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Background: Post marketing surveillance of medical devices has to be done to avoid injuries and it is highly required to evaluate and ascertain the risks and benefits associated with the medical devices. Aims and Objectives: The aim of the study was to assess the knowledge and attitude about materiovigilance among doctors working in a tertiary care hospital. Materials and Methods: A cross-sectional study involving faculty and postgraduate residents of a tertiary care hospital using questionnaire which had 12 questions pertaining to attitude and knowledge of materiovigilance. Results: The survey questionnaire was sent to 300 health-care professionals among them, 259 respondents completely answered the questions. There were 96 teaching faculty, 163 were postgraduates residents. The average response rate was 86.3%. There was no statistical significant difference seen between the two groups (P = 0.85). Conclusion: More workshops and training programs need to be conducted to create awareness and reporting of adverse reactions due to medical instruments.
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Background: Post-marketing surveillance regulates the safety, quality, and performance of medical devices (MDs). Medical professionals play a key role in the monitoring and reporting of MD Adverse Events (AEs). Since the launch of Materiovigilance (MV) Programme of India, very few published studies were found regarding reporting of MDAE. Aim and Objective: This study aims to know about awareness and outlook of medical professionals regarding MV. Materials and Methods: A cross-sectional study done among medical professionals of various specialties in a tertiary care teaching hospital in South Rajasthan. A pre-validated questionnaire was circulated to 200 doctors containing questions related to knowledge, attitude and practice of MV. Results: About 58.6% of the doctors came to know about the term MV during this study. About 76.7% of participants knew that MD could lead to an AE, but only 11.2% of the participants had the correct knowledge of how to report an AE related to MD. About 66.8% of participants had positive attitude regarding reporting of AE, 23.7% reported the event and 66.6% did not report as they found them mild. Conclusion: Majority of doctors had the knowledge about reporting of AEs, but they were largely unaware of the term MV. Knowledge regarding where to report is very limited. Despite adequate level of knowledge, reporting practices are very limited. Hence, there is a need for regular sensitization and training programs to foster the habit of reporting AE related to MD even if they are mild.
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Background: Medical devices which are now employed in all areas of health care have played a crucial role in patient care. Although, their use is not without risk. Materiovigilance refers to close monitoring for any medical device-associated adverse events by a well-coordinated surveillance system of detection, collection, assessment, reporting, and prevention of adverse events. Aim and Objective: The aim of the study was to assess the knowledge, attitude, and practice (KAP) of materiovigilance among medical surgeons of Gujarat. Materials and Methods: This was an observational, cross-sectional, and questionnaire-based study, conducted among practicing medical surgeons of Gujarat, India. A structured self-administered Google form-based questionnaire in the English language was prepared to collect the relevant data of the study variables. The questionnaire contained a total of 17 questions related to KAP aspects of the materiovigilance. The questionnaire was distributed to the study participants through a digital web link using various social media platforms and their responses were collected. Results: A total of 156 participants responded. Nearly, 71.8% of the participants had an idea about various reporting systems in India to report medical device-induced adverse events, but only 31.4% of the participants were aware of India’s current program for monitoring adverse events. Very few (9%) participants had reported adverse events during their practice. Whereas, 77.6% of the participants were willing to report a medical deviceinduced adverse event in the future. Conclusion: Participants in our study were found to be lacking adequate knowledge and practice of materiovigilance. However, they showed a positive attitude toward materiovigilance. Various educational interventions and training are required to promote the reporting of medical device-induced adverse events.
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Background: A materiovigilance program is a system that is used for the identification, collection, and reporting of possible adverse reactions resulting from the use of medical devices. This monitoring program ensures the safety of patients and aids the post-marketing surveillance process. The Materiovigilance Programme of India (MvPI) was launched on July 6, 2015. Aims and Objectives: The primary objective of the study was to generate evidence based data on the safety of the medical devices used in our institute and to analyze the risk benefit ratio of reported adverse events of medical devices and to communicate the safety information to the stake holders. The secondary objective was to educate and advocate the concept of MvPI and creating a culture of adverse events reporting among health workers. Materials and Methods: A retrospective study was conducted after receiving clearance from the Institutional Ethical Committee, Saheed Laxman Nayak Medical College and Hospital (SLN MCH), Koraput. Data about Medical Device-Associated Adverse Events (MDAEs) were collected from MDMC, SLN MCH, Koraput, for the period from October 2019 to February 2022. MDAE reports were collected by a materiovigilance associate during the period from October 2019 to February 2022. Events were reviewed to verify whether or not they were documented in patient’s electronic records and a database of devices was created, which included the events associated with each device. Device-related MDAEs were classified by patient characteristics and the medical devices used. Results: In the 15-month study period, a total of 56 cases of MDAE were reported to MDMC, SLN MCH, Koraput. Of these, 17.9% MDAEs (10 cases) were adverse events related to surgical gloves, 8.9% (five cases) were associated with pulse oximeters, 7.14% of cases (4 cases) were due to glucometer malfunctioning, and 7.1% were related to HIV diagnostic kits such as false positives and false negatives. Adverse events such as skin rashes, irritation on skin, itching, redness of eyes, and gum bleeding in patients with dental braces were reported. A majority of device defects involved inaccuracy in the data reported by the devices (seen in 10.7% of cases), while six cases were due to device malfunctioning. Conclusion: This study shows only the tip of iceberg of the reporting trends of MDME. There is inequality in reporting by different grades of health care workers and from different departments. It highlights the necessity of conducting awareness programs, training and workshops regularly. Device-related safety and reporting of device-related adverse events should be subject of attention and further research.
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Background:The term “medical device” includes a broad classification of production ranging from therapeutic medicinal devices withlocal uses tohighlyadvanced electronic medicalequipmentandindicativemedicaldevices. These devices vary widely in their production, type and are highly essential for patients’ care. Thus, their manufacturing, distribution, and sales must be managed to ensure their quality, safety, and efficacy. They play a major role in to detection, assessment and management and treatment of many different diseases. That being said, the quality of devices can very different and even the perfectly articulated products can fail in clinical practice. Post-market surveillance istherefore essential to ensure the quality and evaluate the safety and performance of medical devices. Despite the importance placed on surveillance of drug safety, the need for better monitoring of medical device-associated adverse events receives less attention. A well-structured vigilance system is the backbone of a robust regulatory framework to ensure the quality and promote the safe use of medical devices. The regulation of medical devices, however, is a complex and constantly evolving area that is often complicated by legal technicalities. Although the regulations may differ from one country to another.
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Today’s medical devices are the lifesaving tool and these tools are very frequently used globally since long ago. With the increase in the number of medical devices and their uses, there is an increase in the number of adverse events related to such devices. That is why Materiovigilance is an important tool for the identification, collection, reporting, and analysis of any aversive catastrophe related to the use of medical devices and protection of a patient’s life by fending its reiteration. Post marketing surveillance of medical devices has been initiated in many countries, like the United States of America has started a program under the name Medical Device Reporting (MDR), France, Australia and the United Kingdom have also come up with their own programs. Apart from this India has also initiated the Materiovigilance program by Drug Controller General of India (DCGI) at the Indian Pharmacopoeia Commission (IPC) in Ghaziabad in 2015. In this article we have discussed about the risks associated with the use of different classes of medical devices and the need of Materiovigilance program. This article also discusses the adverse events associated with the medical devices, the reporting criteria of those adverse events and the different clinical events of the medical devices.
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The main objective of study is to compare the adverse drug reactions (ADRs) of Zidovudine and Stavudine containing regimens. It is a prospective observational study conducted in the ART centre of a tertiary care teaching hospital in central India. The data collected were recorded on standard ADR reporting forms. Standard scales were used for assessment of ADRs. In twelve months duration total 263 patients on ART were observed for ADRs. 128 patients on Stavudine based regimen and 135 patients were on Zidovudine based regimen. Total 72 ADRs detected in 68 patients. Incidence of ADRs was more in Zidovudine based regimen. Zidovudine associated with early and mild ADRs while Stavudine associated with late and distressing ADRs. Considering the magnitude of ADR related problems, results support the discontinuation of Stavudine based regimens