International – Unique Device Identification and Recall Management: Starting with the Patient in Mind

This article provides an overview of FDA’s medical device Unique Device Identification System Final Rule and explains why including UDIs in health information and in device recalls can improve patient safety. The author offers an anecdotal case study of a patient suffering symptoms that could have been connected to her hip replacement had UDI information and its communication been as efficient as Vehicle Identification Numbers (VINs) in identifying automobile owners in recalls. She makes the case for the importance of having UDIs included in a patients’ medical records and requiring manufacturers to include the UDI in product information.

Introduction

Today, millions of patients rely on medical devices for their care, including life-saving implanted devices such as pacemakers and hip and knee replacements. The introduction of UDIs on medical devices means the devices are beginning to be recorded in inventory systems, health records and registries. Applying UDIs to medical device labels and scanning UDIs as part of medical device clinical, financial and regulatory transactions should result in more accurate and automated device identification as the device moves through distribution and patient use and, if necessary, is part of a device recall. To date, UDIs, even when appearing on the device label, are not consistently recorded as part of manufacturer or US Food and Drug Administration (FDA) recall notifications. Without the UDI, those managing recalls must depend upon text-based, non-standard device identifiers, a practice negatively impacting medical device supply chain efficiency, increasing overall healthcare costs and raising safety concerns for patients. The costs to patients and healthcare systems of ambiguous device identification information appearing in recall data have been cited in various business and government reports…