Risk Responsibility & Risk Management

Warning
All herein after risks are serious actions that may damage the instruments, affects patient health or user health, and can be danger for patient health and life. All actions should be taken to reduce such risk..It is the user responsibility to repoty for any incidence or near incidence to the manufacturer as immediate action.

Energy Hazards

Risk	Estimation Of Risk	Risk Reduction	Evaluation Of Risk
Heat	Can effect product shape and cause scale	Correct use of temperature and use of electroplishing, acid pickling, Ultrasonic cleaning and passivation technique.	Hazard related to heat is minimized.
Mechanical force	Causes change in shape, damages the blade and cutting ends and other unnecessary load strike cause effect on product damage.	Correct use of forging load, proper use of machines and care in storage reduces the risk.	Proper storage and expert workers are used to avoid the above risk.
Moving parts	All moving parts are functioning and there is unnecessary friction for damaging the device.	Proper half-moon, box and other accessories are manufactured and prepared for reduction in risk.	Cutting test, Strength stability and boil test are conducted for evaluation of the risk.
Suspended mass	Can cause rust in the form of contamination	Use for the required purpose and apply preservation techniques such as, oiling and Passivation to minimize the risk.	Clean the instrument in ultrasonic cleaner during manufacturing and Clean the instruments as per instructions during operation.

Biological Hazards

Risk	Estimation Of Risk	Risk Reduction	Evaluation Of Risk	Result estimated	Responsible
Bio contamination	Can cause rust on the device due to hand sweating, chloride atmosphere and tap water, Bacteria, Ammonia gas	Avoid the atmosphere of ammonia gas, chloride ions, tap water.Use gloves during operation to avoid hand sweating having the particles ofHydrogenSulfide	Check the instruments with the help of boil test. Apply some force	No rust No indication of stress corrosion cracking.	User
Bio incompatibility	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.	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.	Check that there is no deposits of any color due to dust or contamination.	No depositsNo rust	User
Incorrect formulation (Chemical composition	Damage of the devices .Effect on the life of the devices. Dirty devices.Misuse of the devices. Damage during operation. Effect on patient health.	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.	Mill test CertificateChemical Composition ReportBoil Test Report Hardness Test Report	No rust Good functioning	Manufacturer
Toxicity	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.	pH of the solution and detergents must be maintained in between the range of 6.0 to 8.0.	Proper techniques of Autoclaving and Sterilization	No rust	User
Cross infection	Can damage health and can create a danger for life.	Instruments should be sterilized every time before using it for next operation.(Line start-up inspection)	No damage and infection	Good functioning of the instrument.	User
Inability to maintain hygienic safety	Rust Reduction in device life Danger for patient life	Use proper safety instructions as given at the end of this chapter.	All environment control and safety hygienic conditions are followed.	Log time use of the device.	User
Degradation	Improper functioning Damage in patient health	Properly stored All safety conditions are followed.	Instrument is working properly, having required surface level and shine.Easy to use	Good functioning of the instrument.	user

Environmental Hazards

Risk	Estimation Of Risk	Risk Reduction	Evaluation Of Hazard	Responsible
Likelihood of operation outside prescribed environmental conditions	Can cause rust, damage, infection, reduction in life of the device and patient Severe injury	Proper hygienic conditions Provide protection equipment and good atmosphere.	There is no contamination and dust. All controls are checked and verified.	User
Incompatibility with other devices	Due to high hardness and heat effects, device can damage / break suddenly.Breakage	Use proper specification for getting required hardness. Use sterilization solution having pH in between 6.0 to 8.0	Hardness test report Check the pH of the solution with calibrated pH meter	Manufacturer and customer
Accidental mechanical damage	Due to high hardness and heat effects, device can damage / break suddenly.Breakage	Use proper specification for getting required hardness. Use sterilization solution having pH in between 6.0 to 8.0	Hardness test report Check the pH of the solution with calibrated pH meter	User
Contamination due to waste products and /or device disposal	During production, Some foreign particles like chips, chemicals, dust, oil, lint contaminate with the product that causes problem after complete processes. The above particles are the source of instrument staining,, spotting , corrosion and other potentially damaging conditions. Other effective measures are also being documented here. Water also produces mineral deposits which are the cause of corrosion	To avoid the above problems. Instruments are ultrasonic cleaned with the validated time. The frequency of ultrasonic cleaning process depends upon the design and manufacturing techniques of the product., as mentioned on related quality plans. The effectiveness of ultrasonic cleaning process depends upon the time used as determined by validation of the process. Water mineral composition changes from one locality to another locality and it is the basic cause of stain, spot, corrosion and discoloration of instruments. so, to solve the problem created by water, always use deionized water.	Verify that the shape, surface, fitting and setting of devices and Boil test reports showing the result as OK.	User

Hazards Related To Use On The Device

Risk	Estimation Of Risk	Risk Reduction	Evaluation Of Hazard	Responsible
Inadequate labeling	Change the label after consulting with Manufacturer Co. (Pvt) Ltd.	Distributor must properly check the label according to requirement of the directive	Manufacturer should recheck before pasting the label on the device.	Manufacturer
Inadequate warnings instructions	Can cause death or injury due to improper use of the device.	Only relevant person should use the device.	Check that label has warnings, precautions and administration of the device.	Manufacturer
Inadequate specification of accessories	Accessories having different design feature or with wrong material cause inadequacy for device operation.	All accessories / drawings should show complete dimension and tolerance control.	Check that related drawings show all necessary dimensions and accessory is completely fit in the device.	Manufacturer
Over complicated operating instructions	May cause injury or death due to complicated instructions.	Write the instructions in an easy and legible way. Manufacturer Co. (Pvt) Ltd. describes UMDNS (Universal medical Devices Nomenclature system)	Check and verify that proper UMDNS Code is mentioned on the label and Declaration of Conformity.	Manufacturer
Use by unskilled / untrained personnel	Can cause serious injury/death.	Only qualified/relevant person must use it.	Check that instructions related to this risk are mentioned on the label.	User
Reasonably foreseeable misuse	Can cause severe damage on patient’s health.	Must be used only for that purpose for which it is manufactured.	Evaluate that proper instrument name and code/description is mentioned on the label.	User
Insufficient warning of side effects	Can cause rust Degradation Damage of the device. Also reduces the shelf life of the device.	All warnings and precautions should be mentioned correctly.	Verify that all instructions are properly mentioned.	Manufacturer
Inadequate warning of hazards likely with re-use of single use device	Can cause death	Verify that all single use devices are scrapped after first use.	Verify that only Re-usable instruments are being used again after sterilization.	Manufacturer

Hazards From Functional Failure, Maintenance and Ageing

Risk	Estimation Of Risk	Risk Reduction	Evaluation Of Hazards	Responsible
Inadequacy of performance characteristics for the intended use.	No Function No performance Not used for the specified purpose.	Ensure that product is being used for the purpose for which it is manufactured	Check the performance , Shape, Design, Setting and fitting of the instrument as per requirement.	User
Lack of, or inadequate specification for maintenance including inadequate specification of post maintenance functional check	Device life may reduce Device get rusted Device should be sterilized in autoclave and it also should be free of rust. Steam pipe should also be free of rust. Detergents should not have chloride/copper based ions.	Proper maintenance is going to be conducted.	Verify that all parameters written in column 2 that are going to be correct.	Manufacturer
Change in intended use	Can cause injury or death	If the instrument is used for other intended purpose and higher than class I, the customer is responsible for applying to notified body.	Manufacturer Co. (Pvt) Ltd. exported the instrument under class I. Customer / Distributor shall verify conformity to the directive 93/42/EEC.	User
Lack of adequate determination of device.	Lifetime of the device Effect on time of shelf life	Use properly to increase the shelf life of the instrument. Avoid placing the instrument for a longer time in ordinary water or in contact with blood or in salty or humid atmosphere.	Increase in lifetime is verified by proper usage of the device following the safety principles to avoid expected risks Check periodically the interim storage and status of the instrument.	User
Inadequate packaging.(contamination and or deterioration of the device)	Corrosion resulting from moisture left on the surface of instrument, in box joints or sometime in polythene bags during packing.	Reduce the effect of moisture by preheating the autoclave.	Verify the preheating of the autoclave.	User
Improper re-use	Use of the device Acceptability of Risks	Give the instructions for intended use To increase the sampling of the device during inspection and testing	With the best of our knowledge, we have documented the intended use of the device. We, as a manufacturer are not surgeon and we cannot tell the exact use. We have taken the help of number of catalogues provided by customer. If any use or UMDNS number is not given properly, please inform the authorized representative and Manufacturer Co. (Pvt) Ltd.., to enable us taking corrective action by using the correct intended use of the device. Manufacturer Co. (Pvt) Ltd. performs 2% or 4% inspection through out the lot. Residual risk to be verified by the customer. If results at customer’s premises on samples found to be not complying to certain requirements, Manufacturer Co. (Pvt) Ltd.. Will take corrective action by increasing the sampling criteria and customer is responsible to inform the Manufacturer ..	User