Knowledge and Attitudes of Healthcare Professionals Toward Medical Device Safety Reporting: A Cross-Sectional Study in Kerala, India

The rapid advancement of medical technology and the exponential growth of medical device utilization in healthcare delivery have fundamentally transformed modern medicine, offering unprecedented diagnostic and therapeutic capabilities while simultaneously introducing complex safety challenges that demand systematic monitoring and evaluation (1,2). Contemporary healthcare systems worldwide rely extensively on an estimated 1.5 million different types of medical devices currently available in the global marketplace, ranging from simple disposable instruments such as syringes and bandages to sophisticated life-sustaining equipment including artificial hearts, advanced imaging systems, and computer-controlled surgical robots (3,4). This technological revolution has created an intricate ecosystem where medical devices serve as indispensable tools for disease prevention, diagnosis, treatment, and rehabilitation across virtually every medical specialty and healthcare setting.

The World Health Organization provides a comprehensive definition of medical devices as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for one or more specific medical purposes including diagnosis, prevention, monitoring, treatment, or alleviation of disease, injury, or handicap, investigation, replacement, modification, or support of anatomy or physiological processes, supporting or sustaining life, and conception control (5). This broad definition encompasses an extraordinarily diverse range of products, from simple tongue depressors costing pennies to million-dollar magnetic resonance imaging systems, each presenting unique safety profiles and risk-benefit considerations that require careful evaluation and ongoing surveillance throughout their lifecycle.

Medical devices are utilized across the entire spectrum of healthcare delivery, from home-based self-care by patients and their families to highly specialized interventions in advanced tertiary care facilities. Healthcare professionals including physicians, nurses, pharmacists, dentists, optometrists, and allied health practitioners routinely depend on medical devices for screening procedures, diagnostic investigations, therapeutic interventions, palliative care measures, and preventive health strategies (6,7). The ubiquitous nature of medical device utilization means that virtually every patient encounter involves some form of device-mediated care, whether through simple diagnostic tools like thermometers and blood pressure monitors or complex interventional equipment such as cardiac catheterization systems and robotic surgical platforms.

Despite their tremendous benefits and life-saving potential, medical devices present significant risks that can result in serious patient harm, disability, or death when they malfunction, fail to perform as intended, or are used inappropriately (8,9). Medical device adverse events (MDAEs) are defined as any unintended injury or harm to patients that occurs during or as a consequence of medical device use, encompassing equipment failures, design flaws, manufacturing defects, inadequate instructions for use, user errors, and unexpected physiological responses to device materials or mechanisms (10,11). The clinical manifestations of MDAEs can range from minor inconveniences and temporary discomfort to catastrophic failures resulting in permanent disability or death, making their prevention and management critical components of patient safety initiatives.

Global surveillance data reveals alarming trends in medical device-related injuries and deaths that underscore the urgent need for robust monitoring systems and preventive interventions. Over the past decade, international regulatory agencies have documented more than 1.7 million reported injuries and over 83,000 deaths attributed to unsafe or malfunctioning medical devices, representing only the tip of the iceberg given widespread underreporting of adverse events (12,13). These statistics likely significantly underestimate the true burden of device-related harm, as many adverse events go unrecognized, unreported, or are attributed to other causes, creating a substantial hidden epidemic of preventable patient injuries.

Notable examples of large-scale medical device failures have demonstrated the potential for widespread patient harm and the importance of effective surveillance systems. The Johnson & Johnson ASR hip replacement system recall affected over 93,000 patients globally, including 4,700 individuals in India, due to premature device failure causing metal poisoning, tissue necrosis, and the need for multiple revision surgeries (14,15). Similarly, the recall of Medtronic's Sprint Fidelis defibrillator leads affected over 268,000 patients worldwide due to conductor fractures that could result in inappropriate shocks or failure to deliver life-saving therapy (16). The silicone breast implant controversies of the 1990s and more recent textured implant recalls have affected millions of women globally, highlighting the long-term safety challenges associated with implantable devices (17,18).

Cardiovascular devices have been particularly prone to adverse events with serious consequences. Cases of implantable cardioverter defibrillator malfunctions have resulted in inappropriate shocks, failure to detect life-threatening arrhythmias, and premature battery depletion, affecting thousands of patients and necessitating complex revision procedures (19,20). Pacemaker recalls due to software errors, lead fractures, and premature battery depletion have similarly impacted patient safety and highlighted the vulnerability of device-dependent patients to technical failures (21,22). These high-profile cases represent systemic failures in device design, testing, manufacturing, and post-market surveillance that could potentially be prevented through more effective monitoring and reporting systems.

In response to mounting evidence of device-related harm and the limitations of pre-market testing in detecting all potential safety issues, regulatory authorities worldwide have established comprehensive materiovigilance systems designed to monitor medical device safety throughout their entire lifecycle (23,24). Materiovigilance, derived from the Latin words "materia" (matter) and "vigilans" (watching), represents the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other device-related problems following the marketing of medical devices (25,26). These systems aim to provide early warning signals of emerging safety issues, facilitate rapid response to identified problems, and continuously improve device safety through systematic data collection, analysis, and dissemination.

India implemented the Materiovigilance Program of India (MvPI) in 2010 under the Central Drugs Standard Control Organisation (CDSCO) in collaboration with the Indian Pharmacopoeia Commission (IPC) to establish a comprehensive national surveillance system for medical devices (27,28). The program aims to collect, collate, and analyze adverse event reports from healthcare professionals, patients, and manufacturers to identify safety signals, coordinate appropriate regulatory responses, and disseminate safety information to stakeholders. The MvPI system is designed to complement existing pharmacovigilance activities and provide specialized expertise in device-related safety assessment, representing a significant advancement in India's healthcare quality and patient safety infrastructure.

Despite the establishment of robust regulatory frameworks and surveillance systems, significant challenges persist in achieving effective materiovigilance implementation, with underreporting of adverse events representing the most critical obstacle to system effectiveness (29,30). International studies consistently demonstrate that actual adverse event rates are substantially higher than those captured by voluntary reporting systems, with estimates suggesting that only 1-10% of device-related adverse events are formally reported to regulatory authorities (31,32). This massive underreporting problem severely limits the ability of surveillance systems to detect safety signals, assess risk patterns, and implement timely interventions to protect patients from preventable harm.

Healthcare professionals, particularly physicians and pharmacists, occupy pivotal positions in the materiovigilance ecosystem as they are uniquely positioned to observe, recognize, and report device-related adverse events through their direct patient care responsibilities (33,34). Physicians have intimate knowledge of patient clinical status, device utilization patterns, and treatment outcomes that enables them to identify potential device-related problems and establish causal relationships between device use and adverse outcomes. Pharmacists, especially those working in hospital settings, often serve as medication safety experts with specialized knowledge of drug-device interactions, device-related medication errors, and patient counseling regarding device use, making them valuable contributors to comprehensive safety monitoring efforts.

However, multiple barriers impede healthcare professional participation in materiovigilance activities, including lack of awareness about reporting systems, insufficient knowledge regarding what constitutes a reportable event, complex and time-consuming reporting procedures, concerns about legal liability and professional reputation, absence of feedback regarding submitted reports, and systemic factors such as heavy workloads and competing priorities (35,36). These barriers operate at individual, institutional, and systemic levels, requiring multifaceted interventions that address knowledge gaps, streamline reporting processes, provide appropriate incentives, and create supportive organizational cultures that prioritize patient safety reporting.

Previous research has identified significant knowledge deficits among healthcare professionals regarding adverse event recognition, reporting requirements, and surveillance system operations, with studies demonstrating that many practitioners lack basic understanding of what events should be reported, how to submit reports, and what happens to reported information (37,38). Educational interventions have shown promise in improving knowledge and reporting behaviors, but sustainable improvements require systematic approaches that integrate materiovigilance concepts into professional education and continuing medical education programs (39,40). The challenge is particularly acute in developing countries where healthcare systems face resource constraints, competing priorities, and limited infrastructure for safety surveillance activities.

The Indian healthcare context presents unique challenges and opportunities for materiovigilance implementation, given the country's large and diverse population, rapidly expanding healthcare infrastructure, growing medical device market, and complex regulatory environment involving multiple stakeholder groups with varying levels of knowledge and engagement (41,42). Understanding the knowledge, attitudes, and behaviors of Indian healthcare professionals toward materiovigilance is essential for developing effective interventions that can improve adverse event reporting and ultimately enhance patient safety outcomes across the healthcare system.

Despite the critical importance of healthcare professional engagement in materiovigilance activities, limited research has systematically examined their knowledge, attitudes, and perceptions regarding medical device adverse event reporting in the Indian context. Existing studies have primarily focused on pharmacovigilance activities related to drug safety monitoring, with relatively little attention given to device-related safety surveillance despite the growing importance of medical devices in healthcare delivery (43,44). This knowledge gap represents a significant barrier to evidence-based policy development and targeted intervention design that could improve materiovigilance system effectiveness and patient safety outcomes.

The state of Kerala represents an interesting case study for materiovigilance research given its high literacy rates, well-developed healthcare infrastructure, active pharmaceutical industry, and relatively advanced healthcare delivery systems compared to other Indian states (45,46). Kerala's healthcare professionals are generally well-educated and have access to continuing education opportunities, making them an appropriate population for assessing baseline knowledge and attitudes that could inform broader national policy development. Understanding the materiovigilance knowledge and attitudes of healthcare professionals in this relatively advanced healthcare environment can provide insights into both achievements and remaining challenges in system implementation.

The current study addresses these critical knowledge gaps by conducting a comprehensive assessment of healthcare professional knowledge, attitudes, and perceptions regarding medical device adverse event reporting and materiovigilance systems in Kerala, India. By examining both physicians and pharmacists, the research provides comparative insights into profession-specific factors that influence materiovigilance participation and identifies targeted intervention opportunities that could enhance system effectiveness and patient safety outcomes.

METHODOLOGY

A cross-sectional, questionnaire-based study was conducted in Ernakulam district, Kerala, India, from April to June 2023. The study population comprised registered medical practitioners working in various healthcare settings and community pharmacists employed at retail pharmacies. A convenience sampling method was employed to recruit 100 healthcare professionals, including 50 physicians (including dentists) and 50 community pharmacists. Inclusion criteria comprised actively practicing licensed medical professionals and pharmacists willing to participate voluntarily. Participants who declined to respond or provided incomplete questionnaires were excluded from the analysis. A validated 19-item semi-structured questionnaire was developed following comprehensive literature review and expert consultation. The instrument was divided into two main sections, with the first section capturing demographic characteristics including gender, profession, specialization, practice type, and years of experience. The second section focused on knowledge and attitude assessment, covering awareness of MvPI program and reporting systems, understanding of medical device adverse events, attitudes toward reporting responsibilities, barriers to MDAE reporting, and sources of medical device safety information. The questionnaire underwent validation by the Department of Pharmacy Practice research team to ensure content validity and reliability. Data collection was conducted through multiple channels, including personal visits, Google Forms, and WhatsApp distribution to maximize response rates. Participants were informed about study objectives and provided informed consent before questionnaire completion. Anonymous completion was ensured to encourage honest responses. Weekly reminders were sent to non-respondents, and responses received after June 2023 were excluded from analysis.

Collected data were analyzed using Microsoft Excel. Descriptive statistics were employed to summarize participant characteristics and response patterns. Results were presented as frequencies and percentages for categorical variables.

Informed consent was obtained from all participants, and confidentiality was maintained throughout the study period. Participation was voluntary, and participants could withdraw at any time without consequences.

RESULTS

A total of 100 healthcare professionals completed the questionnaire, comprising 50 physicians and 50 pharmacists. The demographic distribution showed that 42% of physicians were male and 58% were female, while among pharmacists, 28% were male and 72% were female. The physician group consisted of 35 hospital or clinic-based practitioners and 15 dentists working in dental clinics. Participants' professional experience ranged from 1 to 35 years across both groups. (Table 1) Among physicians, 30% had 1 year of experience, 22% had 2-5 years, 18% had 5-10 years, and 14% had more than 10 years of experience. For pharmacists, 34% had 1 year of experience, 38% had 2-5 years, 18% had 5-10 years, and 14% had more than 10 years of experience.

Knowledge of the ongoing Materiovigilance Program of India was significantly limited among both professional groups. Only 17 physicians (34%) and 19 pharmacists (38%) demonstrated awareness of the MvPI program, while the majority of physicians (66%) and pharmacists (62%) remained unaware of its existence (Figure 1). Analysis by experience level revealed that healthcare professionals with less than five years of practice showed greater awareness compared to their more experienced counterparts, particularly those with more than five years of experience who had minimal knowledge of materiovigilance and its reporting systems.

A critical finding was that 76% of physicians and 74% of pharmacists had never encountered a medical device adverse event reporting form (Figure 2). This lack of exposure to reporting materials was attributed to several factors including inadequate communication or dissemination of information, limited awareness campaigns, insufficient attendance at continuing medical education programs, and lack of effective communication from the Indian Pharmacopoeia Commission to professional bodies like the Indian Medical Association and Pharmacy Council of India.

The study revealed that most participants (78% of physicians and 88% of pharmacists) had never participated in continuing medical education programs or workshops focused on medical device safety (Figure 3). This limited participation was attributed to various factors including cost considerations with registration fees and travel expenses, inadequate awareness of available educational opportunities, insufficient communication or promotion of relevant events, and competing personal and professional obligations that limited availability for such programs.

Despite limited formal program awareness, participants demonstrated varying levels of understanding regarding medical device risks. When questioned about the potential for medical devices to cause adverse outcomes, 84% of physicians and 68% of pharmacists acknowledged that devices could harm patients and require continuous long-term monitoring. However, significant knowledge gaps were evident, particularly among pharmacists, with 50% expressing uncertainty about medical device adverse events (Figure 4). Many pharmacists lacked awareness of which devices in their pharmacies qualified as medical devices requiring monitoring. Participants who did not believe medical devices could cause adverse events cited their lack of exposure to such cases as the primary reason for their perspective.

Healthcare professionals demonstrated predominantly positive attitudes toward adverse event reporting. The vast majority of participants (88% of physicians and 94% of pharmacists) agreed that reporting medical device adverse events was crucial for patient safety, regulatory oversight, post-market surveillance, continuous learning, and legal compliance (Figure 5). They recognized that reporting helps improve patient safety and enhance the overall quality of healthcare delivery.

Regarding direct professional experience with adverse events, only 20% of physicians and 22% of pharmacists reported encountering medical device-related adverse events during their practice. Conversely, 78% of pharmacists and 80% of physicians indicated they had never observed any device-related adverse events throughout their entire careers (Figure 6). This finding was considered remarkable given the established risks associated with medical device use.

The study revealed significant differences in patient monitoring practices between professional groups. Approximately 60% of physicians reported taking feedback from patients after implanting or prescribing medical devices, while 80% of pharmacists did not routinely collect patient feedback after selling medical devices (Figure 7). This disparity in follow-up practices was attributed to limited resources, time constraints, and privacy concerns regarding the collection of sensitive patient information. During interactions with participants, 48% of physicians and 22% of pharmacists reported discussing medical device adverse events encountered in their practice with colleagues. Such discussions were recognized as important for alerting device designers about potential risks and hazardous situations, while also enabling regulatory agencies to take necessary preventive measures.

The study found that 76% of physicians and 22% of pharmacists believed that materiovigilance should be included in the undergraduate curriculum of healthcare education systems. Participants recognized the importance of materiovigilance knowledge for ensuring patient safety through systematic tracking of medical devices associated with adverse events.

Participants obtained information about medical device benefits and risk factors from diverse sources. Among physicians, 28% relied on medical bulletins, articles, and conferences, 24% utilized the Indian Pharmacopoeia Commission website, 18% consulted manufacturer instructions and demonstrations, and 10% participated in continuing medical education programs. For pharmacists, 24% attended CME programs, (Figure 8) 24% used medical bulletins and articles, 20% followed manufacturer guidelines, and only 4% accessed the Indian Pharmacopoeia Commission website.

Regarding medical device regulation, significant knowledge gaps were identified. Among physicians, 26% demonstrated knowledge of medical device regulation, 38% were unaware of regulatory processes, and 36% expressed no opinion. For pharmacists, 58% showed regulatory knowledge, 18% were unaware, and 24% had no opinion. Notably, 100% of physicians and 78% of pharmacists believed that manufacturing companies significantly influenced medical device regulations in India. Additionally, 76% of physicians and 86% of pharmacists expressed interest in receiving more information about materiovigilance, while 10% of pharmacists were not interested and 24% of physicians had no opinion. When asked about appropriate organizations for reporting medical device adverse events, 34% of physicians and 32% of pharmacists indicated they would inform the Ministry of Health, 22% of physicians and 10% of pharmacists would contact the Indian Pharmacopoeia Commission, and 38% of physicians and 50% of pharmacists would report to the Central Drugs Standard Control Organisation (CDSCO).

DISCUSSION

This comprehensive study provides critical insights into the current state of medical device adverse event reporting knowledge and attitudes among healthcare professionals in Kerala, India. The findings reveal significant disparities between professional awareness and the established materiovigilance infrastructure, highlighting multiple areas requiring urgent attention and intervention.

The low awareness rates of the MvPI program among both physicians (34%) and pharmacists (38%) align with previous studies conducted in tertiary care institutions, suggesting that despite the program's establishment in 2010, its penetration within the Indian healthcare system remains inadequate. This finding is particularly concerning given that materiovigilance has been operational for over a decade, yet the majority of healthcare professionals remain uninformed about its existence and objectives.

The inverse relationship between years of professional experience and program awareness presents an interesting paradox that challenges conventional expectations. Healthcare professionals with less than five years of experience demonstrated greater awareness compared to their more experienced counterparts, suggesting potential deficiencies in continuing education programs for established practitioners. This pattern indicates that recent graduates may have received some exposure to materiovigilance concepts during their training, while seasoned professionals have not benefited from adequate refresher education.

The finding that 78% of physicians and 88% of pharmacists had never participated in CME programs focused on medical device safety represents a critical gap in professional development. This absence of structured educational opportunities directly contributes to the observed knowledge deficits and suggests systemic failures in continuing medical education planning and implementation. The various barriers to CME participation identified in this study, including cost considerations, inadequate promotion, and competing personal obligations, require targeted interventions to improve accessibility and engagement.

The stark finding that 76% of physicians and 74% of pharmacists had never encountered an MDAE reporting form indicates fundamental failures in information dissemination and system accessibility. This represents a more severe situation than previously reported in international literature and suggests that the Indian materiovigilance system faces unique challenges in stakeholder engagement and communication.

The identified barriers to form accessibility, including inadequate communication from regulatory bodies to professional organizations, insufficient awareness campaigns, and lack of mandatory participation requirements, highlight the need for comprehensive system redesign. The suggestion that the Indian Pharmacopoeia Commission should enhance communication with the Indian Medical Association and Pharmacy Council of India to mandate awareness program participation represents a practical solution that could significantly improve form visibility and usage.

Despite limited formal program awareness, the finding that 84% of physicians and 68% of pharmacists acknowledged that medical devices could cause adverse outcomes demonstrates intuitive understanding of device-related risks. However, the significant knowledge gap among pharmacists, with 50% expressing uncertainty about medical device adverse events, reveals profession-specific educational needs that require targeted interventions.

The particularly concerning finding that many pharmacists lack awareness of which devices in their pharmacies qualify as medical devices requiring monitoring suggests fundamental gaps in pharmaceutical education and practice standards. This knowledge deficit could have serious implications for patient safety, as pharmacists serve as the final checkpoint before device distribution to patients. The contrast between theoretical knowledge and practical application becomes evident when examining professional experience with adverse events. The finding that only 20-22% of participants had encountered adverse events during their practice, while 78-80% had never observed such events, presents two possible interpretations: either adverse events are genuinely rare, or more likely, they are significantly underrecognized and underreported due to knowledge gaps and system failures.

The overwhelmingly positive attitudes toward MDAE reporting responsibility demonstrated by both physicians (88%) and pharmacists (94%) represent encouraging findings that contrast with some international studies reporting negative attitudes toward materiovigilance. This suggests that Indian healthcare professionals possess strong professional ethics and recognize their responsibilities toward patient safety, providing a solid foundation for system improvement initiatives.

The universal agreement among physicians and 88% agreement among pharmacists that MDAE reporting enhances patient safety indicates sophisticated understanding of surveillance system principles and quality improvement concepts. These positive attitudes suggest that the primary barriers to effective materiovigilance implementation are systemic and educational rather than attitudinal, offering optimism for successful intervention outcomes. The finding that 48% of physicians and 22% of pharmacists discuss adverse events with colleagues reveals important professional communication patterns that could be leveraged for system improvement. These informal communication networks represent valuable channels for knowledge dissemination and case sharing that could supplement formal reporting mechanisms.

The disparity between physician and pharmacist communication rates suggests different professional cultures and network structures that should be considered when designing targeted interventions. Physicians appear more likely to engage in peer consultation about adverse events, possibly reflecting their greater clinical responsibility and decision-making authority.

The significant difference in patient monitoring practices between physicians (60% providing follow-up) and pharmacists (80% not providing follow-up) reflects fundamental differences in professional roles and responsibilities. However, this finding also highlights missed opportunities for adverse event detection and patient safety improvement.

The barriers to patient follow-up identified in this study, including limited resources, time constraints, and privacy concerns, represent common healthcare system challenges that require systematic solutions rather than individual professional efforts. Implementing structured follow-up protocols and providing necessary resources could significantly improve adverse event detection rates.

The strong support for materiovigilance inclusion in undergraduate curricula expressed by 76% of physicians demonstrates recognition of educational system failures and commitment to preventing similar knowledge gaps in future practitioners. However, the lower support among pharmacists (22%) suggests different perspectives on educational priorities that require further investigation. The preference for curriculum integration aligns with international best practices in patient safety education and suggests that sustainable solutions require systemic changes in healthcare education rather than ad-hoc training programs. This finding supports recommendations for comprehensive curriculum reform that integrates patient safety concepts throughout healthcare education.

The diverse information sources utilized by healthcare professionals reveal both strengths and weaknesses in current knowledge management systems. The reliance on medical bulletins, articles, and conferences demonstrates proactive information-seeking behavior, while the limited use of official regulatory websites suggests accessibility or usability issues with formal information channels.

The finding that only 4% of pharmacists utilize the Indian Pharmacopoeia Commission website compared to 24% of physicians indicates profession-specific barriers to official information access that require targeted solutions. This disparity may reflect differences in digital literacy, website design, or perceived relevance of content to different professional groups. The significant regulatory knowledge gaps identified in this study, with 38% of physicians and 18% of pharmacists unaware of medical device regulations, represent serious concerns for patient safety and system effectiveness. Healthcare professionals who lack understanding of regulatory frameworks cannot effectively participate in surveillance systems or make informed decisions about device safety. The universal belief among physicians and majority belief among pharmacists (78%) that manufacturing companies significantly influence medical device regulations in India reflects broader concerns about regulatory capture and industry influence. These perceptions, whether accurate or not, may undermine confidence in regulatory systems and reduce reporting motivation.

The diverse preferences for reporting channels revealed in this study highlight confusion about appropriate reporting mechanisms and suggest the need for clearer guidance and streamlined processes. The fact that participants identified three different organizations (Ministry of Health, Indian Pharmacopoeia Commission, and CDSCO) as appropriate reporting destinations indicates system complexity that may discourage reporting. The preference for CDSCO reporting among 38% of physicians and 50% of pharmacists suggests some awareness of this organization's regulatory role, but the significant variation in preferences indicates inadequate standardization and communication about proper reporting procedures.

The comprehensive barriers identified in this study encompass individual, institutional, and systemic levels, requiring multi-faceted intervention approaches. Time constraints and workload pressures reflect broader healthcare system challenges that cannot be addressed through materiovigilance-specific interventions alone but require integrated healthcare system reforms. The complex reporting procedures and fear of professional consequences represent modifiable barriers that could be addressed through system redesign and policy reforms. Implementing simplified reporting mechanisms, ensuring anonymity protections, and establishing non-punitive reporting policies could significantly improve participation rates.

These findings have several critical implications for materiovigilance policy and practice in India. The evidence clearly supports the need for comprehensive educational interventions targeting both new and experienced healthcare professionals, with particular attention to profession-specific knowledge gaps and learning preferences.

The study results also support recommendations for reporting system redesign focusing on accessibility, simplicity, and integration with existing clinical workflows. The development of user-friendly electronic reporting platforms with mobile accessibility could address many identified barriers while improving data quality and processing efficiency.

Furthermore, the findings emphasize the importance of enhanced communication strategies to improve program awareness and professional engagement. Collaboration with professional organizations, mandatory participation requirements, and regular awareness campaigns could significantly improve program visibility and utilization.

SUMMARY AND CONCLUSIONS

This study reveals significant gaps in healthcare professional knowledge and engagement with medical device adverse event reporting systems in Kerala, India. While professionals demonstrate positive attitudes toward materiovigilance and recognize its importance for patient safety, limited program awareness and systemic barriers prevent effective participation in adverse event surveillance.

Key findings include low awareness of the MvPI program, minimal exposure to reporting forms and procedures, inadequate participation in relevant continuing education, and positive attitudes toward reporting responsibilities despite limited actual reporting experience. These results highlight the urgent need for comprehensive interventions addressing educational, systemic, and procedural barriers to effective materiovigilance implementation.

Recommendations for improving MDAE reporting include mandatory integration of materiovigilance content into healthcare professional education, simplified and accessible reporting mechanisms, enhanced communication and awareness campaigns, collaboration with professional organizations for program dissemination, implementation of non-punitive reporting policies, and establishment of feedback systems to demonstrate the impact of individual reports.

The success of India's materiovigilance program ultimately depends on healthcare professional engagement and participation. Addressing identified knowledge gaps and systemic barriers through targeted interventions could significantly improve adverse event detection, analysis, and prevention, thereby enhancing patient safety outcomes across the Indian healthcare system.

Future research should examine the effectiveness of specific educational interventions, evaluate the impact of system reforms on reporting rates, and assess long-term trends in healthcare professional knowledge and attitudes toward materiovigilance. Additionally, studies comparing materiovigilance implementation across different Indian states could identify best practices and inform national policy development.

LIMITATIONS AND FUTURE RESEARCH DIRECTIONS

The cross-sectional study design precludes causal inferences about relationships between knowledge, attitudes, and reporting behaviours, while the convenience sampling method and relatively small sample size may limit generalizability to broader healthcare professional populations. The three-month study period may have been insufficient to capture seasonal variations or recent program changes, suggesting the need for longitudinal research designs.

Future research should examine the effectiveness of specific educational interventions, evaluate the impact of system reforms on reporting rates, and assess long-term trends in healthcare professional knowledge and attitudes. Additionally, comparative studies across different Indian states could identify best practices and inform national policy development, while qualitative research could provide deeper insights into barrier mechanisms and potential solutions.

ACKNOWLEDGMENTS

I heartfully thank contribution of Al Shifa hospital and the materiovigilance center under IPC for the valuable support given for the study for providing the requisite infrastructure and resources that facilitated the successful culmination of my project. I thank the students Alen Paul, Jishnu S, Karthika Suresh, Athul Babu, and Risvan N of the Department of Pharmacy Practice at Chemists College of Pharmaceutical Sciences and Research for their support in the research process.

FUNDING: Not a funded project

ETHICS APPROVAL AND CONSENT TO PARTICIPATE:

The Institutional Ethics Committee certified and sanctioned the study proposal by KIMS Al Shifa Healthcare Pvt Ltd. All data acquired was handled in a highly private manner.

DECLARATION OF CONFLICTING INTERESTS

The authors declare that they have no conflict of interest.

ABBREVIATIONS

CME: Continuous medical education

MDAE: Medical device-associated adverse events

ADR: Adverse drug reaction

MvPI: Materiovigilance program of India

NHSRC: National health system resource centre

ACSoMP: Advisory committee on safety of medicinal products centre

CDSCO: Central drug standard control organization

GHTF: Global harmonization task force

REFERENCES

1. World Health Organization. Medical devices: managing the mismatch: an outcome of the priority medical devices project. Geneva: WHO Press; 2010.
2. Kramer DB, Xu S, Kesselheim AS. Regulation of medical devices in the United States and European Union. N Engl J Med. 2012;366(9):848-855.
3. Heneghan C, Thompson M, Billingsley M, Cohen D. Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. BMJ Open. 2011;1(1):e000155.
4. World Health Organization. Medical device regulations: global overview and guiding principles. Geneva: WHO Press; 2003.
5. Central Drugs Standard Control Organisation. Guidelines for materiovigilance for medical devices. New Delhi: CDSCO; 2015.
6. Zippel C, Bohnet-Joschko S. Post-market surveillance in the medical device industry: a systematic literature review of current challenges and future perspectives. Expert Rev Med Devices. 2017;14(9):683-691.
7. Healthcare IT News. Medical device recalls: a global perspective on patient safety challenges. 2018.
8. Ramesh K. Analysis of medical device adverse events: lessons from hip implant failures. J Patient Saf. 2019;15(3):e45-e51.
9. Indian Pharmacopoeia Commission. Materiovigilance Programme of India: annual report 2019. Ghaziabad: IPC; 2020.
10. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32(1):19-31.
11. Meher BR, Joshua N, Asha B, Mukherji D. A questionnaire based study to assess knowledge, attitude and practice of pharmacovigilance among undergraduate medical students in a Tertiary Care Teaching Hospital of South India. Perspect Clin Res. 2015;6(4):217-221.
12. Gagliardi AR, Fenech D, Eskicioglu C, et al. Factors influencing adverse event reporting: qualitative study of how physicians and administrators think patient safety can be improved. CMAJ Open. 2016;4(4):E632-E639.
13. Hasford J, Goettler M, Munter KH, Muller-Oerlinghausen B. Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol. 2002;55(9):945-950.
14. Suke SG, Kosta P, Negi H. Role of pharmacovigilance in India: an overview. Online J Public Health Inform. 2015;7(2):e223.
15. Elkalmi RM, Hassali MA, Ibrahim MI, et al. Pharmacy students' knowledge and perceptions about pharmacovigilance in Malaysian public universities. Am J Pharm Educ. 2011;75(5):96.
16. Gagliardi AR, Fenech D, Eskicioglu C, et al. Factors influencing adverse event reporting: qualitative study of how physicians and administrators think patient safety can be improved. CMAJ Open. 2016;4(4):E632-E639.
17. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385-396.
18. Inman W, Weber JCP. The United Kingdom. In: Inman W, editor. Monitoring for drug safety. 2nd ed. Lancaster: MTP Press Ltd; 1986. p. 13-47.
19. Manna S, Santra S, Santra S. Adverse drug reaction monitoring in a rural tertiary care teaching hospital: participatory approach involving nursing students. Indian J Pharmacol. 2012;44(5):677-678.

Table1: Frequency distribution of gender participation