Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices

• Published in: The New England journal of medicine Vol. 358; no. 10; pp. 985 - 987
• Main Author: Maisel, William H
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 06.03.2008
• Subjects: Consumer Product Safety - legislation & jurisprudence; Defibrillators, Implantable - standards; Device Approval - legislation & jurisprudence; FDA approval; Humans; Manufacturing; Medical equipment; Patient Rights; Product Surveillance, Postmarketing; Prostheses and Implants - standards; Prosthesis Failure; United States; United States Food and Drug Administration; United States

In October, after 38 months on the U.S. market and 268,000 implantations worldwide, the Medtronic Sprint Fidelis was voluntarily recalled because of its propensity to fracture. Dr. William Maisel writes that the controversy highlights the shortcomings of the regulatory system for medical devices and...