FDA to Hold Town Halls on Ethylene Oxide Sterilization Following Toxic Leaks
More stringent ethylene oxide standards were enacted last year, following a number of factory leaks that put workers and nearby residents at risk.
Tag Archives: Medical Devices
-
-
FDA Encourages Vaporized Hydrogen Peroxide for Medical Device Sterilization, Amid Ethylene Oxide Safety Concerns
A leak from a Sterigenics plant in Illinois resulted in a $400 million ethylene oxide exposure lawsuit settlement agreement last year for nearby residents, due to serious health risks
-
FDA Releases New Industry Guidelines for Securing Medical Devices Against Cybersecurity Threats
The new guidelines come as the medical community faces increasing risks from medical device cybersecurity threats, including ransomware and data breaches.
-
Recalled Medical Devices Fast-Tracked Through FDA Approval Process Were Often Based on Flawed, Older Designs: Study
Many recalled medical devices, fast-tracked through the FDA approval process, are based on devices which have been subjected to major recalls, and are more likely to be recalled themselves
-
Security Gaps in 150,000 Infusion Pumps Makes Them Vulnerable to Hacking: Report
Medical device manufacturers have done little to close cybersecurity gaps in infusion pumps and other vulnerable machines, even after years of experts warning about hacking risks
-
Conflicts of Interest Rampant In Healthcare Industry, Requiring Oversight: Study
Findings show need for more extensive oversight to protect patients' interests, the researchers noted
-
FDA Guidance Seeks To Prevent Electromagnetic Interference Between Medical Devices
-
FDA Relies Too Heavily On Post-Marketing Adverse Event Reports To Identify Drug, Medical Device Problems: Study
-
Sterigenics Faces Ethylene Oxide Exposure Lawsuit Filed By Georgia Plant Employees
-
Ethylene Oxide Class Action Lawsuit Filed Against B. Braun Medical Over Allentown, Pennsylvania Plant Emissions
