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KH/JS-CE-QXB03 A/0
KH/JS-CE-QXB03 A/0
4 the team of risk analysis Name Wang zhi ming Position/Responsibility Vice general manager, supervise production & technique department Technique adviser Manager of Technique Department Standardization Engineer Manager of Quality Department Manager of Logistic Department Marketing Manager Sales Manager Attending physician Duty Team Leader
Jiang de cheng Ma hao ming Yin zhuo Jiang qing xing Cao hua Wu zheng qian Wang tong Huang fei peng Xu li 5 Product Descriptions
Team Member Team Member Team Member Team Member Team Member Team Member Team Member Team Member Team Member
5.1 Overview The object of risk management involves surgical instruments. The company provides the surgical instruments is an essential tool for orthopedic surgery, orthopedic implants all products are required to meet the appropriate surgical instruments to properly install and reliably fixed to the patient's body, the safety of implantable devices also remove the need to use The appropriate surgical instruments. The production of surgical instruments with a variety of materials, such as: stainless steel, titanium, aluminum and non-metallic materials. Human exposure to traumatic surgical instruments, required hardness, toughness is moderate, leaving debris and difficult to oxidative corrosion, and have some biocompatibility. 5.2 Function Surgical instruments is a tool for orthopedic surgery. Purpose is to ensure safe and smooth implants implanted or removed. 5.3 use of the environment Surgical instruments available to medical institutions, the need for treatment of qualified and 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 Chapter total 20pages page2
KH/JS-CE-QXB03 A/0
damage; - the consequences of harm, that is: how serious it is. Now according to the requirements of ISO14971, the two parts of surgical instruments for 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 surgical instruments that may affect the security features of the problem of determining the following table: Table 1 the characteristic problem of determining the safety
Serial Number C.2.1 1.1 Determines Whether or not affects
1.2
1.3
1.4
1.5
devices in the diagnosis, prevention, care, treatment or mitigation, trauma and Not applicable disability compensation, replacement or correction of anatomy, etc. What is the indication (e.g. patients who need Orthopedic surgery patient population)? Whether to maintain or Not applicable support medical equipment life?
Continued Table 1 The characteristic problem of determining the safety Serial Number 1.6 Determines In the case of failure of medical devices need special intervention? Implantable medical devices are expected to be used? Medical equipments are Whether or not affects
Not applicable
C.2.2 C.2.3
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KH/JS-CE-QXB03 A/0
surgery when necessary, contact with patients.
C.2.4
Applicable. The company's products, its biological properties and mechanical properties were already recognized by the medical profession.
C.2.5
Not applicable
C.2.6
Not applicable
C.2.7
Not applicable
C.2.8
Not applicable
C.2.9
Applicable. The company's products in the form of non-sterile products for use by the user (installer) for cleaning and disinfection. Not applicable
C.2.10
C.2.11 C.2.12
C.2.13
Not applicable
C.2.18
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Medical devices have limited storage life? For delayed and (or) long-term use effects? What kind of medical equipment to withstand mechanical forces? What determines the life of medical devices? Single-use medical devices are expected? The need for safety of medical devices out of operation or disposal?
C.2.22
Not applicable Applicable. Surgical instruments used in the wear and tear or improper operation. Not applicable. Can be reused, clean and sterilized before use. Not applicable
C.2.23 C.2.24
C.2.25
Continued Table 1 The characteristic problem of determining the safety Serial Number C.2.26 Determines Installation or use of medical devices requires special training or special skills? How safe use of information provided? the Whether or not affects Applicable. The installation of surgical instruments with the necessary skills to use the need for surgical (orthopedic) medical use. Applicable. The installation of surgical instruments with the necessary skills to use the need for surgical (orthopedic) medical use. Not applicable Applicable. The success of surgical instruments depends on surgeons to use clinical experience, depending on the surgeon can correct operation of surgical instruments. Not applicable Not applicable 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. medical device Not applicable Not applicable
C.2.27
C.2.28
C.2.29
C.2.29.1 C.2.29.2
Need to establish or introduce new production processes? Successful use of medical devices, is decisive depends on human factors, such as user interface? User interface design features will result in the wrong? Medical equipment is used for distraction caused by the wrong environment? Are there parts of medical
C.2.29.3
equipment connected?
or
accessories
C.2.29.4 C.2.29.5
Are
there
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C.2.29.6
Not applicable Applicable. Surgical instruments with the necessary skills required by the surgery (orthopedics) doctors to operate. Not applicable Not applicable
C.2.29.7
C.2.29.8 C.2.30
C.2.31
Not applicable
C.2.32
Not applicable
C.2.33
Whether to retain the medical equipment data on Not applicable critical patient care?
Whether the use of medical devices depends on the basic properties? Manufacturing process should be considered in the risk Whether due to equipment caused by improper selection of materials of biological compatibility issues? Not applicable
C.2.34
35
Applicable. Surgical instruments with the necessary skills required by the surgery (orthopedics) doctors to operate.... Applicable. Improper control of such material, the occurrence of misuse, abuse will result in bio-compatibility issues; affect the product's life, resulting in surgery can not proceed.
35.1
35.2
Whether the material due to improper control devices, resulting in bio-compatibility issues and product failures?
Continued Table 1 The characteristic problem of determining the safety Serial Numbe r Determines Whether due to improper design, resulting in device products in the clinical application of the process of fracture? The processing of products possible risks? Whether or not affects
35.3
35.4
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Applicable. Products in the blanking process, due to fracture caused by taking the wrong material or biological compatibility issues. Applicable. Products in the blanking process, due to fracture caused by taking the wrong material or biological compatibility issues. Applicable. Improper operation of the heat treatment process, not achieve the required hardness, will lead to product failure Applicable. Products in the polishing process, the pollution will be polishing paste, there is no net washing polishing paste, affecting the cleanliness of the product, resulting in bio-compatibility issues. Applicable. Products in the polishing process, the pollution will be polishing paste, there is no net washing polishing paste, affecting the cleanliness of the product, resulting in bio-compatibility issues. Not applicable. Corrosion test is mainly used to test whether the product is made of stainless steel resistant to corrosion. The liquid is often used as a bleach or disinfectant hydrogen peroxide, and has been fully diluted. Not in the product composition of the surface of residual risk. Not applicable. Laser marking does not affect the mechanical properties. Applicable. Products in the passivation process, the processing liquid is diluted nitric acid solution, such as nitric acid solution to clean without a net, there are residual elements left nitric acid solution to produce bio-compatibility issues. Products in the packaging process, due to packaging errors caused by the product mix, making products in use and the model specification does not harm patients
35.4.1
35.4.2
35.4.3
35.4.4
35.4.5
35.4.6
35.4.7
Product marking equipment will result in fracture of the factors that produce? Product marking equipment will result in fracture of the factors that produce?
35.4.8
35.5
Products in the packaging process is causing a mixed problem? Products in the transport process caused by equipment faults will produce the factors?
35.6
Products during transport, due to the breakdown of the product packaging was damaged, resulting in surgery can not be normal.
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6.2 Risk management process Surgical Instruments products are the specific characteristics of safety-related judgments, clear and product safety hazards related to the terms of harm are the reasons for the refinement and analysis, its analysis and risk assessment, and take down measures the risk of a re-evaluation of risks, the table below:
Continued Table 2 surgical instruments list of potential hazards and measures Applicable Possible harm Whether standards Measures to the new Or related Serious Risk reduce risk Reason of risk documents Level Occurrence rank occurrence possibility (1) Do not have the Broken surgical instruments, such failure can not meet necessary skills by the surgery (bone) doctor from operating equipment. 2 2 4 Instructions in the manual Manual operation instrument No 2 1 2 ACC
Serial Number
Potential harm
Measures taken to reduce the risk analysis Serious Occurrence Risk Level possibility rank
26
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In the product
KH/JS-CE-GZ03 A/1
29
manual
for
products to be given sufficient 2 2 4 anatomical knowledge and understanding of orthopedic to with Manual operation instrument No 2 1 2 ACC
surgeons operate.
35.3
(3) designers do not follow procedures for product design and development operations
Tailor-made "design and development control procedures" and "design change control procedures", and periodically reviewed.
KH/QP-08 KH/QP-09
No
ACC
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(5) With the size of the deviation device products, resulting in the product is not fit for surgery. 4) The product does not achieve the required hardness, heat treatment process, leading to product breakage, increased wear Mechanical processing card KH/ZB-01.12 General Inspection Instructions
KH/JS-CE-GZ03 A/1
In production
the
35.4.2
No
ACC
35.4.3
Formulated the "heat treatment instructions," and the special process was confirmed, while strictly enforced.
KH/JS-09.10
No
ACC
Serial Number
Potential harm
Continued Table 2 surgical instruments list of potential hazards and measures Applicable Possible harm Risk Whether standards the new reduction Or related Serious Occurrence Risk Reason of risk documents Level possibility rank approaches occurrence
Measures taken to reduce the risk analysis Serious Occurrence Risk Level possibility rank
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Set up special library materials, Improper Biological compatibility 35.2 of the product hazards surgical instruments material control biological compatibility issues. the 2 2 4 equipment, and the establishment of special management, monthly reconciliation of debit objects, to prevent mistakes made. MWI-011 No 2
KH/JS-CE-GZ03 A/1
ACC
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(1) Process may be left on surface caused harmful substances in biological compatibility problems for patients the of by to oil, after Cleaning process for each channel one by one to confirm and verify the cleaning process to develop work instructions, and products sent to the Institute of Suzhou University, Biological evaluation of radiation tests to verify the process taken by the company's reasonable. Training of cleaning operatives, cleaning work
KH/JS-CE-GZ03 A/1
polishing paste cleaning the surface may still be oil, polishing paste, detergent residue composition, resulting harm patients. (2) passivation treatment, surface cleaning is not completely made acid residues, resulting in harm to patients. in to 2 5 10
No
ACC
35.4.8
10
No
ACC
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in strict accordance with the requirements of operating instructions for cleaning and make a clean record, to ensure that products meet the requirements of every cleaning. If the cleaning agent composition change or cleaning of changes in a timely manner Further validation and revalidation
KH/JS-CE-GZ03 A/1
35.4.4
(3) products in the polishing, the cleaning is not complete so the surface acid residues, resulting in harm to patients.
10
No
ACC
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(4) after cutting, due to damage caused by taking the wrong material Control of the machining process to develop "machining process cards."
KH/JS-CE-GZ03 A/1
35.4.1
No
ACC
Serial Number
Potential harm
Continued Table 2 surgical instruments list of potential hazards and measures Applicable Measures taken to reduce Possible harm Whether standards the risk analysis Measures to the new Or related Serious Occurrence Risk Serious Occurrence Risk reduce risk Reason of risk documents Level possibility rank Level possibility rank occurrence
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In the packaging process, batch print for the same product with a bar code corresponding to the label, approved by product packaging. Packaging re-confirmed by the inspectors.
KH/JS-CE-GZ03 A/1
35.5
In the product packaging process, due to product mix, resulting in surgery products do not apply.
No
ACC
35.6
In the transport process, the products subject to the impact of external forces, the occurrence of product caused by deformation or scratches
10
Product packaging design can resist the impact of external forces for the special box packaging and make the necessary fixed.
No
ACC
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in the surface of the product. Requirements before using the operator fails to carry out sterilization and disinfection;
KH/JS-CE-GZ03 A/1
89
Instructions in the use of this product is not sterile, the use of steam sterilization method.
No
ACC
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7 criteria for acceptability 7.1 Assessment of the severity criteria
KH/JS-CE-GZ03 A/1
The enterprises will be divided into five severity levels, details in Table 3.
Table 3 severity assessment chart Severity Level S S1 without any harm S2 mild damage Serious harm to S3 S4 fatal hazards Catastrophic harm S5 Severity Can be negligible Minor injury or no injury Lead to injury Resulted in one death or serious injury Led to many deaths
Evaluation ranking 0 1 2 3 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.
Evaluation ranking 1 2 3 4 5 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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KH/JS-CE-GZ03 A/1
Possibility of occurrence P6 P5 P4 P3 P2 P1
Often Sometimes Accidental Little Very little
Severity Level
S2
Mild
S3
severe
S4
fatal
S5
catastrophic
Little 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.
The risk may be negligible Permissible risk (decrease has taken reasonable and practicable measures) Do not want to, and conditional permit risk (and then reduce the unrealistic) Does not allow the risk of
8
Verification
Department
Facts description
According to the monthly "and the rejection rate tables yield" and the annual "Product quality
Quality Department
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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target 1, to
KH/JS-CE-GZ03 A/1
enhance of
the
training
technical improve
Marketing Department
Technical service personnel are not sufficient; the number of the Service certificate is not enough; occasional delivery is not on time
increasing
the
KH/JS-18.1 KH/JS-04.4
timely
delivery
9 Summaries The company's products, surgical instruments, in accordance with ISO14971 requirements 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 regulatory requirements MDD93/42/EEC. All the hazards on the risk of surgical instruments are described and evaluated the risks within the acceptable range, in normal circumstances would not cause harm to operators and patients, but does not cause life-threatening, and therefore, we believe that surgery device products compared to the 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 medical devices KH/QP-CE03 medical device risk management procedures Department Employee Date Department Employee Date
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