Medtronic to Ramp-Up Device Inspections (Biloine Young @ OTW)
Medtronic, Inc., the world’s largest stand-alone medical device maker, is no longer going to rely on irregular reports from doctors or patients to monitor its medical devices. Instead the company will ramp up its own monitoring of devices after they are implanted in an attempt to catch potential safety problems earlier. According to Anna Yiukhananov, writing on Aprl 16 for Reuters, Medtronic CEO Omars Ishrak said it was the responsibility of companies to monitor their own devices for safety problems.
Ishrak indicated that the use of registries or nationwide databases may not be adequate to collect the kind of data he believes necessary to identify safety problems. “We need improvements in device surveillance,” he said. . “The FDA alone does not have the infrastructure… so companies have to play a leading role in this.”
Ishrak indicated that Medtronic plans to invest “heavily” in keeping track of patients’ health after they get a new device, and doing regular follow-up analysis of the data to spot any worrying trends.