Procedural sedation analgesia considerations for ASC leaders
The promise of quicker recovery and fewer complications from sedation, anesthesia, and pain management have drawn clinicians and patients alike to procedures performed in ambulatory surgery centers (ASCs) and other outpatient settings. However, sedation, anesthesia, and analgesia add their own risks to those of the procedure itself. Understanding the latest…
FDA updates warning about plastic syringes made in China
Editor's Note An ongoing US Food and Drug Administration (FDA) evaluation of plastic syringes made in China reveals that quality problems are more widespread than initially believed, the agency reported on March 19. The update to an original November 23 safety notice recommends the following action to alleviate potential quality…
New EPA standards to reduce ethylene oxide emissions
Editor's Note New standards from The Environmental Protection Agency promise to cut nationwide emissions of ethylene oxide—employed to sterilize more than half of US medical devices—by more than 90 percent. According to a March 15 MedPage Today report, the aim is to reduce cancer risk among the 13 to 14…
FDA issues warning on fraudulent, unreliable medical device testing data
Editor's Note The FDA has issued a warning regarding fraudulent, duplicated and otherwise unreliable data coming from third party test labs that produce data for medical device companies, including many based in India and China. Issued February 20, the alert warns medical device manufacturers that they are responsible for confirming the…
FDA recalls BrightView SPECT systems
Editor's Note The FDA has issued a Class I recall of Philips’ BrightView, BrightView X and BrightView XCT Single Photon Emission Computed Tomography (SPECT) scanners due to a component failure that could result in the system’s detector falling on patients. Philips sent all affected customers an Urgent Medical Device Correction…
FDA announces urgent chest drain recall
Editor's Note The FDA has announced a recall of the Atrium Express Dry Suction Dry Seal Chest Drain, a disposable device used to remove air and/or fluid from the chest cavity or mediastinum and to aid in lung expansion and breathing. The drain is being recalled by maker Maquet Cardiovascular,…
Session: What to expect from healthcare policy, regulation in 2024
Editor's Note Since the pandemic, the view of the healthcare industry in congress has essentially gone from “hero to zero” – a shift with potentially big implications for the healthcare business leaders gathered at yesterday’s closing session from Soumi Saha, PharmD, JD, senior vice president of government affairs at Premier…
Sonio, AI-powered prenatal ultrasound management solution, announces implementation by Pediatrix MFM Practice
New York, New York (January 31, 2024)–Sonio today announced that Pediatrix Medical Group, the U.S.’s leading provider of highly specialized health care for women, children and babies, has deployed Sonio, a cloud-based, AI-powered prenatal care reporting and image management solution. This new technology is intended to simplify and streamline ultrasound…
FDA updates safety recall of certain saline, sterile water medical products
Editor's Note The US Food and Drug Administration (FDA) on January 24 updated its safety recall communication from November 6 to add to the voluntary recalls of saline and sterile water medical products associated with Nurse Assist, LLC. The FDA recall notice lists various water-based medical products manufactured by Nurse…
Blast from the past: Improving medication safety in the OR
The US Food and Drug Administration receives more than 100,000 medication-related reports, and some of them, according to the AORN Journal, “involve patient death.” AORN’s 2024 updated guidelines include safety updates for perioperative staff when handling, transporting, and administering medication, which can be a complex process prone to errors. In…
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