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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 1^st edition of risk management was released in the year 2000. The 2^nd 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.

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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.

	Severity
Occurrence		Negligible S1	Minor S2	Serious S3	Critical S4	Catastrophic S5
	Frequent P5
	Probable P4
	Occasional P3
	Remote P2
	Improbable P1

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.

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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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