Editor's Note The Food & Drug Administration on June 6 identified the recall by Maquet Datascope Corp of its CARDIOSAVE Hybrid Intra-aortic Balloon Pump as Class I, the most serious. The recall was initiated because of a design issue that allows fluid to seep into the device, which can lead…

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Editor's Note: This study from Iowa State University shows companies have cut funding for research and development (R&D) in response to the medical device tax imposed by the Affordable Care Act. Since 2013, the 2.3% excise tax has significantly reduced: R&D investment by $34 million Sales revenue by $188 million…

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Editor's Note ECRI Institute on June 5 announced a new consultative service focused on helping healthcare organizations prevent surgical fires by uncovering hidden vulnerabilities. There have been guidelines published by ECRI Institute and others to prevent and extinguish fires for many years, but implementation of the guidelines is the challenge,…

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Editor's Note The Food & Drug Administration on June 4 announced that it had approved new labeling on potential risks for liquid-filled intragastric balloons by Apollo Endosurgery and ReShape Lifesciences. The new labeling for the Orbera and ReShape balloon systems includes more information about possible deaths linked to the use…

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Editor's Note In this study, the use of radial-artery grafts for coronary artery bypass grafting (CABG) resulted in a lower rate of cardiac adverse events and a higher rate of patency at 5 years than saphenous-vein grafts. A total of 1,036 patients (534 radial artery, 502 saphenous vein) from six…

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Editor's Note US hospitals added 6,200 jobs in May to a seasonally adjusted 5,167,400, the Bureau of Labor Statistics reported on June 1. That is 99,800 more employees than a year ago. The overall unemployment rate fell by 0.1 in May to 3.8%, an 18-year low.

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Editor's Note The Food & Drug Administration on June 1 announced the recall by SunMed Holdings of 18,808 units of its STAT-Check and Medline manual resuscitator bags. The recall was initiated because the patient port retaining ring of the bags may not fully seat, which could allow the patient port…

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Editor's Note Rates of infection after colonoscopies and osophagogastroduodenoscopies (OGDs) performed in ambulatory surgery centers (ASCs) are higher than previously thought and vary widely by facility, this study from Johns Hopkins finds. Rates of postendoscopic infection per 1,000 procedures within 7 days were: 1.1 for screening colonoscopy 1.6 for nonscreening…

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Editor's Note The Joint Commission on May 31 issued a new Quick Safety advisory to help prepare healthcare organizations for disasters such as, power failure, fire, flood, industrial accident, or cyberattack. The advisory, "Quick Safety 41: Emergency management: Need for continuity of operations planning," provides risk factors, safety recommendations, and…

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Editor's Note The Food & Drug Administration on June 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system as Class I, the most serious. The recall was initiated because of the possibility for an interruption to occur in the electrical connection between the system’s power…

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