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Decision of the Board of the Eurasian Economic Commission dated April 3, 2018 No. 47
"On the Classifier of Types of Adverse Events Related to the Use of Medical Devices"
BOARD OF THE EURASIAN ECONOMIC COMMISSION
DECISION
dated April 3, 2018 N 47.
CLASSIFIER
TYPES OF ADVERSE EVENTS ASSOCIATED WITH THE USE OF
MEDICAL DEVICES
Chairman of the Board
Eurasian Economic Commission
T. SARKISYAN
Approved
By decision of the Board
Eurasian Economic Commission
dated April 3, 2018 N 47.
CLASSIFICATOR
TYPES OF ADVERSE EVENTS ASSOCIATED WITH THE USE OF
MEDICAL DEVICES
I. Detailed information from the classifier
| First level term code | Second level term code | Name | Description |
| A. Event type codes | |||
| A01000 | activation, installation or disconnection | a problem involving a deviation from the documented performance characteristics of the product and relating to the sequence of events for activating or installing the product or one of its components at a particular location | |
| A01001 | installation difficulties | a problem related to users' difficulty or inconvenience in installing the product, components of the product, or both, in a specified location | |
| A01002 | activation failure | a problem related to the inability of the product or product components to activate | |
| A01003 | disconnect failure | a problem involving failure of the product or one of its components when disconnected or disengaged as intended | |
| A01004 | premature activation | a problem related to early and unexpected activation of the product, product components, or both in the system | |
| A01005 | activation delay | a problem involving delayed and unexpected activation of a product, product components, or both in a system | |
| A01100 | computer hardware | A hardware-related problem that affects product performance or communication with another product | |
| A01101 | hardware problem computer | a hardware-related problem that affects the performance of the product | |
| A01102 | network problem | A problem involving deviations from the documented system specification that affects the overall performance of the system, or the performance of individual products, or a set of products connected to that system | |
| A01200 | computer software | a problem with written programs, code, or software system that affects performance or communication with another product | |
| A01201 | application program problem | a problem related to the requirement for software to perform its functions during its intended use or application | |
| A01202 | programming problem | a problem with written program code or application software used to meet an identified need or performance objective of the product, including incorrect software, dose, parameters, and power calculations | |
| A01300 | connection or installation | a problem related to the interfacing of products, components of products, or functional units designed to provide a means of transmitting liquid, gas, electricity, or data | |
| A01301 | connection problem | a problem related to the linking of products, product components or functional units designed to provide a means for the transmission of liquid, gas, electricity or data | |
| A01302 | shutdown | A problem involving connected products, product components, or both, and the presence of sufficient open space (when disconnected) to prevent the flow of gas, liquid, or electric current between connectors | |
| A01303 | trip failure | a problem with interconnected products, components of products, or both, consisting of the fact that interruption of fluid, gas, electric power, or information transmission cannot be accomplished without disrupting the connection of the components or disconnecting them as necessary. | |
| A01304 | installation problem | a problem related to the connection of products, components of products, or both, consisting of the fact that the channels of switching systems and other functional units designed to provide a means for the transmission of liquid, gas, electricity, or information are inadequate or inappropriate | |
| A01305 | unreliable or intermittent connection | a problem due to unreliable or intermittent connection of products or product components | |
| A01306 | incorrect connection | a problem due to improper connection of products or product components or connection that does not conform to the product specification | |
| A01400 | electricity | a problem due to failure of electrical or electronic circuitry or product components | |
| A01401 | sparking | a problem involving an electric current flowing through a gap between two conductive surfaces, usually resulting in visible flashes of light | |
| A01402 | circuit failure | A problem related to failure of internal network pathways or electrical circuitry (i.e., electrical components, circuit boards, wiring) | |
| A01403 | sensing element problem | a problem related to product functions that are designed to respond to physical stimuli (temperature, light, motion, heart rate) but do not transmit the received signal for interpretation or measurement. | |
| A01404 | power supply problem | a problem related to the product's built-in power source (e.g., batteries, transformers, fuel cells, or other power sources) | |
| A01405 | spark | a problem involving the release of electricity between two bodies previously electrically charged (e.g., electrostatic discharges) | |
| A01500 | external conditions | a problem related to the environmental conditions in which the product will be used or stored (e.g., temperature, noise, lighting, ventilation, and power supply) | |
| A01501 | surrounding particles | a problem associated with fine solid or liquid particles, such as dust, smoke, gases or mist, suspended directly in the atmosphere in which the product is used | |
| A01502 | gases or vapors | a problem related to the visibility, odor, or toxicity of ambient vapor or gas that affects the operation of the product | |
| A01503 | inappropriate storage | a problem due to unsatisfactory or improper storage of the product | |
| A01504 | power loss | a problem related to insufficient primary power provided by the facility (e.g., electrical, gas pressure, fluid pressure) | |
| A01600 | implantable product failure | migration, malfunction or failure of the implanted product (active or inactive) | |
| A01601 | migration of the product or product components | A problem involving unwanted movement of a product, product components, or both, caused by movement away from the center or offset from the source | |
| A01602 | a problem related to bone breakdown | a problem caused by the relationship between the bone and the implanted product | |
| A01700 | incompatibility | a problem with a product that is not compatible with other products, product components, the patient, or a substance (drug, body fluid, etc.) that it contains or carries. | |
| A01701 | incompatibility of components or accessories | a problem involving a mismatch between the product, components of the product, or both, when operated under the same application conditions, resulting in dysfunction between the product and its components. | |
| A01702 | Incompatibility at the product-to-product level | a problem involving incompatibility between two or more products, when the products are operated under the same conditions of use, resulting in dysfunction of more than one product. | |
| A01703 | incompatibility at the patient-product level | A problem related to a patient/product interaction at the physiologic or anatomic level that affects the patient or the product (e.g., biocompatibility and immunologic problems). | |
| A01800 | infusion | a problem related to the failure of the product to deliver the intended fluids or gases (e.g., delivery of medication at an inappropriate rate, removal of fluid from the system, etc.). | |
| A01801 | content release problem | A problem related to the inability of a product, components of a product, or both, to free itself from contents | |
| A01802 | improper delivery or infusion | A problem related to unreasonable regulation and delivery of therapeutic agents (e.g., air, gas, drugs, or liquids to the product or patient under excessive pressure generated by a pump) | |
| A01803 | filling problem | A problem related to the inability of the product, components of the product, or both, to extend or increase the delivery of the intended agent (e.g., saline or air) | |
| A01804 | no flow | a problem arising from the product's inability to deliver specified liquids or gas | |
| A01805 | excessive flow | A problem related to an overdose of a delivered treatment (for example, drugs or fluids delivered to the product or patient under excessive pressure). | |
| A01806 | insufficient supply | A problem related to an inadequate dose for treatment (e.g., epidural, intrathecal, intravenous, subcutaneous administration of drugs or fluids delivered to the product or patient under excessive pressure). | |
| A01900 | marking, labeling and instructions for use | A problem related to the accuracy and appropriateness of written, printed, graphic, or audio/video materials that come with the medical device or its packaging | |
| A01901 | application instruction problem | a problem with any materials that accompany the medical device, including instructions related to the identification, technical description and use of medical devices provided by the manufacturer of the product. | |
| A01902 | labeling issue | A problem with written, printed, or graphic material that is attached to a medical device or its packaging or related materials | |
| A02000 | material | a problem related to any deviations from the documented performance characteristics of the product relating to the limited life of all materials used to manufacture the product | |
| A02001 | rupture | a problem involving pressure inside a tank or container increasing to the point where the tank or container ruptures | |
| A02002 | cracking | a problem involving undesirable separation or visible opening across the length or width in the materials used in the construction of the product | |
| A02003 | degradation | a problem associated with harmful changes in the chemical structure, physical properties and appearance of the materials used in the construction of a product | |
| A02004 | material discoloration | a problem with unwanted lines, patterns or noticeable discoloration of the material | |
| A02005 | material fragmentation | a problem related to unexpected tearing of the product into small pieces | |
| A02006 | material perforation | a problem involving unwanted material damage characterized by closely spaced stamped or drilled holes | |
| A02007 | material delamination | a problem associated with unwanted separation or breakage of product materials | |
| A02100 | mechanical part | a problem related to any deviation from documented product performance specifications containing technical requirements concerning mechanical damage, including moving parts or assemblies, etc. | |
| A02101 | improper calibration | a product performance problem related to the accuracy of the product due to the calibration of the product | |
| A02102 | disconnecting the product or product components | a problem related to the separation of a product or product components | |
| A02103 | displacement | a problem related to mechanical forces that displace the product or product components from their intended location | |
| A02104 | leakage | a problem with a liquid or gas escaping from the vessel or container in which it is contained | |
| A02105 | mechanical interference | a problem involving obstruction or restriction of the movement of the product or its components | |
| A02106 | problem returning to the intended position | a problem related to failure to return the product, or components of the product, or both, to their intended position | |
| A02107 | unintended displacement | a problem involving unwanted movement of the product caused by malfunction, misdiagnosis, or improper handling of the product | |
| A02200 | non-mechanical part | Problems associated with any deviations from documented product performance specifications containing technical requirements related to chemicals, bonding, optics, or installation | |
| A02201 | chemical problem | a problem related to any deviation from the documented performance specifications of the product containing technical requirements relating to any chemical characteristics (i.e. elements, compound or mixture) | |
| A02202 | communication or transmitted signal strength | a problem associated with a product for receiving or transmitting signals and data, including transmissions between internal components of the product and other external products with which the product is intended to communicate. | |
| A02203 | installation | a problem related to unsatisfactory installation, layout or customization of a particular product or technology | |
| A02204 | optical problem | a problem related to the transmission of light in the visible spectrum, affecting the quality of the transmitted image or otherwise affecting the intended use of a visible spectrum channel | |
| A02205 | telemetry mismatch | A problem related to the variability of signal transmission, which can be characterized as a telemetry coding channel, a way of processing data transmitted from source to destination | |
| A02300 | others | event type not included in this table but related to the product | |
| A02301 | others | event type not included in this table but related to the product | |
| A02400 | output problem | A problem related to any deviation from the intended functional performance of the product related to the end result (e.g., data or test results) | |
| A02401 | Improper energy output to the patient's tissues | a problem related to the amount of energy directed to the patient's tissues | |
| A02500 | packing | a problem related to packaging or delivery | |
| A02501 | pre-application damage | a problem due to damage during packaging or delivery to the place of use of the product | |
| A02502 | supply of non-sterile products | a problem associated with the delivery of a non-sterile product due to a breach of package integrity | |
| A02503 | package | a problem with the materials used for protection in the delivery process or the delivery instructions | |
| A02504 | product contamination during delivery | a problem related to the presence of any foreign matter on the surface or in the packaging of the product that may affect the functional characteristics for its intended use | |
| A02505 | Difficulty in opening or removing packaging materials | a problem related to difficulties for end-users in handling the product, in particular opening or removing the outer packaging | |
| A02600 | defense | A problem involving any deviation from documented product performance specifications containing technical requirements for the implementation and inheritance of design features specific to products used to reduce risks to the patient or patient caregiver or to maintain levels of said risks | |
| A02601 | problem product signaling system | problem related to failure of the alarm system | |
| A02602 | safety issue | a problem related to a product function that prevents unsafe use of the product | |
| A02700 | temperature | a problem with the product reaching unintended elevated temperatures | |
| A02701 | burnt products or components | a problem associated with changes in coloration or destruction due to thermal decomposition of the product or its components | |
| A02702 | fire | a problem involving combustion of product components resulting in any of the following: light, flame, smoke | |
| A02703 | flame | a product-related problem causing burns and unsteady sparking | |
| A02704 | insufficient cooling | a problem with the product or parts of the product, consisting of not being cool enough, both in the active (working) state and in the inactive (non-working) state. | |
| A02705 | overheating of the product or product components | a problem with the product generating high temperatures that jeopardize its function (e.g., overheating that leads to melting of components or automatic shutdown) | |
| A02706 | smoke | a problem associated with a cloud of vapor or gas from the product as a result of fire or combustion | |
| A02800 | unintended function | a problem with the product not working as intended, resulting in malfunctions, misdiagnosis, or improper handling | |
| A02801 | the product displays an incorrect message | a problem related to a product that, when asked by a user about a product problem, provides incorrect information | |
| A02802 | damage to clutch or connection | a problem related to difficulty connecting a product to another object, including another product or components of a product, or to a part of the patient's body. | |
| A02803 | incorrect assembly | a problem related to the use of the product due to incorrect assembly of product components, parts and elements | |
| A02804 | Providing treatment to the wrong area of the body | a problem related to energy delivered to the wrong area of the body | |
| A02900 | application error | a problem with an action or inaction that results in an outcome that does not meet the manufacturer's intent or the operator's expectation. | |
| A02901 | Insufficient or inadequate disinfection and sterilization | a problem related to the introduction of unwanted impurities with the product or inadequate removal of visible contaminants, foreign matter, or organisms deposited on the exterior surfaces, crevices, and joints of the product by a mechanical or manual process designed to render the product sterile, safe for handling, or for further decontamination processes. | |
| A02902 | insufficient training | a problem related to the possible failure to provide satisfactory initial or periodic user training on the operation of the product. | |
| A02903 | maintenance issue | a problem related to product maintenance | |
| A02904 | recovery problem | problem related to product repair | |
| A02905 | product application problem | a problem related to the user's failure to maintain or operate the product in accordance with the manufacturer's recommendations or recognized best practices | |
| A02906 | defective product | a problem related to a product that is in a non-functional or non-functional state | |
| B. Evaluation codes | |||
| B25000 | biological | events affecting life or living organisms | |
| B25002 | biocompatibility | the product induces a reaction at the cellular or tissue level that causes undesirable local or systemic effects in the recipient or beneficiary of the therapy. | |
| B25003 | biological materials | The presence of biological materials in the medical device that cause a reaction other than immediate hypersensitivity. | |
| B25004 | foreign material contamination | presence of foreign materials introduced by contaminated or potentially hazardous products | |
| B25005 | genotoxic problem | An article capable of causing damage to genetic material, e.g. leading to malignant tumors [see ISO 10993 (all parts)]. | |
| B25006 | hematological problem | the product affects or influences blood or blood components | |
| B25007 | endotoxin contamination | The unwanted presence of toxins associated with certain bacteria (e.g., gram-negative bacteria) | |
| B25008 | microbiological contamination | Undesirable presence of microorganisms or microbes such as bacteria and fungi (yeast and mold) | |
| B25009 | material or filtrate of material causing a pyrogenic effect | The undesirable presence of pyrogens or organisms that cause temperature rise resulting from the penetration of these materials from the product | |
| B25100 | counterfeit | Events involving the reproduction of the authenticity of a medical product, false labeling or product information with the intent to deceive and misrepresent the authenticity of the medical product | |
| B25101 | falsification | Mimicking the authenticity of a medical device with intent to deceive | |
| B25102 | product misrepresentation | Product labeling or other information that is not provided or authorized by the company responsible for labeling the product | |
| B25301 | project failure | failure of the product to achieve its intended use due to design flaws, including inadequate risk assessment. | |
| B25302 | design process failure | failure of the product to achieve its intended use due to an inappropriate development process | |
| B25303 | package | inadequate or weak packaging | |
| B25304 | security measures | Inadequate or non-existent security measures | |
| B25305 | utilization | inadequate or insufficient user interface features that determine efficiency, effectiveness, ease of user training and customer satisfaction | |
| B25500 | electrical part | events related to the electrical drive of the product in which an electrical fault manifests itself in a failure of the product (e.g., damage to circuitry, contacts or components), even if the fault is of a non-permanent nature | |
| B25501 | electrical component | Defects in electrical or electronic components (e.g., resistor, capacitor, transformer, microprocessor) resulting in product failure | |
| B25502 | electrical faults | electrical circuit failure resulting from events such as liquid penetration or overheating | |
| B25503 | electrical contact | An electrical problem resulting in product malfunction (e.g. unwanted contact or contact interruptions, corrosion, high resistance, thermal shock or unintended movement) | |
| B25504 | systems energy storage | A product problem related to the electrical energy storage system (e.g., batteries, charging system, or capacitor), including problems such as premature depletion of the power source and battery explosion. | |
| B25505 | incorrect design | product problem due to incorrect wiring, breakage due to unexpected movement and other design flaws | |
| B25506 | insulation | Products that have inadequate or unsuitable insulation material, resulting in exposure to dangerous voltages | |
| B25507 | power supply: power loss | failure of the mains power supply, which causes the product to stop working | |
| B25600 | electromagnetic interference | events related to malfunctions of an active electrical medical device caused by electromagnetic disturbances, including radio frequency interference (RFI) | |
| B25601 | sustainability electromagnetic radiation | impairment of medical functionality due to electromagnetic interference | |
| B25602 | electromagnetic radiation | Medical devices that inadvertently emit electromagnetic interference that affects radio communications, another product or the functional performance of other medical devices or medical systems | |
| B26000 | human factor | An event involving the application of knowledge of human capabilities (physical, sensory, emotional and intellectual) and the limits of its application to the design and development of tools, products, systems, environments and structures. | |
| B26001 | abnormal use | An act or omission by the user or operator of a medical device as a result of behavior that is beyond any reasonable means of risk management by the manufacturer, such as willful violation of instructions, procedure, or use prior to completion of installation, resulting in product failure. | |
| B26002 | shelf life | Use of a medical device beyond its expiration date, resulting in product failure | |
| B26003 | end of life | product malfunction caused by using the product beyond the specified period of use | |
| B26004 | unacceptable environment | use of the product in an environment that causes it to fail or malfunction | |
| B26005 | incorrect calibration | Calibration is incorrect or not performed at all, resulting in inaccurate results provided by the medical device involved in the measurement (e.g., temperature, mass, pH, in vitro study results). | |
| B26006 | installation problem | product malfunction due to improper installation, setup or configuration | |
| B26007 | maintenance | product failure or malfunction as a result of insufficient routine or periodic maintenance | |
| B26008 | unhygienic condition | product malfunction caused by insufficient hygiene status of the user or location of the user | |
| B26009 | patient anatomy (physiology) | Product malfunction caused by inappropriate use or unsuitability for the anatomy (physiology) of the involved patient | |
| B26010 | patient condition | Product failure or poor performance as a result of the patient's condition (possibly sudden) | |
| B26011 | sterilization, disinfection, cleaning | Product failure due to insufficient or improper sterilization, disinfection or cleaning | |
| B26012 | storage conditions | malfunction caused by inappropriate or inadequate storage conditions (e.g. temperature, humidity, light) | |
| B26013 | training | malfunction caused by lack of training or insufficient user training | |
| B26014 | application errors | acts or omissions that result in a different outcome than intended by the manufacturer or expected by the operator, causing product failure. | |
| B26200 | interaction | an event involving heterogeneous medical devices and other equipment integrated to create a medical system | |
| B26201 | communication (wired or wireless) | Medical devices that do not transmit or receive proper signals (e.g., messages received but not understood, messages sent but not received, or messages with corrupted content) | |
| B26202 | shutdowns | Unintentional disconnection of two or more parts of a medical system (e.g., electrical, mechanical, hydraulic, or pneumatic) resulting in product failure. | |
| B26203 | incompatibility between products or system components | product malfunction due to connection or wiring of improper components | |
| B26400 | consumer (user) information | an event related to information provided by the manufacturer for the safe, simple and effective operation of a medical device | |
| B26401 | error in labeling or instructions for use | product failure due to incorrect labeling | |
| B26402 | unusable instructions for use | product failure due to insufficient or missing information in the instructions | |
| B26403 | illegible marking | product failure as a result of the user's inability to read the labeling (e.g., label damage, deterioration in label quality, font size) | |
| B26500 | production | A medical device event that can be traced back to a problem in the manufacturing process, excluding medical device design issues | |
| B26501 | assembly error | product failure due to incorrect assembly | |
| B26502 | cleaning or disinfection process | product malfunction caused by inadequate cleaning or disinfection | |
| B26503 | process contamination | product malfunction caused by exposure to spoiled elements or contamination during production that has not been properly removed during further processing | |
| B26504 | sterilization process | Product failure caused by improper or insufficient sterilization | |
| B26505 | production equipment problem | Product failure due to a problem in the equipment used in the manufacturing process or in the maintenance of that equipment | |
| B26506 | packaging problem | Product failure caused by package breakage (e.g., broken seal or ruptured (damaged) in vitro container set) | |
| B26507 | quality management issue | a product problem resulting from inadequate maintenance or technical conditions for control and verification of product specifications defined by the manufacturer | |
| B26508 | storage problem | product malfunction caused by inappropriate or insufficient storage conditions (e.g. temperature, humidity, light) | |
| B26600 | materials, chemical composition | events related to product components or materials, or how product materials or components react with other elements either in the medical device or in its environment | |
| B26601 | destruction problem | a product problem resulting from wear, weakening, corrosion, or arising from processes such as aging, penetration, and corrosion | |
| B26602 | unsuitable materials | a product problem arising from its application or the use of unsuitable materials for the intended use of the product | |
| B26603 | incompatible materials | A product problem caused by the use of incompatible materials throughout the life of the product (e.g., wearing, corroding) | |
| B26604 | product reactivity problem | Product problem related to materials that do not react properly (e.g., amalgams, impression materials, silicone materials) | |
| B26605 | damage due to sterilization (cleaning process) | Product failure that results in material damage as a result of a chemical agent used during the sterilization or cleaning process (e.g., excessive residual chemical or incompatible sterilizing agents). | |
| B26700 | mechanical part | events related to the mechanisms or physical properties of medical devices, excluding electrical properties | |
| B26701 | component failure | Defective mechanical components, resulting in product failure (e.g. failure of the support bracket) | |
| B26702 | fatigue | a product problem resulting from weakening or deterioration of the material when subjected to a load or series of repetitive stresses | |
| B26703 | destruction | a product problem resulting from the separation of components, object or material into 2 or more parts | |
| B26704 | leakage (depressurization ) | leakage (depressurization) of the product due to a substance, usually liquid or gas, leakage of from the product or failure of a gasket designed for substances to enter or exit the product or a component thereof | |
| B26705 | wear and tear | product problem due to premature or anticipated erosion, deterioration or alteration of the materials used | |
| B26800 | a non-medical problem with the product or a detected failure | events involving a medical device that either functioned in accordance with its intended use or failure was not detected | |
| B26801 | non-medical problem | the judgment is based on the fact that the product has functioned in accordance with its intended use | |
| B26802 | the non-medical problem of product failure | product failure cannot be confirmed due to insufficient evidence | |
| B26900 | Lack of communication with the medical device | An event unrelated to and independent of the medical device | |
| B26901 | Lack of communication with the medical device | The adverse event is not related to the medical device | |
| B27000 | Indirect, unauthorized or contraindicated use | an event involving an unintended use (off-label), not in compliance with regulatory requirements (unauthorized), or contraindicated use of medical devices | |
| B27001 | unintended use | Use of medical devices beyond the intended use as determined by the manufacturer and for which regulatory approval has not been obtained | |
| B27002 | unauthorized use | Use of a product for a medical purpose that does not have regulatory approval or has a new intended use for which no additional authorization has been obtained | |
| B27003 | unauthorized use | a problem due to the use of the product for purposes contraindicated by the manufacturer | |
| B27100 | operational problem (lack of functioning) | events related to lack of or impaired functionality or capability of a medical device | |
| B27101 | alarm signal | failure or insufficient alarm signal | |
| B27102 | faulty data transmission | Failure of a medical device to accurately transmit data to or from another device or location | |
| B27103 | lack of calibration | failure of a product requiring calibration due to failure to calibrate, resulting in inaccurate measurements | |
| B27104 | protective measures | Failure of protective measures (e.g. needle safety, pressure relief valve) | |
| B27105 | temperature failure | product problem due to excessive heating or cooling | |
| B27106 | utilization | product failure due to application errors | |
| B27200 | optical part | events related to the ability of a medical device to transmit light energy | |
| B27201 | optical transmission problem | a product problem related to the product's ability to transmit light energy | |
| B27300 | other | product-related events associated with an evaluation term not related to this code | |
| B27301 | other | events related to the product that are not categorized under other codes included in this table | |
| B27500 | product distribution | A medical device event that can be traced back to a distribution problem prior to first use | |
| B27501 | contamination before first use | product failure caused by exposure to harmful elements, contaminants or pollutants that may affect a component, part or the entire product | |
| B27502 | Quality assurance at health care facilities | Product failure due to inadequate quality assurance procedures at health care facilities | |
| B27503 | installation problem | failure of a product or a batch of products in the distribution chain due to an installation error performed by the manufacturer | |
| B27504 | transportation, handling, delivery | product problems due to shipping conditions, e.g. temperature in the shipping compartment, method of transportation | |
| B27700 | quality system | events related to medical problems of the product as a result of insufficient maintenance or technical conditions to control and verify the product according to specifications defined by the manufacturer | |
| B27701 | quality control issue | a product problem that results from inadequate maintenance or the establishment of methods of control and verification of product specifications as defined by the manufacturer | |
| B28000 | reuse of a single-use product | events related to the reuse of medical devices intended by the manufacturer for single use | |
| B28001 | reuse of a single-use product | product failure due to reuse of products intended for single use | |
| B28200 | software | events related to the medical function of the product or devices generating the information that is compromised, any distortion due to software, malfunction, insufficiency or incompatibility. Note. These conditions include incomplete or insufficient programming, outdated software, and improper installation, including upgrades | |
| B28201 | software configuration | product problems due to using the wrong version or insufficient change management | |
| B28202 | software engineering | Medical device or component failure due to incomplete, incorrect or inadequate software development | |
| B28203 | software installation problem | medical device failure due to software installation operations not performed as prescribed | |
| B28204 | software requirements error | Medical device failure due to incomplete, incorrect or insufficient software development | |
| B28205 | software security | Medical device software failure due to insufficient authorization, access control, and accountability features | |
| B28206 | hardware incompatibility | Product failure due to connection of 2 or more incompatible devices | |
| B28207 | software incompatibility | product failure due to connection of 2 or more incompatible software parts | |
| B28500 | unauthorized interference, sabotage | events related to a deliberate act of interference in the production and distribution of the product in relation to the manufacturer's instructions (sabotage), or manipulation of the product for medical purposes (unauthorized interference), which leads to abnormalities in the operation of the medical product and (or) adverse effects on patient care. | |
| B28501 | unauthorized interference, sabotage | Product failure resulting from unauthorized intervention or harm to medical devices | |
| B28700 | test results | events related to obtaining and reporting inaccurate test results | |
| B28701 | false or inaccurate test results | the product produces false test results that do not correspond to real-world performance (e.g., false positives or false negatives), or inaccurate test results | |
| B29000 | unidentified event | an event for which a probable or ultimate cause cannot be determined | |
| B29001 | unidentified event | probable or ultimate cause is not determined - the condition causing the device operating function to fail is not known | |
II. Classifier passport
| N n/a | Element designation | Description |
| 1 | 2 | 3 |
| 1 | Code | 0__ |
| 2 | Type | 2 - classifier |
| 3 | Name | classifier of types of adverse events associated with the use of medical devices |
| 4 | Abbreviation | KVNSMI |
| 5 | Designation | EC 0__-201 (rev. 1) |
| 6 | Details of the act on adoption (approval) of the directory (classifier) | Decision of the Board of the Eurasian Economic Commission of April 3, 2018 N 47 |
| 7 | Date of enactment (start of application) of the directory (classifier) | 20__ г. |
| 8 | Details of the act on termination of reference (classifier) application | - |
| 9 | Date of termination of reference (classifier) application | - |
| 10 | Operator(s) | RU, Federal Service for Supervision in the Sphere of Healthcare |
| 11 | Assignment | is designed to systematize data on the types of adverse events associated with the use of medical devices provided in the course of monitoring the safety, quality and effectiveness of medical devices in circulation in the Eurasian Economic Union |
| 12 | Abstract (scope of application) | Ensuring information interaction in the implementation of common processes within the Eurasian Economic Union and the functioning of the information system in the sphere of medical products circulation |
| 13 | Keywords | Adverse event (incident), safety of medical devices |
| 14 | Sphere in which the powers of the bodies of the Eurasian Economic Union are exercised | technical regulation |
| 15 | Use of international (interstate, regional) classification | 1 - the classifier is harmonized with international (interstate, regional) classifiers and (or) standards: ISO/TS 19218-1 "Medical devices. Hierarchical structure of codes for adverse events. Part 1. Event type codes"; ISO/TS 19218-2 "Medical devices. Hierarchical structure of codes for adverse events. Part 2. Evaluation codes." |
| 16 | Availability of state directories (classifiers) of the Eurasian Economic Union member states | 2 - the classifier has no analogues in the member states of the Eurasian Economic Union |
| 17 | Method of systematization (classification) | 2 - hierarchical, number of steps (levels) - 2 |
| 18 | Methodology | 1 - centralized maintenance procedure. Addition, modification or deletion of classifier values is performed by the operator as changes are made to ISO/TS 19218-1 "Products medical. Hierarchical structure of codes for adverse events. Part 1. Event type codes" and ISO/TS 19218-2 "Medical devices. Hierarchical structure of codes for adverse events. Part 2. Evaluation codes." In case of exclusion of a value, the classifier record is marked as invalid from the date of exclusion with indication of the act of the Eurasian Economic Commission regulating the expiration of the classifier record. Codes of classifier records are unique, reuse of codes of classifier records, including invalid ones, is not allowed |
| 19 | Structure | information on the structure of the classifier (composition of the classifier fields, areas of their values and rules of formation) is specified in Section III of this classifier |
| 20 | Degree of data confidentiality | information from the classifier refers to open access information |
| 21 | Established periodicity of review | as appropriate changes are made to ISO/TS 19218-1 "Medical devices. Hierarchical structure of codes for adverse events. Part 1. Event type codes" and ISO/TS 19218-2 "Medical devices. Hierarchical structure of codes for adverse events. Part 2. Evaluation codes." |
| 22 | Changes | - |
| 23 | Reference to detailed information from the directory (classifier) | detailed information from the classifier is specified in Section I of this classifier |
| 24 | Method of presentation of information from the directory (classifier) | publication on the information portal of the Eurasian Economic Union |
III. Description of the classifier structure
Table
Structure and requisite composition of the classifier of types
adverse events related to the use of
medical devices
| Name of requisite | Props value area | Rules for forming the value of a requisite | Mn. | ||||
| 1. Information on the type of adverse events associated with the use of medical devices | is determined by the value areas of the nested requisites | is determined by the rules of formation of nested details | 1..* | ||||
|
| 1.1 Tier 1 term code for types of adverse events associated with use of medical devices | normalized character string. Length: 6 | code designation is formed using the sequential method of coding Template: [A-Z]\d{5} For event type codes, "A" is used in the first digit and "B" is used for evaluation codes | 1 | |||
| 1.2 Name of the first level term of types of adverse events related to the use of medical devices | normalized character string. Min. length: 1. Max. length: 1000 | is formed in the form of a word combination in the Russian language | 1 | ||||
| 1.3 Description of the first level term for types of adverse events associated with the use of medical devices | normalized character string. Min. length: 1. Max. length: 4000 | is formed in the form of a description in Russian | 0..1 | ||||
| 1.4 Information on the second level term of types of adverse events associated with the use of medical devices | is determined by the value areas of the nested requisites | is determined by the rules of formation of nested details | 1..* | ||||
|
| 1.4.1 Level 2 term code for types of adverse events associated with the use of medical devices | normalized character string. Length: 6 | The code designation is formed using a sequential coding method Template: [A-Z]\d{5} | 1 | |||
|
| 1.4.2 Name of the second level term of types of adverse events associated with the use of medical devices | normalized character string. Min. length: 1. Max. length: 1000 | is formed in the form of a word combination in the Russian language | 1 | |||
|
| 1.4.3 Description of the second level term for types of adverse events associated with the use of medical devices | normalized character string. Min. length: 1. Max. length: 4000 | is formed in the form of a description in Russian | 0..1 | |||
|
| 1.4.4 Information about the directory (classifier) entry | is determined by the value areas of the nested requisites | is determined by the rules of formation of nested details | 1 | |||
|
| *.1 Effective date | date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD | corresponds to the start date specified in the act of the Eurasian Economic Union authority | 1 | |||
|
| *.2 Information on the act regulating the beginning of validity of the directory (classifier) record | is determined by the value areas of the nested requisites | is determined by the rules of formation of nested details | 0..1 | |||
|
| *.2.1 Type of act | normalized character string. Template: \d{5} | code designation of the act in accordance with the classifier of types of normative legal acts of international law | 1 | |||
|
| *.2.2 Act number | normalized character string. Min. length: 1. Max. length: 50 | corresponds to the number of the act of the Eurasian Economic Union authority | 1 | |||
|
| *.2.3 Date of the act | date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD | corresponds to the date of adoption of the act of the Eurasian Economic Union body | 1 | |||
|
| *.3. Expiration date | date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD | corresponds to the expiration date specified in the act of the Eurasian Economic Union authority | 0..1 | |||
|
| *.4 Information on the act regulating the expiration of the directory (classifier) record | is determined by the value areas of the nested requisites | is determined by the rules of formation of nested details | 0..1 | |||
|
| *.4.1 Type of act | Normalized character string. Template: \d{5} | code designation of the act in accordance with the classifier of types of normative legal acts of international law | 1 | |||
|
| *.4.2 Act number | normalized character string. Min. length: 1. Max. length: 50 | corresponds to the number of the act of the Eurasian Economic Union authority | 1 | |||
|
| *.4.3 Date of the act | date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD | corresponds to the date of adoption of the act of the Eurasian Economic Union body | 1 | |||