Medical Device Risk Analysis
Made on medical devices; It is an evaluation on knowing the error, risks or other possible negative situations, detecting them beforehand, or minimizing the occurrence of a bad situation. In particular, any product used in the health sector carries a risk factor, which may have irreversible consequences. Because of this, every evaluation to be made should consist of studies that require delicacy and meticulousness and applied.
General definition of risk analysis; the risks that may arise during the functions of the enterprises are defined and evaluated carefully and in detail, and taking measures to minimize or completely eliminate these risks. Another definition is; estimating the magnitude of risk in all processes and deciding whether the risk can be tolerated.
All processes related to product safety and performance should be planned based on risk analysis and managed within the scope of emerging standards. All studies on this subject should be included in the Risk Analysis file.
The factors that need to be mastered in order to carry out risk analysis studies are given below.
- Storage of the product
- User and usage characteristics
While creating a medical device risk analysis file, it is necessary to have a good grasp of standard information, regulations and clinical information. Risk analysis does not only cover the evaluations within the company or about the process. The contents of this file are given below with examples.
- Regulations on the use of medical devices
- Examples and evaluations of the risks encountered or to be encountered
- Systematic methods on how to proceed in terms of decision making
- It has been developed with standard features and mostly for medical device manufacturers. Associated with medical devices; It also serves as a guide for other persons or organizations in the sector.
- File plays an active role in the risk management process and in the development of this process.
Medical device risk analyzes fall under the scope of medical product risk management. Some of the purposes of this regulation;
- To define the conditions that medical devices must meet before being placed on the market
- Establishing conformity assessment procedures according to device classifications
- Monitoring and reporting to national authorities of existing mechanisms to protect public health
A few of the reasons for performing a medical device risk analysis are given below.
- Evaluation of the device-related situations by the manufacturer
- Minimizing risks
- Implementation of assessments
The topics that need to be created for risk analysis that need to be done in a different scope for each medical device are given below.
- Description of the device
- Description of the device
- Numerical characteristics of the device
- Determining the intended use of the device
- Indication of foreseeable hazards and conditions of occurrence that vary according to normal and incorrect use of the device
- Determining the probability and risk levels of the damages that will be caused by each hazard situation.
Some of the steps that the medical device risk analysis should have are given below. For more detailed information, the regulation should be examined step by step or experienced organizations should be contacted.
- All potential risks in the product lifecycle should be estimated and evaluated. Planning this is the task of the risk analysis team.
- Risk estimates should be made for all risks.
- Risk analysis; It includes risk estimation and hazard definition. Since risk is defined as the severity of a hazard and the probability of its occurrence; The risk estimation is mostly based on an assessment consisting of the level of risk and the probability of it happening. Serious risks that need to be prioritized will emerge in this way.
- Risk analysis; It also benefits from historical risk analyzes of equivalent products. In this regard, it is necessary to record all the findings, which determine the persons and institutions performing the analysis, the scope of the analysis and the review criteria.
- Analysis process; It is a process that is recorded in the risk management document. Therefore, every work done during the evaluation and every data that emerges should be reported.
- If the risks that cannot be reduced by the risk control steps during the analysis do not reach acceptable levels, the producer; can accept that the benefit of the product outweighs the risk by making use of the literature and data. This will be beneficial in terms of completing risk control in a way that informs users and patients.