ISO 14971 is one of the ISO standards that define the international requirements for medical device manufacturers by managing risk associated with the use of medical devices. It actually provides a framework to systematically manage risk to people, property and to the environment.
The International Organization for Standardization (ISO) developed these standards and the terminology, which were revised and published in 2012. In the medical device industry, the risk management process goes beyond development and manufacturing. It is one of the most vital parts of any company’s processes.
The ISO 14971 standard defines the international standards and best practices throughout the entire lifecycle of any device and may form the basis for the appropriate submissions to both the European Union and US regulatory authorities.
Risk Management Process
An integral part of any medical devices’ technical documentation is the risk management file. This document details the risks associated with the use of the device and which measures the manufacturer introduces to optimize the device’s safety and performance. In order to construct a risk management file the manufacturer monitors and analyses the risks associated with the device throughout the design and development phases of the device manufacture.
ISO 14971 can be used to assist manufacturers who wish to sell their products on the European market. ISO 14971 is a harmonized standard, which may be used to help manufacturers clarify and implement the regulatory requirements of the EU Medical Device Directives (EU MDD). This ISO standard was published in its latest version in 2012 and clarifies discrepancies between the standard and the directives in the “Z” annexes in the European foreword. (These annexes ensure the regulatory connection between the requirements of the EU MDD and the use of the harmonized standard to support compliance for medical devices).
Companies also need to establish a suitable process that should document a risk management plan for each device under construction and which is destined for the US market. In March 2012 the FDA published a revision of a document they initially published in August 2011. This document entitled “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications” describes the intersection of the FDA Guidance with ISO 14971 . Appendix A of this document provides guidance applicable to medical devices subject to premarket approvals (PMA) and / or de novo petitions.
Mitigating Risk at All Stages
Essentially risk management is the process that actually identifies the risks, the process should be flexible in order to mitigate any risks during the production or life cycle of the medical device. ISO 14971 is an FDA-recognized standard and, when implemented by a medical device manufacturer, may be used to help meet the design validation requirements specified in the Design Controls section of Part 820 of the FDA regulation governing quality systems.
Furthermore, it is stated in the aforementioned guidance document that "the manufacturer’s good documentation practice may help streamline the premarket process for the FDA whenever the manufacturer’s risk appraisal of the medical device are directly and indirectly evaluated pertaining to risk estimation, risk evaluation, risk acceptability, risk control measures and the residual risk associated with the device."
What's Included in Medical Device Risk Analysis
Risk management responsibilities and authorities should be assigned and management review requirements should be specified. This procedure requires the user to assess and evaluate the acceptability of individual risks, introduce the appropriate control measures to contain the risks, as well as, assess the overall residual risks throughout the life cycle of a medical device.
The steps of the risk analysis for each medical device include:
- Documentation of intended use of the medical device
- Identification of possible hazards of the medical device
- Estimation of risk for each hazardous situation
- Evaluation of the individual risks
- Implementation of mitigation measures
- Recording of the risk analysis activities and results
- Documentation of analytical activities and results
- Inspection of risk management file for compliance
Components of the ISO 14971 Process
A management committee for the process includes the resources and the personnel. The personnel must be people who have the knowledge and the experience to carry out their assigned tasks.
Quite often companies will hire a reputable third party to work with the qualified personnel as the regulations are sometimes vague and can be overwhelming – it has been reported in the literature that a search within the FDA website on ISO 14971 produces 564 items. The results of this complex process must be accurately documented.
The manufacturer of the medical device must make risk management decisions that directly or indirectly evaluate the following areas:
- Risk assessment
- Risk evaluation
- Risk acceptability
- Risk control measures
- Overall residual risk
Careful documentation of these risk management decisions may enhance the pre-market review process for the FDA and the manufacturers.
FDA Assessment of the Medical Device
The guidance helps to understand the FDA's considerations when they are making an assessment of the benefit-risk profile of a medical device that has been designed to deliver the most advantageous benefits with the least amount of risk. The device should provide the best assurance of safety and effectiveness.
Some of the considerations by the FDA with an assessment include:
- What endpoints were evaluated, and how will patients value the benefit?
- Was the magnitude of the treatment effective?
- Did the study accurately predict which patients will experience a benefit?
- How are sub-populations effected? Was there a difference?
- Could the duration endpoint, both primary and secondary, be determined?
- Is the benefit achieved valuable to the patient?
The International Organization for Standardization provides a process to assess safety and the benefits of medical devices. A management committee follows strict guidelines when completing risk assessment prior to the FDA assessment.
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