Risk Analysis, Evaluation and Control

Hi Friends!!!

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.

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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 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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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.

NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

Check out for this blog about Computed Tomography,  x ray and MRI scan.

Generations of CT Scanners

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x ray machine working principle

components of x ray tube

MRI scan 

MRI With Contrast

Brain MRI

Types of MRI scanners

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Lung Anatomy, Function and Diseases

Hi friends!!!

The knowledge of human body is what differentiates Biomedical Engineering from other groups of Engineering, with that in mind we have started a new segment in Biomedical Views to discuss about Anatomy and physiology of various human organs.

From now viewers can expect mixed variety of topics in our blog like Medical devices, Anatomy and Physiology, Medical Device regulatory, Recent trends in Biomedical Engineering and Healthcare.

Today we are going to discuss about Lung Anatomy, Function and Diseases.

The lungs are one of the important organs in human body which facilitates the breathing process. Therefore it is important for every healthcare professional to know in detail about Lungs.

Let's get into the topic.

WHAT IS LUNG?

The lungs are the main organ of respiratory systems. The respiratory system is responsible for inhaling oxygen (inspiration) and exhaling carbon dioxide (expiration). As we breathe, air from the atmosphere enters lungs and lungs are responsible for transporting oxygenated air to the red blood cells. And the oxygen in the red cells are utilized by all the cells of our body. The lungs are also responsible for getting rid of carbon dioxide from deoxygenated blood as we breathe out.

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WHAT IS THE PATHWAY OF BREATHING?

When we breathe, air from the atmosphere enters into the mouth and nose. Then the air reaches the trachea through throat and larynx. Here the trachea divides into two hollow tubes called bronchus. The right bronchus connects to the right lung and left bronchus connects to the left lung. The bronchus are further divided into smaller air tubes called bronchioles. At the end of bronchioles, there is a small tiny air sac called as alveoli is present. The air travels in this structure and reaches the alveoli. 

 

HOW GAS EXCHANGE TAKES PLACE?

The air entering the lungs reaches alveoli through bronchioles. The alveoli are tiny air sacs in the lung where the exchange of oxygen and carbon dioxide takes place. There are about 600 millions of alveoli in our human body.

I

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HOW IS THE ANATOMY OF LUNGS?

Lungs are a pair of spongy air filled organs located on either side of the chest wall ( thorax). Lungs are conical in shape with rounded point at their apex and flatter base where they meet the diaphragm. The right lung is shorter to accommodate the liver below. And left lung has an indentation bordering where the heart accommodates. It is called as cardiac notch. Left lung is smaller and lesser in capacity compared to right lung.

WHAT IS DIAPHRAGM?

Diaphragm is a dome shaped muscle sheet which separates chest from the abdomen. During inhalation diaphragm flattens and contracts which enlarges the chest cavity, and air enters into the lungs. During exhalation diaphragm relaxes and retains it's dome shape and air is forced out of lungs.

WHAT ARE THE LAYERS OF LUNGS?

Lungs are covered by two protective layers as following

Visceral Layer (Inner Layer) which covers the lung.

Parietal Layer( Outer Layer) which covers the chest cavity.

 
WHAT ARE THE PARTS OF LUNGS?

The lungs are divided into right lung and left lung. Each lung can be divided into following lobes.

The right lung can be divided into Upper Lobe, Middle Lobe, Lower lobe. The left lung is divided into Upper lobe, Lower lobe

WHAT ARE THE FUNCTIONS OF LUNGS?

One of the important function of lungs is that it is responsible for the change pH of blood in human body ( whether the blood is more acidic or more alkali). Lungs maintains the pH of blood by increasing or decreasing the amount of carbon dioxide in the body.

Lungs also plays an important role in conversion of Angiotensin 1 to Angiotensin 2. These chemicals are responsible for the maintenance of normal blood pressure in human body.

Lungs acts as a blood reservoir which is considered as a crucial function of lungs. The lungs contains about 500 to 1000 ml of blood which is useful during exercise. Lungs interact with heart and help them work more efficiently at the time of exercise.

The mucus that lines the respiratory passages traps dust particles and bacteria. Cilia (tiny hair like projections) , move the dust particles and bacteria towards upward position where they  will be coughed out or swallowed and destroyed by digestive system.

Certain membranes of Lungs secretes  Immunoglobulin -A which protects the lungs from some infections. Another important function of lungs is that in certain types of collision lungs acts as a shock absorber for the heart. Lungs filter small blood clots and remove small air bubbles ( known as embolism) ,if they occur.

RESPIRATORY SYSTEM DISEASES

 

Respiratory system diseases are categorized into two main categories, Infections and chronic diseases

Some of the common disease in lungs are:

 

ASTHMA

Asthma is a respiratory condition in which patients air is narrow ,inflamed, swell and produce extra mucus and makes it difficult to breathe.

 

BRONCHIECTASIS

Bronchiectasis is a condition where mucus collects in the lungs and there is a risk of infection. It results in irreversible dilation of bronchi.

 

PNEUMONIA

Pneumonia is a infection of lung in which air sacs are filled with pus or fluid and makes it difficult to breathe.

 

TUBERCULOSIS

Tuberculosis is a contagious infectious disease ,which spreads to other parts of the body.

 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE

COPD is a group of lung diseases which leads to obstruction of air flow to the lungs which interferes the normal breathing.

 

LUNG CANCER

Is an uncontrolled growth of abnormal cells in the lung.

 

CYSTIC FIBROSIS

Cystic Fibrosis is a hereditary disorder which affects the cells that produce mucus, sweat and digestive juices. It leads to infection by causing sticky mucus to build up in the lungs and digestive system

 
PLEURAL EFFUSION

Also commonly referred as " water on the lungs". The Pleural Effusion is build up of excess of fluids between the layers of pleura outside the lungs.

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IDIOPATHIC PULMONARY FIBROSIS

Is a chronic progressive disease which results in the scarring (fibrosis) of lung tissues.

 

SARCOIDOSIS

Sarcoidosis is an inflammatory condition in any part of our body , which most commonly affects lungs and lymph nodes.

Now I hope you have acquired some knowledge about Lungs Anatomy, Function and Diseases.  We will discuss in detail about a topic related to Biomedical Engineering in our future blogs.

      

        Welcome Our Team Member!!!

        Content contributed by                  

      Varshini, MBBS, Final Year

        Let’s here from our Team mate,                                       

      

Hello all !!!

I’m very happy and excited to be associated with Biomedical Views. Being a Medical student it’s always a dream to share my thoughts and knowledge to the healthcare professionals. Hope this journey helps others and myself to gain knowledge in the field of healthcare.

Happy learning!!!

                                              

NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

Check out for this blog about Computed Tomography,  x ray and MRI scan.

Generations of CT Scanners

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x ray machine working principle

components of x ray tube

MRI scan 

MRI With Contrast

Brain MRI

Types of MRI scanners

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12 Lead ECG Placement

HOW TO READ AN ECG

Holter Monitor

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