Assessment of patterns and predictors of medical device-related adverse events among oncology patients: a cross-sectional study at a tertiary care hospital.

Abstract

Background: This study aims to identify patterns and predictors of medical device-related adverse events (MDAEs) among radiotherapy patients. Understanding MDAEs is crucial for optimizing patient safety during radiotherapy.

Methodology: An observational study conducted from August to December 2023 involved 139 patients undergoing radiotherapy. Demographics, clinical characteristics, and AE reports were collected from patient datasheets and analyzed using SPSS Version 28.

Results: Study findings revealed that patients with head and neck cancer were significantly associated with higher rates of skin (OR: 3.56, CI: 1.59-7.96) and mucous membrane reactions. Specific dose ranges, particularly 800-2800 cGy, also predict mucous membrane reactions (OR: 11.12, CI: 3.42-36.1). Furthermore, smokeless habits significantly influenced both skin (OR: 6.04, CI: 1.99-18.3) and mucous membrane reactions (OR: 8.77, CI: 2.57-29.9). In contrast, head and neck cancer patients had reduced likelihoods of pharynx reactions (OR: 0.37, CI: 0.13-1.00), particularly with doses between 2801 and 4800 cGy (OR: 0.45, CI: 0.96-21.6).

Conclusion: This study identified a few significant predictors for the occurrence of various types of MDAEs among patients undergoing radiotherapy. Reporting MDAEs can prevent adverse effects caused by medical devices and enhance radiotherapy safety.