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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
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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
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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
NumberDetermines Whether or not affects
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
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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.
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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
NumberDetermines Whether or not affects
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
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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?
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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.
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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
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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
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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
SerialNumber Potential
harmReason ofoccurrence
SeriousLevel
Occurrencepossibility
Riskrank
Riskreduction
approaches
ApplicablestandardsOr relateddocuments
Whethe n
ri
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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
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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
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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
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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
SerialNumber Potential
harmReason ofoccurrence
SeriousLevel
Occurrencepossibility
Riskrank
Measures toreduce risk
ApplicablestandardsOr relateddocuments
Whetherthe new
risk
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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
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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
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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
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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
-- --
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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
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