ISO 14971 – Medical Device Company’s risk management standard. Although there are only a few medical device safety measures to consider, ISO 14971 is a widely accepted standard for risk management in medical devices.

Risk Management:

According to ISO 14971, medical device specifications and risk management processes should be documented. The risk management process is a systematic procedure for identifying, categorizing, assessing, and controlling risks associated with medical design, device manufacturing policies, procedures, and practices.

The risk management process is not limited to medical devices; any product development project must include a risk management process and must document the procedures from start to finish. Furthermore, risk management and control are applicable in a variety of situations such as,

• When a new medical device is developed, or a derivative device is manufactured.
• Advancement of a specific part of an already released device
• Modifications to an existing device design
• Non-conforming and mislabeled devices
• Changes in the raw materials used in the device, such as changes in manufacturing sites or suppliers and CAPA (Corrective action and preventive action) requests, can pose a risk to patient safety.

The risk management process begins with documenting policies and procedures, creating a risk management file, and evaluating and implementing a risk management plan (RMP).

Risk Management Plan (RMP)

A Risk Management Plan is a written document that outlines the risk management process for a particular medical device. It is a critical document in MDR (Medical Device Reporting) documentation as per 21 CFR Part 803 to obtain CE (European Conformity) marking for medical devices, indicating that the medical device manufacturing process, procedures, and practices meet all regulatory requirements and are authorized to project devices in the market. Furthermore, RMP should be revised and reviewed throughout the device manufacturing process.

Must plan all risk management activities ahead of time. The plan lays out a strategy for risk management activities to be carried out throughout the medical device’s life cycle. The risk management strategy must include the risk acceptability criteria for the medical device to be developed. The criteria’s inclusion in the risk management plan helps ensure an objective assessment of the residual risks later in the process.

Importance of Risk Management

• Risk assessment is a legal requirement.
• It helps save unnecessary costs associated with product or device recalls by identifying design flaws early on, ensuring the safety of the medical device for the patient or end-users.
• It includes risk analysis, evaluation, and risk control measures in regulatory submissions.
• It provides insights into planning and implementing preventive measures to avoid product liability damages.
• It ensures that the medical device is safe and effective in its intended use.
• Potentially dangerous medical products/devices on the market are kept away.
• It increases the credibility of the manufacturer and the company.

Risk Management Process for Medical Devices

Risk management is now a requirement for medical device manufacturers. The risk management requirements are created based on the risk analysis and stated in broad rather than specific terms. Reduce risks as much as possible while maintaining a high level of health and safety protection. The regulations established a procedure for medical device manufacturers to investigate product safety by identifying hazards and estimating risks based on available data.

To manage risk first, identify Hazards. To analyze and evaluate risk, use the potential consequences of a threat. The risk estimation is compared to the medical device risk-acceptance criteria, and if it is too high, the risk must be reduced through risk control measures. It cannot be eliminated as the risk is assessed and managed. To manage and to control the risk, the risk management process framework includes the following,

• Document the process of what should be done and how to reduce risk.
• Define who is responsible for authorizing the risk analysis and who is in charge of risk control measures.
• Review the risk evaluations and estimates with the quality board.
• Define the skills and knowledge needed to implement risk assessment methods and train employees who lack these abilities.
• Create and keep written documentation to show policy and procedure adherence.
• Include validation checks to ensure that the procedures followed are under the risk management procedures and policies.
• Check for the effectiveness of the risk management process.

Risk Identification

Preliminary hazard analysis (PHA) is a technique used early in the product development process to assist manufacturers in identifying hazards, sources, or events that could cause harm while the device is still in the manufacturing phase. This technique is helpful for management in determining whether or not to proceed with developing a specific product if the risk evaluated is high and helps to list out the measures to mitigate the risk during the development phase.

Manufacturers expect to know the possible hazards of the medical device during the identification phase of the risk management process. The sources of hazards like the raw materials used, machines in the manufacturing sites, package information, etc.,  are significantly overlooked. The sources of hazards are monitored continuously to protect the device and the users during manufacturing, transportation, and storage.

A clinical hazard list (CHL) is a technique for claiming the device’s completeness. It lists the foreseeable hazards that could occur while using the device from the end-user perspective, but CHL cannot be used to estimate the hazards caused by the device. Manufacturers should use HAL (Harm assessment list) in conjunction with CHL and PHA to identify, evaluate and estimate the harm.

Risk Analysis

Risk analysis will assist the company in defining the intended use of the medical device, which will aid in risk management efforts. It will also help in focusing on potential sources of harm. At this stage, identify the foreseeable hazards and determine the cause to analyze the estimated risk associated with the cause.

Risk Estimation

Risk Estimation is when determining the severity and probability of risk will aid in quantifying or estimating the potential risks associated with the medical device. During this phase, potential hazards’ causes and effects are specified in a table known as the Risk Assessment and Control Table (RCAT). This table, also known as a risk analysis chart, risk matrix, or risk table, is considered the heart of risk management. This table provides an overview of potential risk hazards, scenarios, causes, and control measures to reduce the estimated risk as much as possible and the hazard that requires immediate attention.