A PRISMA 2020–Compliant Systematic Review: KAP Studies conducted on Healthcare Professionals, Students and Consumers about Medical Device related Adverse Events in Indian Hospital settings

1.1 Background and Rationale

There is a large range of medical instruments, equipment, implants, software, and in vitro reagents used in the delivery of modern healthcare. Ranging in sophistication between a basic glucometer and an intricate cochlear implant and cardiac stent, these devices touch the patient and, therefore, their post-market safety surveillance is not negotiable. Medical device safety is a patient safety priority that the World Health Organization (WHO) has identified as being globally of importance, thus highlighting the importance of an effective materiovigilance system. The Drug Controller General of India (DCGI) launched Materiovigilance Programme of India (MvPI) on July 6, 2015 on the behalf of the Ministry of Health and Family Welfare, the headquarters of which is the Indian Pharmacopoeia Commission (IPC), Ghaziabad. The program operates through a network of Medical Device Adverse Event Monitoring Centres (MDMCs) and mandates the collection, monitoring, and reporting of adverse events through the standardized Medical Device Adverse Event (MDAE) Reporting Form. India’s Medical Devices Rules 2017 (amended 2020) further strengthened the regulatory framework, requiring manufacturers, importers, and distributors to report serious MDAEs within stipulated timelines. Despite this infrastructure, underreporting of MDAEs is a pervasive challenge in India, as it is globally. The cornerstone of any effective surveillance system is the knowledge, attitude, and practice (KAP) of its stakeholders. Healthcare professionals are the primary observers and reporters of MDAEs, while students represent the future workforce, consumers are direct device users, and manufacturers have post-market obligations. Characterizing KAP across these groups in the Indian context is therefore vital for evidence-based policy intervention.

1.2 Review Objectives

This systematic review aimed to:

• Systematically synthesize published KAP evidence on materiovigilance in India across all stakeholder categories
• Quantify knowledge levels, attitudinal profiles, and reporting practices related to MDAEs
• Identify common barriers and facilitators to MDAE reporting
• Assess the impact of educational interventions on KAP outcomes
• Generate evidence-based recommendations for strengthening MvPI implementation

2. Methods

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 standards were followed in conducting this study. The PICo (Population, Interest, Context) framework was used to formulate the review question, and the protocol was created in advance.

2.1 Eligibility Criteria

Inclusion Criteria: (1) Original research articles (observational cross-sectional, pre-post interventional, or quasi-experimental designs); (2) Conducted entirely in India or among Indian healthcare settings; (3) Reporting data on knowledge, attitude, and/or practice related to materiovigilance or MDAE reporting; (4) Targeting any stakeholder population including physicians, nurses, pharmacists, pharmacy students, medical students, interns, postgraduate residents, consumers, or manufacturers; (5) Published in peer-reviewed journals in English; (6) Any year of publication.

Exclusion Criteria: (1) Review articles, editorials, letters, conference abstracts without full data; (2) Studies outside India or primarily addressing pharmacovigilance without distinct materiovigilance focus; (3) Studies with insufficient KAP data for extraction; (4) Duplicate publications from the same dataset.

2.2 Information Sources and Search Strategy

Systematic electronic database searches were conducted in PubMed/MEDLINE, Google Scholar, Scopus, Directory of Open Access Journals (DOAJ), and Indian Citation Index. The search employed combinations of the following Medical Subject Headings (MeSH) and free-text terms: “materiovigilance,” “medical device adverse event,” “MDAE,” “MvPI,” “knowledge attitude practice,” “KAP,” “medical device surveillance,” “India,” “medical device reporting.” Reference lists of included articles and key journals (IJBCP, JCDR, Perspectives in Clinical Research, NJPPP) were hand-searched. No date or language restriction was applied.

2.3 Study Selection

Using the eligibility criteria, two independent reviewers screened titles and abstracts; conflicts were settled by a third reviewer or by consensus. The whole texts of research that might qualify were obtained and evaluated. The PRISMA 2020 flow diagram (Figure 1) details the selection procedure.

2.4 Data Extraction

A data extraction form was standardized and the following were the major items that were captured: First author, year, journal, study design, setting, state/region, type of participant, sample size, data collection tool, domains assessed (K/A/P), key quantitative KAP findings, barriers identified, educational outcome of the intervention, and author conclusions.

2.5 Quality Assessment

The methodological quality of the included research was assessed using the JBI Critical Appraisal Checklist of Cross-Sectional research (11 criteria) and the JBI checklist of Quasi-Experimental Studies (when it comes to interventional research). All but one study was rated as low quality, moderate, and high.

2.6 Synthesis Approach

Because of high levels of heterogeneity in population of participants, questionnaire measures, and outcome measures among the included studies, formal meta-analysis was not undertaken. A narrative synthesis was done, synthesizing proportions and ranges of data, and the themes were clustered around: (1) areas of knowledge, (2) attitudinal patterns, (3) rates of practice and reporting, (4) barriers, (5) interventional outcomes, and (6) population-specific profiles.

3. Study Selection — Prisma 2020 Flow

Figure 1 below presents the systematic search and selection process. A total of 15 primary studies were ultimately included in this review.

4. Characteristics Of Included Studies

Table 1 presents the bibliographic and methodological characteristics of all 15 included studies. Together they span 2022–2025, cover 11 Indian states, and collectively enrolled approximately 3,260 participants representing postgraduate residents, MBBS interns, medical students, pharmacy students, consultant physicians, surgeons, nursing staff, pharmacists, physiotherapists, dentists, and consumers.

Table 1: Characteristics and Key Findings of Included Studies (n=15)

Abbreviations: PG = Postgraduate; UG = Undergraduate; HCP = Healthcare Professional; K = Knowledge; A = Attitude; P = Practice; MvPI = Materiovigilance Programme of India; MDAE = Medical Device Adverse Event; N =   Number of Population; TN + AP = Tamil Nadu + Andhra Pradesh

RESULTS

5.1 Overview of Included Studies

The 15 included studies were published between 2022 and 2025. Geographically, studies were conducted across 11 Indian states: Gujarat (4 studies), Karnataka (3), Tamil Nadu (2), Maharashtra (2), Kerala (1), Andhra Pradesh (1 combined with TN), Uttar Pradesh (1), and 1 multi-state study. Study designs were predominantly cross-sectional observational (n=12) with two pre-post educational intervention studies (S2, S12) and one quasi-experimental design. Total enrolled participants across studies: approximately 3,260. Types of participants included postgraduate medical residents (4 studies), mixed healthcare professionals (4 studies), MBBS interns (1 study), undergraduate medical students (1 study), pharmacy students (1 study), surgeons (2 studies), consumers (1 study), and combined group of HCPs (1 study). Self-administered structure questionnaires were used in all studies. Sample sizes ranged from 73 (S1) to 496 (S10).

5.2 Knowledge Domain

5.2.1 Awareness of Materiovigilance Programme of India (MvPI)

The weakest area of all 15 studies was always the knowledge of the MvPI and the composing elements. The pre-intervention awareness of MvPI by name is as low as 14.8% (S2), postgraduates 55.41). In S3, 2/3 of postgraduates were aware that CDSCO was the regulator, but considerable numbers mixed up MCI or USFDA with the responsibility of MvPI. There was awareness among the mixed HCPs in S15 of the existence of the concept of materiovigilance and of the availability of an ADR reporting system on medical devices in India, but the level of operational knowledge was superficial. The year of the MvPI introduction (2015) and the IPC as the National Coordinating Centre were not remembered well: out of S10 (496 medical professionals in Tamil Nadu and Andhra Pradesh), only 41.9% of them correctly recognized IPC as the National Coordinating Centre. In S8 (215 HCPs, Gujarat), the correct identification of MvPI as the current program was 62.79% and the relatively high rate can be explained by the tertiary teaching hospital and the presence of an active MDAE monitoring center.

5.2.2 Knowledge of Medical Device Classification

One of the areas of common knowledge assessment was the risk-based classification of medical devices (Categories A, B, C, D under MDR 2017). However, the correct answers were 56.4 percent (S11, surgeons) to 87.44 percent (S8). Issues with S10 included 57.3% of the respondents being aware of classification as a risk-based method, and 41.1% being able to identify the categories of devices. One of the most difficult specific items within the studies was that of identifying Category C devices: in S1, they identified category C at 67.12 percent correct, and in S5 (only) 49.7 percent correct. These results demonstrate that the risk stratification principle is moderately well-understood, but the knowledge of granular classification is absent.

5.2.3 Knowledge of Who Can Report and How

There was a mixed nature in the understanding of reporter eligibility. Under S3, two in five (133 out of 200; 66.5%) postgraduates were aware that hospital technology managers and other healthcare professionals can report but a widespread awareness that anyone having direct or indirect information on the devices can report was low. In S8, 167/215 (77.67%) correctly made the inclusive reporter eligibility. In S15, 22% of respondents were aware of who is to report MDAEs. Among S14 (interns), 76.7% had the correct knowledge of the reporting system.  HCPs in tertiary institutions, which are parts of MvPI networks (S8: 79% knew all reporting methods), were more likely to know the reporting modalities than those in a community or peripheral setting. The lack of familiarity with the actual MDAE reporting form was a recurrent finding across the studies, with S10 (22.2% saw the form), S13 (pharmacy students, 65.25% had not seen the form) and S14 (interns, 63.3% had not seen the form) all reporting this.

5.3 Attitude Domain

5.3.1 Belief that Medical Devices Can Cause Adverse Events

Near-universal agreement existed across studies that medical devices can cause adverse events (range: 84–96.5%). In S1, 59.46% held a positive attitude toward MDAE reporting. S3 reported 95% acknowledged that medical devices could cause adverse events, and 96.5% believed reporting was essential. In S5 (surgeons), the mean attitude score was 82.4 ± 10.5, with 86.1% agreeing that HCPs bear a responsibility to report. In S14 (interns), 90% agreed that reporting every MDAE is an HCP’s responsibility, and 92.5% felt reporting should be compulsory.

5.3.2 Willingness to Report and Perceived Responsibility

Attitudinal willingness to report in future was high: in S10, 93.5% were willing to report; in S6 (Gujarat doctors), 94.25% were willing. In S12 (pre-post study, Karnataka), pre-intervention attitudes about MvPI training need were at 78% agreeing and improved to near-universal post-intervention. Notably, in S5, surgeons who had actually reported MDAEs had significantly higher attitude scores (mean 82.4 ± 10.5) compared to non-reporters (77.1 ± 11.2; p=0.024), confirming the attitude–behaviour link.

5.3.3 Curriculum Integration Attitudes

A strong consensus emerged across studies that materiovigilance should be integrated into undergraduate and postgraduate medical and pharmacy curricula. In S1, the majority of postgraduates agreed upon inclusion of materiovigilance in UG/PG curriculum. In S2 (pre-post study), 84% pre-workshop believed MDAE reporting should be included in induction programs; post-workshop this rose to 97.8% (p=0.00024). In S9 (Chennai HCPs), 76.81% felt MvPI should be taught in detail to HCPs. In S13 (pharmacy students), 92.37% believed reporting adverse events associated with medical devices is necessary.

5.4 Practice Domain

5.4.1 Actual MDAE Reporting Rates

The most striking and consistent finding across all 15 studies is the profound gap between positive attitudes and actual reporting behaviour. Reported MDAE reporting rates ranged from a mere 2% (S15, mixed HCPs Karnataka) to 25.5% (S5, surgeons). In S10 (496 medical professionals across TN and AP), only 12.1% had ever reported an MDAE — despite 93.5% expressing willingness to report. In S11 (Gujarat surgeons), 77.6% had never reported despite 94.7% agreeing that reporting improves patient safety. In S3 (200 postgraduates), only 22.5% had actually reported despite 96.5% believing it was essential.

The most representative population-level finding comes from S7 (370 healthcare workers, Gujarat), where the average knowledge score for doctors was 5.7/10 and for paramedical staff 3.76/10, and overall reporting rates remained very low, underscoring systemic deficiencies.

5.4.2 Familiarity with MDAE Reporting Form

Familiarity with the MDAE reporting form was uniformly low at baseline across all studies. In S1, only 20.54% had seen the reporting form. In S8, only 27.91% of the 64.19% who had noticed adverse events actually reported them. In S14, 63.3% of interns had not seen the reporting form. Post-educational intervention data from S12 showed dramatic improvement: from 16.6% to 91.2% familiarity with the MDAE form (p<0.001). In S2, post-workshop 100% of students were aware of the MDAE form compared to some pre-workshop.

5.4.3 Training in MDAE Reporting

Formal training in how to report MDAEs was received by a minority of participants in all baseline cross-sectional studies: 16.1% in S10, 19.5% in 5, 21.91% in S1, 35.8% in 14. After intervention in S2, trained participants rose from 7.4% to 78.7%. In S12, knowledge of who can report improved from 55.7% to 89.25% post-training (p<0.001).

5.5 Barriers to MDAE Reporting

Barriers identified across studies were categorized into individual, institutional, and systemic dimensions:

5.5.1 Individual-Level Barriers

Lack of knowledge about MvPI, reporting procedures, and the MDAE form was the most commonly cited individual barrier. Fear of litigation or punitive consequences was highlighted in S6 and S7, with the recommendation that educational campaigns clarify that reports cannot serve as the basis for legal action against reporters. Perceived futility — doubts about whether reports lead to action — affected both HCPs and consumers (S4: n=22 cited this barrier). Cognitive overload and time constraints in clinical settings were prominent in S6 (71.83% of doctors cited time constraints).

5.5.2 Institutional-Level Barriers

Absence of a hospital-level materiovigilance reporting culture, lack of institutional support, and absence of MDAE reporting centers in smaller hospitals were consistently cited. In S9, 169/220 HCPs supported establishing MDAE reporting centers in every hospital — suggesting recognition of this gap. Many institutions lacked a designated materiovigilance officer or coordinator.

5.5.3 Systemic and Tool-Related Barriers

The MDAE reporting form itself was identified as a barrier in S7 (Gujarat): the form was a lengthy five-page document available only in English, making it inaccessible to multilingual healthcare workers and patients. Absence of simple digital reporting platforms and lack of regional language materials further limited engagement.

Consumer-specific barriers (4) included: lack of knowledge about MvPI (n=37), doubts about report impact (n=22), unfamiliarity with reporting channels, and language barriers.

5.6 Consumer Perspective

Study S4 uniquely addressed consumer reporting — an understudied population in materiovigilance literature. Among 76 consumers enrolled from OPD/IPD settings at AMU, Aligarh, the majority had encountered adverse events related to medical devices either themselves or in their surroundings, yet only 9 individuals had ever reported. Primary barriers were lack of knowledge about MvPI (n=37) and doubts about whether reports would have any tangible impact (n=22). The study recommended public awareness campaigns, multilingual/multilingual reporting mechanisms, and social media-based MvPI engagement to empower consumer participation.

5.7 Educational Interventions

Two studies evaluated the effect of structured educational interventions on materiovigilance KAP. S2 (Bangal N et al., Maharashtra, 2025) conducted a pre-post workshop study with 94 second-year MBBS students. Post-workshop, awareness of MvPI rose from 14.8% to 96.8% (~0 p-value); awareness of who can report MDAE improved from 69.1% to 97.8%; and training experience increased from 7.4% to 78.7%. S12 (Binu KM et al., Karnataka, 2025) enrolled 307 multi-professional healthcare workers; post-educational intervention, knowledge of device classification improved from 21.5% to 92.83%, awareness of all reporters from 55.7% to 89.25%, and MDAE form familiarity from 16.6% to 91.2%, all with p<0.001. These results compellingly demonstrate that targeted education produces rapid, statistically significant, and clinically meaningful KAP improvements.

5.8 Population-Specific Summary

The stakeholder analysis indicates the different KAP profiles:

Postgraduate Resident: Intermediate level of baseline knowledge (4955%), high level of positive attitude (6096%), and low level of actual reporting (2223%). Close desire to take part in materiovigilance campaigns. More clinical experience latter senior PGs were more adherent to practice.

MBBS Interns: Good-moderate knowledge on classification and reporting systems (76.7%), and very positive attitudes (90% supported HCP responsibility), but very low training and reporting rates (35% had experienced MDAE, only a few had reported). Represent early training high-yield targets.

Medical Students (Undergraduate): The level of understanding of the specifics of MvPI is very low (14.8%), though very receptive to educational intervention (near-universal improve after workshop). There is the greatest potential benefit of curriculum integration.

Pharmacy Students: Attitudinal results were reasonably high (8992%), however 6580% had not actually viewed the MDAE form and had never reported. This is a serious loophole considering that pharmacists are the important reporters.

Surgeons: MDAEs were found in high proportions in surgeons; 4870% of the surgeons exposed to medical devices reported, and the reporting rates were 2526. Technical MDAE classification information was very scanty. Correlated reporting was also significant with knowledge and attitude scores (p<0.05) indicating that knowledge alone is not all that is needed without practice enablers.

Wide cadres’ variation (Multi-Cadres): Mixed Healthcare Professionals. The physicians performed higher in terms of knowledge compared to the paramedical employees. Dentists, physiotherapists and nurses were less aware of the baseline. The most drastic improvements were experienced in multidisciplinary educational programs.

Consumers: Low awareness and maximum obstacles. Literary underrepresentation; unique investigation (S4) showed that the knowledge of MvPI is almost completely missing when a practical reporting is involved. One of the large gaps in the system of materiovigilance in India.5.9 Summary of KAP Proportions by Population Type

Table 2: Pooled KAP Summary by Stakeholder Category