WS/T 655-2019 English PDF (WST655-2019)
WS/T 655-2019 English PDF (WST655-2019)
WS/T 655-2019: Safety management for lung ventilator
HEALTH INDUSTRY STANDARD OF
THE PEOPLE REPUBLIC OF CHINA
Safety Management for Lung Ventilator
ISSUED ON: OCTOBER 19, 2019
IMPLEMENTED ON: MAY 01, 2020
Issued by: National Health Commission of PRC
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Basic Requirements ... 5
4.1 Management organization ... 5
4.2 Management responsibilities ... 5
4.3 Management system ... 6
4.4 File management ... 7
4.5 Requirements for use ... 8
5 Safety Inspection ... 8
6 Safety Confirmation before Use ... 10
7 Label of Safety Performance Status ... 11
8 Routine Maintenance ... 11
9 Repair ... 11
10 Cleaning and Disinfection ... 12
Appendix A (Informative) Expiratory Treatment Record List ... 13
Appendix B (Informative) Original Record List of Safety Inspection and Test of Ventilator ... 15
Appendix C (Normative) Ventilator Safety and Performance Status Labels .. 17 Bibliography ... 20
Safety Management for Lung Ventilator
This Standard specifies the safety management requirements for lung ventilator used in clinical treatment by medical institutions before and during clinical use; including management and technical requirements for operators, performance testing, clinical use, emergency deployment, and maintenance, etc.
This Standard is applicable to the safety management of lung ventilator used in clinical treatment by various medical institutions.
This Standard is not applicable to high-frequency jet ventilator, high-frequency oscillatory ventilator and equipment used only to increase patient ventilation. 2 Normative References
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document.
GB 8982 Oxygen Supplies for Medicine and Aircraft Breathing
GB 15982 Hygienic Standard for Disinfection in Hospitals
JJF 1234 Calibration Specification for Ventilators
WS 392 Clinical Application of Ventilator
3 Terms and Definitions
For the purpose of this document, the terms and definitions given in GB 8982, JJF 1234 and WS 392 and the following apply.
3.1 Lung ventilator
A life-supporting mechanical ventilation device designed to rescue or treat patients with respiratory insufficiency or respiratory failure, based on increased or supplied patient ventilation and/or delivery of aerosol.
4.2.3 The medical device management department shall perform the following duties:
a) Organize the safety testing, maintenance and repair of ventilator; and deal with the technical problems related to safety;
b) Ensure that the supporting facilities and environmental conditions used by the ventilator shall meet the requirements of the manufacturer's instruction manual; c) Formulate safe operation regulations (post workbooks); and regularly carry out basic knowledge training and training skills of the operators using the ventilator as per the models;
d) Collect safety management information and adverse events, conduct an annual safety control evaluation. Submit an evaluation report to the medical institution's safety management organization, and propose improvements;
e) Responsible for the establishment of ventilator accounts and safety control files. 4.2.4 The ventilator use department shall perform the following duties: a) Organize the staff of this department to learn and implement the safety management system of ventilator;
b) Organize the operators to receive training on operating procedures; operate only after passing the assessment; and ensure the implementation of standard operating procedures;
c) Daily maintenance of the ventilator;
d) Once the ventilator malfunction is found, make sure to implement the emergency plan.
4.3 Management system
4.3.1 It shall include the emergency plan system, personnel training assessment system, use operation management system and file management system.
4.3.2 The emergency plan system shall include the following:
a) It shall establish emergency deployment procedure, including the authorized person who initiates the procedure when the ventilator cannot meet clinical use; b) it shall configure non-invasive ventilator or simple ventilator to ensure that the life support of the therapeutic ventilator can be obtained clinically in an emergency; d) Various test records.
4.4.3 The medical device management department shall send special personnel for custody of the files; or the file management department of the medical institution shall manage the files in a unified manner.
4.4.4 All files shall be kept for 5 years after the ventilator is terminated. 4.5 Requirements for use
4.5.1 The ventilator shall not be connected to the power supply through the power converter (terminal block); it shall be directly connected to the power supply by a three- phase plug; and ensure that the power plug is within the operator's field of vision. 4.5.2 The source of oxygen input to the ventilator shall meet the requirements of GB 8982.
4.5.3 The pressure of oxygen and compressed air shall be in the range of 0.25 MPa ~ 0.65 MPa.
4.5.4 The ventilator for clinical use shall be recorded for respiratory therapy. For the content of respiratory therapy, please refer to Appendix A.
5 Safety Inspection
5.1 Inspection items
5.1.1 The appearance items shall include the following items:
a) The ventilator shall be marked with manufacturer, model, exit-factory date and number, power supply rated voltage, frequency, gas source name and pressure range;
b) The control knob on the ventilator panel has the correct gear position, clear steps and smooth rotation;
c) The external circuit of the ventilator is clearly identified and marked; d) The instruction manual and accompanied accessories are complete.
5.1.2 The general alarm inspection should include the following items:
a) Anti-mis-operation power switch;
b) Mute function;
f) Gas temperature.
5.2.2 Ventilation performance testing method shall comply with the provisions of JJF 1234.
5.2.3 The parameters of 5.2.1 a) ~ f) shall meet the requirements of JJF 1234. 5.2.4 Ventilation performance test shall be performed by technicians of medical device management departments with corresponding capabilities of medical institutions or entrusted by competent maintenance service agencies.
5.2.5 The newly purchased and repaired ventilator shall be tested. Only after passing the test can it be delivered for clinical use.
5.2.6 The ventilator in clinical use shall be periodically tested, each cycle time ??? 1 year. 5.2.7 When there is a dispute over the performance parameter value of the ventilator, the legal measurement technical agency shall conduct arbitration test.
5.2.8 The various tests conducted in 5.2.5 ~ 5.2.7 shall be recorded in detail. For the recorded items and contents, see Appendix B. The original records of inspection and testing shall be archived and kept.
6 Safety Confirmation before Use
6.1 Before each use on a patient, the clinical user or the technical staff of the medical device management department shall, after the connection of the air source, power supply, breathing tube and humidification tank of the ventilator, inspect the safety of the ventilator according to the requirements in 5.1 and make detailed records. 6.2 The performance of the ventilator shall reach the following state:
a) All accessories are intact and in standby state;
b) The alarm system works normally;
c) Install a filter on the inhalation or exhalation end;
d) Set the ventilator to constant volume ventilation in assist/control (A/C) mode; connect the simulated lung after setting the basic parameters; and the difference range between the ventilator monitoring exhaled tidal volume and the set tidal volume shall be ???10%;
e) Set the oxygen concentration to 21% ~ 100%, respectively; and the difference between the value of the oxygen concentration detected by the oxygen battery and the set value shall be ???5%.
7 Label of Safety Performance Status
7.1 The ventilator shall be used as a medical device for mandatory verification; and the safety performance status label shall be affixed to each ventilator. 7.2 The safety performance status labels are divided into three types: "Qualification Certificate", "Deactivation Certificate" and "Temporary Failure Certificate". The qualified label is green, the deactivation label is red, and the temporary fault label is yellow.
7.3 The style of the safety performance label is shown in Appendix C.
7.4 After performing the tests from 5.2.5 to 5.2.7, the medical device technical testing personnel shall paste the performance status label according to the test results. Paste the "qualified" label for those passing the test; and paste the "deactivated" label for unqualified.
7.5 When the ventilator placed in the ward or other clinical diagnosis and treatment environment, or cannot be used normally due to failure or other reasons, the person who uses the ventilator shall paste the "temporary failure" label and report it to the medical device management department for repair.
8 Routine Maintenance
8.1 The maintenance plan of the ventilator shall be formulated according to factors such as the frequency of use of the ventilator and the time of use, and the number of repairs and maintenance shall be ??? 2 times per year.
8.2 The internal or external air compressors, oxygen sensors, leather pads, filters or filter nets and other vulnerable and consumable parts shall be maintained according to the manufacturer's requirements and actual use conditions.
8.3 Replace consumable parts regularly according to usage conditions to ensure that the performance status of vulnerable parts is in good condition.
8.4 The maintenance date, personnel, specific content and performance status after maintenance shall be recorded in detail, and the maintenance records shall be archived and kept.
9.1 The medical device management department of a medical institution may repair the ventilator by itself, or it may entrust a qualified and capable maintenance service