Editor's Note The Food & Drug Administration (FDA) on October 17 announced a public workshop to discuss the newly released draft guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The need for effective cybersecurity to ensure medical device function and safety has become more important with…

Read More

Editor's Note The Food and Drug Administration (FDA) on October 16 announced that as part of the Administration’s efforts to strengthen cybersecurity in healthcare, the FDA and Department of Homeland Security (DHS) have agreed to greater coordination and cooperation for addressing cybersecurity in medical devices. Under the agreement, DHS will…

Read More

Editor's Note Despite ethical and legal obligations to protect patient privacy and efforts to establish best practices for healthcare information security, breach rates have increased since 2010, this study finds. Of 2,149 breaches that involved 176.4 million records, the most common entities breached were healthcare providers, with 1,503 breaches that…

Read More

Editor's Note The Food & Drug Administration (FDA) on October 1 released a “Playbook,” developed by the Medical Device Cybersecurity Regional Incident Preparedness and Response (MITRE) Corp, to assist hospitals and other healthcare providers respond to cybersecurity incidents involving medical devices, the American Hospital Association reports.  The MITRE Playbook outlines…

Read More

Editor's Note The ECRI Institute on October 1 released its 2019 Top 10 Health Technology Hazards. Among the hazards: First is cybersecurity attacks Second is blood and body fluids on mattresses after cleaning Third is retained sponges Fifth is mishandling flexible endoscopes after disinfection Ninth is cleaning fluid seeping into…

Read More

Editor's Note The Food and Drug Administration (FDA) has taken steps to ensure that medical device manufacturers do as much as possible to defend against hacking and other threats to their devices, according to a new report from the Department of Health & Human Services Office of Inspector General. The…

Read More

Editor's Note This year’s three winners of the Design by Biomedical Undergraduate Teams (DEBUT) challenge included assistive surgical devices: First place−$20,000 went to a team from Johns Hopkins University, Baltimore, for a minimally invasive brain retractor. Second place−$15,000 was awarded to a team from Clemson University, South Carolina, for a…

Read More

Sometimes surgeons ask to have nonmedical devices sterilized, such as spoons, hockey pucks, and fish hooks. Healthcare staff may want to accommodate their requests, but there are times when they cannot do so. A central service (CS) should only sterilize medical devices that have undergone validation testing, which demonstrates that…

Read More

Editor's Note Nominees for the Best Medical Technology of 2018 were recently chosen by The Galien Foundation, the August 6 Medical Design & Outsourcing reports. Among the 10 most innovative medical devices are: Boston Scientific’s Axios stent and electrocautery enhanced delivery system Boston Scientific’s SpyGlass direct visualization system for cholangiopancreatoscopy…

Read More

Editor's Note Engineers and neurosurgical researchers at the University of Minnesota have created a 3D-printed device with living cells that could help patients with long-term spinal cord injuries regain some function, according to this August 9 report from the University of Minnesota. For the procedure, a 3D-printed guide, made of…

Read More