Methods for Universal Authentication of Medical Devices

Christian Schmidt,Joachim Storsberg,Callie Blase,Ilham Alshiraihi,Mark A. Brown

doi:10.3844/ajisp.2019.1.4

Abstract

The need for effective means of authentication of medical devices has increased with the growing number of falsified in vitro diagnostics and devices being introduced across world markets. Such substandard products result in negative consequences ranging from harm to patients and/or failure to impart the desired clinical outcomes to a loss of public trust in healthcare providers and regulatory agencies. Herein, we discuss the growing specter of medical device falsification, related cybersecurity threats and selected novel approaches suggested for authentication.

Highlights

Counterfeit medical products can be traced as far back as the 1600’s with the documented emergence of a black market for fraudulent variations of cinchona bark, which was highly desired for its anti-malarial properties (Glass, 2013) with an even greater threat to health and international markets again in the 1800’s with the emergence of adulterated or inferior forms of purified quinine (Glass, 2013)
Counterfeit products span the breadth of medical devices from those with dental applications to surgical products
There has been a recent spike in truly lifethreatening issues and consequent deaths associated with an alarming increase in the number of inauthentic devices for implantation such as plates, screws and spinal implants

Summary

Introduction

A medical device is defined as "...an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes" (Federal Food, Drug and Cosmetic Act; Allport-Settle, 2010). The corresponding and harmonized regulatory framework for medical devices in Europe is known as the Medical Device Directive (MDD). Such regulatory frameworks throughout the world have, along with the World Health Organization (WHO), identified noteworthy safety issues resulting from an apparently ever-growing number of falsified medical devices, available across a range of world markets. More and more reports seem to indicate a considerable percentage of forged medical devices in low-income countries, with developed countries confronted with this issue (World Health Organization, 2018). Despite its rigorous regulatory standards, approximately 5% of the US medical device market is comprised of fraudulent products (Glass, 2013; Nighswonger, 2003; World Health Organization, 2018; Fig. 1 and 2).

Annual FDA Device Inspections

Findings

Discussion