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.
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.
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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