Smiths Medical has issued an Urgent Medical Device Correction Letter for two potential issues with CADD infusion system infusion sets.
Tag: medical device safety
Having an optimized HTM program that delivers efficiency and effectiveness to a hospital is an often-overlooked part of the patient satisfaction equation.Read More
The playbook for threat modeling aims to provide insights to organizations developing or evolving an approach to creating threat models for medical devices.Read More
An Atlanta resident died of hypoglycemia after his Dexcom G6 glucose monitoring device failed to sound an alarm; his widow is pursuing a wrongful death suit.Read More
The FDA says its goal is to prevent patients from experiencing adverse effects from certain materials used in medical devices.Read More
“We believe that HHS and CMS should expeditiously take steps to add the device identifier portion of UDIs in Medicare claims, and we ask you to commit to finalizing this change as soon as possible,” write the lawmakers.Read More
Not allowing medical device companies to present information about the FDA’s analysis of their products in product liability cases against them results in unfair court trials, posits an article by Reuters.Read More