AAMI News, September 2014, Volume 49, Issue 9
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).
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.
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 unique forum held this past spring that can help you navigate the regulatory waters to develop safe, effective medical devices.
A hospital was cited by a surveyor for the Centers for Medicare & Medicaid Services (CMS) for keeping the humidity level lower than that specified in the instructions for use for certain sterile products used in the operating room—even though the humidity level had been deemed acceptable for the OR itself. (AAMI News September 2014)
- Dialysis Standards Collection Undergoes Major Update
- News in Brief
- Focus on Industry
- Certifications for HTM and Quality System Professionals in Development
- Clinical Engineering World Loses 'Real Champion'
- Ask AAMI? Human Factors Training
- Tech World: Student Overcomes Her Shyness to Land Dream Job
- In Profile: Physician Reinvent Thyself!
- Nonprofit Brings BMET Expertise to the Developing World
- Volunteer Spotlight: Alan Lipschultz
- Members on the Move