From Recalls to Reliability: Tools to Ensure Software Safety in MedTech

This article originally appeared in Medcity News on June 14, 2024.

In 2023, the FDA identified 62 medical device recalls with 42 identified to date in 2024. Most recently, Tandem Diabetes Care recalled its Apple iOS app after over 200 reported injuries. While the issues behind the 2024 recalls are diverse, software problems are an important theme. Software, while transformative for healthcare and other safety-critical sectors, poses significant risks when it fails — as in the high-profile cases of the Boeing 737 Max 8 and Tesla. For medical device manufacturers, detecting and addressing software issues is vital to ensure patient safety — especially as devices increasingly depend on software and AI for diagnostics and treatments.

Let’s take Smiths Medical as a recent example of why software issues are so difficult to troubleshoot. Smiths recently recalled approximately 86,000 syringe pumps, specifically the Medfusion 3500 and 4000 models. These two models have been recalled every other year since 2020 due to software problems. A critical FDA warning letter sent to Smiths in late 2021 highlighted systemic issues with their existing design validation procedures and practices.

Validation is paramount in ensuring trust in safety-critical devices. It confirms a device’s design follows the approved design plan for medical devices in the US, and conforms to FDA Quality System Regulations (QSR: 21 CFR part 820). Smith’s failure to provide sufficient evidence that each device fully complied with this section highlights a significant quality issue and perhaps a broader industry problem. Understanding the difficulty of meeting these rigorous standards is key to preventing quality problems in the future.