Mark Heston: If You See it—Buy It
“If you see it—buy it!” Have you heard this phrase before? In my mind, it has nothing to do with Amazon or eBay. I worked with a peer who used this phrase a lot. After […]
William Hyman: A Lesson in Instructions
Instructions that come with a medical device are intended to provide “adequate directions for use” such that the device can be used safely and effectively. To meet that goal, instruction documents must have two key […]
David Braeutigam: Cybersecurity Is the New Electrical Safety Concern for HTM
In the March 1971 issue of Good Housekeeping, Ralph Nader wrote an article about the risk of electrical shock caused by medical equipment in hospitals. Our industry responded by testing medical equipment for leakage current […]
Matt Dummert: Thoughts on the FDA Servicing and Remanufacturing Workshop
I had the opportunity to attend this week’s FDA public workshop, which focused on the distinction between medical device servicing and remanufacturing activities. I do not intend to cover all the specifics of the workshop […]
Zach Collins: Stop Wasting so Much Time on Risk Analysis
Why are you wasting so much time figuring out how to get new medical equipment safely on the network? It really doesn’t make sense to reinvent the wheel over and over when you could be working […]
William Hyman: When Are the Risks Worth the Benefits?
We like to pretend we know how to measure risks and benefits and then compare them. While risk is perhaps a little more developed in terms of the now-classic combination of severity and frequency (likelihood), […]
Anand Oswal: Weaving Wireless Technology into a Location Fabric
Patient experience is a primary focus of healthcare organizations. When new patients arrive, the typical hospital campus environment is terra incognita to them: Where do I register? How do I get to the lab? Where […]
