Doctors say defective heart device exposes failure of safety monitoring.

Doctors say defective heart device exposes failure of safety monitoring.
Bloomberg News (2/15, Cortez) reports, "St. Jude Medical Inc. (STJ)'s Riata, a cable used in heart defibrillators, is the latest example of a defective medical device that wasn't spotted quickly enough because US surveillance systems are lacking," according to an article published in the New England Journal of Medicine. "St. Jude and US regulators aren't conducting studies needed to guide treatment for patients with Riata leads, though technology is available to do so, the researcher said." Robert Hauser, a Minneapolis Heart Institute cardiologist who wrote the article said, "Patients in the United States continue to be exposed to underperforming and potentially hazardous medical devices after they have been approved by the Food and Drug Administration, despite multiple recalls and some tragic adverse events."