Natl. J. Physiol. Pharm. Pharmacol.(2025), Vol. 15(5): 295-300

Original Research

10.5455/NJPPP.2025.v15.i5.3

A questionnaire-based cross-sectional study of awareness, attitude, and practice of materiovigilance among the postgraduates at a tertiary care institute

Manjushree Kulkarni, Hemanth Kumar Komerahalli Hemagiraiah, Kishore Mavinakattekoppal Sreekantaiah^*

Department of Pharmacology, Mysore Medical College and Research Institute, Mysore, India

*Corresponding Author: Kishore Mavinakattekoppal Sreekantaiah. Department of Pharmacology, Mysore Medical College and Research Institute, Mysore, India. Email: drkishoregowda1972 [at] gmail.com

Submitted: 05/03/2025 Accepted: 24/04/2025 Published: 31/05/2025

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Introduction

Medical devices are essential tools in healthcare that facilitate the diagnosis, monitoring, and treatment of various medical conditions, encompassing a wide spectrum from basic items like bandages and syringes to advanced technologies such as heart pacemakers, coronary stents, magnetic resonance imaging machines, and healthcare software applications. Their diverse functionalities enhance patient care, improve treatment outcomes, and enable efficient healthcare delivery (Jefferys, 2001; Maisel, 2004).

The adverse events reported from India include electrical burns from defibrillator failures, metal-ion exposure from hip replacements, and overheating incidents in incubators, highlighting the significant safety concerns in the regulation of medical devices under the Drugs and Cosmetics Act of 1940 and its 1945 rules (Kaunain Sheriff, 2018; Meher, 2018; Banerjee, 2022).

The increasing prevalence of medical devices in healthcare has underscored the urgent need for a robust surveillance system to monitor and identify adverse events associated with their use to prevent further occurrences of such life-threatening issues (Maisel, 2004; Thomas and Galvin, 2008). Implementing such a system will facilitate timely detection and response to potential hazards, ultimately enhancing the overall quality of care in healthcare settings.

The Materiovigilance Program of India (MvPI) was initiated by the Ministry of Health and Family Welfare on July 6^th 2015, and it aimed to enhance awareness and safety monitoring of medical devices in our country [Meher, 2018; Guidance Document, Materiovigilance Programme of India (MvPI)]. This initiative was bolstered by the introduction of the Medical Device Rules in 2017, which established regulatory frameworks to ensure the safety and efficacy of medical devices available in the Indian market and promoted better healthcare outcomes (Medical Device Rules, 2017).

Materiovigilance is defined as a combined system of performance characterization, monitoring, identifying, collecting, reporting, and analyzing any untoward occurrence caused by medical devices (Saifuddin et al., 2022).

From 2015 to 2019, the Indian Pharmacopoeia Commission received approximately 1,931 reports of medical device-associated adverse events (MDAEs), highlighting the need for rigorous monitoring (Shukla et al., 2020). It is crucial to assess the risks and benefits of medical devices during the premarketing development stages. This comprehensive evaluation ensures the safety and efficacy of devices throughout their lifecycle.

The MvPI was initiated to increase awareness among healthcare professionals (HCPs) regarding the critical nature of reporting MDAEs. This initiative aims to cultivate a culture of safety and empower professionals to share experiences that contribute to an enriched repository of credible, evidence-based data on medical devices.

The spontaneous reporting of MDAEs by healthcare providers and stakeholders is the cornerstone of a medical device surveillance system. By fostering this engagement, the MvPI enhances patient safety and fortifies public trust in medical technologies. Ultimately, the programme acts as a beacon of vigilance, illuminating the path toward safer healthcare solutions (Feigal et al., 2020).

Limited awareness, attitude, and practice regarding MDAE reporting have been noted among HCPs in various countries (Mazeau et al., 2004; Mohamed et al., 2015; Alsohime et al., 2019). However, there is a paucity of data on the understanding and attitudes of medical professionals toward materiovigilance in India. Consequently, we conducted this study to shed light on their comprehension and reporting practices related to MDAEs.

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Material and Methods

Study design

This was a questionnaire-based cross-sectional study conducted among postgraduates in Mysore Medical College and Research Institute, Mysore, Karnataka, which is a MDAE monitoring center under MvPI. A questionnaire on knowledge, attitude, and practice measures awareness toward reporting medical device-related adverse events. The study was divided into four sections: demographic information, knowledge of materiovigilance, attitude, and practices toward MDAEs.

Data collection

The questionnaire was distributed among 200 postgraduates of Mysore Medical College and Research Institute, Mysore. Google Forms were used to manage the survey questionnaire as it was user-friendly. The participants were asked to answer in multiple-choice formats.

Statistical analysis

Data were analyzed and entered manually into the Microsoft Excel 2019 version manually. Quantitative variables are expressed as percentages.

Ethical considerations

The study was conducted following approval from the Institutional Ethical Committee of Mysore Medical College and Research Institute to ensure ethical standards were met.

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Results

A total of 200 postgraduates participated in this study (categorized by profession and department). In terms of departmental affiliation, the largest group was from medicine with 30 participants (15%) followed by surgery with 28 participants (14%) followed by pathology with 22 participants (11%), and anesthesiology with 20 participants (10%).

Smaller groups came from obstetrics and gynaecology, Pediatrics, Orthopedics, and Ophthalmology, and otorhinolaryngology cumulatively comprising of 54 participants (43%). Departments such as Dermatology, Microbiology, Psychiatry Pharmacology, and Radiology have contributed fewer participants (Fig. 1).

Second- and first-year postgraduates contributed approximately 39.5% and 34%, respectively. However, third-year postgraduates contributed only around 26.5% of total study (Fig. 2).

Knowledge-based questions

The majority of 186 (93%) participants understood the primary objective of the MvPI, which is monitoring the safety and adverse events caused by medical devices.

A significant majority, 169 (84.5%), correctly identified that medical devices in India are classified based on a risk-based approach, considering factors like invasiveness and intended purpose. Other incorrect responses included the type of material, cost of the medical device, and manufacturer.

The majority of the patients 162 (81%) correctly identified bone fixation plates as Category C devices. Other responses included surgical dressings 8 (4%), hypodermic needles 12 (6%), and scalpel 18 (9%).

Most participants, 180 (90%) recognized that clinicians and nursing staff, medical device manufacturers, and hospital technology managers can report adverse events.

Fig. 1. Departmental affiliation of participants.

Fig. 2. Number of participants from first to third year of postgraduation.

Around 133 (66.5%) participants knew that the Central Drugs Standard Control Organization (CDSCO) is the regulatory authority in India that has been handling the MvPI. However, 52 participants (26%) chose the Food and Drug Administration (FDA) and 15 (7.5%) chose the Medical Council of India as the regulatory authority for MvPI (Table 1).

Attitude-based questions

A majority of 191 (95.5%) participants agreed that training and education regarding materiovigilance should be mandatory among postgraduates. A vast majority, 190 (95%) participants acknowledged that medical devices could induce adverse events. Most participants, 193 (96.5%) believed it was essential to report adverse events related to medical devices. Similarly, 196 (98%) respondents agreed that it is the responsibility of HCPs to report adverse events. An overwhelming majority of 195 (97.5%) participants agreed that reporting adverse events would improve the quality of healthcare (Table 2).

Practice-based questions

Not even half, that is, 88 participants (44%), encountered any adverse events due to the medical device during their practice. However, only 45 (22.5%) participants actually reported these events, indicating a gap between observation and reporting. A majority of 110 (55%) were familiar with the adverse event reporting form for medical devices created by the CDSCO.

Table 1. Knowledge regarding materiovigilance.

Table 2. Attitude regarding materiovigilance.

Table 3. Practice regarding materiovigilance.

Only 43 (21.5%) participants had been trained on how to report medical device adverse events (MDAEs) and as less as 32 participants (16%) had participated in workshops or continuing medical education (CME) sessions specifically addressing the safety of medical devices, indicating a need for increased educational efforts in this area (Table 3).

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Discussion

The integration of medical devices into patient care has a well-established history. A robust and comprehensive surveillance system for medical devices is essential for ensuring their safety and maintaining high-quality standards globally. In addition, such frameworks are designed to enhance patient safety and optimize the effectiveness of healthcare systems. A key objective of the MDAE reporting initiative is to raise awareness among stakeholders about the significance of this reporting process.

The healthcare professionals involved in this study were well-informed about the objective of the Materiovigilance Programme of India (MvPI), which was launched by the Government of India to monitor MDAEs. Most participants accurately identified the criteria for proper classification. Additionally, the majority recognized that medical devices are categorized based on their associated risk levels; however, a few faced challenges in correctly classifying them. A comparable study conducted by Meher et al. (2021) also reported a strong understanding of medical devices and their classifications.

In our study, participants demonstrated a favorable attitude toward MDAE reporting. The majority acknowledged that medical devices have the potential to cause adverse events and recognized that reporting such incidents plays a crucial role in improving patient safety. Similarly, a study conducted by Kurien et al. (2014) reported a positive outlook toward the reporting of adverse events associated with medical devices.

The findings of our study indicate that the practice of reporting adverse events among participants remains suboptimal. This may be attributed to various challenges faced by postgraduate trainees, including time constraints, inadequate training, and ambiguity in reporting guidelines. According to the FDA, only 0.5% of adverse events correlated with medical devices are reported (Teow and Siegel, 2013). Although some participants in our study experienced MDAEs, they did not report them, possibly because of a lack of awareness and an insufficiently structured reporting system.

Similarly, a study conducted by Gagliardi et al. (2018) identified multiple barriers to effective materiovigilance, including the absence of a well-defined reporting framework and a lack of a supportive environment for reporting.

A significant proportion of participants had neither attended any training programs on adverse event reporting nor reported any adverse events. A study conducted by Coyle et al. (2005) highlighted that the early exposure of postgraduate medical trainees to educational programs on medical event reporting had a positive impact on their attitude toward reporting.

This study has certain limitations that should be acknowledged. First, the study focused exclusively on a single cohort of HCPs, which may limit the generalizability of the findings. Second, the study adopted a single-centered approach, restricting the scope of its applicability to a broader population. Finally, the reliance on self-reported data introduces the potential for response bias because participants may overestimate their knowledge or adherence to reporting practices.

Future research initiatives could benefit from multicentric, prospective studies involving diverse groups of HCPs to enhance the generalizability of our findings. However, further exploration is warranted to assess the effectiveness of awareness programs and training sessions in improving the reporting of MDAEs among postgraduate trainees.

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Conclusion

The present study revealed that postgraduate trainees at a tertiary care teaching hospital in Mysore Medical College and Research Institute possess a satisfactory understanding of various aspects of materiovigilance and demonstrate a positive attitude toward reporting MDAEs. However, there is a significant gap between their knowledge and the actual implementation of the MDAE reporting practices. Addressing these deficiencies requires targeted interventions, such as regular workshops and structured training programmes to enhance HCPs’ engagement in proactive reporting. Furthermore, revising the existing medical curriculum to incorporate comprehensive materiovigilance training at both undergraduate and postgraduate levels is imperative to foster a culture of vigilance and accountability in medical device safety.

Acknowledgments

We sincerely express our gratitude to the postgraduate students of MMCRI (Mysore Medical College and Research Institute) for their valuable participation and support in our study. Their cooperation and insights have significantly contributed to the success of this research. We extend our heartfelt thanks to the faculty and staff of MMCRI for providing the necessary guidance, resources, and encouragement throughout this endeavor. Special appreciation goes to my mentors and colleagues for their constructive feedback.

Funding

This study was conducted independently without any external financial support.

Conflicts of interests

No conflict of interest.

Authors’ contributions

Dr. Manjushree Kulkarni contributed to the study design, data collection, and manuscript drafting. Dr. Hemanth Kumar K H provided guidance on study methodology and contributed to the completion of the study. Dr. Kishore M S, Dr. Hema N G, and Dr. Syed Mohsin Ahmed guided and helped validate the questionnaire for this study.

Data availability

The author will provide access to the datasets used in this study upon reasonable request.

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