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Surveillance and assessment of medical device-associated adverse events in a tertiary care hospital: An observational study
For correspondence: Dr Vithya T., Department of Pharmacy Practise, Al Ameen College of Pharmacy, Bengaluru 560 027, Karnataka, India e-mail: vithijas@gmail.com
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Received: ,
Accepted: ,
How to cite this article: TV, Bollineni S, FT, Ganachari P, Khan MSA, Prasad S. Surveillance and assessment of medical device-associated adverse events in a tertiary care hospital: An observational study. Indian J Med Res. 2026;163:304-8. doi: 10.25259/IJMR_1988_2025
Abstract
Background and objectives
Medical devices are essential in hospitals for diagnosis and treatment but may also cause unintended adverse events. Materiovigilance plays a crucial role in detecting, reporting, and preventing such events to safeguard patients. This study aimed to monitor, assess, and report medical device-associated adverse events (MDAEs) in a tertiary care hospital and to identify the devices most frequently implicated.
Methods
A prospective observational study was conducted at a tertiary care hospital in Bengaluru, India, from May 2023 to January 2024. Daily ward rounds were carried out in collaboration with the biomedical team to identify device-related issues. Confirmed MDAEs were documented using the standard reporting forms of the Materiovigilance Programme of India (MvPI).
Results
Among 1,100 medical devices in use, 31 (2.81%) were associated with adverse events. Most affected patients were females, with an average age of 61 years. Frequently implicated devices included disposable syringes and intravenous (IV) cannulas. The common events included thrombophlebitis, blocked or damaged needles, and elevated serum creatinine following contrast use. Most adverse events involved Class B devices. Causality assessment classified the majority as probable or possible.
Interpretation and conclusions
The overall frequency medical device associated of adverse events associated was low. However, the findings underscore the importance of continuous device surveillance. Strengthening awareness and structured reporting under MvPI can improve early detection, timely intervention, and long-term patient safety in clinical practice.
Keywords
Adverse events
Materiovigilance
Medical device
Patient safety
Risk classification
Medical devices play a key role in disease management, diagnosis, and therapy in modern medicine. Their use in healthcare systems around the world has grown rapidly, ranging from simple tools like catheters and cannulae to complex imaging machines and implants.1 Despite contributing to improved clinical outcomes, medical devices are not entirely free from risk. Medical device adverse events (MDAEs), which may compromise patient safety and strain healthcare resources, can be caused by device malfunction, human error, and material flaws.
The rise in awareness of these hazards has been paralleled by an increase in the global adoption of materiovigilance practices.2 Materiovigilance is the systematic tracking, assessment, and prevention of adverse events associated with medical devices.3 In most countries, especially those with low and middle incomes, materiovigilance is not as developed as pharmacovigilance. Because of a lack of awareness, organised reporting procedures, and regulatory frameworks, adverse events are frequently underreported despite our growing reliance on medical technology.
India has one of the biggest and fastest-growing markets for medical devices. Public health needs to be closely monitored as the rapid growth of both domestically produced and imported devices continues. In July 2015, the Indian Pharmacopoeia Commission coordinated with the Ministry of Health and Family Welfare to launch the materiovigilance programme of India (MvPI) in response to this issue.4 The programme’s goals were to make adverse event reporting easier, enhance device safety monitoring, and encourage manufacturers and healthcare professionals to report incidents.
At the hospital level, materiovigilance practice implementation is uneven. Numerous adverse events pass undetected or unrecorded because of a lack of sensitization among clinical personnel, inadequate integration between biomedical engineering and clinical services, and the absence of feedback processes.5 Further, there is limited empirical data from Indian tertiary care hospitals on the frequency and type of MDAEs.6 The majority of the literature available is descriptive or policy-based, providing very little real-world perspective into device-related patient injury.7 Accordingly, this study was undertaken to fill this gap by actively monitoring and evaluating MDAEs in a tertiary care hospital. The main objectives were to measure the frequency of adverse events attributed to medical devices, determine the kinds of devices most associated with these events, and measure causality according to World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria. Secondary objectives involved classifying events according to severity and risk class and facilitating the communication of safety information to concerned parties to prevent future events.
Methods
This prospective observational study was conducted from May 2023 to January 2024 at the department of Pharmacy Practise, St Philomena’s Hospital, Bengaluru, Karnataka, India. The study was coordinated by both the department of Pharmacy Practice and the Biomedical Engineering Department. The hospital also functions as a recognized MvPI centre. The hospital provides a wide range of diagnostic and therapeutic services and caters to a diverse patient population. As an MvPI centre, the hospital conducts frequent monitoring of all medical devices through its dedicated biomedical engineering department. The biomedical engineer serves as the MvPI centre coordinator, while the clinical pharmacist functions as the deputy coordinator. Ethical clearance was received from the Institutional Ethics Committee before the commencement of the study in accordance with National guidelines, the ICMR Ethical Guidelines for Biomedical and Health Research on Human Participants (2017), and the Declaration of Helsinki (2013 revision). Informed consent was obtained from patients or their legal representatives only in cases where an adverse event was identified after device use in patients.
Study population and surveillance of MDAEs
The study population comprised all inpatients and outpatients during the study period who were exposed to medical devices, with inclusion of all consecutively identified suspected medical device–associated adverse events (MDAEs). Both post-use (patient-experienced) and pre-use (intercepted) events were documented. These events were captured through routine surveillance and reporting activities. For medical device–associated events (MDAEs) that were identified before the device reached the patient (e.g., blocked needles, pre-use device defects, or technical malfunctions), no patient was directly exposed. Hence, the IEC had approved a waiver of consent for such pre-use events, since they did not involve patient participation or risk. These pre-use MDAEs were reported across multiple specialties including Medicine, Surgery, Orthopaedics, and Critical Care wards/OPDs, depending on where the devices were intended for use. As these events occurred prior to patient application, the clinical condition of the patient had no bearing on their occurrence. Patients (or their legal representatives) were informed about the nature of the event, its suspected association with the medical device, and its mandatory reporting to the MvPI centre whenever consent was required, before documentation. All adverse events involving medical devices as defined under the MvPI were included. Device malfunctions already known to be defective or under recall were excluded. Daily ward rounds were conducted by the research students alongside the biomedical engineer. These included visits to inpatient wards, scanning centres, labs, and operating theatres. Suspected device-related reactions were evaluated by biomedical staff and, if confirmed, documented using the standard MvPI reporting form.8
As this was an event-based observational study, no prior sample size calculation was performed; instead, all eligible cases of suspected medical device adverse events occurring during the study period were included. Additional verification involved reviewing patient case records, consulting healthcare personnel, and checking device details such as batch number, serial number, and calibration status.
Documentation and assessment of medical device adverse events
All confirmed events were documented using the medical device adverse event (MDAE) reporting form issued by the Indian Pharmacopoeia Commission under MvPI.9 The form captured patient details, device name and specifications, description of the adverse event, clinical outcomes, any harm caused, reporter information, and severity and causality assessments. Patient confidentiality was maintained throughout. Each reported MDAE was categorised by device risk class (A–D) as per MvPI guidelines,10 and asserious or non-serious according to WHO definitions (e.g., life-threatening, requiring hospitalisation, or resulting in disability). For the purpose of this study, ‘harm’ was defined as any adverse clinical outcome experienced by the patient, directly or indirectly attributable to the device malfunction or failure. Events that did not reach the patient, but disrupted workflow were categorized as ‘no patient harm.’ Causality was assessed using the WHO-UMC system (certain, probable, possible, unlikely, assessable) by the hospital’s MvPI coordinators in consultation with the biomedical engineering department and clinical experts. To ensure validity, inaccuracies in blood pressure and SpO₂ measurements were confirmed by cross-validation with reference standards (mercury sphygmomanometer for BP and repeat testing with alternate devices for SpO₂), along with evaluation by the hospital’s biomedical engineering team. Device integrity failures and injection malfunctions were verified through direct inspection and service log documentation. Event assessment involved MvPI coordinators, biomedical engineers, and trained clinical staff, all of whom had undergone formal MvPI training on adverse event reporting, causality interpretation, and device risk classification, ensuring consistency in evaluation. Devices were also grouped by category (diagnostic, therapeutic, assistive, reagent, or combined use).11
Statistical analysis
Data were compiled using Microsoft Excel (2019). Descriptive statistics (frequencies and percentages) were used for categorical variables. The chi-square test was applied to assess associations between device class, category, and event severity. A P value less than 0.05 was considered statistically significant.
Follow up action
Findings from confirmed MDAEs were shared with the hospital’s Medical Director and Biomedical Engineering team. Where appropriate, clinical departments were debriefed, and preventive steps were discussed. Devices linked to serious or repeated events were flagged for maintenance, manufacturer follow up, or recall. Anonymized reports were submitted to the National Coordination Centre (NCC-MvPI) for inclusion in the National database.
Results
Over the 9-month study period, 31 MDAEs were identified from ∼1,100 medical devices in active use, yielding an overall device-associated adverse event rate of 2.8% Of these, 14 events (45.2%) reached patients, and 17 events (54.8%) were intercepted before patient use. Of 14 patients affected by MDAEs, 8 (57.1%) were females and 9 (64.3%) were aged 19–65 yr. No children were affected. The general ward reported the highest number of MDAEs, followed by the department of radiology, ICU, OPD, and emergency department. More than half of the events (n=18, 58.1%) were categorized as serious.
Most MDAEs involved Class B (low-to-moderate risk) devices (n=26, 83.9%), with the remainder linked to Class C (moderate-to-high risk) devices (n=5, 16.1%). No events were reported with Class A or Class D devices. The most frequently implicated devices were disposable syringes (n=8, 25.8%), intravenous cannulas (n=6, 19.4%), and blood pressure monitors (n=4, 12.9%), while other devices accounted for fewer events (Table). Common MDAEs included syringe malfunctions, IV cannula-related thrombophlebitis, and inaccurate blood pressure readings. Less frequent events involved malfunctioning SpO₂ probes, post-contrast adverse effects, and device integrity failures. According to WHO-UMC criteria, the majority of events were classified as probable (n=16, 51.6%) or possible (n=9, 29.0%), with only a smaller proportion deemed certain. Significant associations were observed between device type and event severity (P=0.010), as well as between device category and both severity (P=0.002) and event type (P<0.001). No significant association was found between device class and severity (P=0.058).
| Medical device | Frequency, n (%) | Medical device adverse events | Stage of occurrence |
|---|---|---|---|
| Intravenous (I.V.) cannula | 5 (16.1) | Thrombophlebitis | Post-use |
| Blood pressure monitor | 4 (12.9) | Incorrect non-invasive Blood pressure reading | Pre-use |
| Contrast media (Iohexol, Iodixanol) | 3 (9.7) | Elevated serum creatinine | Post-use |
| Disposable syringe | 4 (12.9) | Blocked needle | Pre-use |
| Pulse oximeter (SpO2 Probe) | 3 (9.7) | Defective probe | Pre-use |
| Disposable syringe | 3 (9.7) | Leaked/cracked/damaged needle | Pre-use |
| Suction catheter | 2 (6.4) | Improper suction/withdrawal failure | Pre-use |
| Diagnostic kit (Trop-I test) | 1 (3.2) | False positive result | Pre-use |
| Contrast medium (Diatrizoate sodium) | 1 (3.2) | Loose stools | Post-use |
| Contrast medium (angiogram) | 1 (3.2) | Compartment syndrome (left hand) | Post-use |
| Nasal cannula (adult) | 1 (3.2) | Nasal sore at the contact site | Post-use |
| Urinary catheter | 2 (3.2) | Haematuria/Bladder discomfort | Post-use |
| Non-invasive ventilator | 1 (3.2) | Repetitive headache episodes | Post use |
| Total | 31(100) |
17 pre-use; 14 post-use |
Discussion
This study evaluated the frequency and characteristics of medical device associated adverse events in a tertiary care hospital. The frequency of MDAEs was low; however, nearly half of these events reached patients, a finding consistent with Najmi et al,12 which is something hospitals need to take seriously. Many of the reported incidents involved commonly used consumables, which is expected given their frequent use in clinical settings. However, such events, though relatively common, were frequently classified as serious in our study, highlighting their potential clinical impact.13 Even devices generally regarded as low risk, like Class B, were occasionally linked to serious issues, as shown by Ferner et al14 and Deshwal et al.15 Therefore, even low-risk devices can become harmful if there is misuse or it is of poor quality.
In most cases, the events were probably or related to the device used, as per Kumar et al16 and the WHO-UMC criteria. This suggests that healthcare personnel were generally successful in accurately attributing the adverse events to the respective devices.17 Moreover, certain trends were observed, such as a higher incidence of serious events associated with specific categories of devices.
One of the main strengths of this study is that it was done prospectively meaning the data was collected as events happened, similar to the approach used by Deo et al18 and Forster et al.19 This study benefitted from close collaboration between the clinical pharmacy and biomedical engineering departments facilitated timely identification and reporting of MDAEs. The study has certain limitations. The sample size was relatively small, and long-term patient outcomes after the adverse events were not systematically tracked beyond discharge. Yet all reported medical device-associated adverse events were monitored and managed appropriately during hospitalisation. The findings were based on data from a single-centre study, which may not reflect nationwide trends, further limiting what we can say about long-term impact, as noted by Raghav et al.20
To improve things, hospital staff need regular training, and there should be simple ways to report problems, as recommended by Srinivas et al21 and Alsohime et al.22 Hospitals should also start looking at MDAE data regularly, just like they do with medication errors. From a wider point of view, strengthening reporting systems and training is essential; broader policy measures such as mandatory reporting may be considered in the future if supported by larger datasets, and staff should be supported and encouraged to report device problems, as recommended in previous studies.23 The findings highlight that even widely used medical devices can pose risks without careful monitoring. Strengthening awareness, timely reporting, and preventive measures along with regular training of healthcare professionals remain essential to minimize device-associated adverse outcomes and improve patient safety. From a policy perspective, closer integration with the MvPI may play an important role in ensuring early detection of risks, informed regulatory decision-making, and safer use of medical devices in healthcare systems.
Acknowledgment
Authors acknowledge the valuable inputs and publicly available resources provided by the Materiovigilance Programme of India (MvPI), National Health Systems Resource Centre, which were referred to during the preparation of this study.
Author contributions
VT: Concept, design, definition of intellectual content, manuscript writing; SB: Concept, design, literature search, clinical studies, data acquisition, data analysis, manuscript writing; TF: Data analysis, statistical analysis, manuscript writing; PG: Literature search, data acquisition, manuscript writing; MSAK: Clinical studies, data acquisition, manuscript writing; SP: Clinical oversight, manuscript writing. All authors have read and approve the final printed version of the manuscript.
Financial support & sponsorship
None.
Conflicts of Interest
None.
Use of Artificial Intelligence (AI)-Assisted Technology for manuscript preparation
The authors confirm that there was no use of AI-assisted technology for assisting in the writing of the manuscript and no images were manipulated using AI.
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