Medical device software safety questions | Bart Durham Injury Law

Medical device software safety questions

Medical device software is an important part of the medical industry. The software is required so various devices can operate effectively. If the software fails at any point it can lead to various issues with the patient. Today, we will discuss safety surrounding medical devices when it comes to the technology being used on a regular basis.

One of the most dramatic and tragic cases of software causing an issue with medical device technology occurred in the 1980s. This is when the software malfunctioned in a Therac-25 radiation machine. The malfunction caused the machine to issue radiation levels much higher than what was prescribed for the patients and ultimately led to their deaths.

Software in medical devices has led to other major issues, most notably in the Infusion Pump. A report from 2010 documented that there was an uptick in the severity and number of Infusion Pump recalls, according to the Food and Drug Admistration (FDA). From Jan. 1, 2005 to Dec 31, 2009, there were 56,000 reports for faulty infusion pumps made to the FDA.

Another safety issue when it comes to medical devices is the ability to access external equipment. Having remote access raises a lot of safety concerns, specifically ensuring that the device and the software are protected from various threats and keeping the information confidential along the way.

Defective medical devices that use software rely on the technology to work properly in order to prevent injuries to patients. When patients are injured due to failures in software, they could wind up requiring additional surgery to fix an original issue that has worsened.

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