The Costs of VigilanceThe Costs of Vigilance

Originally Published MX May/June 2006

EDITOR'S PAGE

For companies in the business of developing cardiac rhythm management (CRM) devices—and for observers who have been watching the sector's troubles over the past year—March and April were eventful months.

First, in the middle of March, industry association AdvaMed released a proposed format for CRM manufacturers to follow when issuing performance reports about their products. Toward the end of April, a Canadian study published in the Journal of the American Medical Association suggested that the surgical risks of replacing an implantable cardioverter-defibrillator (ICD) are greater than those of leaving a possibly flawed device in place. Additionally, an AdvaMed analysis of FDA data revealed that reliability rates for ICDs improved significantly from 2001 to 2005. And finally, the Heart Rhythm Society (HRS) released the draft recommendations of its task force on postmarket surveillance, analysis, and performance reporting for CRM devices.