Some one in 10 Americans will have a medical device implanted into their bodies at some point in their lifetimes, yet less than 1% of these devices have been tested in rigorous clinical trials regarded as standard by U.S. regulators. The September issue of AMA Journal of Ethics® (@JournalofEthics) explores implantable material and device regulation, particularly the tension inherent in clinician-investigators’ and the FDA’s obligation to balance patient-subjects’ safety with patients’ demand for timely access to technologies and interventions that might improve or extend their lives. Articles include:
Listen and learn Listen and learnIn the journal’s August “Ethics Talk” podcast, editorial fellow Ariel Wampler, MD, a plastic and reconstructive surgery resident physician at Lahey Hospital & Medical Center in Burlington, Massachusetts, describes what few know about material and device regulation. In addition, Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University Medical Center, explains why we should ask more questions about device representatives’ intraoperative roles during implantations. Related CoverageThe unexplained disorder: A test of stigma, ethics and empathy The August issue also features two other author-interview podcasts:
Listen to previous episodes of the podcast, “Ethics Talk,” or subscribe in iTunes or other services. These AMA Journal of Ethics CME modules are each designated by the AMA for a maximum of 1 AMA PRA Category 1 Credit: Additionally, the CME module “Ethics Talk: Medical Device Representatives in the Surgical Suite” is designated by the AMA for a maximum of 0.25 AMA PRA Category 1 Credit. The offerings are part of the AMA Ed Hub, an online learning platform that brings together high-quality CME, maintenance of certification, and educational content from trusted sources, all in one place—with activities relevant to you, automated credit tracking and reporting for some states and specialty boards. Related CoverageTallying economic benefits, harms of care comes with challenges Submit manuscripts and artwork Submit manuscripts and artworkThe journal’s editorial focus is on commentaries and articles that offer practical advice and insights for medical students and physicians. Submit a manuscript for publication. The journal also invites original photographs, graphics, cartoons, drawings and paintings that explore the ethical dimensions of health or health care. A look ahead A look aheadUpcoming issues of the AMA Journal of Ethics will focus on palliative surgery, health care and homelessness and health justice and diversity in medical school admissions. Sign up to receive email alerts when new issues are published. The post Why implantable medical devices are a big test for regulators recently appeared on Medical Update News.
0 Comments
Leave a Reply. |
About UsWe are a group of medical and allied medically trained professionals that love to post information and updates about things happening in the world of medicine. Medical Update News
ArchivesCategories |