Medical device software criticized as under-regulated, Los Angeles Times, September 1, 2011

The Los Angeles Times reports today’s medical devices are governed by “software” that is the electronic component that governs everything from pacemakers to digital thermometers. This software is approved under the FDA’s 510(k) clearance process without clinical trials. An Institute of Medicine report recently criticized the process that brings untested medical devices to the marketplace and recommends the 510(k) process is “fatally flawed” and needs to be replaced.

“The IOM finds the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness through the device life cycle. The IOM outlines its criteria for this framework in this report.”

Between 1983 and 1997, one in four medical devices used software.

The story in the Times outlines what happened to one patient in July 2007 when his volumetric infusion pump failed. It can take as little as one error in code that makes a difference in whether a device shuts off or functions properly. His was one of 700 deaths that year linked to infusion pumps and led to the recall of about 200,000 pumps from one manufacturer.

The FDA will have a Public Meeting – Recommendations Proposed in Institute of Medicine Report – on September 16, 2011 in Silver Spring, Maryland. The FDA notice is here.