Surveillance for Medical Devices - USA

Surveillance for Medical Devices - USA

INTRODUCTION

The world of medical devices encompasses a wide variety of products from single use disposable to short- or long-term implantable to multiple use durable capital equipment, from products that are used to monitor to those used to diagnose or treat, and from products that deliver their effect through electronic means to those who do so via mechanical or chemical means. In addition, all these products involve both the user and the patient (at times the same) and are used in a variety of settings (e.g. from hospital to home care).

The Center for Devices and Radiological Health (CDRH) is that part of the US Food and Drug Administration (FDA) that helps ensure that the world of medical devices (see addendum for definition) intended for human use is safe and effective and helps reduce unnecessary exposure to radiation from medical, occupational, and consumer products. The industry that CDRH regulates has a US market valued at more than $75 billion as of 2002 and consists of approximately 8000 medical device firms, more than 80% of whom have fewer than 50 employees (Gallivan, 1997; US Department of Commerce, 2004).

The agency’s mandate is carried out through both premarket product evaluation and postmarket over-sight that continues over the lifetime of the prod-uct, from early design to widespread use, and, ultimately, to obsolescence. At major junctures of a product’s life cycle, the FDA must weigh the product’s benefits and risks. Central to this risk management function is the FDA’s decision for marketing, one that must ensure that beneficial medical products are available (and labeled with adequate information on their benefits and risks) while protecting the public from unsafe products or false claims (Food and Drug Administration, 1999). Once marketed, a product’s continued safety and effectiveness must be ensured not only by over-sight on the part of industry and the FDA, but most importantly by healthcare providers’ and patients’ appropriate product selection and use based on the product’s labeling.