JAMA internal medicine
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JAMA internal medicine · Nov 2014
Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.
Postmarketing surveillance is critical to evaluating the safety and effectiveness of medical devices. The US Food and Drug Administration (FDA) may order the manufacturer of a high-risk device to conduct postmarketing surveillance studies, known as postapproval studies (PASs), at the time of approval. ⋯ Postapproval studies have the potential to provide additional information to better understand medical device performance. However, small sample sizes, delays in reaching protocol agreement, and lack of availability of findings may hinder their ability to be clinically useful. Owing to the lack of information on the effect of studies, it is unclear whether the program achieves its aims. Improved completion and accessibility of PASs could help answer important questions of safety and effectiveness about medical devices. To better understand the real-world performance of these products, they should be better integrated with other sources of information about device performance.
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JAMA internal medicine · Nov 2014
Randomized Controlled Trial Comparative StudyBrief intervention for patients with problematic drug use presenting in emergency departments: a randomized clinical trial.
Medical treatment settings such as emergency departments (EDs) present important opportunities to address problematic substance use. Currently, EDs do not typically intervene beyond acute medical stabilization. ⋯ In this sample of drug users seeking emergency medical treatment, a relatively robust brief intervention did not improve substance use outcomes. More work is needed to determine how drug use disorders may be addressed effectively in the ED.
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JAMA internal medicine · Nov 2014
Association between arterial catheter use and hospital mortality in intensive care units.
Arterial catheters are used frequently in intensive care units (ICUs). Clinical effectiveness and adverse events associated with the use of the catheters have not been formally evaluated in clinical studies. ⋯ In this propensity-matched cohort analysis, arterial catheters were not associated with improvements in hospital mortality in medical ICU patients requiring mechanical ventilation. Given the costs and potential harms associated with invasive catheters, randomized clinical trials are needed to further evaluate the usefulness of these frequently used devices.
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JAMA internal medicine · Nov 2014
CommentLack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices.
Under the 510(k) process, the US Food and Drug Administration (FDA) clears about 400 implanted medical devices that are considered moderate to high risk for market each year without requiring clinical testing. Instead, the FDA requires the applicant to provide scientific evidence that the new device is "substantially equivalent" to a device or devices already on the market (predicate devices). Companies are legally required to submit the evidence to the FDA and to make publicly available at least a summary of the evidence. ⋯ Despite the legal requirement that scientific evidence of substantial equivalence be publicly available for medical devices cleared by the FDA through the 501(k) process, such information is lacking for most implanted medical devices cleared between 2008 and 2012, as well as for their predicates.