Risk analysis is a process where harmful hazards are identified and risk is mitigated when identified with particular correlation of this risk to occurrence rates and severity level. It is part of a larger process called risk assessment, that additionally includes a risk evaluation. Risk assessment itself is part of the risk management process for which, in the case of a medical device, the manufacturer is required to review on a continuous basis, related documentation during the life-cycle of the device. The process then becomes dynamic and continuous as it adapts to internal and external changes.
The driver of the framework is the country’s national legislation and various applicable clauses with a purpose to ensure medical devices conform with regards to quality, safety and effectiveness.
Legislative instruments include the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, and the Therapeutic Goods (Medical Devices) Regulations 2002.
The Australian authority; Therapeutic Goods Administration (TGA), responsible for assessing medical devices also refer to Australian or the international standards agencies to ensure product compliance with legislation. Manufacturers often use either harmonised standards referenced in the European Commission website or standards published by the International Organization for Standardization (ISO). Some of the more frequented standards are as follows:
Risk analysis is particularly important for medical devices for the assessment of benefits and potential risks through qualitative and quantitative characteristics that could affect the safety of the medical device and, where appropriate, their defined limits; as well as to estimate the risk of hazardous event by studying a group of events that can lead to such situation (ISO 14971). It is often referred to as “the right thing to do” because it is considered obligatory in that, it protects the user of the device, product, brand and manufacturer’s credibility and minimises associated costs where recalls become a necessity.
TGA requires that the necessary documentation is made available for assessment (including the Australian Declaration of Conformity) when applications are made for the registration of medical devices and the subsequent inclusion of the product in the Australian Register of Therapeutic Goods (ARTG)
The risk report is an assessable document for products with a risk classification of III and AIMD and where the TGA audits applications during their ongoing monitoring process of approved products on the ARTG.
• Risk management documentation should include:
The Risk Management report is therefore a key document and the write up and related format to be as close as possible to the requirements of ISO 14971. Effectively, it is meant to provide a thorough analysis to ensure safeguards are in place with the use of the device and the use of proper identification of all benefit/risk factors.
There are other steps where the risk analysis as well as its evaluation is important:
– In the preparation of the information on benefits and risks to include in the instructions of use, for TGA approval;
– for an optimal and quick communication with TGA if any change that impacts the benefits and risk balance, especially if related to the usage of the device;
– when any adverse event is reported (post market) and;
– in the compulsory reassessment of the risk by the manufacturer, in case of death or serious injury reported after classifying the risk as acceptable.
TGA requires that products meet EP to successfully register medical devices for supply in Australia. Table 1 summarizes those EP for risk analysis:
Active medical devices are devices that use energy for functionality and as such, specific requirements apply.
Electromedical safety standards are often referred to, for electrically powered products from the high risk medical devices such as pacemakers to the lower risk products such as blood-pressure monitors. Compliance to at least EP 9.2 and 12 becoming critical for the assessment of associated risks.
Where there is interaction with other electromedical devices, related clauses found in most part of the IEC61000 family of standards are used to cover electromagnetic compatibility (EMC).
For devices with medicinal substances, the risk analysis will incorporate interactive assessments of the combination product and as in all medical devices a review where substantial changes occur. A determination of a risk will then be followed with an update of associated documents pertaining to revalidation tasks to ensure continual safety of the product and the maintenance of its intended purpose.
For medical devices containing materials of animal, microbial or recombinant origin, the performed risk analysis should consider potential contamination from such sources as well as any potential change related to the material or manufacturing process.
Risk analysis is a crucial step in the life cycle of a medical device. Compliance with clauses of the EP and in conjunction with the use of ISO14971 will ensure that hazards are identified and action plans are in place to maximise patient safety and minimise product related failure events.
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