Tisch
Product name: (name on registration standard)
Risk assessor and background: (project leader, doctor from medical angle, designer from technical angle, application angle and market angle, providing personnel qualification certificates, such as training qualification and professional title).
Compile: date:
Date of approval:
1. Compilation basis
1. 1 related standards
1)YY03 16-2003 application of medical device risk management in medical devices
2)GB9706. 1- 1995 Medical electrical equipment Part I: General safety requirements;
3) IEC 60601-1-4:1996 Medical Electrical Equipment-Part I: General Safety Requirements-4: Parallel Standard: Medical Programmable Electrical System.
4) Product standards and others
1.2 product related information
1) User Manual
2) Hospital usage, maintenance records, customer complaints, accident records, etc.
3) Articles and other information in professional literature
2. Purpose and scope of application
This is a report on XXXX risk management, in which all possible hazards and the reasons for each hazard are judged. The severity and probability of possible damage caused by each hazard are estimated. When a certain risk level is unacceptable, take control measures to reduce the risk, and evaluate the residual risk after taking risk measures. Finally, make the level of all remaining risks acceptable.
This report is applicable to ... products in the design and development stage (or small batch production stage).
3. Product description
The object of this risk management is … (if photos or pictures can be added), product overview, mechanism and instructions for use:
Taboo:
The equipment consists of the following parts: (text description or schematic diagram)
4. Determine the intended use and safety-related characteristics of the product.
(Answer the questions in Appendix A to determine the characteristics of medical devices that may affect safety)
4. 1 What is the intended use and purpose of the product? How to use it?
Factors to be considered: prospective users and their spirit, physical quality, skill level, cultural background and training, etc.
Ergonomic issues, the use environment of medical devices and who installed them.
Can patients control and influence the use of medical devices?
Are medical devices used to sustain life or to sustain life?
Do you need special intervention in case of medical device failure?
Are there any special problems in the interface design that will lead to careless use errors (see 4.27)?
Equipment for diagnosis, prevention, treatment, relief or trauma compensation, anatomical correction and pregnancy control.
Which function?
4.2 Are medical devices expected to come into contact with patients or other people? How to contact? How long is the contact?
Factors to be considered: nature of expected contact: surface contact, invasive contact and/or implantation.
The duration of each contact.
Frequency of each contact
4.3 What materials and/or ingredients are contained in, used with or in contact with medical devices?
Factors to consider: Are the safety-related characteristics known?
4.4 Is the energy for or from the patient?
Factors to be considered: the form of transmitted energy and its control, quality, quantity and duration.
4.5 Are there substances provided to or extracted from patients?
Factors to be considered: whether the substance is supplied or extracted.
Single substance or several substances?
And minimum transmission rate and its control.
4.6 Are biomaterials reused after being treated by medical devices?
Factors to be considered: the treatment method and the type of substance to be treated (such as automatic blood transfusion and dialysis)
4.7 Are medical devices provided in sterile form or sterilized by users, or sterilized by other microbial control methods?
Factors to be considered: Is the medical device intended to be used once or repeatedly?
Packaging and storage life of medical devices
Limit on the number of reuse cycles
Limitations of sterilization treatment methods used
4.8 Are medical devices expected to be routinely cleaned and disinfected by users?
Factors to consider: the type of cleaning agent or disinfectant used.
Limit of disinfection cycles
The design of medical devices may affect the effect of daily cleaning and disinfection.
4.9 Are medical devices expected to improve patients' environment?
Factors to be considered: temperature, humidity, atmospheric composition, pressure and light.
4. 10 is the medical device measured?
Factors to be considered: measurement variables
Accuracy and precision of measurement results (CMC mark with measurement function)
4. 1 1 Are the medical devices analyzed?
Factors to be considered: Does the medical device show conclusions drawn from input or obtained data (mainly software)?
Calculation method and confidence limit adopted
4. 12 are medical devices expected to be used in combination with drugs or other medical technologies?
Factors to consider: determine the drugs or other medical technologies that may be used, and whether patients with potential problems related to interaction comply with treatment.
4. 13 is there any unexpected energy or material output?
Energy-related factors to be considered: noise and vibration, heat.
Contact radiation temperature (including ionizing, non-ionizing and ultraviolet, visible and infrared)
Leakage current and electric and/or magnetic fields
Material-related factors to be considered: emissions of chemicals, wastes and body fluids.
4. 14 are medical devices sensitive to the environment?
Factors to be considered: operation, transportation and storage environment (including light, temperature, vibration, leakage, sensitivity to changes in energy and refrigeration forms, electromagnetic interference).
4. 15 do medical devices affect the environment?
Factors to be considered: the impact on energy and refrigeration, the emission of toxic substances and the generation of electromagnetic interference.
4. 16 Do medical devices have basic consumables or are they from Fujian?
Factors to be considered: the specifications of consumables or accessories and the restrictions on users' choice of them.
4. Does17 need maintenance and calibration?
Factors to be considered: whether the maintenance and/or calibration are carried out by operators or users or professionals, and whether special substances or equipment are needed for proper maintenance and/or calibration.
4. 18 is there any software for medical devices?
Factors to consider: Is the software expected to be installed, verified, modified or replaced by users and/or operators?
4. 19 is there a storage period for medical devices?
Factors to be considered: signs or descriptions and disposal of such medical devices.
4.20 Is there any effect of delay and/or long-term use?
Factors to be considered: ergonomics and cumulative effects
4.2 1 What kind of mechanical force does the medical device bear?
Factors to be considered: Is the force borne by medical devices under the control of users or through interaction with other personnel?
4.22 What determines the life of medical devices?
Factors to consider: aging and battery exhaustion
4.23 Is the medical device expected to be used once?
4.24 Do medical devices need to be safely withdrawn from operation or disposal?
Factors to be considered: waste products generated when medical devices are disposed of by themselves. (For example, do medical devices contain toxic or harmful substances, or can these substances be recycled?)
4.25 Does the installation or use of medical devices require special training?
Factors to be considered: including debugging and delivery to end users.
Is it possible to be installed by someone who does not have the necessary skills?
4.26 Is it necessary to establish or introduce a new production process?
The introduction of new production technology into production equipment must be regarded as a new hazard source (such as new technology and new production scale).
4.27 Does the successful use of medical devices depend decisively on human factors, such as user interface? Factors to consider: user interface design features that may lead to misuse and are not easily misused.
4.27. 1 Do medical devices have connecting parts or accessories?
Factors to be considered: possibility of wrong connection, difference, similarity with other products, connection force, feedback of connection integrity, tightness and looseness of connection.
4.27.2 Does the medical instrument have a control interface?
Factors to be considered: interval, coding, grouping, graphic display, feedback mode, error, slip, control difference, visibility, starting or changing direction, whether control is continuous or intermittent, and reversibility of binding or action.
4.27.3 Does the medical device display information?
Factors to be considered: visibility, directionality, integrity and perspective in different environments, clarity of displayed information, unit, color coding, and accessibility of decisive information.
4.27.4 Are medical devices controlled by menus?
Factors to be considered: complexity and number of layers, understanding of state, setting path, guiding method, number of steps of each action, clarity of sequence, storage problems, and importance of control functions related to accessibility.
4.28 Is the medical instrument mobile or portable?
Factors to be considered: necessary clamping, handle, wheel, brake, mechanical stability and durability.
5. Hazard determination
(According to Appendix D, the answers include at least five aspects: energy, biology, environment, use and maintenance, with emphasis on the analysis of hazards and their causes. It can also be listed according to the characteristics of the product itself, but it is required to compare with 3. Product expectation.
Judge safety-related characteristics to classify dangerous uses and problems; First, use professional knowledge to find the potential causes intuitively, and further cause analysis can apply FMEA (Failure Mode and Effect Analysis) and FTA (Fault Tree Analysis) methods. )
6. Risk assessment
6. 1 evaluation criteria (same as the risk management plan)
6. 1.3 risk acceptance criteria
Risk = severity × probability level
6.2 Risk Assessment Form
7. Risk control
Through the above evaluation, we can see the acceptable degree of product risk. There is no need to take control measures (list the serial number of hazards) for the risks in widely acceptable areas, and further measures must be taken to control the risks in reasonably feasible areas and unacceptable areas.
8. Residual risk assessment
After taking risk reduction measures, the risk of hazards, such as …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….
If there are large risks that cannot be reduced, it is necessary to collect and review information and literature about the expected use and expected medical benefits to determine whether the benefits exceed the risk level after taking control measures for all the remaining risks in Table 3.
9. Post production information
As this product has not been fully produced, once it is officially produced,
10. Conclusion
Through the analysis and evaluation of hazards, the risk caused by hazards is acceptable, so the product is safe.
extreme
Safety risk analysis report of serum alkaline phosphatase detection kit
1. General
Serum alkaline phosphatase assay kit (hereinafter referred to as ALP assay kit) is an enzyme reagent for clinical examination of in vitro diagnostic chemical reagents. Because the examination is not carried out in the human body or on the human body surface, it will not cause direct risk to the patient or the person being examined. However, in some cases, the risks associated with in vitro diagnostic reagents may lead to or contribute to wrong decisions, which may constitute indirect risks. In addition, the hazards related to use and related risks should also be considered. This safety risk analysis report is mainly based on the requirements of YY/T03 16-2000 "Medical Devices-Risk Management-Application of Risk Analysis" Part I, Appendix A and Appendix B "Guidelines for Risk Analysis of Medical Devices in Vitro Diagnosis" and GB7826-87 "Failure Mode and Impact Analysis (FMEA) Procedure for System Reliability Analysis Technology".
2. Qualitative and quantitative determination of medical devices
2. 1 intended use and purpose
ALP detection box is an 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 measuring the change of absorbance in unit time. ALP test kit is expected to be used in the diagnosis of hepatobiliary and skeletal diseases.
2.2 Is the product in contact with patients or other personnel?
ALP test box is an in vitro diagnostic reagent, which does not contact with patients, and generally does not contact with the skin of operators.
2.3 Product manufacturing material safety
The ALP detection box adopts AR grade chemical analytical purity, and the chemicals used in this kit are all clinical routine biochemical reagents. NaN3 is toxic to a certain extent, but its content is very small, and other substances are non-toxic, so contact with skin should be avoided as far as possible when using the kit. Waste bottles and waste liquid treatment should meet the requirements of environmental protection.
2.4 Is there energy applied to or obtained from the patient?
No energy is applied to the patient, and no energy is obtained from the patient.
2.5 Are there substances provided to or obtained from patients?
The ALP test kit does not contact with the patient, but the medical staff indirectly draws blood from the patient.
2.6 Whether the kit has been processed by instruments before use.
The reagents extracted from ALP detection box by pipette are all disposable, and there is no reuse after treatment.
2.7 Is the product provided in sterile form or can be used by users after sterilization?
The product is analytically pure medical chemical reagent, which is prepared, tested and packaged in a 654.38+ million-class clean room without user sterilization.
2.8 Whether the patient's environment has been improved?
not applicable
2.9 Does it have measuring function?
ALP detection box is used to measure the ALP content in human serum by means of instruments, and the reagent itself has no measurement function.
2. Is10 processed and analyzed?
not applicable
2. Is11combined with medicine or other medical technologies?
It must be used on biochemical analyzer with certain absorbance accuracy.
2. Does12 have unsatisfactory energy and material output?
not applicable
2. Is13 sensitive to the environment?
ALP test chamber should be protected from light, low temperature and dry during transportation and storage, and there are no special requirements for operation.
2. 14 Consumables for supporting use
ALP test boxes generally do not need consumables, but they need to be calibrated or diluted with distilled water if necessary.
2. 15 Maintenance and calibration
not applicable
2. Does16 equipment have software?
not applicable
2. 17 storage life
ALP test chamber requires the storage environment to meet the requirements of technical standards, and the storage period is six months. The production date and storage period are listed in the special package of the kit.
2. 18 delay/long-term use effect
When using ALP test kit, the use of the kit cannot be postponed because of the unstable chemical substances.
2. 19 mechanical force
not applicable
2.20 factors that determine product life
Standardized and correct use, transportation and storage conditions are the basic conditions to ensure the design life of products.
2.2 1 scheduled usage mode
The detection of ALP extracted by pipette is disposable.
2.22 Dangers affecting the environment
The product was created in the workshop of 654.38 million+. After preparation, mixing, testing and packaging, no volatile gases were removed. After use, the product was destroyed as medical waste together with blood samples.
2.23 Do users need special training?
Users don't need special training, but they must meet the qualifications of biochemical inspectors in hospitals and be able to operate under the guidance of professionals or after reading the instruction manual in detail.
2.24 Inconsistency and Inconsistency of Batch
The inhomogeneity and inconsistency of batches directly affect the test results, resulting in the risk of misjudgment of diseases. It is necessary to control the intra-batch precision, inter-batch precision and accuracy and other related indicators.
2.25*** Same interference factors
In addition to the strong electromagnetic interference around the biochemical analyzer, R 1 and R2, during the use of ALP test box, the sample volume ratio, temperature and reaction time have a direct impact on the success or failure of the test results.
2.26 Identification error
Improper identification directly affects the authenticity of transportation, storage and test results of products. Marks include single packaging bottle marks, packaging box marks and transportation and storage marks. For example, the double reagents R 1 and R2 are incorrectly labeled, which leads to the failure of detection, unclear identification of expiration date, distorted detection results due to misuse of expired products, and unclear deterioration of products due to storage at low temperature in the dark.
2.27 inappropriate instructions for use
Improper instructions can't guide the operation, such as the ratio of R 1 to R2, the validity period of sample volume, the temperature and time after the first bottle opening (incubation time, reaction time, measurement time), and the requirement of not touching the skin during operation, etc., which should comply with relevant regulations, otherwise it will cause detection errors or harm to the environment.
2.28 Energy hazards
not applicable
2.29 Biological hazards
not applicable
3. Risk assessment and prevention
3. 1 Expected use and purpose risk
Alkaline phosphatase detection box is used to determine the content of alkaline phosphatase in serum. Clinical diagnosis of hepatobiliary and skeletal diseases. Each batch of products is strictly controlled with intra-batch precision, inter-batch precision, accuracy and stability. The products were compared with imported and domestic similar reagents in the laboratories of the Second Xiangya Hospital of Central South University and Hunan Cancer Hospital, which met the requirements of testing and registered products. Therefore, the risk of accuracy and reliability in use has been reduced to an acceptable limit.
3.2 Risk of contact with patients or others
Testers should operate according to the relevant operating procedures of the laboratory, and the reagents will not contact the skin and mucosa of the operators, which has been clearly stated in the precautions in the product instruction manual. If it comes into contact with skin and mucous membrane, please wash it with tap water immediately, which will not cause harm to the operator.
3.3 Material safety risks
The chemicals used in the reagents are all routine clinical biochemical reagents in China at present. Although NaN3 is toxic, its content is very small and it has no corrosive effect on the skin. In the product manual, used waste liquid and bottles are required to be treated as medical waste to prevent harm. We believe that the safety risk of materials has been reduced to an acceptable limit.
3.4 Risks of applying or obtaining energy to patients
not applicable
3.5 Obtaining substantial risks from patients
For the blood test of patients, professionals use disposable sterile syringes to take blood samples and then send them for inspection, so there is no risk of obtaining substances from patients during the repeated use of ALP test boxes.
3.6 Risk of reuse of instruments after treatment
The single bottle of the product is a reusable liquid packaging bottle, and the reagent extracted by the pipette is used once each time, so there is no risk of reuse after being treated (sterilized) by the instrument.
3.7 Risk of aseptic use
ALP kit is a clinical chemical reagent, and there is no risk in aseptic use.
3.8 Improve patients' environmental risks
3.9 Determination of risks
not applicable
3. 10 risk analysis and treatment
not applicable
3. 1 1 Risk of combined use with drugs or other medical devices
The absorption accuracy and constant temperature accuracy of biochemical analyzer have influence on the detection results. As long as the instrument is maintained according to the routine of the laboratory, the accuracy and function of the instrument are guaranteed, and the testing personnel are qualified professional laboratory medical personnel, then the risk can be minimized.
3. 12 Energy and material export risks
not applicable
3. 13 Environmental sensitivity risk
The product is required to be stored at a low temperature of 2℃~8℃ away from light to prevent deterioration. When used and stored according to the requirements of the product instruction manual, the risk of environmental sensitivity has been minimized.
3. 14 consumption risk of supporting use
Not applicable, a small amount of distilled water should be used if necessary. The quality of distilled water should meet the requirements of distilled water used in biochemical laboratories, and there is no water quality risk.
3. 15 Maintenance and calibration risks
not applicable
3. 16 Software risk
not applicable
3. 17 storage life risk
In the product standard, product packaging label and product instruction manual, the shelf life is specified as six months. Within one month after the expiration of stability testing sampling, the performance of the product meets the requirements of various indicators in the standard, so the risk of shelf life has been minimized.
3. 18 Risk of long-term or long-term use impact
Product standards and instructions stipulate that expired products are strictly prohibited, so there is no risk of delayed use.
3. 19 mechanical force risk
3.20 Risk determining product life
Chemical reagents are required to prevent strong sunlight, and product deterioration will affect service life. Avoid high-temperature or low-temperature storage and prevent freezing from damaging the molecular structure of reagents, which are clearly stipulated in product standards, instructions for use and packaging labels. Therefore, the factors that determine the product life are minimized.
3.2 1 expected usage pattern risk
The single packaging bottle of the product is packed with liquid multi-purpose consumables, and the reagent extracted by the pipette is disposable. After use, the mixed blood samples must be processed and destroyed, so the risk of predetermined use mode is basically impossible.
3.22 Impact of environmental risks
In the whole process of production, transportation, storage and use, the product will not cause harm to the environment. After use, it will be disinfected according to the relevant regulations of hospital laboratories and medical wastes, so the environmental risk has been reduced to an acceptable minimum.
3.23 Personnel Professional Training Risks
Personnel engaged in hospital biochemical tests are professionals with certain knowledge and skills, and the risk of professional training for personnel by products has been minimized.
3.24 Risk of batch unevenness and inconsistency
In the product standard, the PH value, CV (within batch), CV (between batches) and accuracy of reagents are strictly controlled, which is a mandatory item before leaving the factory, so the risk of uneven and inconsistent batches has been minimized.
3.25*** Interference Risk
The biochemical laboratory of the hospital itself is built in a place with small external interference sources, which ensures the anti-interference ability of the instrument and the control accuracy of temperature and time. As long as the operators operate according to the requirements of the manual and the national clinical laboratory operating procedures formulated by the Ministry of Health, the interference risk of the instrument has been minimized.
3.26 Identifying the Risk of Errors
In product standards, product identification includes single packaging bottle identification and packaging box (middle packaging) identification, and single packaging bottle identification and packaging box identification are mandatory items before leaving the factory. The contents of various identification settings have been reviewed and improved by experts from the Provincial Medical Device Standardization Technical Committee, thus minimizing the risk of identification errors.
3.27 Improper use indicates risks.
Product specifications are specified in the product standards, which are assessed as mandatory items before leaving the factory. The format, content and safety precautions of the product instruction manual have been reviewed, revised and improved by experts, so the risk of unknown product instruction manual is minimized.
3.28 Energy Risk
not applicable
3.29 Biological risk
not applicable
Through the above-mentioned hazard judgment, risk estimation, prevention and resolution in the whole process of raw material production, configuration, detection, labeling, packaging, transportation, storage, use method and safety precautions, storage and post-use treatment, as well as the whole process control and risk prevention measures for product quality in registered product standards, instructions for use and enterprise rules and regulations, it can be seen that the safety risk coefficient of kit products produced by our company has been reduced to a minimum, which can meet the aquatic products acceptable to users.