FDA announces framework for strengthening medical device cybersecurity
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…
ECRI Institute releases 2019 Top 10 Health Technology Hazards
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…
FDA takes steps to address cybersecurity concerns of medical devices
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…
Assistive surgical devices win in biomedical engineering design competition
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…
Validate and verify medical devices to ensure safety
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…
Galien Foundation chooses 10 most innovative medical devices of 2018
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…
New 3D-printed device with living cells could help treat spinal cord injuries
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…
Siemens, NuVasive announce partnership to create new spine imaging technology
Editor's Note Siemens Healthineers (Erlangen, Germany) and NuVasive (San Diego, California) have entered into a strategic partnership to create integrated 3D imaging, surgical automation technology, and navigation for minimally invasive spine procedures, the August 9 Becker’s Spine Review reports. The collaboration, called the “Spine Precision Partnership,” will integrate Siemen’s Cios…
US House votes to kill medical device tax
Editor's Note A bill that would repeal the medical device tax cleared the House of Representatives on July 24 in a 283-132 vote. the July 24 The Hill reports. The tax provided part of the funding for the Affordable Care Act. Rep Erik Paulsen (R-Minn), the bill sponsor, says the…
Major healthcare data breaches down in first half of year
Editor's Note Cybersecurity firm Cryptonite reports there were eight major healthcare data breaches in the first half of 2018, down from 19 during the same time in 2017, according to the July 18 Healthcare Informatics. However, the number of patient records breached this year was up, with more than 1.9…
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