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 »  Materials and Me...
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 Table of Contents    
Year : 2023  |  Volume : 55  |  Issue : 2  |  Page : 128-132

Reporting of adverse events related to medical devices: A single-center experience from a tertiary care institute of national importance in India

Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India

Date of Submission25-Jun-2021
Date of Decision21-Apr-2023
Date of Acceptance28-Apr-2023
Date of Web Publication03-Jun-2023

Correspondence Address:
Bikash Ranjan Meher
Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijp.ijp_495_21

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 » Abstract 

As frontline health workers, nursing professionals have a crucial role in reporting medical device-associated adverse events (MDAEs). A questionnaire-based study was carried out to evaluate the knowledge, attitude, and practice of senior nursing officers (SNOs), nursing officers (NOs), and nursing students (NSs) toward MDAE. The response rate of the survey was 84% (n = 134). The mean score of knowledge of SNOs, NOs, and NSs was 2.03 ± 0.92, 1.71 ± 0.96, and 1.52 ± 0.82, respectively (P = 0.9). A large proportion of study participants (97%) considered that the use of medical device could sometimes cause untoward occurrences and detecting and reporting those events will enhance the safety of patients. However, many of them (67%) have not reported it during clinical posting. The participants of this survey possessed limited knowledge of MDAE. However, their attitude toward MDAE was encouraging and a continuous training program may improve their knowledge regarding MDAE and enhance the reporting practice.

Keywords: Adverse events, adverse reactions, materiovigilance, medical device

How to cite this article:
Meher BR, Dash A. Reporting of adverse events related to medical devices: A single-center experience from a tertiary care institute of national importance in India. Indian J Pharmacol 2023;55:128-32

How to cite this URL:
Meher BR, Dash A. Reporting of adverse events related to medical devices: A single-center experience from a tertiary care institute of national importance in India. Indian J Pharmacol [serial online] 2023 [cited 2023 Oct 4];55:128-32. Available from: https://www.ijp-online.com/text.asp?2023/55/2/128/378030

 » Introduction Top

Medical devices have a pivotal role in the health-care delivery system by facilitating the diagnosis, monitoring, and management of diseases.[1] Rapid advancement in scientific innovation and technology has led to a surge in the use of both simple and complex usable medical devices in recent years.[2] The worldwide trade of medical devices has proliferated significantly in the past decade and half, i.e., from 260 billion US Dollars to over 380 billion US Dollars.[3] Similarly, India is an important emerging market and placed among the top 20 markets globally for medical devices and is expected to be a 20–30 billion USD industry by 2025.[4] A wide range of instruments, apparatus, machine, appliance, implant, software, material, or reagent for in vitro use which plays a pivotal role in the diagnosis, prevention, alleviation, or treatment of the disease constitute medical device.[5] Although medical device application is primarily safe, deaths, serious injuries, and malfunctions can occur occasionally.[6],[7],[8] The United States Food and Administration receives 1000 reports of confirmed or possible medical device malfunctions, serious injuries, and deaths every year.[9] Therefore, it is essential to report any suspected untoward occurrences following the use of a medical device to understand its safety and performance. “Materiovigilance is defined as the activities involving detection, collection, assessment, reporting, and prevention of any undesirable occurrences resulting from the use of medical devices by a well-coordinated surveillance system.”[10] In 2011, the International Medical Device Regulators Forum was formed to facilitate harmonization and convergence in medical device use worldwide.[11] The Government of India also started the Materiovigilance Program of India (MvPI) on July 6, 2015, to generate credible data regarding device-related safety issues and to protect the health of its citizen.[12] The Indian Pharmacopoeia Commission (IPC) was established with the objective to promote the highest standard for drugs in human functions as the national coordination center for MvPI.[13] Under the egis of this program, many medical colleges and health-care facilities across the countries have recognized as medical device adverse event monitoring centers to facilitate the collection and reporting of medical device-associated adverse events (MDAEs).[3] This program has also empowered health-care professionals, device manufacturers, importers, and users to report any MDAE encountered by them. Despite all these measures, MDAE reporting in India is far from satisfactory. Only 1931 MDAEs were reported to IPC between July 2015 and October 2019, and most of them (75%) were reported by marketing authorization holders.[3] Lack of awareness among medical and nursing professionals about materiovigilance might be an important reason for the underreporting of MDAE. Hence, this study was carried out to evaluate the knowledge, attitude, and practice (KAP) of nursing officers (NOs) and nursing students (NSs) regarding reporting of MDAE.

 » Materials and Methods Top

Study site

We carried out this study in an institute of national importance situated in the eastern part of India.

Study design and study population

The study was a cross-sectional study conceptualized to evaluate the KAP of nursing professionals regarding any adverse events occurred following the use of different medical devices. NOs and NSs were included as study participants after obtaining their written informed consent.

Ethical issue

We started this study after obtaining the approval of the Institutional Ethics Committee of AIIMS, Bhubaneswar (T/IM/NF/Pharm/20/94 dated August 10, 2020).

Study duration

The study was conducted between October and December 2020 (3 months).

Study tool

A structured questionnaire was prepared by the investigators following the relevant literature.[14],[15] The survey questionnaire was comprised of two segments. The first segment included questions regarding the demographic profile of study participants, whereas the second segment consisted of 14 questions (open and closed ended) pertaining to the KAP domain of MDAE. The content validity of the study tool was conducted by a panel comprising medical pharmacologists and biomedical engineers to ascertain the pertinence, precision, and directness of questionnaire. Cronbach's alpha (α = 0.79) was calculated to evaluate the reliability of the study tool. Pilot testing of the study tool was carried out among 20 NOs and students to assess the relevance, usefulness, and lucidity of questions. Based on the feedback survey, the questionnaire was modified.

Study procedure

The modified study questionnaire was disseminated among the respondents, and their reply was collected and evaluated. Knowledge of the participants regarding materiovigilance was evaluated by a scoring system. Each appropriate response was awarded with a score of 1, whereas no score was given to an inappropriate response. The mean score of knowledge-related questions was estimated and compared between the three groups of study participants. Closed-ended questions which can be replied by simple “yes or no” were used to evaluate the attitude and practice of the NOs and students.

Statistical analysis

All the relevant data were entered into the Microsoft Excel sheet and analyzed using Statistical package for the social sciences software (SPSS version 20.0, IBM SPSS inc., Chicago, IL, USA). Continuous and categorical data were represented as mean ± standard deviation and proportion, respectively. One-way analysis of variance and Chi-square test were used for evaluating the difference between study groups. Assuming that 10% of the respondents were aware of materiovigilance, a sample size of 139 was required to produce a 95% confidence interval of 5% precision.

 » Results Top

Demographic data

The questionnaire was dispersed to 160 participants, and out of which, 134 returned the completely filled questionnaire. The study participants consisted of three groups: 30 senior NOs (SNOs) in Group I, 75 NOs in Group II, and 29 NSs in Group III. Seventy-eight of them were male, and 56 were female.

Knowledge-related questions

There were four questions about the knowledge of medical devices and MDAE. Among the respondents, 15 (50%) SNOs, 24 (32%) NOs, and 15 (49%) NSs correctly indicated the ongoing national program of India for monitoring adverse events related to medical devices (P = 0.08). Similarly, only 18 (60%) SNOs, 38 (51%) NOs, and 14 (49%) NSs correctly mentioned the basis of device classification in India (0.61). The summary of participants' responses to knowledge-related queries is described in [Table 1]. The mean knowledge score of SNOs was more than NOs and NSs. However, the difference in knowledge scores between the three groups was not statistically significant (P = 0.09) [Table 2].
Table 1: Response of participants to knowledge-based questions

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Table 2: Comparison of mean knowledge score (maximum=4) between three groups

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Attitude- and practice-related questions

Ten questions were asked to assess the attitude and practice of participants toward MDAEs. The study revealed that a large number of the participants, 25 (83%) SNOs, 68 (90%) NOs, and 59% NSs, considered MDAE reporting as a professional obligation (P = 0.01). Similarly, 30 (100%), 71 (95%), and 28 (97%) of SNOs, NOs, and NSs, respectively, regarded that adverse event reporting will enhance patient safety (P = 0.42).

As far as the practice of MDAE is concerned, the significant proportion of participants (66% SNOs, 64% NOs and 48% NSs) expressed that they had encountered malfunction of devices on few occasions during their duty. However, only 43% of SNOs, 40% of NOs, and 16% of NSs played some role in reporting such events. The majority of the participants had neither seen any medical device reporting form nor attended any training on materiovigilance. The detailed data of attitude- and practice-based questions are depicted in [Table 3].
Table 3: Response of participants to attitude- and practice-related questions

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 » Discussion Top

Materiovigilance is a relatively new concept and materiovigilance program was launched in India in 2015. There is a lack of sufficient data with respect to the understanding and behavior of medical practitioners and other health-care personnel toward adverse event reporting related to medical devices. As far as we are aware, this study was the first study carried out to evaluate the KAP of nursing professionals in India regarding reporting of MDAE.

In this study, only 40% of the respondents acquainted about the ongoing program started by the union government to report MDAE. The majority (65%) were not aware of the types of MDAE to be reported and where to report it. This limited knowledge suggests that, unlike adverse drug reaction reporting, MDAE reporting has not received wider attention among nursing professionals. In this study, almost 65% of participants mentioned that they had encountered malfunctions and other untoward occurrences during the use of medical devices, but the majority of them (78%) have not reported these events. This low rate of reporting could be attributed to factors such as lack of knowledge about reporting procedures and unawareness about the existing system for reporting any untoward events associated with medical devices. It may also be because reporting of MDAE is not mandatory for health-care professionals. Underreporting of MDAE by health-care professionals was also reported in few studies conducted in India and elsewhere.[14],[16] Large proportion of participants (79%) in this study had not seen the MDAE reporting form prepared by the Central Drugs Standard Control Organisation for collecting information on MDAE in India.

Similarly, 83% of participants had not attended any training or workshop on materiovigilance. These findings agree with few other studies on medical professionals' KAP about materiovigilance and factors influencing reporting of MDAE.[14],[17] The likely explanation for the lack of exposure and training of study participants of this study is that materiovigilance is not included in the nursing curriculum of India. Moreover, no training is imparted to NSs on MDAE during their undergraduate and postgraduate training periods.

Despite limited knowledge and lack of training, participants in this study demonstrated a positive attitude toward adverse event reporting. Many of them felt that MDAE reporting could enhance patients' safety and it is their professional duty to report them. If this positive attitude can be reinforced by continuous training, it may foster a reporting culture among nursing professionals, which will eventually enhance adverse event reporting. The medical device adverse event monitoring centers and adverse drug reaction monitoring centers spreading across India can take the lead in conducting training programs for nursing and other health-care workers with the guidance and cooperation of the IPC.

 » Conclusion Top

MDAE reporting practice among Indian nursing professionals is not yet fully established. Most of the respondents indicated a lack of familiarity with the existing reporting system MDAE. However, they displayed a positive mindset toward adverse event reporting despite a lack of adequate knowledge and training. MDAE reporting among nursing professionals might increase if knowledge and skill are imparted to them through continuous educational intervention programs.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

 » References Top

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Handa N, Ishii K, Matsui Y, Ando Y. Reporting of cardiovascular medical device adverse events to pharmaceuticals and medical devices agency, Japan. EBioMedicine 2015;2:1211-6.  Back to cited text no. 2
Shukla S, Gupta M, Pandit S, Thomson M, Shivhare A, Kalaiselvan V, et al. Implementation of adverse event reporting for medical devices, India. Bull World Health Organ 2020;98:206-11.  Back to cited text no. 3
The Medical Devices Sector Plays a Critical Role in Improving Healthcare Access. However, the Ecosystem is Currently not Conducive for the Sector to Drive Accessibility and Affordability. Available from: https://www2.deloitte.com/content/dam/Deloitte/in/Documents/life-sciences-health-care/in-lshc-medical-devices-making-in-india-noexp.pdf. [Last accessed on 2021 Mar 12].  Back to cited text no. 4
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Wawrzynski J, Gil JA, Goodman AD, Waryasz GR. Hypersensitivity to orthopedic implants: A review of the literature. Rheumatol Ther 2017;4:45-56.  Back to cited text no. 6
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:e000155.  Back to cited text no. 7
Machado-Alba JE, Cardona-Trejos EA, Delgado-Pascuaza YL, Torres-Bahamon DR, Portilla A. Adverse events associated with medical devices in patients at different clinics and hospitals in Colombia. J Patient Saf Risk Manag 2019;24:245-50.  Back to cited text no. 8
FDA Regulation of Medical Devices. Available from: https://fas.org/sgp/crs/misc/R42130.pdf. [Last accessed on 2021 Mar 14].  Back to cited text no. 9
Kumar P, Kalaiselvan V, Kaur I, Thota P, Singh GN. Materiovigilance programme of India (MVPI): A step towards patient safety for medical devices. Eur J Biomed Pharm Sci 2016;12:497-501.  Back to cited text no. 10
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Meher BR. Materiovigilance: An Indian perspective. Perspect Clin Res 2018;9:175-8.  Back to cited text no. 12
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  [Table 1], [Table 2], [Table 3]


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