2562 - Radiation Therapy Post-Market Surveillance: Assessing Patient and Device Complications

Purpose/Objective(s):

Although charged-particle radiation therapy system treatments have existed for decades, device complications continue to cause adverse effects for patients. Furthermore, there is limited research on the type of malfunctions occurring. In this abstract, we aim to characterize the type of device problems and patient complications that have occurred to better understand complications stemming from radiation therapy delivery. We expect that radiation therapy device complications will cause inaccurate radiation doses to patients and expect there to be more mechanical complications than software complications with these devices.

Materials/Methods:

Using the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, we used statistical software (Python) to analyze all the data listed since 2016 coming from mandatory and voluntary reporters. We also assessed the Total Product Life Cycle report for medical charged-particle radiation therapy systems.

Results:

From the MAUDE database, we showed that there were 44 injuries, 214 malfunctions, and 5 deaths since 2016. Common radiation exposure patient adverse effects were 11 radiation overdose, 3 unintended radiation exposure, and 2 radiation exposure unintended, and 2 radiation underdose events. The most common device complication events were 170 computer software problems, 28 use of device problems, 14 improper procedures, and 12 dose calculation errors, as shown in Table 1.

Conclusion:

We show that, in the last 10 years, many patients suffered from injuries, malfunctions, and deaths due to charged-particle radiation therapy device complications with many receiving an inappropriate amount of radiation exposure. We also show that computer software problems are the most commonly reported device complications and were more commonly reported than mechanical device complications. The continued presence of these health consequences and device complications necessitates refinement, especially regarding software improvements of radiation therapy system treatments.

Table 1

Table 1 shows the most common device complications, and the number of events in each category.