AAMIBlog

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 with any questions or difficulties as you tried it for the first time? Now think about the last time you […]

By now, nearly everyone in the HTM community is aware of the substantial and unexpected changes in Joint Commission requirements for on-schedule completion of scheduled maintenance. I won’t go into the details here because recent webinars from AAMI and ECRI Institute, and one forthcoming from ACCE, are spreading the word. The gist is that we […]

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 evaluate risks and benefits, and then compare them in order to make a rational decision about undertaking the activity. While […]

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 Class II and III recalls, the risk is proportionally lower. The recognition of a problem often begins with an increase […]

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 important way. Hospitals and other healthcare organizations have a three-to-five-year planning horizon to prepare for this change. While that may […]

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 the summit that “risk management is everyone’s business.” Starting with the keynote address of Jeff Natterman, the risk manager for […]

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 37 with Wireless Medical Telemetry Service (WMTS) systems that operate there. Hospitals and healthcare organizations that operate WMTS systems on […]

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 auto recalls, “The Engineer’s Lament.” In our world of healthcare technology, Gladwell’s piece helps all of us, engineer or not, […]

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? But the other hand has the true story: a QMS gives enough structure and support to disparate individuals so that, […]

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 that during the initial period, there will be at least a greater challenge in using the equipment and a possible […]