ISO 14971 and the Risk Management of Medical Devices plays an integral part of demonstrating product safety throughout the life cycle of medical devices. In fact, the focus of all global medical device regulations relate to risk and how these are mitigated, to demonstrate that the clinical benefit of using the medical device outweighs the risks associated with using the medical device.
ISO 14971 is an international standard, a set of ‘state of the art’ and best practice principles adopted by medical device manufacturers. The standard sets out how risks should be identified, assessed for severity and likelihood of occurrence, applying control measures, re-assessment of the risk once control measures are in place, evaluation of residual risks introduced by control measures.
It provides a framework to follow to assess risk at each stage of the product life cycle:
* Design
* Manufacturing
* Packaging
* Transport
* Storage
* Use
* Obsolescence/disposal
The standard is a harmonised/consensus standard. This means that it should be used to demonstrate medical device compliance for the aspects of risk management in accordance with medical device regulations. This includes EU MDR 2017/745, EU IVDR 2017/746, UK MDR 2002 and FDA CFR 21.
The first aspect to consider when implementing ISO 14971 is planning. A risk management plan should be developed to demonstrate how risk management will take place. This should be a set of instructions detailing in what form risk management activities will be conducted, the type of risk management principles that will be applied (FMEA for example). It should set out the criteria for what constitutes an acceptable risk compared to an unacceptable risk, and what the actions are based on the risk acceptability criteria.
The risk management plan should include the stages at which risk management should take place, and who should be involved in risk management activities. It should also include when and how risk management should take place in relation to post market surveillance and vigilance activities, such as if there was an adverse incident relating to the use of the medical device, that was not foreseen when originally assessing the risks of the medical device.
The aim of the plan is to ensure that medical device manufacturers reduce risks to as low as possible. Risk management is an ongoing process and documentation continually kept up to date within the risk management file.
Each medical device type should have its own risk management documentation, this is usually kept with the technical documentation in the medical device file.
Manufacturers of medical devices are responsible for identifying all the known and foreseeable risks associated with the use of the medical device both within its intended use and misuse of the medical device, the risks should be assessed in both normal and fault conditions.
Once risks have been identified they should be assessed based on their severity and likelihood of occurrence. They should also be assessed for acceptability based on the level of risk identified. One way this can be done is through FMEA.
Severity is given a number of 1 to 5, with 1 being the lowest risk and 5 being the highest risk and the same for likelihood of occurrence. Its important to remember that the severity of the identified risk will always be the same even after control measures have been put in place, but the likelihood of risk can be moved to a lower number once mitigated and controlled.
Once risk control and mitigation factors have been put in place, the manufacturer should assemble the risk management team to evaluate the risk control measures to ensure that the risk has been reduced to as low as possible. They should also evaluate any residual risks that remain after the control measures have been put in place by performing the risk analysis of the control measure against the original risk identified. If the control measures do not mitigate the risk to an acceptable level, then they should take action such as redesign, changes in manufacturing and so on, and then assess the risk again.
Once the device is in its final finished form ready for release. The Risk Management Team should evaluate the over all risk documentation that has been generated and evaluate if the residual risks are acceptable and that all residual risk information where a risk is still possible is documented either on the medical device labelling in the form of symbols following ISO 15223-1, and in the instructions for use, providing the end user with important information on how to use the device safely.
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