AAMI News October 2019, Volume 54, Issue 10
Medical devices are designed for when they perform as intended. They should have the same thoughtfulness in design for when they fail.
The AAMI Foundation is in the midst of launching several exciting initiatives.
The FDA has issued final guidance describing the rigorous methods it uses when considering uncertainty during benefit-risk determinations related to premarket decisions for medical devices.
AAMI and the International Organization for Standardization (ISO) have published two sterilization standards that focus on the packaging of sterilized medical devices:
- News in Brief
- The Value of Quality Management Systems in Sterilization
- Using Technology to Collaborate and Advance Patient Care
- AAMI Board Member Takes the Helm of UConn Clinical Engineering Program
- AAMI Revitalizes Mentorship Program
- AAMI to Offer CBET Study Course
- AAMI Publications Win Honors
- New TIR Helps Industry Meet Global Quality Management Expectations
- Tech World: Wet Packs! How Did We Get These Stinking Wet Packs?
- Big Picture: Georgia Biomedical Instrumentation Society
- Asked & Answered: Sterilization and Metal-on-Metal Contact
- Career Center: Adding Customer Service to your HTM Toolbox
- One on One with Horlando Cintron
- AAMI All Star: Jia Yao
- Members on the Move
- Standards Spotlight: A Fresh Start for Medical Device Interoperability
- Advertisers in this Issue