FDA Probes Third-Party Service and Repair of Medical Devices

March 22, 2016

Diving into what can be a contentious debate, the Association for the Advancement of Medical Instrumentation (AAMI) reports that the Food and Drug Administration (FDA) is gathering information from original equipment manufacturers (OEMs),

New TIR Takes Hard Look at Medical Device Sustainability

February 9, 2016

Suppliers, manufacturers, distributors and other healthcare technology professionals all have a responsibility to reduce potential negative impacts on the environment when making decisions involving the development and use of medical devi

Industry, Nurses Address Barriers to Clinical Training on New Technologies

January 25, 2016

Learning how to use new healthcare technology is a complex challenge, and success hinges on high-level support at any organization, according to nurses, vendors, and other experts who attended the AAMI Foundation’s first Industry Council meeting. This diverse group—which included representatives from BD (formerly CareFusion), Connexall, Hospira (a Pfizer company), Masimo, and Medtronic, as well as patient safety advocates and healthcare professionals—met at AAMI’s headquarters in Arlington, Va. recently, to discuss the current state of training, identify challenges, and describe what they would like to see in the future.

FDA Narrows 'Convenience Kit' Definition for UDI Labeling

January 4, 2016

The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA) has released draft guidance that redefines “convenience kit” for industry and agency staff, creating a stricter

New Section Added to Sterile Processing Benchmarking Tool

December 15, 2015

A new section focused on immediate-use steam sterilization (IUSS) has been added to AAMI’s and the International Association of Healthcare Central Service Materiel Management’s (IAHCSMM) sterilization benchmarking tool to help subscribers