Archives of internal medicine
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Acid-suppressive medications are increasingly prescribed for noncritically ill hospitalized patients, although the incidence of nosocomial gastrointestinal (GI) tract bleeding (GI bleeding) and magnitude of potential benefit from this practice are unknown. We aimed to define the incidence of nosocomial GI bleeding outside of the intensive care unit and examine the association between acid-suppressive medication use and this complication. ⋯ Nosocomial GI bleeding outside of the intensive care unit was rare. Despite a protective effect of acid-suppressive medication, the number needed to treat to prevent 1 case of nosocomial GI bleeding was relatively high, supporting the recommendation against routine use of prophylactic acid-suppressive medication in noncritically ill hospitalized patients.
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Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk. ⋯ Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%). These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices.
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Electronic health records (EHRs) are increasingly used by US outpatient physicians. They could improve clinical care via clinical decision support (CDS) and electronic guideline-based reminders and alerts. Using nationally representative data, we tested the hypothesis that a higher quality of care would be associated with EHRs and CDS. ⋯ Our findings indicate no consistent association between EHRs and CDS and better quality. These results raise concerns about the ability of health information technology to fundamentally alter outpatient care quality.