The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA) has scheduled a two-day public workshop this fall to tackle complex questions related to the third-party servic
The Association for the Advancement of Medical Instrumentation (AAMI) will offer a two-part webinar to explain the process for introducing a novel sterilization process to a healthcare product and identify the regulatory hurdles that must
Friends and colleagues are mourning the sudden death of Vicki Hitchins, PhD, a research microbiologist in the Center for Devices and Radiological Health at the Food and Drug Administration (FDA).
Earlier this month, medical device sterilization pioneer James Whitby, MD, died at his home in London, Ontario, Canada surrounded by family. He was 92.
Many members of the healthcare technology community say they expect the Food and Drug Administration (FDA) to take some kind of regulatory action regarding the third-party repair and refurbishment of medical devices, but they don’t know w
In the future, medical devices will need to gather and process a deluge of data and present what’s most important for healthcare professionals to address—without overloading or misdirecting them.
An impressive lineup of healthcare technology experts and innovators, along with patient safety champions, standards volunteers, young professionals, and students is set to receive an Association for the Advancement of Medical Instrumenta
AAMI Offers Guidance for Submitting Comments on Third-Party Repair, Refurbishment of Medical Devices
Earlier this month, the Food and Drug Administration (FDA) announced it was gathering information from original equipment manufacturers (OEMs), third-party companies, and the healthcare community about the service, repair, refurbishment,
“On April 17, 2003, I died.” That year, Matt Whitman, a Michigan state trooper, now retired, was hit by a drunk driver and had to undergo neck surgery. The operation went smoothly, but in the recovery room, a new danger emerged.
Sterile processing professionals have cited an urgent need for better training to ensure medical devices and instruments are properly cleaned and patients are protected.