It is well known that few things in life are risk free and that we therefore take on risk whenever we seek the benefits of healthcare. This leads to the straightforward notion that we should […]
Recalls typically are based on a conclusion reached by the manufacturer that there is a problem with a device that can lead to, for a Class I recall, serious adverse health consequences or death. For […]
The decision this past summer by the Federal Communications Commission (FCC) to allow TV White Space (TVWS) devices to share Channel 37 with Wireless Medical Telemetry Service (WMTS) systems changes the spectrum environment in an […]
Last week, I listened to an impressive lineup of panelists and attendees at the seventh AAMI-FDA Summit, this one tackling the subject of risk management. The inspiration for this update is a recurring theme in […]
On Aug. 6, 2015, the Federal Communications Commission (FCC) approved the use of TV White Space (TVWS) devices in the 600 MHz band. As part of the order, TVWS devices are allowed to share Channel […]
I’m fascinated by the wide variety in how people in healthcare technology define, view, manage, and tolerate risk. I have added to my reading list on this topic a recent article by Malcolm Gladwell on […]
On one hand, a quality management system or QMS sounds like a sterile, standards-based construct: a checklist of things that need to be done. Where’s the value added with all of the procedures and paperwork? […]
A reasonable expectation in the adoption of new medical technology is that the direct users will require training and experience in achieving a reasonable level of comfort and efficacy. A corollary of this expectation is […]
AAMI President Mary Logan’s March quarterly update to the AAMI community describes precisely the essence—and challenge—of safety management: Risk, not outcomes, is what determines safety. A shared challenge among medical device companies, as well as […]
