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Digemid Analyzes Over 2,300 Reports of Adverse Medical Device Incidents in 2023 to Enhance Patient Safety

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In an effort to bolster patient safety, the General Directorate of Medicines, Supplies, and Drugs (Digemid) of Peru’s Ministry of Health, through its National Center for Pharmacovigilance and Technovigilance (Cenafyt), has rigorously analyzed 2,360 reports of adverse incidents related to the use of medical devices in 2023. These reports were primarily submitted by healthcare professionals and holders of health registrations, highlighting ongoing concerns about the safety of such devices on the national market.

Kelly Serrano, the head of Cenafyt at Digemid, emphasized that adverse incidents can occur due to a variety of factors, including malfunction, misuse, or changes in device characteristics. “Adverse incidents are undesirable events that cause harm to patients, users, or operators. Addressing these incidents promptly ensures the continued safety and efficacy of medical devices in healthcare settings,” she explained.

Enhancing Safety and Oversight: Digemid’s Rigorous Analysis of Medical Device Incidents in Peru

The analysis conducted by Cenafyt is a critical part of the Peruvian System of Pharmacovigilance and Technovigilance, which serves a dual purpose: to maintain a vigilant oversight over pharmaceuticals and medical devices, and to implement preventive measures that mitigate risks associated with their use.

The initiative to scrutinize over 2,300 reports demonstrates a robust commitment to healthcare safety and transparency. By encouraging continuous reporting from healthcare providers and other stakeholders, Digemid aims to create a feedback loop that not only identifies potential risks but also helps in formulating strategies to reduce these risks before they lead to more severe outcomes.

The proactive steps taken by Digemid reflect a broader trend towards greater regulatory oversight of medical devices worldwide. As medical technology evolves, so too does the complexity of potential risks, making it essential for regulatory bodies like Digemid to stay ahead of possible complications through meticulous monitoring and swift action.

Medical Device

Vigilance and Public Trust: Digemid’s Role in Enhancing Medical Device Safety and Healthcare Outcomes

This vigilant approach has significant implications for public health policy. By ensuring that medical devices are as safe as possible, Digemid is not only protecting individual patients but is also upholding public confidence in the healthcare system. Effective pharmacovigilance and technovigilance are crucial in maintaining the delicate balance between technological advancement and patient safety.

The commitment of Digemid and Cenafyt to evaluate and act on these adverse incident reports is a testament to their dedication to improving healthcare outcomes. It also serves as a model for similar institutions in other regions, emphasizing the importance of active surveillance systems in the dynamic field of healthcare.

In conclusion, while the challenges posed by medical device incidents are complex, the rigorous analysis and responsive actions of bodies like Digemid are essential in managing and mitigating risks, ensuring that the health benefits of medical devices far outweigh the potential harms.

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Resource: General Directorate of Medicines, Supplies, and Drugs, May 06, 2024

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