The concept of Risk Management for Medical Device and In-Vitro Diagnostic Device is complex because of the diversity of collaborators including medical practitioners, the organizations providing health care, governments, industry, patients and members of the public.
It is to be understood by the collaborators that use of such devices involve a great degree of risk even if the risk is reduced to an acceptable level.
ISO 14971 assist the manufacturers of the medical device to identify the hazards associated with the medical device.
Risk Management for Medical Device is an integral part of the Medical Device Quality Management System (MD-QMS).
Risk Management for Medical Device includes establishment, implementation, documentation and maintenance of ongoing processes of Medical Device:
For each type of medical device, the Medical device Risk Management file is maintained.
The elements of the Risk Management file include:
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If during risk control option analysis, the manufacturer determines that risk reduction is not practicable, the manufacturer shall conduct a benefit-risk analysis of the residual risk. After the risk control measures are implemented, the manufacturer shall evaluate the residual risk using the criteria for risk acceptability defined in the risk management plan. If a residual risk is not judged acceptable using the criteria established in the risk management plan and further risk control is not practicable, the manufacturer may gather and review data and literature to determine if the benefits of the intended use outweigh this residual risk.
If the overall residual risk is judged acceptable, the manufacturer shall inform users of significant residual risks and shall include the necessary information in the accompanying documentation in order to disclose those residual risks.
The residual risks are communicated to the intended user in the information supplied to manufacturer- Instructions for Use and Label.
Both risk management and clinical evaluation are interdependent. As a part of clinical evaluation, all the clinical risks are identified and are integrated in the risk management file.
Risk Management is also linked with PMS activities. The manufacturer will collect information from various sources about the similar medical devices and other products on market and shall consider the information as an input to risk management. Also, the conclusions of the risk and benefit-risk analysis will be fed into PMS report and Periodic safety Update Report.
Software failure; exceptional misuse situations, such as sabotage or tampering with a medical device;
Novel hazards that are poorly understood, e.g. imprecise knowledge of the infectivity of the causative How to the agent of Bovine Spongiform Encephalopathy (BSE) prevents quantification of the risk of transmission;
Certain toxicological hazards, such as genotoxic carcinogens and sensitizing agents, where it might not be possible to determine a threshold of exposure below which toxic effects do not occur.
FMEA means Failure mode and effects analysis.
The various methods of risk analysis are:
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