In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health is taking additional steps to advance innovation in medical device sterilization, including recognition of new standards and updates to technical information reports.
Is technology replacing the human element in hospitals and clinics, or enhancing it? In this AAMI Research Review, a pair of newly published studies exemplify how accounting for the humans that use a technology can enhance its effectiveness… and vice versa.
A global pandemic is still upon us, but that certainly does not mean that healthcare technology innovation is standing still. To help the medical device industry look to the future and prepare, experts from regulation and academia alike are bringing attention to the acceleration and pitfalls of innovation.
Increased use of remote and telehealth programs, networked medical devices, and “smart” product storage come with their own inherent risks.
To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.
Make sure your 510(k) submissions pass with flying colors. Explore the latest regulations impacting bacterial endotoxin testing.
This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.
It’s time to embrace new technology and promote standardization to raise best practice protocols.
With the publication of IEC 60601 3rd edition, manufacturers have been scrambling to meet EU and Canadian deadlines and formally incorporate a risk management process in the quality management systems. Device electrical and mechanical safety continues to be a critical path on the road to regulatory approvals and ongoing compliance.