FDA issues statements on VHP sterilization; hip surgery device safety
Editor's Note Recent announcements from The US Food and Drug Administration (FDA) validate vaporized hydrogen peroxide (VHP) as an established device sterilization method and warn against the use of the Synovo Total Hip Replacement system. Issued January 8, the announcement about VHP is part of the agency’s multi-pronged approach to…
Investigation reveals medical device safety testing concerns
Editor's Note Published December 21, a year-long investigation by KFF Health News into medical device malfunctions found that the FDA allows the sale of most medical devices, including many implants, without requiring tests for safety or effectiveness. Instead, manufacturers need to show only that they have “substantial equivalence” to an…
Brain stimulation improves surgeon dexterity with robotic tools
Editor's Note Mild electric stimulation to the back of surgeons’ heads could enhance robotic surgery accuracy and precision, according to findings published in the journal Scientific Reports on December 20. The study tasked 36 participants – approximately half male, half female, none of whom had experience with robotic surgery –…
Burns prompt recalls of airway scopes, electrosurgical pads
Editor's Note Reports of burn injuries have prompted two medical device recalls: one for Megadyne patient return electrodes and one for Olympus bronchofiberscopes and bronchovideoscopes. According to a December 21 notice from AORN, the former recall is a voluntary correction on the part of Megadyne Medical Products, Inc. Following reports…
First hospital joins FDA’s medical device information sharing and analysis initiative
Editor’s Note Charlotte, North Carolina-based Atrium Health is the first hospital to join the Medical Device Information Analysis and Sharing (MDIAS) public-private partnership (PPP) between the Food and Drug Administration (FDA) and private sector stakeholders. The news was announced December 12 by Mitre, a nonprofit research organization and the independent…
New wearable device system could aid in remote medical monitoring
Editor's Note A new wearable monitoring device system from researchers at the University of Arizona aims to make digital health access more equitable. These research findings were published in the Proceedings of the National Academy of Sciences on December 4. The new device can reportedly send health data up to…
Researchers develop new early stage breast cancer detection device
Editor's Note Researchers from the University of Waterloo have devised a new, noninvasive method for detecting early stage breast cancer in just 2 minutes using very low electro-magnetic frequencies. The findings were first published in August in the Nature journal Scientific Reports. The research team discovered that very low electro-magnetic…
New MRI scanner is reportedly 10 times more powerful than regular machines
Editor's Note An international team of researchers has unveiled a new magnetic resonance imaging (MRI) scanner that is reportedly significantly more powerful than conventional MRI machines, a November 27 article published by Nature Methods reports. The new MRI is said to record up to 10 times with more detail than…
FDA encourages new cybersecurity standards on medical device manufacturing
Editor's Note The US Food and Drug Administration (FDA) has recognized the latest guidance on medical device cybersecurity from the Association for the Advancement of Medical Instrumentation (AAMI), an AAMI November 14 press release reports. This latest cybersecurity recognition is encouraging its use across the medical device manufacturing industry to…
New water quality standard released by AAMI
Water is a major component of medical device processing. It is used in cleaning solutions, rinse water, and to generate steam for sterilization. Because of its crucial role in medical device processing, the Association for the Advancement of Medical Instrumentation (AAMI) determined it was necessary to upgrade the Technical Information…
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