Friday, September 18, 2020

ISO 14971:2019 Risk Management for Medical Device

 Hi Friends!!!


Today we are going to discuss about 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.


We will discuss in detail about each clauses of ISO 14971:2019. In today's content we are going to discuss about Clause 3 and Clause 4 of  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.



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WHAT ARE THE CLAUSES ?


The ISO 14971:2019 has 10 clauses as following.


Clause 1: Scope.

Clause 2: Normative reference.

Clause 3: Terms and Definition.

Clause 4: General requirement for risk

                 management.

Clause 5: Risk Analysis.

Clause 6: Risk Evaluation.

Clause 7: Risk Control.

Clause 8: Evaluation of overall residual risk.

Clause 9: Risk management review.

Clause 10: Production and Post production

                   activities.


The ISO 14971:2019 has three annex.


Annex A: Rationale of requirements.

Annex B: Risk management process medical

                 device.

Annex C: Fundamental risk concepts.


Let’s discuss about each Clause in detail.


CLAUSE 3: TERMS & DEFINITION



WHAT ARE SOME OF THE IMPORTANT

DEFINITIONS?



RISK

The risk is the probability of occurrence of harm and severity of harm.


HAZARD

The hazard is a potential source of harm. Example: Snakes in the forest.


HARM

Harm is an injury or damage to health of people or damage to property or environment.


HAZARDOUS SITUATION

The hazardous situation is a circumstance in which people, property and environment are exposed to one or more hazards. It is a possible sequence of events which might lead to harm.


REASONABLY FORESEEABLE MISUSE

The reasonably foreseeable misuse is a use of product or system in a way not intended to be used by manufacturer, but which can result from a readily predictable human behavior.


BENEFIT

The benefit is a positive impact or a desirable outcome of the use of medical device on the health of the individual or a positive impact on patient management or public health.


LIFE CYCLE

The life cycle is all phases in a life of medical device from initial conception to final decommissioning and disposal.


OBJECTIVE EVIDENCE

Objective evidence is a data supporting the existence or variety of something.



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CLAUSE 4: GENERAL REQUIREMENT FOR RISK

MANAGEMENT

The following are the general requirement for risk management.


Risk Management process


Management responsibility

The top management should provide evidence for its commitment towards risk management process by ensuring the provision of adequate resources and assignment of qualified personals for risk management or risk analysis.


Risk Management plan

The risk management plan should have following details.

1. The scope of risk management activities.

2. Assignment of responsibilities and authorities.

3. Requirement for review of risk management activities.

4. Methods to evaluate overall residual risk.

5. Verification activities.

6. Collection and review of post production data.


Risk Management file

The risk management file should include risk management plan, intended use, foreseeable misuse, risk analysis, risk evaluation, risk controls and evidence for all these processes.



Now I hope you have acquired some knowledge about ISO 14971:2019 Medical Device Risk Management.  We will discuss in detail about remaining clauses of ISO 14971:2019 in our future blogs.


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