Categories

Tag: Reigel vs. Medtronic

Why the Electronic Medical Record Needs to be Viewed as a Medical Device

In our rush to establish a national electronic medical record (EMR) system as part of the American Recovery and Reinvestment Act of 2009, powerful silos of independent EMR systems have sprung up nationwide.

While most systems are being developed responsibly, like the Wild, Wild West, many have been developed without an objective eye toward quality and the potential  harm they may be causing our patients.

As most readers of this blog are aware, since 2005 the medical device industry in which I work has had widely publicized instances of patient deaths splashed all over the New York Times and other mainstream media outlets from defibrillator malfunctions that resulted in a just a few patient deaths.

The backlash in response to these deaths was significant: device registries were developed, software improvements to devices created, and billions of dollars in legal fees and damages paid to patients and their families on the path to improvement.  In addition, we also learned about the limits of corporate responsibility for these deaths thanks to legal precedent established by the Reigel vs. Medtronic case.

Continue reading…

Registration

Forgotten Password?