A recent post on AAMIBlog asked the question, “Will Unique Device Identifiers Live Up to the Hype?” As a self-proclaimed UDI enthusiast, I would argue that, while the UDI program isn’t perfect, it is a […]
The ongoing roll out of unique device identifiers (UDIs) promises several expected benefits derived from medical devices possessing UDI codes. The Food and Drug Administration (FDA) recently published Medical Device Safety Action Plan that describes […]
This year, I had the opportunity to attend a conference and take part in panel discussions with the main topic of “the customer comes first.” A number of the questions posed to the panel centered […]
The FDA’s database for medical device recalls has a search function that includes a pull-down menu for the root cause of the recall. These root causes correspond to the single “FDA Determined Cause” on each […]
As healthcare technology management (HTM) professionals, we understand how challenging it is to manage medical device recalls, perform field safety correction, and advise affected customers. All three of these notifications (i.e., recalls, field safety correction, […]
This year, we’ve seen an even hotter-than-usual debate about the servicing of medical devices and healthcare technology, thanks in part to calls for new standards, a congressional mandate for an FDA report on the subject, […]
Last month, the FDA issued its guidance document Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices and a commentary by Bakul Patel. The essence of the form of interoperability addressed is the transfer […]
