Napoli Bern Ripka, LLP Blog

Faulty Software in Medical Devices

A flaw in a computer code caused a drug pump to administer heavy overdoses - led to a recall, warnings and rewriting of the equipment's software. The discovery also illustrated a new threat behind some lifesaving medical devices. This was found after a routine piece of medical equipment started mysteriously killing hospital patients a few years ago. Microprocessors run everything from patient monitors to artificial pancreases, and potential software flaws are a growing concern. A product might not malfunction because it was poorly designed or badly made - the traditional suspects - but because the computer code running it includes a mistake. 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.

When there are flaws in a medical device’s design and/or manufacturing, it can cause injury and even death. A patient looks to these medical devices for help, but in some cases the devices end up hurting rather than helping. The FDA is responsible for the approval and oversight of these devices, and when flaws arise, major problems arise as well. When a patient with a heart murmur is relying on their pacemaker to keep them alive, the workings of the device is crucial to the life of the patient. What would happen if a pacemaker stopped working and left the patient without the support that they needed? In a situation like this, it is important to have a lawyer that has the experience in dealing with large insurance companies, corporations, and the government.

Of 23 recalls last year that the FDA classified as life-threatening, three involved faulty software. Manufacturers test and inspect the software on their products, such as dialysis systems and patient monitors, before putting devices on the market. But they've been slow to follow the FDA in adopting new forensic technology because it is costly and still evolving, industry officials say. As a result, FDA software specialists are amassing evidence to show companies the value of the new testing. Meanwhile, traditional software checks, while good at detecting some flaws, are not thorough enough to find every mistake, according to computer scientists.

The FDA created the forensic software unit in 2004 which employs about 10 mathematicians, computer scientists and a physicist who once designed military satellites About two years ago, Fitzgerald recalled, the forensic software team was assigned to investigate a dialysis machine, in use for two decades, that suddenly began malfunctioning on patients with terminal illnesses. The team investigated but could not find a problem with the software. Six months passed before the manufacturer finally found a defect that only mattered when the machine worked nonstop, as it did on the terminally ill. "We declared the software innocent," Fitzgerald said.

Product liability and medial device malfunction go hand in hand. Therefore it pays to have a lawyer experienced in both arenas. At Napoli Bern Ripka, there is over 60 years of combined experience in dealing with cases regarding faulty medical devices. They have experience in dealing with large corporations and insurance companies that seem to intimidate others.