Risk: Bio contamination

Estimation of Risk:

• Can cause rust on the device due to hand sweating, chloride atmosphere and tap water, Bacteria, Ammonia gas.

Risk Reduction:

• Avoid the atmosphere of ammonia gas, chloride ions, and tap water.
• Use gloves during operation to avoid hand sweating having the particles of Hydrogen Sulfide.

Evaluation of all risks:

• Check the instruments with the help of boil test.
• Apply some force.

Result Estimated:

• No rust.
• No indication of stress corrosion cracking.

Responsible:

• User

Risk: Bio incompatibility
Estimation of Risk:

• Color change and black deposits appear due to clotting of blood on the device.
• Some bacteria and chemicals also produce different color.
• Tap water has also effect for producing fade color and affecting the life.

Risk Reduction:

• Do not put the devices in blood during operation.
• Always clean with distilled water after operation.
• Avoid the instruments from dust and other contamination.
• Properly preserve the instruments.

Evaluation of All Risks:

• Check that there is no deposit of any color due to dust or contamination.

Result Estimated:

• No deposits
• No rust

Responsible: 

• User

Risk: Incorrect Formulation (Chemical composition)
Estimation of Risk:

• Damage of the devices.
• Effect on the life of the devices.
• Dirty devices.
• Misuse of the devices.
• Effect on patient health.

Risk Reduction:

• Use material for devices as stated in ISO 7153.
• Use Chemicals of suitable concentration for Acid pickling, Electro polishing, Ultrasonic Cleaning etc.
• Proper hardness for better working and functioning.

Evaluation of all Risks:

• Chemical Composition Report
• Boil Test Report
• Hardness Test Report

Result estimated:

• No rust
• Good functioning

Responsible:

• User

Risk: Toxicity
Estimation of Risk:

• Depletion of Chromium layer can cause toxicity
• Stainless steel is corrosion resistant because it has chromium oxide layer that prevents it from rust and corrosion and if the solution of high pH is used then this solution or detergent strengthens on the surface of the instrument and during sterilization in the autoclave the detergents or solution strengthens by the effect of heat and also removes chromium oxide layer and as a result of the removal of chromium oxide layer, corrosion occurs.

Risk reduction:

• PH of the solution and detergents must be maintained in between the range of 6.0 to 8.0.

Evaluation of all Risks:

• Proper techniques of Autoclaving and Sterilization

Result estimated:

• No Rust

Responsible:

• User

Risk: Cross infection
Estimation of Risk:

• Can damage health and can create a danger for life.

Risk reduction:

• Instruments should be sterilized every time before using it for next operation.(Line start-up inspection)

Evaluation of all Risks:

• No damage and infection

Result estimated:

• Good functioning of the instrument.

Responsible:

• User

Inability to maintain hygienic safety 
Estimation of Risk:

• Rust
• Reduction in device life
• Danger for patient life

Risk reduction:

• Use proper safety instructions and recommendations as given illustrated in maintenance guide

Evaluation of all Risks:

• All environment control and safety hygienic conditions are followed.

Result estimated:

• Log time use of the device.

Responsible:

• User

Risk: Degradation 
Estimation of Risk:

• Improper functioning
• Damage in patient health

Risk reduction:

• Properly stored

Evaluation of all Risks:

• All safety conditions are followed.

Result estimated:

• Instrument is working properly, having required surface level and shine.
• Easy to use.
• Good functioning of the instrument.

Responsible:

• User

Risk: Likelihood of operation outside prescribed environmental conditions
Estimation of Risk:

• Can cause rust, damage, infection, reduction in life of the device and patient
• Severe injury

Risk reduction: 

• Proper hygienic conditions
• Provide protection equipment and good atmosphere

Evaluation of all Risks: 

• There is no contamination and dust.
• All controls are checked and verified.

Result estimated: 
Responsible: 

• User

Risk: Incompatibility with other devices 
Estimation of Risk: 

• The devices having different materials must not be cleaned in the same media together because it can cause galvanic corrosion.

Risk reduction: 

• Use corrosion resistant material.
• Use only one type of material during ultrasonic leaning process.

Evaluation of all Risks: 

• No corrosion and staining.

Result estimated: 

• No Rust
• Good functioning of the instrument.

Responsible: 

• User

Risk: Accidental mechanical damage
Estimation of Risk: 

• Due to high hardness and heat effects, device can damage / break suddenly.
• Breakage

Risk reduction: 

• Use proper specification for getting required hardness.
• Use sterilization solution having pH in between 6.0 to 8.0.

Evaluation of all Risks: 

• Check the pH of the solution with calibrated pH meter.

Result estimated: 

• Good functioning of the instrument.

Responsible: 

• User

Risk: Change in intended use 
Estimation of Risk: 

• Can cause injury or death

Risk reduction: 

• If the instrument is used for other intended purpose and higher than class I, the User is responsible for applying to notified body.

Evaluation of all Risks: 

• Life Care exported the instrument under class I. User / Distributor shall verify conformity to the directive 93/42/EEC.

Result estimated: 

• Safe patient health

Responsible: 

• User

Risk: Insufficient warning of side effects 
Estimation of Risk: 

• Can cause rust
• Degradation
• Damage of the device.
• Also reduces the shelf life of the device.

Risk reduction: 

• All warnings and precautions should be mentioned correctly.

Evaluation of all Risks: 

• Verify that all instructions are properly mentioned.

Result estimated: 

• No Rust
• Good functioning of the instrument.

Responsible: 

• User