Orcanos for Medical Devices Risk Management following ISO 14971:2019.
Application of Risk Management to Medical Devices Following ISO 14971:2019 Version
It is imperative to understand the Application of Risk Management to Medical Devices. Technically, we could say it involves Identifying, Assessing, and Prioritizing risks. In general, it simply means that Risk Management helps us reduce risk.
Before the invention of ISO 14971, there were no standards for device manufacturers to use. Then came the idea of ISO 14971 where manufacturers could apply the principles contained in ISO 14971 list to their medical devices to ensure safety.
The product safety standard couldn’t address all the possible risks in medical devices, hence, the decision by the Standard Development Committee (SDC), to create ISO 14971, the first version of which was published in 2000. In 2007, another version was released.
The Evolution of the ISO 14971 Version
The European Union introduced a harmonized version that combined the two previous versions with new changes for European Device manufacturers. The Harmonized European Version harmonized the three directives related to medical devices namely;
As a result, any manufacturer that wants to sell their medical devices in Europe must comply with the EU 2012 harmonized standard. Meanwhile, the rest of the world can use the 2007 ISO 14971 and the 2009 ISO 14971 standards for medical device risk management.
The Importance of ISO 14971 2019 Version
There are a lot of changes that came with the 2007 ISO 14971 version. Similarly, the introduction of ISO 14971 2019 version came with several changes that differ from the 2007 version. Most of the changes between the 2007 and 2019 ISO versions are in the clauses.
The ISO 14971: 2007 had 9 clauses namely;
The Difference between ISO 149721: 2019 and ISO 14972: 2007
We’ll look at the changes adopted in the ISO 14971: 2019, but first we need to list the clauses. The current 2019 version unlike the 2007 version, has 10 clauses namely;
Note the introduction of a new clause (Normative Reference) to the latest edition in the second step. Also, there changes in the arrangement of the steps between steps 3 and 10.
Likewise, some keywords changed in the latest version. For example, the Evaluation of Overall Residual Risk Acceptability was changed to the Evaluation of Overall Residual Risk. The Risk Management Report is now Risk Management Review. Lastly, Production and Post Production Information became Production and Post Production Activities.
These changes might seem insignificant, but most companies have had to revise their documents to accommodate the changes.
There are other standards e.g IEC 62304, IEC 62366- 1, IEC 60601- 1, to mention but a few. The major difference between the ISO 14971 and other standards is their approach to risk management. ISO 14971 provides the fundamental procedures to manage all risks while other standards that attend to only specific risks. The combination of all these standards forms the basics of all medical devices’ risk management.
The Clauses of ISO 14971:2019
Clause 3: Terms and Definitions.
These terms include;
Clause 4: General Requirement for Risk Management.
The sub-clauses include:
Clause 5: Risk Analysis.
Risk Analysis is the use of available information to identify hazards and to estimate the risk – Section 3.19 ISO 14971: 2019. It involves the identification of hazards and hazardous situations, identification of characteristics that are related to safety, and risk estimation.
Clause 6: Risk Evaluation.
After risk estimation comes risk evaluation. It involves clearly identifying what amount of risk is acceptable. A common way of doing this is by the use of Risk Evaluation Matrix. As earlier stated, risk evaluation is basically what risks are acceptable and which ones are not, hence, the working principle of Risk Evaluation Matrix.
It is a chart of the occurrence of risk against the severity. The unacceptable parts are made red, the acceptable ones are marked green, and yellow stands for the middle region where further consideration is probably needed.
Clause 7: Risk Controls.
Section 7.0 of ISO 14971 provides that manufacturers shall determine risk controls that are appropriate for the reduction of risk to the acceptable level. Simply put, it refers to the steps you take once you’ve identified unacceptable risks.
There are quite many options for Risk control, they include;
Clause 8: Evaluation of Overall Residual Risk.
Having evaluated individual residual risks for your medical device, there is the need to also make an overall evaluation of the residual risk of your medical device. The occurrence versus severity chart is also used for this. If it happens that the overall residual risk of your medical device is not acceptable, that is, the overall residual risk is higher than the benefits, the medical device is not fit for sale.
Clause 9: Risk Management Review
This is a summary of all risk management activities stating any risk-benefit analysis and explanation of overall residual risk acceptability. It identifies voids between planned management activities and what was achieved. All identified voids should be filled before proceeding to sell your medical device.
Clause 10: Production and post-production information.
There are quite many ways of going about this, but the best method will be to use the post-market surveillance together with an upgraded risk management plan. Once the device is released, a post-market surveillance plan starts. It basically involves the monitoring of residual risks even when the device is out, to ensure the continued validity of the risk evaluation.
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