Federal Standards not met by a High Risk Medical Device

When the FDA discovered major concerns with a life-sustaining heart pump in 2014, it issued a warning letter to the manufacturer, threatening to inform other federal health agencies of the findings. For years, however, no such warning was issued. An FDA representative said the agency instead put the warning letter to an online database among thousands of others, as is Standards procedure.

Despite federal inspectors finding problems with the device linked to patient deaths and injuries, agencies such as the Centers for Medicare & Medicaid Services and the United States Department of Veterans Affairs continued to pay for the HeartWare Ventricular Assist Device, or HVAD, to be implanted in new patients. While the flaws mentioned in the warning letter remained unsolved, taxpayer monies continued to flow to the original device producer, HeartWare, and then to the firm that acquired it in 2016, Medtronic.

Experts say patients are put at danger if critical safety information in FDA warning letters does not make it to other government entities responsible for determining which medical devices to fund. When the FDA issues warning letters, it acknowledges that it does not directly contact other agencies, instead referring to its online database, which is accessible to both government employees and the general public.

Even while the problems remained unsolved and patients were still receiving implants, the HeartWare letter was removed from the public database roughly two years ago. Letters older than five years are removed from the database. CMS, which administers Medicare and Medicaid, refused to explain why it continued to pay for a gadget that failed to fulfil regulatory Standards. It referred queries concerning the HeartWare warning letter to the Food and Drug Administration.