Materiovigilance in Intensive Care Unit: Assessing Medical Device Adverse Events in Geriatric Patients
Author(s)
Deeksha S, PharmD1, JEESA GEORGE, M Pharm2, Dr. Adusumilli Pramod Kumar, .3, Nandana A, .3, Hemappriya M, .3.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India, 3Department of Pharmacy Practice, Faculty of Pharmacy, Ramaiah University of Applied Sciences, Bangalore, India.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India, 3Department of Pharmacy Practice, Faculty of Pharmacy, Ramaiah University of Applied Sciences, Bangalore, India.
OBJECTIVES: Medical devices are integral to patient care in Intensive Care Units (ICUs), especially among geriatric patients who are more vulnerable due to age-related physiological decline and comorbidities. This study aimed to assess the pattern of adverse events related to medical device use in geriatric ICU patients and evaluate the causality between devices and reported adverse outcomes.
METHODS: A prospective cross-sectional study was conducted over seven months (November 2024-May 2025) in a tertiary care hospital ICU. A total of 100 patients aged 65 years and above using at least one medical device were included. Adverse events were identified from clinical records, nursing notes, and patient interviews. Causality was assessed using the EU MDCG framework. Descriptive statistics and chi-square tests were applied to analyze trends and associations.
RESULTS: A total of 122 medical device-associated adverse events (MDAEs) were identified. The most common device involved was the intravenous cannula (20G), accounting for 37.7% of cases. Frequent adverse events included swelling (30.32%), hematoma (11.47%), leakage (7.37%), and bluish discoloration (6.55%). Most MDAEs were linked to invasive (88.5%), sterile (91.8%), and single-use (91.8%) devices. Causality assessment classified 53.27% of events as probable and 42.62% as related. Statistically significant associations were observed with age (p=0.03), number of devices used (p=0.01), comorbidities (p=0.04), and patient education level (p=0.02).
CONCLUSIONS: Geriatric ICU patients face a high incidence of MDAEs, particularly from commonly used invasive devices. Implementation of tailored materiovigilance strategies, periodic monitoring, and enhanced staff training are essential to mitigate risks and ensure safer device use in this vulnerable population.
METHODS: A prospective cross-sectional study was conducted over seven months (November 2024-May 2025) in a tertiary care hospital ICU. A total of 100 patients aged 65 years and above using at least one medical device were included. Adverse events were identified from clinical records, nursing notes, and patient interviews. Causality was assessed using the EU MDCG framework. Descriptive statistics and chi-square tests were applied to analyze trends and associations.
RESULTS: A total of 122 medical device-associated adverse events (MDAEs) were identified. The most common device involved was the intravenous cannula (20G), accounting for 37.7% of cases. Frequent adverse events included swelling (30.32%), hematoma (11.47%), leakage (7.37%), and bluish discoloration (6.55%). Most MDAEs were linked to invasive (88.5%), sterile (91.8%), and single-use (91.8%) devices. Causality assessment classified 53.27% of events as probable and 42.62% as related. Statistically significant associations were observed with age (p=0.03), number of devices used (p=0.01), comorbidities (p=0.04), and patient education level (p=0.02).
CONCLUSIONS: Geriatric ICU patients face a high incidence of MDAEs, particularly from commonly used invasive devices. Implementation of tailored materiovigilance strategies, periodic monitoring, and enhanced staff training are essential to mitigate risks and ensure safer device use in this vulnerable population.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD121
Topic
Health Service Delivery & Process of Care, Patient-Centered Research, Real World Data & Information Systems
Disease
Geriatrics, Injury & Trauma, No Additional Disease & Conditions/Specialized Treatment Areas, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory), Sensory System Disorders (Ear, Eye, Dental, Skin)