WS/T 655-2019 (WS/T655-2019, WST 655-2019, WST655-2019)
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Safety management for lung ventilator
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WS/T 655-2019
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| Standard ID | WS/T 655-2019 (WS/T655-2019) | | Description (Translated English) | Safety management for lung ventilator | | Sector / Industry | Health Industry Standard (Recommended) | | Classification of Chinese Standard | C05 | | Classification of International Standard | 11.020 | | Word Count Estimation | 16,140 | | Date of Issue | 2019 | | Date of Implementation | 2020-05-01 |
WS/T 655-2019
HEALTH INDUSTRY STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.020
C 05
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
1 Scope
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.
ventilator.
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 Repair
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
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