA said.</p> Mon, 04 Dec 2023 14:38:48 -0600 Products /news/headline/2023-08-24-fda-announces-class-i-ventilatory-recall-draeger-products-pediatric-use <p>Draeger Medical, Inc. is <a href="https://www.fda.gov/medical-devices/medical-device-recalls/draeger-recalls-carina-sub-acute-care-ventilators-contaminants-airpath">recalling</a> its Carina Ventilators due to the presence of contaminants in the device’s airpath, which exceed acceptable levels if used by pediatric patients for more than 30 days. The Carina Sub-Acute Care Ventilator is used for people who require full or partial breathing assistance from a mechanical ventilator inside a hospital. The ventilator can be used for invasive (trachea tube) or non-invasive (mask) ventilation. The Food and Drug Administration has deemed this to be a Class I recall, due to the likelihood of serious injuries or death. Clinicians may continue to use the device with adult patients but are instructed to cease its use for pediatric patients.<br />  </p> Thu, 24 Aug 2023 15:00:38 -0500 Products /news/headline/2023-07-21-pfizer-issues-update-sterile-injectables-plant-struck-tornado <p>Crews are working to restore power and assess damage to a Pfizer plant in North Carolina that makes sterile injectables for U.S. hospitals after a tornado struck the facility July 19, the company <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-post-tornado-relief-plans-rocky-mount" target="_blank">said</a> July 21. The facility makes nearly 25% of all Pfizer’s sterile injectables and nearly 8% of all the sterile injectables used in U.S. hospitals. </p> <p>Most of the damage was caused to the warehouse facility, which stores raw materials, packaging supplies and finished medicines awaiting release by quality assurance. </p> <p>“Pfizer is working diligently to move product to other nearby sites for storage and to identify sources to replace damaged raw materials and supplies,” the company said. “Pfizer is also exploring alternative manufacturing locations for production across our significant manufacturing presence in the U.S. and internationally and across the company’s partner network. After an initial assessment, there does not appear to be any major damage to the medicine production areas.”</p> <p>Nancy Foster, AHA’s vice president of quality and patient safety policy, said, “AHA is keenly aware that drug shortages, including sterile injectables, can have serious consequences for patients. While we are still seeking to more fully understand the full nature of the impact of the destruction of this plant, it is clear that it produced many sterile injectables that are used every day in the care of critically ill patients and those undergoing surgery. We are reaching out to the relevant federal agencies, the group purchasing organizations, and others to learn more about Pfizer’s resiliency in the face of this tragic destruction of its plant. We are also looking to learn about alternative sources or substitute medications that may be available so that hospitals can continue to provide the highest quality care to the sick or injured people in their communities.”</p> Fri, 21 Jul 2023 16:07:46 -0500 Products /news/headline/2023-07-10-agencies-target-unapproved-pharmaceutical-products-india <p>Federal agencies last month stopped over 500 unapproved pharmaceutical products and medical devices, including opioid and other controlled substances, from entering the U.S. from India, the Food and Drug Administration <a href="https://www.fda.gov/news-events/press-announcements/fda-roundup-july-7-2023" target="_blank">reported</a> Friday. Conducted in collaboration with India, the operation targeted packages entering the U.S. through International Mail Facilities in New York and Chicago.</p> Mon, 10 Jul 2023 15:09:57 -0500 Products /news/headline/2023-07-07-agencies-seek-information-medical-payment-products <p>The Consumer Financial Protection Bureau, Centers for Medicare & Medicaid Services, Department of Health and Human Services, and Department of the Treasury jointly released a <a href="https://s3.amazonaws.com/files.consumerfinance.gov/f/documents/cfpb_request-for-information-on-medical-payment-products_7.2023.pdf">Request for Information</a> regarding certain medical payment products, including medical credit cards, loans and other financial products used to pay for health care. The questions in the RFI relate to the prevalence and nature of these products, as well as their impact on consumers and consumer protections.  <br />   <br /> Specifically, the agencies are interested in “whether these products may contribute to health care cost inflation, displace hospitals’ provision of financial assistance, lead patients to pay inaccurate or inflated medical bills, increase the amount patients must pay due to financing costs, or otherwise harm patients’ mental, physical, and financial well-being, including through downstream credit reporting and debt collection practices.”</p> <p>Comments on the RFI are due within 60 days of publication in the Federal Register.  </p> Fri, 07 Jul 2023 15:03:00 -0500 Products /news/headline/2023-06-06-fda-releases-guidance-help-hospitals-conserve-pneumatic-tourniquet-cuffs <p>As urged by the AHA and its professional membership group the Association for Health Care Resource & Materials Management, the Food and Drug Administration yesterday released <a href="https://www.fda.gov/medical-devices/letters-health-care-providers/non-sterile-single-use-pneumatic-tourniquet-cuffs-conservation-strategies-letter-health-care" target="_blank">guidance</a> to help hospitals and other health care providers conserve pneumatic tourniquet cuffs after a recent recall led to local supply shortages. The devices are mainly used in elective limb surgeries and emergency and trauma settings. The conservation strategies include using alternative devices and reusing existing devices after following appropriate sterilization/disinfection procedures.</p> Tue, 06 Jun 2023 14:22:12 -0500 Products /news/headline/2023-04-24-fda-updates-use-recommendations-halyard-surgical-n95-respirator <p>In response to questions from AHA and others and informed by testing results, the Food and Drug Administration April 21 <a href="https://www.fda.gov/medical-devices/safety-communications/risk-protection-failure-certain-om-halyard-surgical-n95-respirators-surgical-masks-and-pediatric">announced</a> that health care providers without alternative options may continue to use a certain version of the O&M Halyard FLUIDSHIELD Surgical N95 Respirator Mask for fluid barrier protection if they wear a face shield over the respirator. </p> <p>The agency April 12 <a href="/news/headline/2023-04-12-fda-dont-use-certain-n95-respirators-and-masks-made-om-halyard">announced</a> () that health care providers and consumers should not use certain N95 respirators made by O&M Halyard because they do not meet quality and performance expectations, and should not use certain surgical masks and pediatric face masks made by the company for fluid barrier protection. FDA continues to evaluate quality and performance information for these products and will provide updates as more information becomes available. The agency said it also continues to work with providers to assist with challenges and can help them find alternative sources and products. </p> Mon, 24 Apr 2023 15:56:34 -0500 Products /news/headline/2023-04-06-fda-withdraws-approval-premature-birth-drug <p>The Food and Drug Administration today <a href="https://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena" target="_blank">withdrew approval</a> for Makena and its generics, citing a confirmatory study that did not verify clinical benefit. Makena had been approved under the FDA’s accelerated approval pathway to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. Makena and its generics cannot lawfully be distributed in interstate commerce, effective immediately. FDA is aware that some products have already been distributed, so health care providers should talk to their patients, if applicable.</p> Thu, 06 Apr 2023 14:42:43 -0500 Products /news/headline/2022-12-19-fda-issues-class-i-recall-venous-access-catheter-kits <p>The U.S. Food & Drug Administration has <a href="https://www.fda.gov/medical-devices/medical-device-recalls/teleflex-and-arrow-international-llc-recall-arrow-mac-two-lumen-central-venous-access-and-pressure" target="_blank">issued a Class I recall</a>, the most serious type of recall, for the Arrow MAC Two-Lumen Central Venous Access Kits and Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter Kits. Inadequate connections between the top and bottom housings could result in leakage, infection, serious injuries or death. No injuries or deaths have been reported.</p> Mon, 19 Dec 2022 15:20:08 -0600 Products