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WS/T 654-2019: Safety management for medical devices
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Safety management for medical devices
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WS/T 654-2019
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PDF similar to WS/T 654-2019
Standard similar to WS/T 654-2019 WS/T 655 GB/T 36388 GB 18469 WS/T 653 Basic data | Standard ID | WS/T 654-2019 (WS/T654-2019) | | Description (Translated English) | Safety management for medical devices | | Sector / Industry | Health Industry Standard (Recommended) | | Classification of Chinese Standard | C05 | | Classification of International Standard | 11.020 | | Word Count Estimation | 21,290 | | Date of Issue | 2019 | | Date of Implementation | 2020-05-01 | | Issuing agency(ies) | National Health Commission | WS/T 654-2019: Safety management for medical devices---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Safety management for medical devices
ICS 11.020
C 05
WS
People's Republic of China Health Industry Standard
Medical device safety management
Published on October 18,.2019
2020-05-01 implementation
Published by the National Health Committee of the People's Republic of China
Contents
Foreword ... Ⅱ
Introduction ... III
1 Scope ... 1
2 Normative references ... 1
3 Terms and definitions ... 1
4 Management requirements ... 2
4.1 Basic principles ... 2
4.2 Management organization ... 3
4.3 Management Responsibilities ... 3
4.4 Management System ... 3
4.5 Risk Management ... 5
4.6 Collection and analysis of safety information ... 6
4.7 Supervision and inspection of safety and performance control system ... 6
4.8 File management ... 6
5 Personnel requirements ... 7
6 Environment and facility control ... 7
6.1 Environment ... 7
6.2 Facilities ... 7
7 Process control ... 8
7.1 Safety confirmation before clinical use ... 8
7.2 Control during use ... 8
7.3 Emergency response to adverse events ... 8
8 Safety and performance testing ... 8
8.1 Testing laboratory ... 8
8.2 Testing standards and appliances ... 8
8.3 Detection cycle ... 9
8.4 Test records ... 9
9 Supplier Management ... 9
Appendix A (Normative Appendix) Safety and Performance Status Identification ... 10
Appendix B (informative) Classification of medical device risk levels ... 12
References ... 16
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was drafted. Chinese People's Liberation Army Joint Logistics Support Army Drug Instrument Supervision and Inspection Station, Capital Medical University, Central Theater
General Hospital, Third Medical Center of General Hospital of Chinese People's Liberation Army, China Medical Equipment Association.
Drafters of this standard. Sun Xiwen, Li Yongxue, Li Yiyong, Duan Xinan, Mi Yongwei, Peng Mingchen, Zhang Zhiqiang, and Meng Jianguo.
Introduction
With the rapid development of modern economic society in our country and the continuous progress of medical device technology, the scale and level of medical devices have become modern
An important symbol of medical technology capabilities of medical institutions. The status and role of medical devices in the medical process are becoming more and more prominent.
Key supporting technologies for technological and medical development.
Many large, medium and high-risk medical devices have been widely used in medical institutions in China, not only in large tertiary hospitals, but also in second-tier hospitals.
Level hospitals, and even grassroots medical and health institutions, have become an important basic guarantee for promoting and improving the level of medical technology.
It is worth noting that any misalignment and deviation of the technical performance and status parameters of the medical device during clinical use may be different degrees
This affects the quality of medical treatment, causing injuries and even death to personnel.
Strengthening and standardizing the safety management of clinical use of medical devices by medical institutions, reducing the risk of clinical use of medical devices, and improving medical treatment
Quality, an important measure to ensure medical safety, is also the unshirkable responsibility of medical institutions. The standard preparation team is based on relevant national laws and regulations.
Study and analyze the actual situation of medical device safety management in clinical use in China's medical institutions, summarize practical experience, and solicit opinions from all parties
See the basis of this standard.
Medical device safety management
1 Scope
This standard specifies the safety management requirements for active medical devices entering medical institutions before and during clinical use, including medical treatment.
The structure established by the organization's medical device management organization, the responsibilities of organizations at all levels, the elements of various management systems that should be established, and the methods of safety management
Laws, etc .; also specifies technical requirements to ensure the safety and effective performance testing, operating specifications, maintenance, etc. of medical devices.
This standard applies to the safety management of active medical devices used clinically by medical institutions.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB 16895.24 Electrical installations of buildings-Part 7-710. Requirements for special equipment and locations Medical facilities
YY/T 0841 Periodic test and post-repair test of medical electrical equipment
3 terms and definitions
The terms and definitions defined in GB 16895.24 and the following apply to this document.
3.1
Medical device
In order to achieve diagnosis, treatment, monitoring, remission, compensation for disease, injury or disability; research on anatomical or physiological processes,
Replacement, regulation; control of pregnancy; the purpose of examining human samples, its effects on the human body and in vivo are not through pharmacology
Obtained by scientific, immunological or metabolic means (but these means may be involved and play a certain auxiliary role), alone or in combination.
Generic term for instruments, equipment, appliances, materials or other items used in the human body, including the software required.
3.1.1
High risk medical device
Medical devices with high potential hazards must be strictly controlled for their safety and effectiveness.
Note. This type of medical device corresponds to the third type of medical device in the Regulations on the Supervision and Administration of Medical Devices.
3.1.2
Medium risk medical device
Medical devices that can ensure their safety and effectiveness through special controls.
Note. This type of medical device corresponds to the second type of medical device in the Regulations for the Supervision and Administration of Medical Devices.
3.1.3
Low risk medical device
Medical devices whose safety and effectiveness can be guaranteed through routine control.
Note. This type of medical device corresponds to the first type of medical device in the Regulations for the Supervision and Administration of Medical Devices.
3.1.4 active medical device
Need to use electric, pneumatic and other medical devices to drive their functions.
3.2
Medical venue
A place used to diagnose, treat, monitor and care for patients.
Note. To ensure that patients are protected from possible electrical hazards, additional protective measures are used in medical facilities. The type and performance of these hazards depends on the situation.
The treatment varies. Divide sites according to their different uses and different medical procedures.
3.2.1
Category of class 1
Medical sites that use active medical device components in the following ways.
-The active medical device parts are in contact with the outside of the body;
-Contact parts invade any part of the body.
3.2.2
Venue of class 2
Active medical device components are used in places such as cardiac diagnostics, operating rooms, and vital life-threatening treatments.
3.3
Medical engineering personnel
Personnel with a medical engineering background, college degree or equivalent, and personnel engaged in medical device safety and quality technical assurance.
4 Management requirements
4.1 Basic principles
4.1.1 The clinical use safety control management of medical devices should run through the entire life cycle of medical devices, covering the procurement, installation, and inspection of medical devices
Collection, clinical use, maintenance, inspection and calibration, storage, emergency deployment, personnel training, safety and quality evaluation, and file management
There are processes.
4.1.2 Medical institutions shall use medical devices registered in accordance with the law and with qualified certification documents.
4.1.3 Medical institutions should formulate a medical device safety management plan, and formulate operation management systems and procedures for medical devices with different risk levels
Procedures, applicable standards, operating procedures, use and testing and evaluation record formats, etc., and shall form normative documents to relevant departments and persons
Ordered.
4.1.4 Medical institutions shall be equipped with managers who meet the safety management of medical devices and medical engineering professionals with safety and quality technical guarantee.
4.1.5 Medical institutions shall provide corresponding work and storage places and necessary testing equipment for the safety management of medical devices.
4.1.6 For medical equipment indispensable for diagnosis and treatment activities and emergency treatment, a plan for emergency deployment shall be formulated.
4.1.7 The safety protection of medical electrical equipment shall comply with the relevant regulations of GB 16895.24.
4.2 Management organization
4.2.1 Medical institutions shall set up the leadership of medical institution leaders, medical business management departments, medical device management departments, and medical device clinical
The medical device clinical use safety management organization composed of the use department and the logistics support department is responsible for the safety of medical device clinical use
Management work.
4.2.2 The safety management of clinical use of medical devices shall be incorporated into the medical safety management system of medical institutions.
4.3 Management responsibilities
4.3.1 The leaders of medical institutions shall perform the following duties.
a) Fully responsible for the safety management of clinical use of medical devices;
b) organize the development of plans, plans and regulations for medical device safety management;
c) Responsible for the configuration of medical device managers, medical engineering technicians and related testing equipment required for medical device safety management.
4.3.2 The medical service management department shall perform the following duties.
a) organize the implementation of medical device safety management plans, plans and regulations;
b) supervise and inspect the implementation of safety management plans, plans and regulations;
c) Formulate emergency plans for medical device safety management and organize drills regularly;
d) Coordinate related matters related to medical device safety management.
4.3.3 The medical device management department shall perform the following duties.
a) Fully responsible for the safety control technology of medical devices;
b) Formulate safety control plans, safe operating procedures and management systems for medical devices;
c) Responsible for the relevant technical training of medical device use departments and operators;
d) Responsible for the organization of medical device testing, maintenance and repair, handling technical issues related to safety and quality;
e) Formulate emergency treatment plans for various first aid and life support medical devices;
f) Organize the collection of safety control information for medical devices, conduct annual safety control evaluations,
The person in charge of the full control management organization and the medical institution submits the evaluation report and proposes improvements;
g) Responsible for establishing records of medical device ledger and security control work.
4.3.4 The user department shall perform the following duties.
a) organize the personnel of this department to learn the safety management system of the medical devices used;
b) organize operators to receive training and assessment of operating procedures;
c) ensure the maintenance and self-inspection of medical devices within the scope of their duties, and cooperate with the medical device management department to ensure the integrity of the medical devices;
d) organize drills for emergency disposal plans for medical devices used by the department;
e) Establish a high- and medium-risk medical device use record system, collect safety information, and provide timely feedback to the medical device management department.
4.3.5 The logistics support department shall perform the following duties.
a) Provide and guarantee the use of medical equipment, such as temperature, humidity, ventilation and other related facilities;
b) Provide and guarantee the supply of water, electricity, medical gases, etc. that meet the requirements of medical equipment.
4.4 Management system
4.4.1 Medical institutions shall formulate a medical device management system and formulate normative documents to be issued to relevant departments for implementation.
4.4.2 The medical device management system shall include an acceptance system before clinical use, a routine maintenance (including inspection, calibration) system, and a maintenance system
Degree, personnel training and assessment system, clinical use department management system, medical device medical injury incident reporting and processing system, rescue and health
Life support medical device emergency deployment system, medical device disposal management system, medical device safety and quality evaluation system, medical device safety
Full and performance status identification management system.
4.4.3 The pre-clinical acceptance system should include the following.
a) Medical device supplier qualification, medical device qualification certification documents;
b) Random technical documents for medical devices, including instruction manuals, maintenance manuals, etc .;
c) The name, address and contact information of the manufacturer of the medical device's instructions and labels; the general name, model,
Specifications; production batch number and production date; medical device performance, main structure and scope of application; precautions for use; maintenance and
Maintenance methods and environmental requirements;
d) Complete random accessories for medical equipment;
e) the standards on which medical devices are accepted;
f) The qualified medical equipment shall be numbered and ledger shall be established; the acceptance information shall be recorded in the archives.
4.4.4 The routine maintenance (including inspection and calibration) system shall include the following.
a) According to the requirements of medical device instructions and random technical documents, specify the technical items and standards for medical device inspection, inspection, and calibration.
Standard value and cycle, and specify the specific person responsible;
b) Items and content requirements to be recorded during routine maintenance inspection, inspection, and calibration.
4.4.5 The maintenance system shall include the following.
a) time limits and procedures for fault reporting;
b) Principles for medical engineering professionals to deal with faulty medical devices on the spot;
c) Procedures and technical standards for safety and quality inspection and calibration of medical devices before they are put into clinical use after repair;
d) Record content and archiving requirements of medical device maintenance information.
4.4.6 The personnel training and assessment system shall include the following.
a) Personnel training should include all management personnel involved in medical device safety, and medical engineering majors in maintenance, repair, and testing
Personnel and clinical users;
b) there should be a training and assessment plan for the appropriate personnel;
c) Pre-job training and appraisal rules for newly purchased medical equipment and newly hired personnel;
d) Training assessment data should be archived.
4.4.7 The management system of the clinical use department shall include the following.
a) Responsibilities of clinical use departments for routine maintenance of medical devices;
b) Under the guidance of the medical device management department, formulate device operation procedures and ensure their implementation;
c) Establish personnel for medical device safety supervision and inspection in this department, and specify the time, period and inspection items of supervision and inspection to ensure safety
All and quality meet the requirements of relevant regulations;
d) the requirement for regular self-assessment of the intactness and safety and quality status of medical equipment in this department;
e) Establishing clinical use records of medical devices;
f) Procedures and disposal methods for discontinuation of use and gradual reporting of medical device safety hazards or medical damage.
4.4.8 The medical device safety incident reporting and handling system shall include the following.
a) procedures for reporting medical device safety incidents;
b) the definition of the degree of medical device safety incidents and emergency measures;
c) Records of medical device safety incident information include medical device names, numbers, and related information, using departments and personnel, patients
Name, medical record number and related information, time of occurrence, plot of medical incident safety incident, possible cause analysis of safety incident,
Disposal measures and means adopted;
d) procedures, results of safety incident analysis, and feedback procedures for corrective actions;
e) The implementation of rectification measures and accountability of relevant responsible departments and personnel.
4.4.9 The emergency deployment plan for medical devices should include the following.
a) the headings of various first aid, surgical and life support medical devices;
b) Authorized departments and personnel for emergency deployment;
c) emergency deployment process;
d) Contact information of relevant departments and personnel.
4.4.10 The medical device disposal management system shall include the following.
a) Requirements for donation and transfer of medical devices;
b) Relevant documents for medical device transfer and its guarantee of safety and effectiveness;
c) requirements for safety and effectiveness measures of medical devices that accept external donations and transfers before clinical use;
d) Basic requirements and procedures for termination of use of medical devices.
4.4.11 The medical device safety and quality evaluation system shall include the following.
a) Principles and requirements for the safety and quality evaluation of high-risk medical devices, medium-risk medical devices and low-risk medical devices;
b) Define the time period for evaluation, organize and participate in the evaluation department and personnel;
c) Specify the information content and collection methods, evaluation methods, and evaluation report content to support the evaluation;
d) Each year a medical device safety and quality evaluation report is formed and submitted to the management review meeting for review;
e) The evaluation results are fed back to relevant departments and personnel, and the implementation and supervision procedures of rectification measures.
4.4.12 The technical maintenance of medical devices with different risk levels shall prepare work instructions, including operating procedures and applicable relevant national and industry standards.
4.4.13 The management system for the safety and performance status identification of medical devices shall include the following.
a) Establish the requirements for the safety and performance status identification of high-risk medical equipment such as rescue, surgery and life support;
b) determine the departments and personnel using different types of status indicators;
c) the timing of marking (or hanging);
d) Use standard status identification, see Appendix A.
4.5 Risk Management
4.5.1 Medical institutions shall, in accordance with the intended purpose of clinical use of medical devices, technical requirements, and the dangers that may result from failure or misoperation.
Degree of harm, classify medical device risk levels with reference to the "Medical Device Classification Catalog" issued by the State Food and Drug Administration,
(See Appendix B), and establish equipment categories for each risk level, classified management. Formulate corresponding management goals and management systems.
4.5.2 The newly purchased or newly introduced medical devices shall be jointly graded by the medical device management department and the clinical use department.
Confirmed and incorporated into the corresponding risk level management.
4.5.3 The safety management organization for the clinical use of medical devices in medical institutions shall conduct a risk analysis and evaluation of clinical use of medical devices at least once a year.
And provide feedback and notification to the departments and personnel involved in the analysis results and rectification requirements in accordance with prescribed procedures.
4.5.4 When a large medical device has an adverse impact on the environment or a group or a major medical injury occurs, the medical device clinically uses
The safety management organization shall immediately convene a meeting, listen to the situation report, collect relevant information, study the emergency treatment principles and plans or start the corresponding
emergency plan.
4.6 Collection and analysis of safety information
4.6.1 Medical institutions shall establish procedures for the collection and evaluation of medical device safety and quality information. The collection of quality information shall include the following.
a) medical device adverse events;
b) complaints from clinical users or patients regarding medical devices;
c) the content, safety and performance inspection/test results of medical device maintenance;
d) the notification of safety and performance of medical devices by government medical device regulatory authorities;
e) Recall information from medical device manufacturers.
4.6.2 The analysis and evaluation results of medical device safety and quality information shall be used as a modification of the medical device use and maintenance plan and medical device operating procedures.
/ Process optimization and basis for medical device management and user training content adjustment.
4.7 Supervision and inspection of safety and performance control system
4.7.1 Medical institutions shall have systems and measures for internal audit. Leaders of medical institutions should organize medical business management departments, medical devices
Internal audit of medical device safety jointly attended by management and user departments. Internal audit ≥ 1 time per year.
4.7.2 The internal audit of medical device safety management shall cover the entire process of the safety management system. including acceptance, use, inspection, maintenance,
Maintenance and management activities. Auditors should be independent of the scope being reviewed.
4.7.3 The contents of medical device safety management review shall include the following aspects.
a) Applicability of medical device safety management systems and procedures;
b) performance reports of management and supervisors;
c) the recent internal audit report of medical device safety;
d) report on the implementation of corrective and preventive measures;
e) Analysis of clinical feedback on the use of medical devices;
f) patient complaint report on medical devices;
g) Other relevant factors, such as medical device quality control activities, resources, and staff training.
4.7.4 The medical device safety management review shall form a written resolution. The review decision includes the safety evaluation results of the medical device in the year,
Comparison of overall management effectiveness, existing problems, improvement time frames and measures, and ways of implementing measures. Review decisions shall be archived.
4.8 Archive management
4.8.1 Archives include technical archives and administrative archives. The requirements for the production, use, and update of various medical device archives should be specified.
4.8.2 The archives should be neatly stored, easy to find and check, and set up the data directory by category.
4.8.3 The administrative file shall include the following.
a) Medical equipment ledger; photocopy of registration certificate and certificate of compliance;
b) preventive daily maintenance records;
c) Reports and treatment records of medical equipment damage;
d) personnel training and assessment records;
e) emergency deployment records;
f) medical device safety evaluation report;
g) Medical device disposal documents.
4.8.4 The technical files shall include the follow...
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