AAMIBlog

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 recall notice. There are six different entries on the menu that use the word software. These are (in the order […]

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 […]

In April, Rep. Brian Fitzpatrick (R-PA) introduced HR 2163, the Medical Device Guardians Act. This act proposes to add physicians and physician offices to those that must report medical devices misadventures under the FDA’s Medical Device Reporting (MDR) requirements. The legislation excels in brevity and simplicity by amending the term “covered device user facility” in […]

Two standards in development will, if approved, significantly impact the healthcare technology management (HTM) field. If they aren’t already on your organization’s radar, they should be. The first one involves a push by medical device manufacturers to get hospital-based and non–manufacturer-based service organizations to follow some of the quality systems requirements that manufacturers currently follow. […]

The FDA Reauthorization Act of 2017 completed its passage through Congress on Aug. 3, and the bill will become law once signed by President Trump. Although a major focus of this legislation is FDA user fees that are paid by manufacturers, it also addresses a number of other topics, including a favorite of everyone involved […]

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 […]

The latest addition to the long-running battle over adequate access to service manuals for medical devices is The Joint Commission’s (TJC) announcement, via George Mills, at the recent AAMI Annual Conference that starting in January there will be a new element of performance, EC.01.01.01, EP 3, which states: “The organization has a library of information […]

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 […]

The regulation of medical devices by the FDA remains a hot topic for makers of medical devices and HTM professionals, whether they are employed by hospitals, manufacturers, or third-party entities. There are at least seven ways that the regulation of medical devices could fundamentally change. Three of these are legislative in which a bill is […]

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 PMA process has been approved. A Class II device that has reached the market via a 510(k) Premarket Notification has […]