Blog Articles
Critique by physicians on medical device recall system, highlighting its inefficiencies and failures in meeting public health needs.
The article discusses a critique by physicians on the current medical device recall system in the United States, highlighting its inefficiencies and failures in meeting public health needs. These observations are detailed in a recent publication in the journal Health Affairs and come amidst an ongoing review of device recalls by the Government Accountability Office (GAO).
Smiths Medical class I recall affecting Model 4000 syringe pumps distributed between November 2010 and July 2023
The article discusses a Class I recall affecting Model 4000 syringe pumps distributed between November 2010 and July 2023. These pumps are used in healthcare settings for administering various fluids, including blood and drugs. The recall was issued due to software issues in earlier versions that could potentially disrupt the alarm system, pump functions, and control screen, leading to delayed or interrupted therapy.
800 U.S. facilities recorded 22,000 alerts in 2023 for immediate help due to emerging threats or active violence.
The article discusses a rise in hospital violence, often coinciding with COVID-19 surges and full moons, based on data from wearable safety devices used by healthcare workers. Canopy’s Protect system, worn by around 200,000 healthcare staff across 800 U.S. facilities, recorded 22,000 alerts in 2023 for immediate help due to emerging threats or active violence.
Dental care is in crisis. But it’s also a moment of opportunity
“Dental care is in crisis. But it’s also a moment of opportunity” by Steve Pollock, highlights the significant workforce challenges facing the dental care industry. Pollock, a leader in dental care at Sun Life U.S. and DentaQuest, emphasizes the importance of oral health and its connection to overall health, including its links to chronic diseases like diabetes and heart disease.
Supreme Court decision could impact a wide range of medical treatments and products that Americans rely on, all of which are approved based on the FDA’s assessment of safety and effectiveness.
In a recent speech at the National Press Club on February 8, 2024, Xavier Becerra, Secretary of the Department of Health and Human Services (HHS), discussed the far-reaching implications of the upcoming Supreme Court case involving the abortion drug mifepristone. The case, FDA v. Alliance for Hippocratic Medicine, was initially brought to the US District Court for the Northern District of Texas in 2022 by a group of anti-abortion physicians and advocates.
The U.S. Food and Drug Administration (FDA) has proposed a ruling to regulate laboratory-developed tests (LDTs), sparking concerns among Yale experts about potential unintended consequences.
The U.S. Food and Drug Administration (FDA) has proposed a ruling to regulate laboratory-developed tests (LDTs), sparking concerns among Yale experts about potential unintended consequences. LDTs, developed by specific laboratories for in-house use, currently operate without FDA oversight. The FDA’s proposed regulations aim to enhance patient safety but are raising fears that the new rules could impede access to testing for rare diseases and hinder rapid responses to pandemics.
Hospitalized COVID-19 Patients Face Higher Risk of Long COVID, Large CDC-Backed Study Reveals
A recent study backed by the Centers for Disease Control and Prevention (CDC) and conducted by medical researchers using electronic health records (EHR) from over 3 million patients has shed light on the long-term effects of COVID-19. The study focused on post-acute sequelae of SARS-CoV-2 (PASC), commonly known as long COVID, analyzing symptoms and conditions occurring 31 to 150 days after a positive or negative COVID-19 test.
Study reveals only 41% of physicians claim moderate familiarity with FDA’s drug approval process, and just 17% with medical devices.
In a recent article, three professors of medicine, Sanket S. Dhruva, Aaron S. Kesselheim, and Rita F. Redberg, shed light on the gaps in physicians’ knowledge regarding FDA drug and device regulation. They discuss how recent changes in legislation and FDA practices have impacted the evidence required for product approval.
FDA’s CDRH to Reclassify Most High-Risk IVDs, Streamlining Approval Process
The FDA’s Center for Devices and Radiological Health (CDRH) announced its intention to initiate the reclassification process for the majority of in vitro diagnostic devices (IVDs) currently classified as high risk (class III) into a moderate-risk category (class II). This move primarily targets infectious disease and companion diagnostic IVDs.
Breakthrough Microscopy Technique Holds Promise for Brain Tumor Diagnosis and Treatment
Researchers from MIT and Harvard Medical School’s Brigham and Women’s Hospital have developed an innovative microscopy technique that could revolutionize the diagnosis and treatment of brain tumors. The high-resolution imaging method provides unprecedented detail of brain tissue cells and structures, aiding doctors in identifying and treating patients with brain tumors. Brain tumors, accounting for 85% to 90% of primary central nervous system tumors, involve the abnormal and uncontrollable growth of cells.