Rules and Regulations
FDA announces Class 1 recall for Draeger breathing filters
Editor's Note The FDA has issued a Class 1 recall—the most severe category indicating risk of serious injury or death—for Draeger Filter SafeStar 90 Plus (MP05785), Filter SafeStar 55 Plus (MP05790), Filter SafeStar 60A Plus (MP05795), and Filter/HME TwinStar HEPA Plus (MP05801) breathing system filters, affecting all lot numbers. Draeger…
Soap recalled due to to bacterial contamination
Editor's Note DermaRite Industries has voluntarily recalled multiple lots of healthcare products nationwide due to contamination with Burkholderia cepacia, a bacterium that poses serious infection risks to immunocompromised individuals, according to an August 10 article in Newsweek. The recall affects four product lines commonly used in healthcare settings for handwashing…
Healthcare providers express cash flow concerns under new 340B rebate model
Editor's Note Healthcare providers could experience significant cash flow and operational changes under a new voluntary pilot program that fundamentally alters how the nation's second-largest drug payment program operates, according to an August 11 article in Modern Healthcare. As detailed in the article, The Health Resources and Services Administration announced…
FDA orders opioid label changes to highlight long-term risks
Editor's Note The US Food and Drug Administration (FDA) is requiring safety labeling changes for all opioid pain medications to better emphasize and explain the risks associated with long-term use, according to a July 31 announcement. These changes follow a May advisory committee meeting where the agency reviewed data on…
Study: Loophole enables urban hospitals to qualify for rural subsidies
Editor's Note Hundreds of urban hospitals have obtained dual urban-rural Medicare classifications since a 2016 policy change, enabling them to qualify for reimbursement programs intended for rural providers. Fierce Healthcare reported the news August 4. As detailed in the article, a study published in Health Affairs by Johns Hopkins and…
FDA safety alerts flag cardiac devices
Editor's Note The US Food and Drug Administration (FDA) issued early alerts August 6 for three medical devices due to safety concerns: Medline ReNewal’s reprocessed St. Jude Medical electrophysiology catheters, Boston Scientific’s ENDOTAK RELIANCE defibrillation leads with ePTFE-coated coils, and Boston Scientific's WATCHMAN Access Systems. The Medline alert involves specific lots…
FDA issues Class I recall for Philips BiPAP ventilators
Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…
Nearly half of hospital patient harm events go unreported, OIG reveals
Editor's Note Nearly half of hospital harm events—particularly surgical events—were not captured by reporting systems, according to a July 30 TechTarget report on new findings from the Office of Inspector General (OIG). The OIG report examined 299 harm events experienced by a nationally representative sample of 770 Medicare patients discharged…
CMS’s newly finalized TEAM payment model holds hospitals accountable for entire surgical episodes
Editor's Note As part of the Centers for Medicare and Medicaid Services (CMS) newly issued 2026 Final Rule, the Transforming Episode Accountability Model (TEAM) will hold hospitals and health systems accountable for the entire episode of care for major surgeries, from admission through 30 days post-discharge. HIT Consultant reported the…
Brief NIH funding halt sparks backlash
Editor's Note The Trump administration paused new NIH research grants and contracts, prompting widespread concern before abruptly reversing course, according to a July 30 article in Forbes. Citing a separate report in STAT, the article details how the Office of Management and Budget (OMB) directed the NIH to suspend new…
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