Device Safety

Latest Headlines

Latest Headlines

Researchers develop bioplastic that can combat infections from devices

Infections caused by artificial joints and other devices can lead to sepsis, which is often fatal. Now researchers say they have developed a bioplastic that is resistant to bacteria and could be used to combat infections from devices like wound dressings and catheters.

Olympus settles accounting scandal as it struggles to address duodenoscope difficulties

Olympus will pay as much as 11 billion yen ($92 million) to settle two lawsuits based in a 2011 accounting scandal. This comes just as the camera and medical imaging company has been identified as one of several companies whose dirty duodenoscopes have infected some patients with antibiotic-resistant bacteria.

Medical device cybersecurity expert says better 'cybersecurity hygiene' needed

The director of the University of Michigan's center for medical device cybersecurity called for better "cybersecurity hygiene" last week during a roundtable discussion in Washington, DC, sponsored by the New America Foundation.

Olympus releases updated endoscope cleaning instructions amid pushback

Olympus revealed updated cleaning instructions for duodenoscopes linked to a recent superbug outbreak at UCLA, weeks after the FDA warned that the devices' complex design may contribute to the spread of deadly bacteria and called for label modifications.

Congressman of district hardest hit by duodenoscope safety scare seeks explanation from Olympus

Rep. Ted Lieu (D-CA) is calling for a federal investigation into the duodenoscope safety scare that has claimed lives and spread the dangerous pathogen CRE to patients across the nation. And he just sent a letter to Olympus asking the company why it did not seek FDA clearance for a 2010 redesign of its duodenoscope, if it plans to redesign the device in the future, and when the company first learned of the risk posed by the device.

UPDATED: Nearly 10,000 GE, Siemens MRI machines under FDA recall

Almost 10,000 GE and Siemens MRI machines are being recalled, FDA's database shows. The agency classified the recalls in its second-most severe category, meaning the affected machines "may cause temporary or medically reversible adverse health consequences."

Registry data to be shared at meeting of orthopedic surgeons

At the American Academy of Orthopedic Surgeons' annual meeting, which commences tomorrow, findings from the most comprehensive data registry of total hip and knee replacements will be revealed. Dubbed FORCE-TJR, the registry of 30,000-plus patients includes information about risk factors, patient-reported measures of pain, clinical measures like readmission, infection rates, adverse events, and more.

Regulators, industry, doctors dig deep to clean dirty devices following deadly outbreak

Federal regulators, physician groups and medical device manufacturers are wasting little time looking for both quick and long-term fixes to ensure duodenoscopes are properly cleaned and sterilized for reuse. The scramble comes following highly publicized outbreaks of an antibiotic-resistant superbug dubbed CRE (carbapenem-resistant Enterobacteriaceae).

Study: Car breathalyzer could save 59K U.S. lives in 15 years

If breathalyzers were installed in every U.S. car, that could save 59,000 lives and $343 million over a 15-year period, according to a University of Michigan study. But while the technology to prevent a person from driving drunk currently is available as an add-on, it's not clear when, or even if, it will become a standard car feature.

UPDATED: Medtronic steerable sheath recalled, deemed potentially deadly by the FDA

The FDA just labeled the recall of Medtronic's 10 French FlexCath Select Steerable Sheath as a class I recall. This means there is a reasonable probability that the device "will cause serious adverse health consequences or death.