In an article on Mass Device’s newsletter of March 6, 2012, Dr. Robert Hauser is quoted as saying, "Patients in the U.S. continue to be exposed to under-performing and potentially hazardous medical devices after they have been approved by the FDA."[1] Hauser is one of the physicians at the Minneapolis Heart Institute who drew attention to problems with the Guidant pacemakers when a patient he was treating died. Guidant recalled 132,000 of its pacemakers in 2005-6 that had a problem with the pacemaker’s hermetic seal which could fail disrupting the power supply, so that the patient’s heart would not be stimulated to beat.
Hauser indicated that the problems with St. Jude Medical's Riata defibrillator leads, now recalled, might have been caught sooner if it hadn’t been for sluggish policies and practices of the FDA. In an article for The New England Journal of Medicine, Hauser noted that problems with the leads, which are implanted in approximately 79,000 patients in the U.S., were not discovered for a protracted period of time, due to "lax post-market surveillance." Hauser also noted that St. Jude couldn’t detect the defects in the defibrillator leads "until they had already affected thousands of patients."
The FDA recalled the Riata leads in December 2011 although St. Jude had stopped selling the leads in 2009 due to having received increasing reports of patients experiencing insulation abrasion (when the coating on the lead wire fails to cover the lead). St. Jude’s chief medical officer, Mark Carlson, said, "St. Jude’s has a strong history of product safety and reliability," and noted St. Jude will continue to be committed to developing technology and products that save and improve the lives of their patients.
When a patient is meeting with his or her physician prior to surgery, or in the operating room and about to receive a pacemaker or defibrillator, should he or she be asking their doctor before they are anesthetized, "By the way, has this device been thoroughly checked for safety?" Certainly, every patient doesn't have that opportunity –and one would like to believe that whatever device is being installed or implanted actually has been thoroughly tested and in fact works.
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