The Association of Trial Lawyers of America (ATLA) is urging the Food and Drug Administration (FDA) to adopt stricter standards for tracking medical devices. ATLA submitted constructive changes in response to the FDA's request for comments on its Unique Device Identification (UDI) policies. When a medical device - such as a heartbeat regulator - is recalled by its manufacturer, the patients affected usually are not contacted or advised about the problem by either the manufacturer or the physician. With no meaningful system for tracking medical devices, patients and physicians have no real way of determining who exactly is affected by a recall.
With over 1,000 American patients' lives endangered every year due to equipment recalls, of which they are never informed, basic measures must be taken to improve patient safety. Big pharmaceutical and medical device industries have spent millions of dollars to evade accountability at the expense of patient safety. (ATLA)
