Editor's Note The Food and Drug Administration (FDA) on November 26 announced that it plans to modernize its 510(k) approval pathway by pushing device manufacturers to rely on predicate devices that are not older than 10 years. Under the existing pathway, manufacturers can pursue expedited approval for devices that are…

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Multiple requests for new equipment and technology—usually from surgeons but also sometimes from staff—are not uncommon. As part of their due diligence, OR leaders must determine whether the return on investment (ROI) justifies the purchase. Doing ROI calculations systematically—and involving key stakeholders—can help ensure that the organization makes the best…

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The devices and systems we use when diagnosing and treating patients are invaluable to patient care—but they are not perfect. Patients and staff can be harmed if design flaws or system faults aren’t identified and rectified, equipment isn’t adequately maintained or prepared for use, or proper procedures aren’t followed. Preventing…

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Editor's Note The Food & Drug Administration (FDA) recently launched a new app to help streamline electronic health record (EHR) data collection for researchers, The November 7 EHR Intelligence reports. Using the MyStudies app, researchers can access patient-generated health data, EHR patient data, and claims and billing information for use in…

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Editor's Note The Food & Drug Administration on November 5 released the guidance, “Unique Device Identification: Policy Regarding Compliance dates for Class I and Unclassified devices and Certain Devices Requiring Direct Marking,” which takes effect immediately. The new guidance includes updated Unique Device Identification (UDI) direct mark requirements and supersedes…

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Editor's Note ECRI Institute on October 30 announced a new white paper--Value Analysis: Addressing Top Challenges by Using the PICOTS Framework--which presents findings from national seminars on the top five challenges value analysis professionals face daily. The challenges are: Antiquated workflow C-suite buy-in Accessibility to data Physician engagement Bandwidth. The…

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Editor's Note The Department of Health and Human Services (HHS) on October 29 opened the Health Sector Cybersecurity Coordination Center (HC3) at its headquarters in Washington DC. HC3 will play a vital role in early detection of cybersecurity attacks and coordination of information between the healthcare sector and the Department…

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Editor's Note The Food & Drug Administration (FDA) on October 17 announced a public workshop to discuss the newly released draft guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The need for effective cybersecurity to ensure medical device function and safety has become more important with…

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Editor's Note The Food and Drug Administration (FDA) on October 16 announced that as part of the Administration’s efforts to strengthen cybersecurity in healthcare, the FDA and Department of Homeland Security (DHS) have agreed to greater coordination and cooperation for addressing cybersecurity in medical devices. Under the agreement, DHS will…

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Editor's Note Despite ethical and legal obligations to protect patient privacy and efforts to establish best practices for healthcare information security, breach rates have increased since 2010, this study finds. Of 2,149 breaches that involved 176.4 million records, the most common entities breached were healthcare providers, with 1,503 breaches that…

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