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In our previous blog we have discussed about Clause 3 and Clause 4 of ISO 14971:2019. Please check out the link given below.
ISO 14971:2019 Risk management for medical devices
Today we are going to discuss about clauses 5, 6, 7, 8, 9, 10 of ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices. Risk Management is a important part in the medical device life cycle from conceptual stage to disposal stage. Therefore it is important for every healthcare professional to know in detail about ISO 14971:2019.
Let’s get into the topic.
WHAT IS ISO 14971:2019?
The main purpose of ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices is to achieve safety and provide freedom from unacceptable risk. The ISO 14971:2019 is used for identification, assessment and prioritization of risk.
Here the term risk includes patients, operators, equipment, environment and all other persons involved. There are several types of risk management which include Product risk management, Process risk management, Design risk management.
The 1st edition of risk management was released in the year 2000. The 2nd edition was released in the year 2007 which was EU harmonized in the year 2012. The latest edition of risk management was released in 2019.
CLAUSE 5: RISK ANALYSIS
The risk analysis is a systematic use of available
information to identify hazards and to estimate the risk. The tools used for
risk analysis are FMEA and Hazard analysis.
CLAUSE 6: RISK EVALUATION
The risk evaluation is the use of quantitative and
qualitative scale to determine the significance of risk. The following is the
risk evaluation chart used to categorize the risk as acceptable, as low as
reasonably possible and unacceptable based on the occurrence and severity. The
assignment of color coding will vary based on the product or idea being
evaluated.
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Severity |
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Occurrence |
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Negligible S1 |
Minor S2 |
Serious S3 |
Critical S4 |
Catastrophic S5 |
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Frequent P5 |
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Probable P4 |
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Occasional P3 |
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Remote P2 |
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Improbable P1 |
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Red – Unacceptable
Yellow – As low as
reasonably possible
Green – Acceptable
If a risk falls under P1S1, then it is considered as
acceptable risk. This risk evaluation chart should be documented in the risk
management plan.
CLAUSE 7: RISK CONTROL
In risk control process the manufacturer shall
determine the risk controls that are appropriate for reducing the risk to
acceptable level.
The following steps can be taken to control the risk.
1. Inherent safe design and
manufacturing
Eliminate a hazard if it is not related to the
functioning of the device. It reduces the probability of occurrence of hazard.
In rare scenario, it also reduces the level of severity.
2. Adding protective measures in medical devices
Consider applying appropriate protective measures. For
example, alarm, buzzer. The protective measure reduces the probability of occurrence
and level of severity.
3. Information for safety & appropriate training
Provide information about warning, contraindications.
For example, labels, user manuals. Also provide training for user with respect
to handling of device. Information for safety does not reduce probability of
occurrence and level of severity.
RESIDUAL RISK EVALUATION
After risk control measures are applied, the
manufacturer shall evaluate for any residual risk. The evaluation can be done
using a criteria for risk acceptability defined in the risk management plan.
RISK BENEFIT ANALYSIS
If residual risk is not judged acceptable by the manufacturer,
the medical benefits of the intended risk factor should outweigh the residual risk.
Then the risk is considered as acceptable risk. If the medical benefits of the intended
risk factor is less than the residual risk, the risk is considered as
unacceptable risk.
CLAUSE 8: EVALUATION OF
OVERALL RESIDUAL RISK
Based on the severity and occurrence of the harm &
based on the risk acceptance criteria specified in risk management plan, the residual
risk is evaluated.
RISK > BENEFIT – Overall residual risk not
acceptable.
BENEFIT > RISK – Overall residual risk acceptable
If the risk is acceptable, then it should be documented
with supporting evidences.
CLAUSE 9: RISK MANAGEMENT
REVIEW
The risk management review should identify the gap
between plan and actual scenario in risk management process. All the gap should
be filled and justification should be documented to market the product.
CLAUSE 10: PRODUCTION AND POST PRODUCTION INFORMATION
All the residual risk should be monitored as post
market surveillance so that the risk evaluation process remains valid. Based on
the post market surveillance, the risk management plan and risk management file
should be updated.
Now I hope you have acquired some knowledge about ISO 14971:2019 Medical Device Risk Management. We will discuss in detail about a topic related to Biomedical Engineering in our future blogs.
NOTE: Dear friends!!!… Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.
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