Archives of internal medicine
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Review Meta Analysis
Stopping smoking shortly before surgery and postoperative complications: a systematic review and meta-analysis.
To examine existing smoking studies that compare surgical patients who have recently quit smoking with those who continue to smoke to provide an evidence-based recommendation for front-line staff. Concerns have been expressed that stopping smoking within 8 weeks before surgery may be detrimental to postoperative outcomes. This has generated considerable uncertainty even in health care systems that consider smoking cessation advice in the hospital setting an important priority. Smokers who stop smoking shortly before surgery (recent quitters) have been reported to have worse surgical outcomes than early quitters, but this may indicate only that recent quitting is less beneficial than early quitting, not that it is risky. ⋯ Existing data indicate that the concern that stopping smoking only a few weeks prior to surgery might worsen clinical outcomes is unfounded. Further larger studies would be useful to arrive at a more robust conclusion. Patients should be advised to stop smoking as early as possible, but there is no evidence to suggest that health professionals should not be advising smokers to quit at any time prior to surgery.
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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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Comment Letter Comparative Study
Racial disparities in end-of-life care.