Long-term medical device accountability: an information technology solution

Abstract

The Vigilance^TM ID System represents a new medical device accountability paradigm – one that recognizes the challenges that confront regulators, manufacturers, physicians and patients.

The proposed transponder-based system casts aside the current sophistic assumptions that invoke static patient populations and notions of reliable and accessible device records held provincially. Instead, the syllogisms invoked by the Vigilance^TM ID System are based on assumptions that people are mobile, surgeons retire or die, records are often inaccessible or misplaced or illegible.

If the vision of harmonized global medical device accountability is to be realized, a proper paradigm such as the proposed Vigilance^TM ID System or one like it, along with goodwill and cooperation, will be required.