Part I
Product name: (name on the registration standard)
Risk evaluation personnel and background: (project team leader, medical perspective of the doctor, the technical perspective of the designers, the application perspective, the market perspective, and to provide proof of the qualifications of the personnel, such as trained qualifications, title level)
Preparation: date:
Approval :Date:
1. Preparation of the basis
1.1 Relevant standards
1)YY0316-2003 Medical Devices - Risk Management for Medical Devices
2)GB9706.1-1995 Medical Electrical Equipment Part I: General Safety Requirements;
3)IEC60601-1-4:1996 Medical Electrical Equipment - Part I: General Safety Requirements - 4: Parallel Standards: Medical Programmable Electrical Systems
4)Product standards and other
1.2 Relevant information about the product
1)Instruction manuals
2)Hospital usage, maintenance records, customer complaints, accident records, etc.
3)Articles and other information in the professional literature
2. Purpose and scope of application
This paper is a report on risk management for XXXX, which All the possible hazards and the causes of each hazard are determined. For each hazard, the severity of damage and the probability of occurrence of the hazard are estimated. In case of an unacceptable level of risk, control measures were taken to reduce the risk, and the residual risk after the risk measures were evaluated. Finally, the level of all residual risks was brought to an acceptable level.
This report applies to the ...... product, which is in the design and development phase (or in small batch production).
3. PRODUCT DESCRIPTION
The subject of this risk management is the ...... (include photos or pictures if you can), product overview, mechanism, use indications:
contraindications:
The device consists of the following parts: (textual description or schematic diagram)
4. Intended Use and Determination of Safety-Related Characteristics
(Answer, in order, the questions used in Appendix A to determine characteristics of a medical device that may affect safety)
4.1 What is the intended use of the product, its intended purpose? How will it be used?
Factors to be considered: the intended user and his/her mental, physical, skill level, cultural background and training
Ergonomic issues, the environment in which the medical device is to be used and by whom it is to be installed
Whether the patient is able to control and influence the use of the medical device
Whether the medical device is to be used for life-support or life-supporting
Whether the medical device is to be used for life-support or life-supporting in case of Whether special intervention is required in the event of failure of the medical device
Whether there are specific problems with the design of the interface that could lead to inadvertent errors in use (see 4.27)
Which role does the device play in the diagnosis, prophylaxis, treatment, palliation or compensation of trauma, anatomical correction, or control of pregnancy
4.2 Whether the medical device is expected to come into contact with the patient or other personnel, how it will come into contact, and what will happen to the patient when exposed. other persons, how, and for how long?
Factors to consider: nature of anticipated exposure: surface, invasive, and/or implanted
duration of each type of exposure
frequency of each type of exposure
4.3 What material(s) and/or component(s) are included in, or are used with, or come into contact with, the medical device?
Factors to consider: are the safety-related properties known
4.4 Is there energy given to or taken from the patient?
Factors to consider: form of energy delivered and its control, quality, quantity and duration
4.5 Is there a substance given to or taken from the patient?
Factors to be considered: whether the substance is supplied or extracted
Single substance or several substances
and the minimum rate of delivery and its control
4.6 Is the biomaterial processed by a medical device and then reused?
Factors to be considered: mode of handling and type of substance handled (e.g., automated blood transfusion, dialysis)
4.7 Is the medical device supplied or intended to be sterilized by the user in a sterile form or sterilized by other microbiological control methods?
Factors to consider: Is the medical device expected to be used once or reused
Packaging, storage life of the medical device
Limitations on the number of reuse cycles
Limitations on the type of sterilization process used
4.8 Is the medical device expected to be routinely cleaned and sterilized by the user?
Factors to consider:Type of cleaning or disinfecting agent used
Limitations on the number of sterilization cycles
The design of the medical device may affect the effectiveness of routine cleaning and disinfection
4.9 Is the medical device expected to improve the patient environment?
Factors to consider: temperature, humidity, atmospheric composition, pressure, and light
4.10 Is the medical device measured?
Factors to consider: variables to be measured
Accuracy and precision of the measurement results (CMC marking is required for those with a measurement function)
4.11 Are medical devices analyzed and processed?
Factors to be considered: whether the medical device shows conclusions from the data entered or obtained (mainly software)
Calculation methods and confidence limits used
4.12 Is the medical device intended to be used in conjunction with pharmaceuticals or other medical technologies?
Factors to be considered: identification of the potential use of pharmaceuticals or other medical technologies and potential problems associated with interactions Patient compliance with treatment
4.13 Is there an undesired output of energy or material?
Energy-related factors to consider: noise and vibration, heat
Radiation (including ionizing, non-ionizing, and ultraviolet, visible, and infrared) Exposure to temperature
Leakage currents and electric and/or magnetic fields
Substance-related factors to consider: emissions of chemicals, wastes, and bodily fluids
4.14 Are the medical devices environmentally sensitive?
Factors to consider: operating, transportation, and storage environments (including light, temperature, vibration, leakage, sensitivity to changes in energy sources and forms of refrigeration, electromagnetic interference)
4.15 Does the medical device affect the environment?
Factors to be considered: impact on energy and cooling, emission of toxic substances and generation of electromagnetic interference
4.16 Does the medical device have basic consumables or fujian?
Factors to consider: specifications for consumables or accessories and restrictions on their selection by the user
4.17 Is maintenance and calibration required?
Factors to be considered: whether maintenance and/or calibration is achieved by the operator or user or by specialized personnel whether specialized substances or equipment are required for proper maintenance and/or calibration
4.18 Does the medical device have software?
Factors to consider: Is the software expected to be installed, validated, modified, or replaced by the user and/or operator
4.19 Does the medical device have a storage life limit?
Factors to consider: labeling or indication and disposition of such medical devices
4.20 Are there delayed and/or long-term use effects?
Factors to consider: ergonomics and cumulative effects
4.21 What kind of mechanical forces are applied to the medical device?
Factors to consider: Are the forces exerted on the medical device under the control of the user or by interaction with other people
4.22 What determines the life of a medical device?
Factors to consider: aging and battery depletion
4.23 Is the medical device expected to be single-use?
4.24 Does the medical device require safe decommissioning or disposal?
Factors to consider:The medical device itself generates waste products when disposed of. (e.g., does the medical device contain toxic or hazardous materials, or are the materials recyclable)
4.25 Does the installation or use of the medical device require specialized training?
Factors to be considered: including commissioning and delivery to the end user
Is it likely or possible that the installation will be carried out by personnel who do not have the necessary skills
4.26 Is it necessary to establish or introduce a new manufacturing process?
The introduction of a new manufacturing process into a production facility must be considered as a potential source of new hazards (e.g., new technology, new scale of production)
4.27 Does the successful use of a medical device depend decisively on human factors, e.g., user interface? Factors to consider: User interface design features that may cause errors in use and cannot be easily misused
4.27.1 Does the medical device have connecting parts or accessories?
Factors to consider: potential for misconnections, differentiation, similarity to other product connections, connection force, feedback on connection integrity, and overly tight and loose connections
4.27.2 Does the medical device have a control interface?
Factors to consider: spacing, coding, grouping, graphic displays, feedback modes, errors, slippage, control differentiation, visibility, direction of initiation or change, whether control is continuous or intermittent, reversibility of binding or action
4.27.3 Does the medical device display information?
Factors to consider: visibility in different environments, orientation, general and perspective views, clarity of displayed information, units, color coding, accessibility of deterministic information
4.27.4 Is the medical device controlled by menus?
Factors to be considered: complexity and number of levels, knowledge of status, path of setting, method of orientation, number of steps per action, clarity of sequence, storage issues, importance of control functions related to accessibility
4.28 Is the medical device expected to be mobile or portable?
Factors to be considered: necessary clamping, handles, wheels, brakes, mechanical stability and durability
5.Hazard Determination
(Answer according to Appendix D including at least five aspects of energy, biology, environment, use, maintenance, etc., with an emphasis on analyzing the hazards and their causes, and may also be enumerated in accordance with the characteristics of the product itself, but the requirement is to check against the 3 . the product's intended
use and safety-related features of the determination of the problem of the classification of hazards; the first use of professional knowledge to intuitively look for potential causes, and further analysis of the causes can be applied to the FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis) method).
6. Risk Evaluation
6.1 Evaluation Guidelines (same as in the Risk Management Plan)
6.1.3 Guidelines for Risk Acceptability
Risk = Severity Level x Probability Level
6.2 Risk Evaluation Sheet
7. Risk Control
Through the above evaluations, it can be seen that the risk of the product is acceptable. Acceptable degree of risk in the widely acceptable zone ...... (serial number of the listed hazards) need not take further control measures, the risk in the reasonably practicable and inadmissible zone must take further measures to control.
8. Residual Risk Evaluation
After taking risk reduction measures, the risk of hazards such as ...... has been reduced to a broadly acceptable level, and the risk of hazards such as ...... has been reduced to a reasonably acceptable level. (It is also important to state whether new risks have been introduced as a result of the risk reduction measures, and if so, they must be evaluated and controlled again)
If there is a greater risk and it cannot be reduced, information and literature on the medical benefit of the intended use, the intended purpose, must be collected and reviewed in order to decide whether the benefit outweighs the total residual riskTable 3 Risk Levels After Control Measures are Taken
9 .Post-production information
Since this product has not yet been precisely produced, it will be analyzed, evaluated, and controlled again once it is formally produced ......
10.Conclusion
After analyzing and evaluating the hazards, the risks arising from the hazards are all acceptable, and therefore this product is safe.
Part II
Safety Risk Analysis Report for Serum Alkaline Phosphatase Assay Kit (ALP)
1. General
Serum Alkaline Phosphatase Assay Kit (hereinafter referred to as the ALP test kit) is a clinical test in vitro diagnostic reagents in the chemical reagents of the enzyme reagents. Because the test is not performed inside the body or on the surface of the human body, it does not pose an immediate risk to the patient or person being tested. However, in some cases, indirect risks may be posed by the hazards associated with in vitro diagnostic reagents that result in or contribute to erroneous decisions. In addition, use-related hazards and their concomitant risks should also be given consideration. This safety risk analysis report is mainly based on Appendix A, "Characterization Issues Used to Determine the Possible Safety Impacts of Medical Devices" and Appendix B, "Guidelines for Risk Analysis of In Vitro Diagnostic Medical Devices" in the requirements of YY/T0316-2000, "Medical Devices I Risk Management I Part I Application of Risk Analysis", as well as GB7826-87, "Systematic and Reliable Analysis of Failure Mode and Effects Analysis of Technical Failure Mode and Effects ( FMEA) program" to conduct a comprehensive safety risk analysis.
2. Qualitative and quantitative determination of medical devices
2.1 Intended use and purpose
ALP test kit is a kind of in vitro diagnostic reagent, which is based on the principle of biological enzyme reaction and photochemical reaction, and realizes the determination of ALP in samples by determining the change of absorbance per unit of time.
The intended use of the ALP test kit is to diagnose diseases of the liver, gallbladder, and skeletal system. The ALP test kit is intended for use in the diagnosis of hepatobiliary and skeletal disorders.
2.2 Whether the product is in contact with patients or other personnel
The ALP test kit is an in vitro diagnostic reagent, which has no contact with patients, and in general does not come into contact with the skin of the operator.
2.3 Product manufacturing material safety
ALP test kit, manufacturing raw materials are AR-level chemical analysis of pure, the chemical substances used in the kit are the current clinical biochemical routine reagents, NaN3 has a certain degree of toxicity but the content is very small, the rest of the material is non-toxic, so in the use of the kit should be avoided as far as possible to contact with the skin and so on. Waste bottles, waste liquid disposal should be in line with environmental requirements.
2.4 Whether there is energy applied to the patient or obtained from the patient
No energy is applied to the patient or obtained from the patient.
2.5 Is there a substance supplied to or obtained from the patient
The ALP assay kit does not come into contact with the patient, but indirectly, blood is drawn from the patient by medical personnel.
2.6 Whether the kit is handled by the instrument and then reused
The reagents extracted from the ALP test kit by the aspirator are single-use and are not handled and then reused.
2.7 Whether the product is provided in sterile form or prepared for use by the user after sterilization
The product is analytically pure for medical chemical reagents, prepared, tested and packaged in a class 100,000 clean room, and does not require the user to be sterilized for use.
2.8 Whether to improve the patient environment
Not applicable
2.9 Whether to have a measurement function
ALP test kits with the help of the instrument to measure the ALP content of human serum, the reagent itself has no measurement function.
2.10 Whether or not processed for analysis
Not applicable
2.11 Whether or not in conjunction with pharmaceutical or other medical technology
Must be used on a biochemical analyzer with a certain absorbance accuracy
2.12 Whether or not there is an output of undesired energy and substances
Not applicable
2.13 Is it environmentally sensitive
The ALP test kit requires protection from light, low temperature and dryness in transportation and storage, and has no special requirements in operation.
2.14 Consumables
ALP test kits generally do not require the use of consumables, but if necessary, need to be appropriate amount of distilled water for calibration or dilution.
2.15 Maintenance and calibration
Not applicable
2.16 Whether there is software for the device
Not applicable
2.17 Storage life
ALP test kits require a storage environment in accordance with the provisions of the technical standards, the storage period of six months, the date of production and storage period listed in the special packaging of the kit.
2.18 Extended/long-term use of the effect
ALP test kit in use, due to chemical instability, so the kit can not be extended use.
2.19 Mechanical forces applied
Not applicable
2.20 Factors determining the product life
Standardized and correct conditions of use and transportation and storage are essential to ensure that the product reaches its designed life.
2.21 Intended use
The pipette extraction ALP test is for single use.
2.22 Hazards affecting the environment
The product is created in a class 100,000 workshop, through the preparation, mixing, testing, packaging, there is no volatile gas exclusion, and the product is used together with the blood samples are uniformly destroyed according to the medical waste.
2.23 Whether the user requires special training
The user does not require special training, but must meet the qualifications of the hospital biochemical testing personnel, under the guidance of professionals or read the instructions in detail can operate.
2.24 batch inhomogeneity and inconsistency
Batch inhomogeneity and inconsistency directly affects the test results, resulting in the risk of misdiagnosis of the disease, must be controlled within the batch precision, batch-to-batch precision and accuracy and other relevant indicators.
2.25*** the same interfering factors
In addition to the biochemical analyzer should be surrounded by no strong electromagnetic field interference, ALP test kits in the use of the process of R1 and R2 and the proportion of the sample volume volume, temperature and reaction time have a direct impact on the success or failure of the test results.
2.26 labeling errors
Inappropriate labeling, directly affecting the transportation and storage of the product and the authenticity of the test results, labeling, including a single bottle labeling and box labeling and transportation and storage labeling, such as double reagent R1, R2 labeling errors, R1 misuse for R2, resulting in test failure, expiration date labeling is unclear, the misuse of expired products caused by the distortion of the test results, light protection, low temperature storage labeling is unclear, resulting in product failure. Low-temperature preservation is not clearly identified, resulting in product deterioration, and so on.
2.27 Inappropriate instructions
Inappropriate instructions can not guide the operation of such as R1, R2 ratio, the amount of sample, temperature, time (incubation time, reaction time, measurement time) for the first time after the opening of the bottle of the expiration date of the use of time, the operation of prohibited contact with the skin, etc. Requirements should be in line with the relevant provisions, otherwise it will lead to errors in detection or harm to the environment.
2.28 Energy Hazard
Not applicable
2.29 Biological Hazard
Not applicable
3. Risk Estimation and Prevention
3.1 Risk of Intended Usage and Purpose
The ALP test kit is to determine the level of ALP in serum. Clinical determination of hepatobiliary and skeletal system diseases. Intra-batch precision, inter-batch precision, accuracy and stability are strictly controlled in each batch, and the product has been tested by the Department of Laboratory Medicine of the Second Xiangya Hospital of Central South University and the Department of Laboratory Medicine of Hunan Cancer Hospital in the clinic with 80 cases of clinical comparative tests using imported and domestic similar reagents, which is in line with the requirements of the test and the provisions of the registered product, so that the risk of using the accuracy and reliability has been reduced to an acceptable limit.
3.2 Risk of contact with patients or others
Detectors operate in accordance with the relevant operating procedures of the laboratory, the reagent will not come into contact with the operator's skin, mucous membranes, in the product instruction manual precautions have been clearly prompted, in case of contact with the skin, mucous membranes, please immediately rinse with tap water, the operator will not pose a risk of injury.
3.3 Material safety risk
The chemicals used in the reagents are all domestic clinical biochemical routine reagents, although containing NaN3 with a certain degree of toxicity, but the content is very small, and at the same time are not corrosive to the skin, in the product specification, after the use of waste liquids and waste bottles required to unify the treatment of medical waste, to prevent the harm caused by the risk that we believe that the risk of material safety has been reduced to an acceptable limit. Has been reduced to an acceptable limit.
3.4 Risk of exerting or obtaining energy to the patient
Not applicable
3.5 Risk of obtaining substances from the patient
The patient's blood is tested, and the blood samples are taken by professionals with disposable sterile syringes and then sent to be examined, so there is no risk of obtaining substances from the patient in the process of reuse of the ALP test kit.
3.6 Risk of reuse after instrumentation
The single bottle of the product is a liquid packaging bottle for multiple consumptive use, and the reagent extracted by each pipette is for single use, so there is no risk of reuse after instrumentation (sterilization).
3.7 Risk of sterile use
ALP kit is a clinical chemistry reagent, there is no risk of sterile use.
3.8 Risk of improving the patient environment
3.9 Risk of assay
Not applicable
3.10 Risk of analyzing and processing
Not applicable
3.11 Risk of using in combination with pharmaceuticals or other medical devices
There exists an effect of the absorbance accuracy of biochemistry analyzers and the accuracy of thermostat temperature on the results of the assay. As long as the instrument according to the test room routine maintenance, maintenance, to ensure the accuracy and function of the instrument, the inspector is a qualified professional test medical personnel, so the risk can be minimized.
3.12 Energy and Material Output Risk
Not Applicable
3.13 Risk of environmental sensitivity
The product requires a low temperature of 2 ℃ ~ 8 ℃ to prevent deterioration of the light preservation, in the product instruction manual for the use and preservation of the requirements of the environmental sensitivity of the risk has been minimized.
3.14 supporting the use of consumption risk
Not applicable, if necessary, a small amount of distilled water, distilled water quality should be consistent with the biochemical laboratory distilled water requirements, there is no risk of water quality.
3.15 Maintenance and calibration risk
Not applicable
3.16 Software risk
Not applicable
3.17 Storage life risk
In the product standard, product packaging logo and product instructions, the provisions of the storage life of six months, the stability of the test samples expired within one month after the product, performance Meet the requirements of the standard indicators, so the risk of storage life has been minimized.
3.18 Extended or long-term use of the effect of risk
Product standards and instructions for use of expired products are strictly prohibited, so there is no extended use of the effect of risk.
3.19 Risk of mechanical force
3.20 Risk of determining the life of the product
Chemical reagents require protection from strong sunlight, product deterioration affects the life. Avoiding storage at high or low temperatures and preventing icing from destroying the molecular structure of the reagent are clearly defined in the product standards, instruction manuals and package markings. Therefore, the factors that determine the life of the product have been minimized.
3.21 Risk of Intended Use
The single-package vial of the product is a liquid multi-expendable package, and the reagents extracted from the pipette each time are for one-time use, and the blood specimens mixed with it must be disposed of and destroyed after use, so the risk of intended use is basically unlikely to exist.
3.22 impact on the environment risk
The product in the production and transportation, storage, use of the whole process, will not cause harm to the environment, after use in accordance with the relevant provisions of the hospital laboratory, according to the unified disinfection of medical waste, so the risk of impact on the environment has been reduced to the minimum acceptable
3.23 risk of professional training of personnel
The biochemical testing personnel are all qualified and experienced hospitals, hospitals, hospitals, hospitals and other institutions. Biochemical testing personnel are professionals with certain knowledge and skills, the product has minimized the risk of professional training of personnel.
3.24 Risk of batch unevenness and inconsistency
The PH value of the reagents, CV (within the batch), CV (between batches), accuracy, etc., are strictly controlled in the product standard and as a mandatory inspection items, so the risk of batch unevenness and inconsistency has been minimized.
3.25***same risk of interference
The hospital biochemical testing room itself was built in a place where the source of external interference is very small, to ensure that the instrument's ability to prevent interference, the instrument has a temperature, time control accuracy, as long as the operator in accordance with the requirements of the instructions for use and the Ministry of Health developed the "National Clinical Laboratory Operating Procedures" for the operation of the ****same interference risk has been reduced to a minimum.
3.26 Identification error risk
In the product standard, the product identification including single bottle identification, box (in the packaging) identification box transport storage identification made detailed provisions, and single bottle identification, box identification as a mandatory inspection project before leaving the factory, a variety of identification settings content by the provincial medical device standardization technical committee expert review, modification and refinement, so the risk of identification error has been reduced to a minimum. Therefore, the risk of marking errors has been minimized.
3.27 The risk of inappropriate instructions
The product standards for the product description of the content of the specific provisions, and as a mandatory inspection of the product factory to assess the format of the product instructions, the content and safety precautions by the expert review, modification, and improvement, so the risk of product specification is not detailed has been reduced to a minimum.
3.28 Energy risk
Not applicable
3.29 Biological risk
Not applicable
4 Through the above hazard determination, risk estimation, prevention and resolution of the whole process of the kits from the production of raw materials, configuration, testing, marking, packaging, transportation, storage, methods of use and safety precautions, preservation and post-consumption treatment. From the registered product standards and instructions and corporate regulations on product quality of the whole process of control and risk prevention measures, it can be seen that the company's production of reagent kits products, the safety risk factor reduced to a minimum, to meet the user can accept the water to ensure that the product is safe and effective.