"They’re saying, if the cables are extruded, you should pretty much just watch the patient," Brigham and Women’s chief cardiologist Laurence Epstein told the Wall Street Journal. "If the cables aren’t extruded, you should [still] pretty much just watch the patient."
Without updated guidance on how to care for patients who do have defective leads, the precaution may represent an increased cost without a payoff for patient health.
"It’s not clinical care, it’s research," Epstein told the Journal.
Last week the FDA ordered St. Jude to launch a 3-year post-market review of the recalled Riata and Riata ST leads, as well as for its QuickFlex LV CRT, QuickSite LV CRT, Riata ST Optim and Durata leads.
That was bad news for St. Jude, which has worked hard to distance its other leads, especially the Durata, from the high-profile Class I recall of the Riata leads in December 2011. The company recalled the devices, citing reports of high rates of "insulation abrasion," which occurs when the leads’ wires wear through their insulation. St. had Jude begun pulling the devices from shelves a year earlier over the same concerns.
The federal watchdog agency further advised that all patients with the recalled Riata leads undergo X-ray or other imaging to look for abnormalities in the wires that may lead to further problems.
"We believe that imaging recommendations at this time help health care providers manage health care of their patients," the FDA told the Journal.
Mayo researchers cut radiation exposure with better aim, more training
Mayo Clinic cardiologists say they can "dramatically" cut patient radiation exposure from X-rays using intensive radiation safety training and targeted modifications to standard X-ray equipment.
Fashion and function in medical devices
Medical device companies and healthcare providers have focused on providing technologies and techniques that are safe and effective, but patients like Jessica Floeh who designs fashionable pouches for insulin pumps, are looking to bring new life to their life-saving devices with clothing and accessories that hold, hide or accent tracheostomies, colostomy pouches and other needs.
France updates Sunshine laws for medical device companies
France’s new Minister of Social Affairs & Health Marison Touraine formed a working group to push progress on the country’s new Sunshine Act, which would require that medical device companies disclose all agreements with healthcare professionals and the value of all "advantages" granted to them.