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  • Cybersecurity Concerns and Medical Devices: Lessons From a Pacemaker Advisory

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    JAMA. 2017; doi: 10.1001/jama.2017.15692

    This Viewpoint uses a 2017 US Food and Drug Administration (FDA) safety communication about the vulnerability of some cardiac pacemakers to malware to discuss medical device data security and patient safety more generally, and regulatory steps the FDA has and can take to combat the risks.

  • Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements

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    JAMA. 2017; 318(7):619-625. doi: 10.1001/jama.2017.9414

    This study characterizes the quality of clinical studies and data used to support US Food and Drug Administration approval of modifications to high-risk medical devices.

  • Balancing the Need for Access With the Imperative for Empirical Evidence of Benefit and Risk

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    JAMA. 2017; 318(7):614-616. doi: 10.1001/jama.2017.9412
  • JAMA August 8, 2017

    Figure 1: Flow of Patients Through the Cerebral Embolic Protection Device Trial

    aThese are the top 3 reasons for not meeting inclusion criteria. There were 1140 patients who were excluded for other reasons.bThe first 12 patients randomized to the control group served as controls for the intra-aortic filtration group only and the other 120 patients served as controls for both the suction-based extraction group and the intra-aortic filtration group.
  • Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial

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    JAMA. 2017; 318(6):536-547. doi: 10.1001/jama.2017.9479

    This randomized clinical trial compares the efficacy and adverse effects of 2 cerebral embolic protection devices vs a shared control group in reducing ischemic central nervous system injury during surgical aortic valve replacement.

  • Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial

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    JAMA. 2017; 318(6):548-556. doi: 10.1001/jama.2017.9973

    This randomized clinical trial compares the effect of preoperative levosimendan vs placebo on the incidence of postoperative low cardiac output syndrome in patients with low ventricular ejection fraction who were undergoing coronary artery bypass grafting with cardiopulmonary bypass.

  • Practical Improvements for Medical Device Evaluation

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    JAMA. 2017; 318(4):332-334. doi: 10.1001/jama.2017.8976
  • Monitoring Medical Devices: Missed Warning Signs Within Existing Data

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    JAMA. 2017; 318(4):327-328. doi: 10.1001/jama.2017.6584

    This Viewpoint uses the example of gastric band failures to discuss how available data may be used more appropriately to detect problems in the safety and effectiveness of medical devices.

  • JAMA July 25, 2017

    Figure: Annual Procedures and Payments for Gastric Band Placement and Device Reoperations, 2006-2014

    FDA indicates US Food and Drug Administration. Data were extracted from the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project made publicly available through their online query tool, HCUPnet (https://hcupnet.ahrq.gov/). Dotted lines indicating timeline events and payment percentages were added by the authors.
  • Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial

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    JAMA. 2017; 317(6):596-605. doi: 10.1001/jama.2016.20939

    This randomized clinical trial evaluates whether a scalp cooling device is effective compared with no cooling for reducing alopecia in women with breast cancer undergoing chemotherapy.

  • Long-Acting Oral Drug Device May Help Combat Malaria

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    JAMA. 2017; 317(1):17-17. doi: 10.1001/jama.2016.18686
  • Vital Directions for US Health Care: Big Ideas on Small Signposts With Mixed Signals

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    JAMA. 2016; 316(16):1682-1684. doi: 10.1001/jama.2016.12415
  • Programmable Syringe Pump Alert

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    JAMA. 2016; 316(13):1350-1350. doi: 10.1001/jama.2016.13805
  • Need for a National Evaluation System for Health Technology

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    JAMA. 2016; 316(11):1153-1154. doi: 10.1001/jama.2016.8708

    This Viewpoint discusses creation of a US evaluation system for health technology that could quickly identify problematic devices, accurately and transparently characterize and disseminate information about device performance in clinical practice, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices.

  • Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial

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    JAMA. 2016; 316(6):592-601. doi: 10.1001/jama.2016.10302

    This randomized clinical trial compares the effects of use vs nonuse of a cerebral embolic protection device during transcatheter aortic valve implantation (TAVI) on MRI-detected brain lesions in patients with severe aortic stenosis undergoing TAVI.

  • JAMA August 9, 2016

    Figure 1: Treatment Flow of Patients in the CLEAN-TAVI Trial

    aReasons ineligible for transcatheter aortic valve implantation (TAVI): not suitable for transfemoral access (heavy calcification with resulting stenosis, high tortuosity); coronary origin less than 8 mm from the aortic annulus; or aortic annulus size too small or large.bSee 4.2.4 Preinterventional Procedures in Supplement 1.cPatient indicated study consent would be withdrawn if TAVI was without filter protection. Therefore, a cerebral protection device was used, but the patient remained in the control group per the intention-to-treat principle.dStill underwent clinical follow-up.eIndicates clinical instability and inability to leave the intensive care unit (ICU) for magnetic resonance imaging (MRI) assessment.fOf those who received the 2-day MRI in the filter group, 3 of 49 MRIs (6.1%) and in the control group, 2 of 45 MRIs (4.4%) were performed using the 1.5T scanner (absolute difference, 1.7%). Of those who received the 7-day MRI in the filter group, 4 of 45 MRIs (8.8%) and in the control group, 1 of 43 MRIs (2.3%) were performed using the 1.5T scanner (absolute difference, 6.5%).The 1.5T scanner was used because some patients were intermittently pacer dependent with temporary leads in place (not approved for use with 3T MRI).
  • Obesity Device Drains Stomach

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    JAMA. 2016; 316(5):485-485. doi: 10.1001/jama.2016.9807
  • Wearable Biosensors Studied for Clinical Monitoring and Treatment

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    JAMA. 2016; 316(3):255-257. doi: 10.1001/jama.2016.6240

    This Medical News features describes advances in the development of wearable biosensors that can monitor health indicators such as levels of blood glucose or electrolytes.

  • Avoiding Magnetic Interference

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    JAMA. 2016; 315(15):1555-1555. doi: 10.1001/jama.2016.3572