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 […]
I have long been concerned (some might say obsessed) with the distinction between a medical device being “approved” and one being “cleared.” In simple terms, only a Class III device that has successfully traversed the […]
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 […]
While on vacation on the island of Kauai, Hawaii, I decided to hike the Na Pali Coast trail, one of the most stunning, soul-nourishing, and sometimes treacherous coastlines in the world. I completed an eight-mile […]
Sometimes the dividing line between regulation and flexibility can be unclear. Somewhere in the middle of the life cycle for new innovations, there exists a period of time when innovation slows and a crystallization of […]
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 […]
Steve Grimes’ recent paper “Two Steps Forward, One Step Back—How the Industry Must Take in Stride New CMS and TJC Requirements” (BI&T, November/December 2014), provides an excellent but still disturbing summary of the July 2014 […]
There was an interesting thread recently on the listserv for the National Patient Safety Foundation on whether medication barcode readers should beep (or make some other noise) when read. Such systems are typically part of […]
From time to time, I have evaluated situations in which a manufacturer has revised instructions for use and/or on-device warning labels for a product, and thereby provided this new information for new purchasers. In some […]
I am a healthcare consumer and caregiver. Last October, I was lucky enough to speak at the AAMI/FDA Healthcare Technology in Nonclinical Settings Summit. My panel focused on instructions for use (IFUs). My message, based […]
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