- ISSN: 2210-299X
- E-ISSN: 2210-3007
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oa A Decade of Medical Device Safety: Adverse Event Reports Submitted to CDSCO
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Authors:
Sagarika Majhi1
and Lubhan Singh2
- Source: Current Indian Science, Volume 3, Issue 1, Jan 2025, E2210299X411835
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- 03 Jun 2025
- 27 Aug 2025
- 29 Oct 2025
Abstract
Medical device-related adverse events can significantly impact public health by influencing patient safety and medical expenses. More adverse occurrences have been documented due to our growing dependence on medical technology. These incidents can have major repercussions for patients, such as death or serious damage that necessitates surgery. Prompt reporting of these adverse occurrences is crucial for the quick detection and correction of any device malfunctions, reducing patient risks, as stressed by medical specialists. The risk of adverse events is increased by the complexity of medical devices, which includes differences in user interactions, software dependability, and manufacturing quality. To guarantee that devices operate accurately and safely throughout their lives, effective risk management is essential.
Maintaining public health requires constant observation and reporting of unfavorable occurrences. By allowing regulatory bodies and healthcare practitioners to monitor device performance in actual environments, these procedures guarantee that problems are resolved before they become more serious public health emergencies. The Materiovigilance Program in India (MvPI) was created to track adverse occurrences linked to medical devices, produce safety statistics, and promote the best practices to improve patient safety. When medical equipment violates regulations or poses possible threats to patient safety, recalls are essential measures that must be performed. These programs promote accountability and openness in the healthcare system by evaluating recall and adverse event data, which helps guide regulatory choices and raises the general caliber of medical devices on the market. Although precise statistics on the types of adverse events reported to the Central Drugs Standard Control Organisation (CDSCO) are not made public, this article cites typical difficulties, including potentially harmful device malfunctions, incorrect device operation, and unpleasant interactions between the device and the patient.
