FDA Finds Many Possibly Life-Threatening Medical Equipment Malfunctions Result From Software Problems

Main Category: Medical Devices
Also Included In: IT / Internet / E-mail;  Regulatory Affairs / Drug Approvals;  Public Health
Article Date: 01 Jul 2008 - 7:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

The Baltimore Sun on Monday examined how FDA, with help from experts in the information technology and scientific fields, has found that medical equipment "might not malfunction because it was poorly designed or badly made ... but because the computer code running it includes a mistake."

According to the Sun, the "impact of that glitch can be increasingly serious because the latest automation is removing the doctors and nurses who watched for machine mix-ups" in the past. FDA in 2004 created a forensic software department to address the increased number of medical equipment recalls related to software problems. The department includes 10 mathematicians, computer scientists and a physicist who previously designed military satellites. In 2007, 23 of the medical equipment recalls that FDA considered life-threatening involved software problems.

Larry Kessler -- director of the FDA Office of Science and Engineering Laboratories, which oversees the department -- said, "The world of technology is allowing us to do things we never thought possible, and it's largely a great advance." He added, "Where it gets to be scary is, we used to have more human intervention. With software doing more now, we need to have a lower tolerance for mistakes" (Rockoff, Baltimore Sun, 6/30).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.