Types of Risk Analysis in Medical Devices.

Risk management is an important part of the medical device product development lifecycle. It helps medical device manufacturers to ensure that the final product is reliable, works as expected, and causes no harm. The main purpose of the risk management process is to reduce or mitigate the chances of failure in the product.

The one most people are familiar with is risk analysis associated with the design of a medical device.

The following are Types of Risk Analysis –

1.       Design Risk Analysis -  Risk analysis is the first type of risk analysis we are reviewing in this article. The most common types of design risk analysis are the design failure modes and effects analysis (dFMEA) and the fault-tree analysis (FTA). The dFMEA is typically preferred by engineers on a development team because they designed each of the components. However, during a complaint investigation, the FTA is preferred. Therefore, the dFMEA or the FTA will need to be reviewed and updated as post-market data is gathered. If a change to the risk analysis is required, it may also be necessary to update the instructions for use to include new warnings or precautions to prevent user errors.

 

2.       Process Risk Analysis - The purpose of process risk analysis is to minimize the risk of devices being manufactured incorrectly. The most common method of analyzing risks is to use a process failure modes and effects analysis (pFMEA). You begin by identifying all of the possible failure modes for each manufacturing process step. Next, the effects of the process failure are identified. After you identify the effects of failure for each process step, the severity of harm is estimated.

 

3.       Software Hazard Analysis - Software hazard analysis is becoming more important to medical devices as physical devices are integrated with hospital information systems and with the development of software as a medical device (SaMD). It is only necessary to identify hazards and estimate harm. Therefore, the FDA recommends that you assume that the failure will occur and estimate software risks based on the severity of the hazard resulting from the failure.

IZiel Healthcare team uses the structural approach defined by ISO 14971 to construct the risk management file. The risk management file starts with drafting the risk management plan; it consists of the methodology of a risk management process and risk policy. Afterward, hazards, hazardous situations and harm are determined using tools like FMEA (pFMEA and dFMEA) and hazard analysis. The identified risks are then controlled or mitigated by applying risk control and the evaluation of residual risk then follows it. If the residual risk is not acceptable, then a risk versus benefit analysis is carried out.

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