AAMIBlog

I meet with my team every Monday to review issues that occurred over the weekend, repeat service calls for various systems, and any upcoming downtime that we need to notify users about. Our downtime strategy has developed over the last few years from a “let’s at least do it once a year” to a monthly, […]

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 of data from one medical device to another or perhaps from one or more medical devices to a separate processing […]

This past week, we experienced two major natural events that affected a large part of our nation. First, the rapid trajectory of our sun and moon across our continent created, for many, a once-in-a-lifetime opportunity to see a full solar eclipse. But then, the slow and lumbering trajectory of Hurricane Harvey across the Texas Gulf […]

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 being a place where you do not want to live—or so it was for most of my life. Thankfully, it […]

Mornin’, biomed! It’s Bob in IT. I was just on my way to a meeting next door, and I thought I’d drop by to say hello. I wanted to follow-up with you about my request to have you start collecting MAC addresses as part of your staging process. Here’s the thing: MAC addresses are what […]

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 […]