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 […]
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 […]
Two standards in development will, if approved, significantly impact the healthcare technology management (HTM) field. If they aren’t already on your organization’s radar, they should be. The first one involves a push by medical device […]
The FDA Reauthorization Act of 2017 completed its passage through Congress on Aug. 3, and the bill will become law once signed by President Trump. Although a major focus of this legislation is FDA user […]
I want to tell a story. I grew up in Cleveland Ohio, a city that has always held its place in the top two or three cities that everyone likes to poke fun at for […]
The latest addition to the long-running battle over adequate access to service manuals for medical devices is The Joint Commission’s (TJC) announcement, via George Mills, at the recent AAMI Annual Conference that starting in January […]
Think about the last time you saw a demonstration of a new medical device. Were you guided through all the new and innovative features by an expert who was able to step in and assist […]
The regulation of medical devices by the FDA remains a hot topic for makers of medical devices and HTM professionals, whether they are employed by hospitals, manufacturers, or third-party entities. There are at least seven […]
Hey, biomed! It’s me, Bob in IT. I’m from the networking team. I know we haven’t spoken much, but I think we should. You see, we’ve got some problems we need to solve. I have […]
