Diagnostic and treatment of patients are done using multiple medical devices. It is a complex task for researchers to create medical devices that are effective yet safe for human use.
Risk management is the process of identifying hazards and risk control. It is about identifying, analyzing, controlling, and preventing device failures that can cause hazards. These activities provide the foundation for generating risk-benefit analysis of the device; analysing the user, design, and production.
Risk analysis, or hazard analysis, plays an important role in medical device design. It is a structured way of identifying possible hazards associated with the design of medical devices.
Step 1: Risk Management Process
The first step is an exhaustive Risk Management Plan (RMP) detailing the activities associated with risk recognition, mitigation, and surveillance of the product life cycle.
RMPs should also include information collected from production and post-market surveillance, and the impact of that information should be evaluated.
Identify the hazards in these data, estimate the risks associated with them and, if necessary, modify control measures to reduce the risks.
Step 2: Risk Management Activities
A safety analysis starts with identifying product characteristics. Medical device manufacturers should identify and document those qualitative and quantitative features which may affect the device’s safety based on its intended use and intended purpose.
Manufacturers and RMPs should establish procedures to deal with hazardous situations under normal or faulty conditions.
Safety testing, proper choice of materials, sterilization validation, and thorough instructions for use are all ways to reduce the risks.
Step 3: Risk-Benefit Analysis
Generally, a risk-benefit analysis is a structured procedure to appraise any risks, including those which cannot be further reduced. Its purpose is to ensure that the medical benefits of the device outweigh any remaining risks.
After risk-benefit analysis and demonstration of preventive measures, risk index scores are re-evaluated after reducing the risk that cannot be mitigated.
Step 4: Risk Management Report
The risk management report or the risk analysis report of your medical device will summarize all risk management activities. This report should explain how the risk acceptability was determined and conclude by stating that overall residual risk is within acceptable limits.
Step 5: Post Market Surveillance
During the post-production process, experience gained from devices that have been placed on the market is collected from users, service personnel, and customers, so the information should become part of the technical product file.
Medical device risk management should begin early, as soon as conceptual designs are available. An initial hazard analysis can be useful in selecting concepts with a high level of inherent safety. An early design review will allow you to make changes without affecting the development schedule. Changes made later in the design process lead to fewer mitigation options.
Conducting risk analysis during the design of medical devices provides significant benefits and can often reduce the cost of risk-reducing measures.