Long-term medical device accountability: an information technology solution

Issue title: 2th European Conference on Post Marketing Surveillance for Medical Implants

Article type: Research Article

Authors: Knapp, T.R.^;

Affiliations: LipoMatrix, Inc., Neuchatel, Switzerland

Note: [] President and CEO LipoMatrix, Inc.

Abstract: The VigilanceTM 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 VigilanceTM 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 VigilanceTM ID System or one like it, along with goodwill and cooperation, will be required.

DOI: 10.3233/JRS-1996-8115

Journal: International Journal of Risk and Safety in Medicine, vol. 8, no. 1, pp. 85-91, 1996