FDA: Bella Pharmaceuticals recalls all sterile drug products
Editor's Note The Food and Drug Administration on August 18 announced the recall by Bella Pharmaceuticals (Chicago, Illinois) of all lots of unexpired sterile drug products because of a lack of sterility assurance. Affected products include all lots distributed April 17, 2017, to August 10, 2017, nationwide. Products are packaged in…
Few outcome measures meet criteria for accuracy, validity assessment
Editor's Note This study from the Joint Commission finds that criteria for assessing whether outcome measures are accurate and valid enough to use for public reporting, payment, and accreditation are not well-defined. The authors propose four criteria to assess outcome measures: Strong evidence should exist that good medical care leads…
FDA: Class I recall of Zenith Alpha Thoracic Endovascular Graft by Cook Medical
Editor's Note The Food and Drug Administration (FDA) on August 16 classified the recall by Cook Medical Inc (Bloomington, Indiana) of its Zenith Alpha Thoracic Endovascular Graft as Class I, the most serious. Cook Medical is aware of reported cases where the graft became blocked or closed with blood clots…
Five-year outcomes of on-pump vs off-pump CABG
Editor's Note In this multicenter study, on-pump coronary artery bypass grafting (CABG) led to significantly higher rates of 5-year survival and event-free survival than off-pump CABG. From 2002 to 2007, a total of 2,203 patients at 18 medical centers were randomly assigned to undergo either on-pump (1,099 patients) or off-…
Joint Commission: Quick Safety on noises, distractions in ORs
Editor's Note The Joint Commission on August 16 announced a new Quick Safety that focuses on noise and distractions in the OR and how they can make it difficult to hear and discern information or communicate effectively. ORs are prone to high levels of noise, which can be distracting and…
CMS proposes canceling two bundled payment models, scaling back a third
Editor's Note The Centers for Medicare & Medicaid Services (CMS) on August 15 announced a proposed rule that would cancel two bundled-payment models and reduce the number of providers required to participate in a third. The proposed rule would cancel the Episode Payment Models and the Cardiac Rehabilitation incentive payment…
Survey: Half of practices spend $40K per physician to comply with federal regs
Editor's Note A new Medical Group Management Association survey of 750 physician group practices finds that nearly half spend more than $40,000 per physician each year to comply with federal regulations, the August 10 FierceHealthcare reports. Respondents say the most burdensome regulation is Medicare’s new Merit-Based Incentive Payment System (MIPS)…
Report predicts big growth for hybrid OR market
Editor's Note A research report by Marketsandmarkets predicts the global hybrid OR market will reach nearly $1.2 billion by 2022, at a 12.5% annualized growth rate, according to the August 14 HealthCareBusiness daily news. The specialty with the highest growth rate will be thoracic surgery. The biggest driver of hybrid…
Effect of antibiotic duration on colorectal SSIs
Editor's Note When colorectal surgical patients, who were given a single dose of antibiotic before surgery and re-dosing if the procedure lasted longer, were compared to patients given additional antibiotics for 24 hours postoperatively, infection rates were identical, this study finds. A total of 965 patients were included in this…
FDA: Safety Alert on liquid-filled intragastric balloon systems
Editor's Note The Food and Drug Administration (FDA) on August 10 issued a Safety Alert to update healthcare providers on five reports of unanticipated deaths that have occurred from 2016 to the present in patients with liquid-filled intragastric balloon systems used to treat obesity. Four reports involve the Orbera Intragastric…
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- AAAHC seeks stakeholder feedback on revised v44 standards to elevate patient-centered care
- Hospital’s anesthesia reforms slash carbon footprint, expenses
- Study: Shifting imaging to outpatient centers could save billions