Risk Management Report of Surgical Instruments

8/13/2019 Risk Management Report of Surgical Instruments

1/20

Product risk management report KH/JS-CE-QXB03 A/0

Risk Management Report of Surgical instruments

1 Introduct ion

In accordance with MDD (93/42/EEC) requires, in accordance with the "riskmanagement applications for medical devices", analyzed the clinical use of our productsin the hazards that may exist, and the production of each hazard was determined. Foreach hazard to the severity of damage and harm the probability of occurrence wasestimated. In a risk is unacceptable, to take control measures to reduce risk, whiletaking the risk of residual risk after control measures were evaluated. Finally, all theresidual risks to an acceptable level, to ensure safe and effective products on themarket.2 Scopes

The Company's surgical instruments with CE mark products.3 application data

3.1 Application StandardsISO 14971 Medical Device Risk Management applications for medical devicesISO 7153-1 Surgical instruments - Metallic Materials Part 1: Stainless steelISO / TR 14283 Implants for surgery - basic principlesISO 14630 Non-active surgical implants - General requirementsISO 15730 for the stainless steel finishing, polishing and passivation of metals and

other inorganic coatings ASTM A 380 stainless steel parts of the standard criteria for removal and cleaningStainless steel ASTM A 967 Standard Specification for Chemical Passivation

ASTM D4169 transport container system performance test standard operatingprocedures

3.2 Application Information- "AO principles of fracture treatment, " translated Rong Dai Shike- "Study orthopedic surgery, " Zuber pass, Dai Jung Shike

- "Clinical Orthopaedics Anatomy, " edited by GUO Shi Fu- "Clinical Orthopaedics" Li Shimin, editor of the party farming-cho- "Modern Orthopaedics" Zhao Dinglin Editor- "Emergency Orthopedics limb part of the " original ROBERT R. SIMON,

STEVENJ.KOENIGSKNECHTMain translation Xiao Deming

- "Fracture biomechanics Therapy, " Shu-Hui, Wang Xinhua, Du Maoxin editor- "Bone and bone surgical diagnosis and treatment of medical school, " Cao

Jianzhong Hu Guangzhou, Zhang Dayong, Chang Hong Editor- "bone and joint diseases, " Zhang Shiqing, Wang, Ji Asia and Africa, edited by Liu- "Human Anatomy" Gu Xiaosong Editor

Chapter total 20 pages page 1


2/20


4 the team of ri sk analysis

Name Position/Responsibility Duty

Wang zhi ming Vice general manager, superviseproduction & technique

department

Team Leader

Jiang de cheng Technique adviser Team Member

Ma hao ming Manager of TechniqueDepartment

Team Member

Yin zhuo Standardization Team Member

Jiang qing xing Engineer Team Member

Cao hua Manager of Quality Department Team Member

Wu zheng qian Manager of Logistic Department Team Member

Wang tong Marketing Manager Team Member

Huang fei peng Sales Manager Team Member

Xu li Attending physician Team Member

5 Product Descriptions

5.1 OverviewThe object of risk management involves surgical instruments. The company providesthe surgical instruments is an essential tool for orthopedic surgery, orthopedic implantsall products are required to meet the appropriate surgical instruments to properly installand reliably fixed to the patient's body, the safety of implantable devices also removethe need to use The appropriate surgical instruments. The production of surgicalinstruments with a variety of materials, such as: stainless steel, titanium, aluminum andnon-metallic materials. Human exposure to traumatic surgical instruments, requiredhardness, toughness is moderate, leaving debris and difficult to oxidative corrosion, andhave some biocompatibility.

5.2 FunctionSurgical instruments is a tool for orthopedic surgery. Purpose is to ensure safe and

smooth implants implanted or removed.5.3 use of the environmentSurgical instruments available to medical institutions, the need for treatment of qualifiedand experienced doctors during the surgery.6 The implementation of risk management process

It is recognized that the concept of risk has two components:- the probability of occurrence of the damage, ie: how the recurrent occurrence of the



3/20


damage;- the consequences of harm, that is: how serious it is.Now according to the requirements of ISO14971, the two parts of surgical instrumentsfor risk assessment and management products.

6.1 The intended purpose and qualitative and quantitative characteristics of the decision Appendix C of the Company pursuant to the requirements of ISO14971, for surgicalinstruments that may affect the security features of the problem of determining thefollowing table:

Table 1 the characteristic problem of determining the safetySerial

NumberDetermines Whether or not affects

C.2.1What is the intended use andhow to use?

1.1 Expected use of productSurgical instruments are essential tools for orthopedicsurgery, adjuvant complete the operation.

1.2 How to use medical device

The Company's surgical instruments products fromorthopedic doctor according to the type of surgery,choose the appropriate surgery for patients withsurgical instruments.

1.3

What is the role of Medicaldevices in the diagnosis,prevention, care, treatment ormitigation, trauma anddisability compensation,replacement or correction ofanatomy, etc.

Not applicable

1.4What is the indication (e.g.patient population)?

patients who need Orthopedic surgery

1.5Whether to maintain orsupport medical equipmentlife?

Not applicable

Continued Table 1 The characteristic problem of determining the safety Serial


1.6In the case of failure of medicaldevices need specialintervention?

Not applicable

C.2.2Implantable medical devicesare expected to be used?

Not applicable

C.2.3 Medical equipments are Applicable. Part of the surgical instruments during



4/20


expected to and contact withpatients or other staff?

surgery when necessary, contact with patients.

C.2.4

In the medical device whichcontains materials and (or)

components, or for sharing, oraccess to medical devices?

Applicable. The company's products, its biologicalproperties and mechanical properties were already

recognized by the medical profession.

C.2.5Have the energy to givepatients access to or from thebody?

Not applicable

C.2.6 Are there materials available tothe patients or from patients?

Not applicable

C.2.7

Whether the medical deviceswith biological material andthen re-use, injection or

transplant?

Not applicable

C.2.8

Medical care is provided in theform or preparing a sterilesterilized by the user, or othermethod of sterilization ofmicrobial control?

Not applicable

C.2.9Medical devices are expectedby the routine cleaning anddisinfection of the user?

Applicable. The company's products in the form ofnon-sterile products for use by the user (installer) forcleaning and disinfection.

C.2.10Medical equipment areexpected to improve thepatient's environment?

Not applicable

C.2.11Whether the medical device tomeasure?

Applicable. Part of the caliper, sounding devicewith measuring function

C.2.12Whether the analysis andprocessing of medical devices?

Not applicable

C.2.13

Medical equipment areexpected, and other medicaldevices, drugs or other medicaltechniques used incombination?

Not applicable

C.2.14Is there no hope for energy ormaterial output?

Not applicable

C.2.15Medical devices are sensitiveto the environmental impact?

Not applicable

C.2.16Medical devices affect theenvironment?

Not applicable

C.2.17 Are there basic suppliesmedical equipment oraccessories

Not applicable

C.2.18

The need for maintenance and

calibration?Use. Repeated use of the products after use to bemaintained.



5/20


C.2.19Medical devices havesoftware?

Not applicable

C.2.20Medical devices have limitedstorage life?

Not applicable

C.2.21 For delayed and (or) long-termuse effects? Not applicable

C.2.22What kind of medicalequipment to withstandmechanical forces?

Not applicable

C.2.23What determines the life ofmedical devices?

Applicable. Surgical instruments used in the wear andtear or improper operation.

C.2.24Single-use medical devices areexpected?

Not applicable. Can be reused, clean and sterilizedbefore use.

C.2.25

The need for safety of medical

devices out of operation ordisposal?

Not applicable

Continued Table 1 The characteristic problem of determining the safety Serial


C.2.26Installation or use of medicaldevices requires specialtraining or special skills?

Applicable. The installation of surgical instrumentswith the necessary skills to use the need for surgical(orthopedic) medical use.

C.2.27How safe use of theinformation provided?

Applicable. The installation of surgical instruments

with the necessary skills to use the need for surgical(orthopedic) medical use.

C.2.28Need to establish or introducenew production processes?

Not applicable

C.2.29

Successful use of medicaldevices, is decisive dependson human factors, such as userinterface?

Applicable. The success of surgical instrumentsdepends on surgeons to use clinical experience,depending on the surgeon can correct operation ofsurgical instruments.

C.2.29.1User interface design featureswill result in the wrong?

Not applicable

C.2.29.2Medical equipment is used fordistraction caused by thewrong environment?

Not applicable

C.2.29.3 Are there parts of medical

equipment or accessories

connected?

Applicable. In clinical use, some surgical instruments

to be used together with the existence joints, use of

the process should pay attention to the reliability of

connection joints, or cause to fail.

C.2.29.4 Are there medical device

control interface?Not applicable

C.2.29.5Whether to display information

about medical devices? Not applicable



6/20


C.2.29.6Medical devices are controlled

by the menu?Not applicable

C.2.29.7Medical equipment whether theuse by special request?

Applicable. Surgical instruments with the necessaryskills required by the surgery (orthopedics) doctors to

operate.C.2.29.8

User interface is used to triggerthe user's actions?

Not applicable

C.2.30Whether to use the alarmsystem of medical devices?

Not applicable

C.2.31Manner in which medicaldevices may be intentionallymisused?

Not applicable

C.2.32Whether to retain the medicalequipment data on critical

patient care?

Not applicable

C.2.33Whether to retain themedical equipment data oncritical patient care?

Not applicable

C.2.34Whether the use of medicaldevices depends on the basicproperties?

Not applicable

35Manufacturing process shouldbe considered in the risk

35.1

Whether due to equipmentcaused by improper selection

of materials of biological

compatibility issues?

Applicable. Surgical instruments with the necessaryskills required by the surgery (orthopedics) doctors to

operate....

35.2

Whether the material dueto improper controldevices, resulting inbio-compatibility issuesand product failures?

Applicable. Improper control of such material, theoccurrence of misuse, abuse will result inbio-compatibility issues; affect the product's life,resulting in surgery can not proceed.

Continued Table 1 The characteristic problem of determining the safety

SerialNumbe

rDetermines Whether or not affects

35.3

Whether due to improperdesign, resulting in deviceproducts in the clinicalapplication of the process offracture?

Not applicable. Surgical instruments are surgicalinstruments, non-implantable products

35.4 The processing of productspossible risks?



7/20



35.4.1Blanking process of theproduct will product ofbiological compatibility issues?

Applicable. Products in the blanking process, due tofracture caused by taking the wrong material orbiological compatibility issues.

35.4.2

Products in the cutting (clamp,

grinding) process will producea result of improper operationof the equipment failurefactors?

Applicable. Products in the blanking process, due tofracture caused by taking the wrong material orbiological compatibility issues.

35.4.3Products in the treatmentprocess will produce productfailure problem?

Applicable. Improper operation of the heat treatmentprocess, not achieve the required hardness, will leadto product failure

35.4.4Products in the polishingprocess will produce

bio-compatibility issues?

Applicable. Products in the polishing process, thepollution will be polishing paste, there is no netwashing polishing paste, affecting the cleanliness ofthe product, resulting in bio-compatibility issues.

35.4.5In the first washing, it willproduce bio-compatibilityissues?

Applicable. Products in the polishing process, thepollution will be polishing paste, there is no netwashing polishing paste, affecting the cleanliness ofthe product, resulting in bio-compatibility issues.

35.4.6Products in the corrosion testwhether the process ofbio-compatibility issues?

Not applicable. Corrosion test is mainly used to testwhether the product is made of stainless steelresistant to corrosion. The liquid is often used as ableach or disinfectant hydrogen peroxide, and has

been fully diluted. Not in the product composition ofthe surface of residual risk.

35.4.7Product marking equipment willresult in fracture of the factorsthat produce?

Not applicable. Laser marking does not affect themechanical properties.

35.4.8Product marking equipment willresult in fracture of the factorsthat produce?

Applicable. Products in the passivation process, theprocessing liquid is diluted nitric acid solution, such asnitric acid solution to clean without a net, there areresidual elements left nitric acid solution to producebio-compatibility issues.

35.5Products in the packagingprocess is causing a mixedproblem?

Products in the packaging process, due to packagingerrors caused by the product mix, making products inuse and the model specification does not harmpatients

35.6Products in the transportprocess caused by equipmentfaults will produce the factors?

Products during transport, due to thebreakdown of the product packaging wasdamaged, resulting in surgery can not benormal.


8/20

6.2 Risk management processSurgical Instruments products are the specific characteristics of safety-related judgments, clear and product safety hto the terms of harm are the reasons for the refinement and analysis, its analysis and risk assessment, and take down mrisk of a re-evaluation of risks, the table below:

Continued Table 2 surgical instruments list of potential hazards and measures

Possible harm

SerialNumber Potential

harmReason ofoccurrence

SeriousLevel Occurrence

possibility

Riskrank

Measures toreduce risk

ApplicablestandardsOr relateddocuments

Whetherthe new

risk

26

Broken

surgicalinstruments,such failurecan notmeet

(1) Do not

have the

necessaryskills by the

surgery

(bone) doctor

from

operating

equipment.

2 2 4

Instructions in

the manual

have been sold

only to holders

of Surgery

(Orthopaedics),

MD's license.

Manual

operation

instrument

No



9/20

29

(2)Improperuse ofsurgicalinstruments,resulting ininstrumentfracture.

2 2 4

In the product

manual for

products to be

given with

sufficient

anatomical

knowledge and

understanding

of orthopedic

surgeons to

operate.

Manual

operation

instrument

No

35.3

(3) designersdo not followproceduresfor productdesign anddevelopmentoperations

2 2 4

Tailor-made

"design anddevelopmentcontrolprocedures"and "designchange controlprocedures",andperiodicallyreviewed.

KH/QP-08KH/QP-09

No



10/20

35.4.2

(5) With thesize of thedeviationdeviceproducts,resulting inthe product isnot fit forsurgery.

2 2 4

In the

production

process, strict

control,strengthen the

inspection

process.

MechanicalprocessingcardKH/ZB-01.12

GeneralInspectionInstructions

No

35.4.3

4) Theproduct doesnot achievethe requiredhardness,

heattreatmentprocess,leading toproductbreakage,increasedwear

2 2 4

Formulated the"heat treatment

instructions,"and the specialprocess wasconfirmed,while strictlyenforced.

KH/JS-09.10 No

Continued Table 2 surgical instruments list of potential hazards and measuresPossible harm



SeriousLevel

Occurrencepossibility

Riskrank

Riskreduction

approaches


Whethe n

ri



11/20

35.2

Biological

compatibility

of the

product

hazards

Impropersurgical

instruments

material

control the

biological

compatibility

issues.

2 2 4

Set up

special library

materials,

equipment,

and the

establishment

of special

management,

monthly

reconciliation

of debit

objects, to

preventmistakes

made.

MWI-011 No



12/20

35.4.5

(1) to oil,

polishing

paste after

ning the

urface maystill be oil,

polishing

paste,

detergent

residue

composition,

resulting in

harm to

patients.

clea

s

2 5 10 No

35.4.8

Process

may be left

on the

surface ofthe product

caused by

harmful

substances

in biological

compatibility

problems

for patients

(2)passivationtreatment,surfacecleaning isnotcompletelymade acid

residues,resulting inharm topatients.

2 5 10

Cleaningprocess foreach channelone by one toconfirm andverify thecleaningprocess todevelop workinstructions,and productssent to theInstitute ofSuzhouUniversity,Biologicalevaluation ofradiationtests to verifythe processtaken by thecompany'sreasonable.Training of

cleaningoperatives,cleaning work

KH/JS-09.20 24SRPSU-2004-0649SRPSU-2004-0650SRPSU-2004-0651SRPSU-2004-0652SRPSU-2004-0653SRPSU-2004-0654SRPSU-2004-0655

N



13/20

35.4.4

(3) productsin thepolishing,the cleaningis notcomplete sothe surface

acidresidues,resulting inharm topatients.

2 5 10

in strictaccordancewith therequirementsof operatinginstructionsfor cleaningand make aclean record,to ensure thatproductsmeet therequirementsof every

cleaning. Ifthe cleaningagentcompositionchange orcleaning ofchanges in atimelymannerFurther

validation andrevalidation

N



14/20

35.4.1

(4) aftercutting, dueto damagecaused bytaking thewrongmaterial

2 3 6

Control of themachiningprocess todevelop"machiningprocesscards."

Machining processcard

N

Continued Table 2 surgical instruments list of potential hazards and measures

Possible harm



SeriousLevel

Occurrencepossibility

Riskrank

Measures toreduce risk


Whetherthe new

risk



15/20

35.5

Product mixcaused bythepackagingprocesshazards.

In the productpackagingprocess, dueto productmix, resultingin surgeryproducts donot apply.

2 3 9

In thepackagingprocess,batch print forthe sameproduct with abar codecorrespondingto the label,approved byproductpackaging.Packagingre-confirmedby theinspectors.

KH/JS-09.04Packagingoperatinginstructions

No

35.6

Duringtransportationof the producthazards.

In thetransportprocess, theproductssubject to theimpact ofexternal

forces, theoccurrence ofproductcaused bydeformationor scratches

2 5 10

Productpackagingdesign canresist theimpact ofexternalforces for thespecial boxpackagingand make thenecessaryfixed.

KH/JS-09.04Packagingoperatinginstructions

No



16/20


in the surfaceof theproduct.

8 9infection topatients aftersurgery

Requirementsbefore usingthe operatorfails to carryoutsterilizationanddisinfection;

2 3 6

Instructionsin the use ofthis productis notsterile, theuse ofsteamsterilizationmethod.

Instructionbook ofInstrumentsets

No


17/20

KH/JS-CE-GZ03 A/1

7 criteria for acceptability

7.1 Assessment of the severity criteria

The enterprises will be divided into five severity levels, details in Table 3.

Table 3 severity assessment chart

Severity Level S Severity Evaluation

ranking

S1 without any harm Can be negligible 0

S2 mild damage Minor injury or no injury 1

Serious harm to S3 Lead to injury 2

S4 fatal hazardsResulted in one death or serious

injury 3

Catastrophic harm S5 Led to many deaths 4

The definition of serious injury:

a, life-threatening; or

b, body function or permanent damage to permanent damage to body structure;

c, the injury / damage to require medical or surgical repair.

7.2 The assessment criteria probability of occurrence

The orthopedic medical device companies will be divided into six levels of the quantitative analysis,

see Table 4.

Table 4 assess the scale of the probability of harm

P Name probability P Probability (per year) Evaluation

rankingP1 Rare P1 10 -6 1Very few occurred P2 10 -4~10 -6 2

Rare P3 10-2

~10-4

3Incidental P4 10 -1~10 -2 4Sometimes occurs P5 1~10 -1 5Frequent occur P6 1 6

7.3 The estimated level of risk

Orthopedic surgical instruments risk assessment based on the following formula: Risk =

probability the level of severity

Comprehensive description of the risks in Table 5



18/20

KH/JS-CE-GZ03 A/1

Table 5 shows the level of risk comprehensive table Severity Level

S2 S3 S4 S5Possibility ofoccurrenceMild severe fatal catastrophic

P6 Often ALARP NAC NAC NACP5 Sometimes ALARP ALARP NAC NACP4 Accidental ALARP ALARP ALARP NACP3 Little ACC ALARP ALARP ALARPP2 Very little ACC ACC ALARP ALARPP1 Little ACC ACC ACC ACC

Note: ACC is acceptable, ALARP area as is reasonably practicable, NAC is not acceptable.

7.4 Risk acceptance criteria

The production of orthopedic surgical instruments products, integrated by the level of risk, its

assessment of the acceptability criteria in Table 6.

Table 6 Risk Assessment Form

1-5 The risk may be negligible

(6-11)

Permissible risk (decrease has taken reasonable and practicable

measures)

(12-17)Do not want to, and conditional permit risk (and then reduce the

unrealistic)

(18-24) Does not allow the risk of

8

Department Facts description Corrective measures Verification

measures

Quality

Department

According to the monthly "and

the rejection rate tables yield"

and the annual "Product quality

status quo and development

trend report", the product yield,

feed rate of waste, processing

waste rate the quality of work

done better than the target set

-- --



19/20

KH/JS-CE-GZ03 A/1

target

MarketingDepartment Service

Technical servicepersonnel are notsufficient; thenumber of thecertificate is notenough; occasionaldelivery is not ontime

1, to enhance the

training of technical

services; improve

service quality;

2, increasing the

single-package

certification;

3, reasonably and

timely delivery

according to customer

requirements.

KH/JS-18.1

KH/JS-04.4

9 Summaries

The company's products, surgical instruments, in accordance with ISO14971requirements analysis, not found to harm the cause.Currently, the production of the company every step of the process of strict monitoring,the better the quality of the process to ensure product quality, meet regulatoryrequirements MDD93/42/EEC. All the hazards on the risk of surgical instruments aredescribed and evaluated the risks within the acceptable range, in normalcircumstances would not cause harm to operators and patients, but does not causelife-threatening, and therefore, we believe that surgery device products compared tothe risks and its benefits, benefits and more risky.10 related / supporting documents

MDD 93/42/EEC (amended by 2007/47/EC)

ISO 14971:2007 Medical Device Risk Management applications for medicaldevices

KH/QP-CE03 medical device risk management procedures

Department Employee Date Department Employee Date



20/20

KH/JS-CE-GZ03 A/1


Documents

Risk Management Report of Surgical Instruments