Editor's Note The Food and Drug Administration (FDA) on January 21 issued final guidance for “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." The document updates and clarifies information regarding sterilization processes and details about pyrogenicity the FDA recommends that sponsors include…

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Editor's Note ECRI Institute (Plymouth Meeting, Pennsylvania) on January 21 launched its new “Rate This Model” user review and rating tool for hospital equipment purchases. The tool enables OR managers to share their opinions and assign ratings on the performance of medical technologies. The new interactive feature looks and acts…

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Editor's Note In this study, researchers from Yale-New Haven Hospital, New Haven, Connecticut, calculated a risk-adjusted outcomes measure of outpatient colonoscopy, which shows important variation in quality among outpatient facilities. The outcomes measure profiles outpatient facility quality by examining rates of unplanned hospital visits in the 7 days after colonoscopy.…

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Editor's Note The Medicare Access and CHIP Reauthorization Act of 2015 requires that physicians be measured on their meaningful use of electronic health record (EHR) technology for purposes of determining their Medicare payments. EHR incentive programs were designed to encourage the adoption of new technology and measure the benefits for…

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Editor's Note The Food and Drug Administration (FDA) on January 15 issued a draft guidance that outlines important steps manufacturers should take to address postmarket management of cybersecurity vulnerabilities in medical devices. The guidance builds on the FDA’s existing efforts to ensure the safety and effectiveness of medical devices at…

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Editor's Note The Food and Drug Administration (FDA)  on January 15 cleared the Olympus TJF-Q180V duodenoscope with design and label modifications intended to reduce the risk of bacterial infections. The new design of the elevator channel sealing mechanism creates a tighter seal and reduces the potential for leakage of fluids…

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Editor's Note Nearly 209,000 physicians and other healthcare providers will receive 2% cuts in their Medicare payments in 2016 for failing to meet meaningful use standards in 2014. The penalties total an estimated $600 million. Andy Slavitt, acting administrator of the Centers for Medicare and Medicaid Services, said on January…

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Editor's Note The Food and Drug Administration (FDA) on January 15 classified the recall of Brainlab’s Cranial Image-Guided Surgery (IGS) System as Class I, the most serious. The system is being recalled because of potential inaccuracies in the display by the navigation system compared to the patient’s anatomy. This could…

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Editor's Note This large-scale initiative, led by researchers from the Harvard School of Public Health, Boston, to implement surgical safety checklists in 13 South Carolina hospitals was associated with improved staff perceptions of perioperative safety. Included were improved staff perceptions of: mutual respect clinical leadership assertiveness on behalf of safety…

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Editor's Note Medicare data on payments for inpatient surgery are a reliable measure of hospital costs for commonly performed procedures, but are less reliable for lower volume procedures, this study finds. With increased emphasis on shifting risk from payers to providers through bundled payments and accountable care organizations, hospitals are…

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