Importance of Risk Communication and Risk Analysis in Medical Device Industry

Akash Sharma,Gaurav Luthra

doi:10.9734/jpri/2021/v33i31a31662

Abstract

In medical device industry the risk management plays a very vital role. There should be proper communication from each and every stakeholder related to risk management of each respective department, it can be Production, Design and Development or Quality Control and all other departments. In this current research work the role of risk analysis which had been done accordingly ISO 14971 for risk management of medical device using FMEA is implemented. FMEA (Failure Mode and Effects Analysis) plays important role in risk analysis by having several steps for mitigation of risk. Also it had been used for identifying hazard of each risk throughout the lifecycle of the medical device. Risk communication should be advanced so, that the risk identified can be easily controlled by taking appropriate risk control measures. In any medical device industry risk analysis should be done properly and as well the risk communication channel should be strong for proper and immediate action. In this research paper practically the role of Risk communication and risk analysis is covered. Risk management of any of the organization can only be effective if the risk analysis is done strongly and the communication related to risk is proper. In this research FMEA analysis for risk analysis is done on a medical device and also the communication from risk manager to the other entire stakeholders of the risk management from various departments are fully taken into the consideration.

Highlights

Risk Management is the process of identifying, assessing, mitigating, monitoring, controlling, and reporting risks
Risks related to device must be identified and documented based on the methodology in: Risk management in medical devices are considered as the vital part through which the risk is first predicted and analyzed and by applying certain risk control measures the risk is mitigated from the whole loop
Risk management in medical device industry is a days mandatory by the government, without controlling the risk associated with medical device, no industry can supply any of the medical device without identifying the hazards and controlling them and documenting the same in the risk management file

Summary

Introduction

Risk Management is the process of identifying, assessing, mitigating, monitoring, controlling, and reporting risks This Risk Management Plan defines how risks associated with the various medical devices manufactured by KAULMED are primarily identified for the various risk and the risk associated with different medical devices produced are fully analyzed with the point of view of all risk hazards, that can take place during the designing phase as well production and post production. These identified associated risks with that product are mitigated to its possible range, the risk is controlled throughout the process of manufacturing of the medical device. Risk is defined as per ISO 14971:2019 that it is a combined probability of occurrence of the harm and the severity level of that harm and harm is defined as the physical impact on the health of the people or damage to the property or the environment [1,2,3]

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Results

Conclusion