Smiths Medical Issues Urgent Medical Device Correction for Infusion System
Smiths Medical has issued an Urgent Medical Device Correction Letter for two potential issues with CADD infusion system infusion sets.
Tag: medical device safety
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National Evaluation System for Health Technology Coordinating Center Forges Medical Device Partnership
The National Evaluation System for Health Technology Coordinating Center announces a five-year strategic partnership with Aetion, a real-world evidence (RWE) analytics provider, to advance the use of RWE in the medical device and diagnostics ecosystem.
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Joint Commission Issues Safety Advisory on Critical Instruments, Medical Devices
The new advisory highlights the importance of how surgical instruments and other critical devices are reprocessed and reused every day in healthcare.
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Smiths Medical Issues Urgent Medical Device Correction for Infusion System
Smiths Medical has issued an Urgent Medical Device Correction Letter for two potential issues with CADD infusion system infusion sets.
HTM: The Unsung Hero in Your Patient Satisfaction Strategy
Having an optimized HTM program that delivers efficiency and effectiveness to a hospital is an often-overlooked part of the patient satisfaction equation.
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Playbook for Threat Modeling Medical Devices Aims to Strengthen Cybersecurity, Safety
The playbook for threat modeling aims to provide insights to organizations developing or evolving an approach to creating threat models for medical devices.
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Device Used by Many Diabetics at Center of Wrongful Death Lawsuit in Georgia
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.
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FDA, ECRI Partner for Safer Medical Device Materials
The FDA says its goal is to prevent patients from experiencing adverse effects from certain materials used in medical devices.
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Congress Members Call on Authorities to Add Medical Device UDI Info to Medicare Claims
“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.
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Why Courts Should Bring Back Evidence of FDA Clearance in Medical Device Trials
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.
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FDA Issues Draft Guidances for Medical Device Studies after FDA Approval, Clearance
The U.S. FDA has issued guidance documents to help increase transparency and assist reporting and timely completion of studies on certain medical devices’ safety and effectiveness.
