Editor's Note The Food and Drug Administration (FDA) on March 8 issued a warning about magnetic interference between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators (ICDs) or pacemakers in patients. The breast expanders can interfere with the functioning of these cardiac devices, causing them to go into "magnet…

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Editor's Note The US Department of Health and Human Services (HHS) has released guidelines on how the Health Information Portability and Accountability Act (HIPPA) applies to health information a patient creates or manages through a health app and when app developers are required to comply with HIPPA rules. The new…

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Editor's Note The ECRI Institute announced February 2 that Texas Children’s Hospital in Houston has won its 10th annual Health Devices Achievement Award. Texas Children’s winning submission, “Alarm Management Reboot,” describes the hospital’s efforts to improve patient safety by incorporating enterprise-wide alarm management practices to make alarms more meaningful and…

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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Editor's Note The Food and Drug Administration (FDA) on January 15 issued a draft guidance that outlines important steps manufacturers should take to address postmarket management of cybersecurity vulnerabilities in medical devices.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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How can OR managers better prepare staff to handle crisis situations? How can they encourage teamwork? Increasingly, OR leaders are turning to simulation to answer those questions.   OR leaders who think they can’t afford a high-fidelity manikin (one that talks and exhibits physiologic changes) and state-of-the-art simulation lab might…

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Emergencies such as the one described above don’t happen frequently in the OR, but it is important to prepare for them, and simulation has emerged as an ideal educational tool. This scenario took place in a simulation lab, not a real OR, so the danger to the “patient” (manikin) consisted…

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OR Manager and ECRI Institute have joined in a collaboration to bring OR Manager readers periodic articles on topics such as medical technology management and procurement, risk management, and patient safety. ECRI Institute is an independent nonprofit that researches the best approaches to improving patient care.   Every year, hospitals…

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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 The Food and Drug Administration (FDA) on January 4 issued a draft guidance: “Unique Device Identification [UDI]: Convenience Kits—Draft Guidance for Industry and Food and Drug Administration Staff.” The document outlines the FDA’s interpretation that the term “convenience kit,” as defined by 21 CFR 801.3, applies solely to…

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