Insights for a Safer Future: A Comprehensive Summary of Medical Device Alerts in India

Introduction: Patient safety is a top priority for regulatory authorities in India. The Materiovigilance Programme of India (MvPI), monitors reporting of Medical Device Adverse Events (MDAEs) and mandatory device recalls [1]. The Medical Device Rules 2017 and guidelines on safety and performance fur...

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Bibliographic Details
Published in:Drug safety 2023-11, Vol.46 (11), p.1236-1237
Main Authors: Ziaudeen, Z, Jesiah, S, Anusha, D, Haran, V H
Format: Article
Language:English
Subjects:
Biomedical engineering
Complications
Cybersecurity
Decision analysis
Decision making
Federal regulation
Health care
Industrial safety
Information processing
Internet
Manufacturers
Medical device industry
Medical devices
Medical electronics
Medical equipment
Medical technology
Optics
Patient safety
Patients
Product design
Product names
Quality control
Regulatory agencies
Safety
Trend analysis
Trends
Vigilance
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Summary:Introduction: Patient safety is a top priority for regulatory authorities in India. The Materiovigilance Programme of India (MvPI), monitors reporting of Medical Device Adverse Events (MDAEs) and mandatory device recalls [1]. The Medical Device Rules 2017 and guidelines on safety and performance further strengthen the regulatory framework. The Central Drugs Standard Control Organization (CDSCO) manages medical device alerts [2]. Analysis of medical device alerts in India is essential for identifying patterns and recurring issues, leading to improvements in patient safety. Manufacturers can utilize this information to enhance product design and quality control. Hospitals can evaluate device safety, ensuring optimal patient well-being. Thus, it is imperative to analyse the released medical device alert data in India for informed decision-making and continuous enhancement of healthcare standards [3-6]. Aim: To analyse CDSCO's medical device alerts in India and identify trends, patterns, common issues, changes in alert frequency, prevalent device types and recurring safety concerns. Methods: An interprofessional team comprising a pharmacologist, biomedical engineer, healthcare management specialist, and materiovigilance expert conducted a retrospective descriptive study. They analyzed medical device alerts data from CDSCO's website (December 2013 to May 2023). The team categorized the data into tables based on parameters such as Year, Product Name, Manufacturer, Recall Reason, Possible Risks, Description, Issue, Death, Action by. Adverse Effects, and Recommendations. Their analysis identified patterns and trends, providing a comprehensive assessment of the alerts. Results: 22 medical device alerts were identified from 2013 to May 2023 .The trend analysis reveals an increasing number of medical device recalls in recent years, particularly in 2021, 2022, and 2023.. The recalls involve various manufacturers, including Medtronic, Baxter Healthcare Corporation, HOYA Surgical Optics, Cordis, Abbott, and Philips India Limited. Reasons for recalls vary and encompass technical, design, manufacturing, cybersecurity risks and safety concerns. The risks associated with the recalled devices range from minor scratches to serious health complications. Conclusion: Advancements in technology, improved reporting systems, and increased awareness have led to a rise in medical device recalls. This widespread issue involves multiple manufacturers, highlighting the need for industry
ISSN:0114-5916
1179-1942