Risk management is mostly defined as the systematic applications of management. Risk management is to be integrated with different activities like device design control activities and other compliance activities. The main importance of applying risk management to medical devices is to provide the patient with safety. In risk management, the risk evaluation process is a key step.
1.1 Risk Management Procedures
Risk management involves a three-step procedure:
1) Hazards Identifications:
The hazard identification process should account not only for hazards directly related to the medical devices, such as designs and manufactures, but this is also used in the clinical worlds.
2) Risks Assessments:
In risk management, it includes some difficulties of risk assessments are difficult of measurement of the quantities, potential loss and probability of occurrence. There is more chance of errors to measure these contents . Risks with more potential loss and a less probability are often treated differently from other less potential loss. In practically, it is more difficult to manage, but in theory. it is nearly equal priority. The risk assessments face many problems like rareness of resources, specifically time.
3) Risks Mitigation:
Risks mitigation is the process of an organization defining the measures to minimize or the process by which an organization introduces specific measures to minimize or remove unnecessary risks and operations. Risk mitigation is also the process of developing some options and actions to increase opportunities and reduce damage to project objectives. Risk mitigation handling options include:
Acknowledge the existence of risks, make decisions about medical devices and accept them without engaging in special efforts, which is controlled.
Adjust program requirements or constraints to eliminate or reduce the plan risks. This is used to avoid the financial or technical problems.
Reassign organizational accounts and responsibilities and provide the authorities to different people who have the ability to accept the risks
Monitor the environment for changes that affect the nature and/or the impact of the risk.
Implement actions to minimize the impact or likelihood of the risk.
1.2. Principles of Risk Management
The organization identifies the following principles of risk management:
1.3. Risk Management Process
Medical devices are providing risk analysis services. Risk analysis is a structured tool for the evaluation of potential problems. Risk analysis could be encountered in connection with the use of anything, like driving a car or using medical devices. Risk analysis of medical devices includes:
2.1 Why should we perform risk analysis?
2.2 Ways of Risk Analysis
1) Hazard Identification: Toltec has experience with many types of medical devices and can assist you in understanding what hazards exist. The main examples of risk analysis of medical devices are as follows:
3.1 Hazard Detectability
Hazard detection accounts for the likelihood of discovering and correcting a hazard or failure mode prior to an incident. Detection of hazards provides an inverse relationship between the level of detectability and the degree of risk seriousness. Detectability should then be scaled such that increasing scores denote a decreasing likelihood of hazard detection.
3.2 Hazard Correctability
The hazard correctability factor rates the relative ease of mitigating a certain risk. It accounts for the associated feasibility and effort required in reducing a particular risk to the lowest practicable level. In other words, in assessing the level of hazard correctability, both the availability of technical solutions and their economic feasibility and budget constraints should be considered. Practicability has main two procedures, and these are as follows:
1) Technical practicability: Ability to mitigate the risk regardless of cost
2) Economic practicability: The ability to reduce a risk without making the medical device into an unsound economic proposition
3.3 Types of Hazards
1) Biological hazards: These include bio-contamination, bio-incompatibility, incorrect formulation, toxicity, allergen-city, mutagen-city, ontogeny, carcinogenicity, re-and/or cross-infection, progeny-city, inability to maintain hygienic safety and degradation.
2) Physical and Mechanical hazards: These include erroneous data transfer, lack of, functional checks, inadequate maintenance, lack of adequate, loss of electrical/ mechanical integrity, inadequate packaging, re-use and/ or improper re-use.
3) Others: These include electricity, radiation, volume, pressure, supply of medical gases and supply of anesthetic agents.
4) Medical hazards: Hazards related to the use of the medical device, etc. This medical hazard includes trained and untrained people, width, etc.
5) Energy hazards: These include heat, electrical vibrations, etc.
6) Communication hazards: These include mistakes and experts errors, complexes or confused systems or unknown devices and their states, etc.
The risk analysis includes the three factors of risk assessment, risk communications and risk managements. This risk analysis is to assure that medical devices processed in healthcare institutions are sterile. A risk analysis is performed to identify the risks to reduce the likelihood of a sterilization failure occurring.
Step 1) Risk Assessment: The risk analysis begins with a risk assessment. The possible risks are reviewed and then rated to assess which risk or risks pose the highest vulnerability. The CSSD Risk Assessment form can be completed using the following steps:
Step 2) Risk Management: Next are the risk managements, which perform some actions that are known for the risks rated as the highest in huge . This plan is used to reduce the failure of risk which is occurring when it is used . This is the part of the risk analysis which is used to eliminate the risks and to develop the plans.
Step 3) Risk Communication: A risk analysis should be conducted annually or whenever major changes occur. This step is used to provide communication between the different people for managing the risk plans.
1) National Regulatory Requirements: XXX shall establish, document and maintain a quality management system to ensure that all known potential risks within the field of application of risk management to medical devices are identified and that all relevant risks are controlled in such a manner that the products of our company do not harm the user/consumer.
2) Risk Management Process: The XXX shall establish and maintain a process for identifying hazards associated with devices, estimating and evaluating the risk and alternatives of the risks, controlling the risk and monitoring the risk. The XXX shall document the risk management processes, which include:
3) Management Responsibilities: There are many management responsibilities of general requirements. These are:
Policy: The top management of our company is committed with regard to evaluates, IDs, and risk controls, which is related to a safety plan. The risk management plan is used to communicate with the organizations so that they can easily understand the problems.
Suitability: The company’s management shall review the continuing suitability and effectiveness of the quality management system at defined intervals to fulfill the requirement of customers and authorities, satisfy the company’s stated risk management policy and meet the company’s risk management objective.
6.1 Task, Responsibilities and Authorities
The Managing Director is the leader responsible for overall system qualities, policies of risk management and objectives. The responsibilities and policies of risk management plan are as follows:
6.2 Risk Management Team
XXX has set up the risk management teams, which are used for developing, maintaining, establishing and reviewing the system of quality managements. The managers or director of management has selected the technical manager as the quality management representative, who shall have the defined authority for:
6.3 Risk Management Plan
The risk management file is the subset of the risk management plan. These include following:
6.4 Risk Management File
The company will have to save and maintain the record of all the risk management activities in the risk management file for the particular medical device or accessory being considered.
A medical device can be easy for one person to use safely and effectively, but creates present problems for different people. On the other hand, the medical devices that are easy for a certain group of users to use safely and effectively could be difficult for different groups. The users have to needs the medical devices so that they users can use it safely and effectively.
7.1 Characteristics of Medical Devices Users
The main characteristics of medical devices users are as follows:
7.2 Medical Device User Interfaces
A well-designed user interface will facilitate correct actions and will prevent or discourage actions that could result in hazards. The user interfaces are as follows:
In risk management, it can help demonstrate that a manufacturer has addressed the needs of the intended users and documented the incorporation of human factors engineering (HFE). Submitting this documentation can streamline and facilitate, which is the part of the pre-market review process that is concerned with safe and effective device use. The information that should be included with the device use documentation is described below.
8.1 Device Overall
8.2 Device User Interface
8.3 Device Use
8.4 Device User Population
8.5 Device Use Environments
8.6 Use-Related Hazards
The validation and verification process of medical devices are as follows: Testing and evaluation processes and results associated with determining.
The scope of the medical devices is as follows:
Performance measurement is the measurement of the accuracy of the medical device or the medical system. It is using by the standard measurement system whose accuracy is known and is the determination and the record of the deviations. It is established whether the medical devices are appropriate to the international standards or not. The problems are also determined if the device is not adequate to the international standards.
11.1 Objectives of Performance Measurements
In the objective of the performance measurement, the following procedures are observed.