Unique Device Identifiers—Missing in Action

Abstract

Faulty and unsafe medical devices can cause substantial harm to patients, who may experience the consequences of missed diagnoses, unsuccessful procedures, or ineffective treatment. However, the US Food and Drug Administration (FDA) authorizes most medical devices based on nonclinical testing and/or limited clinical evidence. 1,2 A robust postmarket surveillance system is thus essential to gather critical data on safety and effectiveness. However, FDA surveil-

Otolaryngologists and the MAUDE Database: Hammers Looking for a Nail

“…2 Furthermore, the FDA has a very limited ability to track device utilization because relatively few products are monitored through registries or associated with unique current procedural terminology codes. 5 The long-awaited inclusion of unique device identifiers in claims forms would enable the FDA and investigators to overcome these barriers by conducting active postmarket surveillance using routinely collected electronic health data. 5 Until this vision is realized, we must carefully consider how best to leverage the legacy MAUDE system.…”

“…5 The long-awaited inclusion of unique device identifiers in claims forms would enable the FDA and investigators to overcome these barriers by conducting active postmarket surveillance using routinely collected electronic health data. 5 Until this vision is realized, we must carefully consider how best to leverage the legacy MAUDE system. The authors note that "the public availability of the MAUDE database […] lends itself well to research by interested investigators."…”