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Code rot, also known as software rot, is when software deteriorates over time due to a variety of internal factors. Code rot implies that a device’s software is no longer stable or reliable. This instability poses a threat to individuals who use medical devices that rely on software to perform accurately. Unfortunately, code rot can occur because of an organization’s lack of attention to internal operational problems. This lack of attention from a company’s IT department is likely due to external pressures, including the threat of a data breach. IT departments work closely to prevent the risk of a data breach; however, this leads to a lack of urgency about internal issues involving the software itself. Due to a lack of FDA regulations, these internal issues tend to go unnoticed until it is too late.
Medical devices often rely on important software; therefore, code rot can threaten patient safety. New regulations for progression in medical technology are made by the USDA, the American Hospital Association, and the U.S. Department of Commerce’s National Telecom & Information Administration, however, technical debt continues to hinder universal success.
Technical debt is a concept in the development and reconfiguration of software where a short fix is made in place of a more stable fix. The hope is that the stable fix will be made in the future. Similar to economic debt, interest is created, and extra work is needed to compensate for the original internal operational issues. With small corrections being made to an aging software, no real operation update is being made to prevent code rot.
In order to prevent code rot, multiple parties need to be involved. Some of these parties include the government, IT departments, and engineers. These parties should work closely together to solve operational issues. Much like the urgency of solving external issues, like cybersecurity, these parties should spend an equal amount of time on internal issues. This ensures that the product itself is good and prevents any technical mishaps.
Similarly, it is important that these parties continuously monitor the existing software to prevent code rot. Consistent monitoring may allow an expert to catch a bug in the code or identify a software upgrading opportunity. The organization’s self-monitoring should be combined with government regulation. This ensures that regardless of an organization’s morals, the code is being checked on a regular basis.
If you or a loved one suffered from a defective medical device due to code rot, contact a Philadelphia defective medical device lawyer at Brookman, Rosenberg, Brown & Sandler. Our lawyers can help clients recover monetary and non-monetary losses that resulted from code rot. Contact us online or call us at 215-569-4000 for a free consultation. Located in Philadelphia, we proudly serve clients throughout Pennsylvania and New Jersey, including Delaware County, Chester County, and Philadelphia County.