AAMI News

AAMI News: September 2014, Vol. 49, No. 9

 

FDA Guides Manufacturers on Home Use Devices

Medical device manufacturers should consider a host of factors—such as the physical environment and the user interface—as early as possible in the design of new products intended for home use, according to a new guidance document from the U.S. Food and Drug Administration (FDA). Read more...

Ventilator Technology to Take Center Stage

Improving the efficiency of alarms and understanding the importance of usability testing are two of the topics scheduled for this month’s AAMI/FDA Summit on Ventilator Technology, bringing together a multidisciplinary audience to work through important safety issues related to this type of medical equipment. Read more...

Ventilator Summit

Free Report Offers Tips for Smoother Device Approvals

Are you a medical device manufacturer trying to interpret standards and understand regulatory expectations to get your product to market as quickly as possible? AAMI is offering a free resource stemming from a forum that can help you navigate the regulatory waters to develop safe, effective medical devices. Read more...

Experts to Tackle OR Humidity Question

To work through this complicated issue, AAMI will convene a meeting next month to discuss how healthcare delivery organization (HDOs) can lower their humidity levels in the OR, without creating new problems for themselves. Read more...

OR Humidity


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