Registry-Based Prospective, Active Surveillance of Medical-Device Safety

Abstract Background The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary…

Class I Medical Device Recall: Bard Peripheral Vascular Inc. Recalls Halo One Thin-Walled Guiding Sheath Due to Sheath Separation, Kinking, or Tip Damage

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Class I Medical Device Recall: bioMerieux Recalls NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents due to Potential Inaccurate Test Results

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents Lot Numbers: See List Below Distribution Dates: May 03, 2016 to August 18. 2016 Devices Recalled in the…

Mammography Facility Adverse Event and Action Report

BackgroundAs part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide. In order…

Presentation and Transcript posted for Webinar – Postmarket Management of Cybersecurity in Medical Devices Final Guidance

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