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WS/T 603-2018Safety Management for cardiac defibrillator (English PDF)

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Issued by

National Health Commission

Level / Type

National · Recommended

Issue date

August 17, 2018

Implementation date

August 1, 2019

Scope

WS/T 603-2018 (Safety Management for cardiac defibrillator) is available as an English-translated PDF.

WS/T 603-2018 — This standard specifies the personnel, environment, safety performance of the cardiac defibrillator used by medical institutions before and during clinical use.

Management and technical requirements related to maintenance. This standard applies to the safe management of cardiac defibrillators used in clinical settings in medical institutions.

Cardiac defibrillator monitor, cardiac defibrillation pacing monitor the safety management can be carried out with reference to this standard.

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Document preview — WS/T 603-2018

National Standard of the People's Republic of China

ICS: 11.020
Classification: C 05

Issued by: National Health Commission

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Basic requirements
4.1 Management Organization
4.2 Management responsibilities
4.3 Management System
5 Personnel requirements
6 Environmental requirements
7 Pre-clinical acceptance
8 Daily safety confirmation
9 Periodic detection
10 Period detection
10.1 Time interval
10.2 Manual cardiac defibrillator test items and methods
10.3 Automatic external defibrillator testing items and methods
11 Maintenance
11.1 Maintenance content and interval
11.2 Battery Maintenance
11.3 Charging capacitor maintenance
12 Repair

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard was drafted. The Central Military Commission Logistics Department Ministry of Health Bureau of Pharmaceutical Instruments, the People's Liberation Army No. 307 Hospital, China the First Affiliated Hospital of the People's Liberation Army General Hospital, the China Medical Equipment Association, and the Chinese People's Armed Police General Hospital.

1 Scope

This standard specifies the personnel, environment, safety performance of the cardiac defibrillator used by medical institutions before and during clinical use.

Management and technical requirements related to maintenance.

This standard applies to the safe management of cardiac defibrillators used in clinical settings in medical institutions. Cardiac defibrillator monitor, cardiac defibrillation pacing monitor the safety management can be carried out with reference to this standard.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document.

For undated references, the latest edition (including all amendments) applies to this document.

Medical electrical equipment - Part 2-4. Safety requirements for cardiac defibrillators JJF 1149 Cardiac Defibrillator Calibration Specification YY/T 0841 Medical electrical equipment Medical electrical equipment periodic test and post-repair test

3 Terms and definitions

The following terms and definitions apply to this document.

Cardiac defibrillator cardiac defibrillator Applying electrical pulses to the patient's skin (external electrodes) or exposed hearts (in vivo electrodes) through the electrodes to normalize the heart rhythm Medical electrical equipment.

Manual defibrillator manual defibrillator the cardiac defibrillator is manually selected by the operator for energy, charging, and discharging.

Automatic external defibrillator automated external defibrillator, AED Once the operator is activated, the defibrillator automatically analyzes the ECG signal (ECG) obtained by placing the electrodes on the chest surface to identify the heart.

Rhythm, a defibrillator that performs a charging operation on its own when a heart rhythm is detected.

Periodic test recurrent test Full performance testing of specified items at time intervals as specified by national verification procedures or as recommended by calibration specifications.

Testing during use

The detection performed during two periodic tests.

4 Basic requirements

4.1 Management Organization

4.1.1 There should be medical care consisting of the head of the medical institution, the medical business management department, the medical device management department and the clinical use department.

Device Safety Management Organization.

4.1.2 The safety management of cardiac defibrillators should be incorporated into the medical device safety management system.

4.2 Management responsibilities

4.2.1 The head of the medical institution shall perform the following duties.

a) Fully responsible for the safety management of cardiac defibrillators;

b) resource allocation to ensure safe management of cardiac defibrillators;

c) organize the development of a safety management system for cardiac defibrillators;

d) Regularly organize the safety evaluation of cardiac defibrillators.

4.2.2 The medical business management department shall perform the following duties.

a) the implementation of safety management plans and regulations for organizing cardiac defibrillators;

b) supervise and check the implementation of safety management plans and regulations for cardiac defibrillators;

c) develop emergency plans for the safety management of cardiac defibrillators and organize drills on a regular basis;

d) Coordinate the safety management aspects of the defibrillator.

4.2.3 The medical device management department shall perform the following duties.

a) is fully responsible for the safety management techniques of the cardiac defibrillator;

b) develop safe operating procedures;

c) develop technical specifications for the safety management testing of cardiac defibrillators;

d) implement safety management related technology testing activities;

e) Responsible for relevant technical training for users;

f) undertake maintenance work on the cardiac defibrillator;

g) Collect safety management information for cardiac defibrillators, submit evaluation reports to medical device safety management organizations, and propose improvements;

h) Responsible for the establishment of equipment files, including equipment model, serial (number), use department, safety management records, etc., all files the information should be kept for 5 years after the device is terminated.

4.2.4 The clinical use department shall perform the following duties.

a) Organize personnel in this department to learn and implement the safety management system for cardiac defibrillators;

b) organize the personnel to receive training and assessment of the operating procedures;

c) designate the department's safety management supervisor;

d) Once the fault is found, ensure that the emergency plan is implemented and repaired in accordance with the fault repair system;

e) responsible for the maintenance of the cardiac defibrillator to ensure the integrity of the cardiac defibrillator;

f) Establish a daily safety confirmation record for the cardiac defibrillator (should include whether the accessory is complete, the appearance is intact, the function is normal, Inspector, date of inspection, use registration record (should include date of use, user, patient name and medical record number, technique) Operating parameters, equipment status, etc.) and maintenance records (should include maintenance content, maintenance date, maintenance personnel).

4.3 Management System

4.3.1 The safety management of cardiac defibrillators should be throughout the life cycle of the equipment, covering acceptance, clinical use, maintenance, periodic testing, Emergency deployment, personnel training, file management and other processes.

4.3.2 The safety management system, plan, applicable standards, operational procedures, etc. of the defibrillator should be established and documented to relevant departments and phases.

The personnel are released.

4.3.3 The safety management system shall include the acceptance system before clinical use, the daily safety confirmation system, the maintenance system, the inspection system, Maintenance system, personnel training and assessment system, emergency allocation system, safety evaluation system and file management system.

5 Personnel requirements

5.1 Managers should be familiar with the safety management system and related standards for cardiac defibrillators.

5.2 The user should be trained after passing relevant technical training, understand the basic theory and basic knowledge of the cardiac defibrillator, and master the operation.

Skills and emergency handling skills to properly use the cardiac defibrillator. See Appendix A for operational specifications.

5.3 Personnel performing performance testing shall have a professional background in medical engineering, and shall be engaged in this work after relevant technical training and passing the examination.

5.4 Electrical safety testing personnel shall comply with the requirements of YY/T 0841.

6 Environmental requirements

The environment in which the cardiac defibrillator is used should meet the specific requirements of GB 9706.8 and the instructions for use of the defibrillator.

7 Pre-clinical acceptance

7.1 Before the cardiac defibrillator is put into clinical use, it shall be administered by the medical device management department or by a third-party metrology technical institution with corresponding qualifications.

It will be inspected and accepted with the department, and will be delivered to the department for use after passing the test.

7.2 The inventory should be in accordance with the contract or equipment packing list to ensure that the accessories are complete.

7.3 Electrical safety testing shall comply with the requirements of YY/T 0841.

7.4 Performance testing shall be in accordance with JJF 1149.

7.5 Acceptance test should be recorded and archived.

8 Daily safety confirmation

8.1 Cardiac defibrillators should be confirmed daily by the clinical use department.

8.2 Confirmation includes defibrillation electrode plates, ECG electrode wires, batteries, conductive paste, disposable defibrillation pads, power cords, etc.

The accessories are complete.

8.3 The installation of the adult electrode plate and the child electrode plate is correct, and there is no rust spot on the electrode plate; the appearance of the ECG electrode wire is intact and there is no damage;

The disposable defibrillation pads should be within the validity period; the battery is powered normally.

8.4 Select any preset energy value (such as 100J), press the charging button, there is charging indication; wait for the charging to reach the preset value, there is a sound and light prompt;

Discharge the defibrillation handle on the electrode holder of the cardiac defibrillator; observe the defibrillation energy self-test value, the maximum allowable error should be ±4J or ±15% (both take the larger value).

9 Periodic detection

9.1 It shall be carried out by a technician of the medical device management department with corresponding capabilities, or a third-party metrology technical machine with corresponding qualifications shall be entrusted.

Construction proceeds.

9.2 The detection interval, test items and methods shall comply with the requirements of JJF 1149.

10 Period detection

10.1 Time interval

The medical device management department or the use department shall conduct the test once every 6 months.

10.2 Manual cardiac defibrillator test items and methods

10.2.1 Energy release error check

10.2.1.1 Set the preset energy of the cardiac defibrillator to charge at least 3 points (including the maximum energy point) from low to high.

10.2.1.2 After the charging is completed, the energy is released through the discharge resistor of the cardiac defibrillator (usually the electrode plate holder), and the display is observed.

Self-test energy value, the error with the set value should not exceed ± 4J or ± 15% (both take a larger value).

10.2.2 Charging time check

Set the preset energy of the cardiac defibrillator to the maximum energy point (such as single-phase wave 360J, two-phase wave.200J), press the charging button and start counting when the charging is completed, the sound and light will be prompted to stop timing, which should be less than 20s.

10.2.3 Checking the number of times of charging and discharging

Set the preset energy of the cardiac defibrillator (such as 100J) for charging; after the charging is completed, release it through the discharge resistor of the cardiac defibrillator itself.

energy. After the interval of 10s, the above charging and discharging operations are repeated again; it should be completed successfully for 3 consecutive times.

10.2.4 Internal discharge inspection

Set the preset energy of the defibrillator (such as 100J) to charge; do not discharge after charging, wait and observe the energy of the cardiac defibrillator Prompt signal, the cardiac defibrillator should automatically complete the internal discharge within 2 minutes.

10.3 Automatic external defibrillator testing items and methods

10.3.1 Electric shock rhythm identification correctness check

The defibrillation electrode piece is attached to the defibrillator tester electrode plate, and the defibrillator tester outputs an electric shock rhythm to the AED, and the AED should detect the Heart rhythm, voice prompts and start charging.

10.3.2 Energy release error check

After the AED is fully charged, the voice prompts the operator to discharge or automatically discharge. After the discharge is performed, observe the discharge displayed by the defibrillator tester.

The error between the energy value and the preset value specified in the instruction manual shall not exceed ±4J or ±15% (both of which are larger).

11 Maintenance

11.1 Maintenance content and interval

The user should perform 1 maintenance of the defibrillator's rechargeable battery and charging capacitor every 3 months.

11.2 Battery Maintenance

11.2.1 For the defibrillator with battery power display, there should be no battery failure alarm; when the battery power is <= 60%, the AC charging is turned on.

11.2.2 When using the internal battery, set the defibrillator preset energy to.200J or maximum energy, and perform charging and discharging operations.

11.2.3 For maintenance-free batteries, check the battery expiration date and replace the expired battery.

11.3 Charging capacitor maintenance

11.3.1 Within the energy selection range of the defibrillator, select 3 energy points (including the maximum energy point) from low to high for charging.

11.3.2 After the charging is completed, discharge through the discharge resistor of the cardiac defibrillator itself.

12 Repair

12.1 A malfunctioning cardiac defibrillator should be tested by the medical device management department.

12.2 Confirm that the malfunctioning cardiac defibrillator should be immediately evacuated from the clinical use site and initiate an emergency deployment plan.

12.3 The repaired cardiac defibrillator should be tested. The test items and methods should meet the requirements of YY/T 0841 and JJF 1149.

Appendix A

(informative appendix) Cardiac defibrillator operation specification A.1 manual defibrillator A.1.1 Manual defibrillator should read the instruction manual carefully before use.

A.1.2 Cardiopulmonary resuscitation and artificial respiration should be stopped immediately before defibrillation.

A.1.3 Sensors and instruments that do not have anti-defibrillation function are removed from the patient prior to defibrillation.

A.1.4 Defibrillation procedures are not accessible to metal parts, patient beds and other personnel present.

A.1.5 The defibrillation electrode plate must not touch other electrodes or metal parts connected to the patient. The electrode plate should not be shorted or discharged to the air.

A.1.6 Use the instrument's own standard accessories to remove the rust spots on the defibrillation electrode plates in time to ensure good contact with the electrode plates.

A.1.7 Defibrillation electrodes when used in conjunction with surgical equipment, confirming that the cardiac defibrillator is capable of protecting high frequency surgical equipment A distance of at least 15 cm is maintained between the plate and the surgical electrode.

A.1.8 For patients with a pacemaker implanted in the body, the defibrillation electrode plate should not be close to the internal pacemaker during defibrillation, and should be checked immediately after defibrillation.

The function of the beater.

A.1.9 Defibrillator users preset energy based on the patient's transthoracic impedance and cardiac defibrillator discharge waveform (single-phase or biphasic) Charging, after the charging is completed, the operation is discharged.

A.2 Defibrillator monitor A.2.1 meets A.1.

A.2.2 Obtain an electrocardiogram (ECG) signal through the ECG electrode and the defibrillation electrode, and select the synchronous mode or the asynchronous mode according to the patient's heart rhythm.

A.3 defibrillation pacing monitor A.3.1 Meets A.2.

A.3.2 Familiar with clinical indications for fixed pacing and on-demand pacing.

A.3.3 Ensure that there is no conductive connection between the patient and the bed and other grounded metal parts before switching on the pacing signal.

A.3.4 First set the pacing parameters to the minimum value, and then adjust the pacing parameters according to the patient's condition.

A.3.5 During pacing, the patient's ECG waveform is observed in real time to monitor and evaluate the pacing effect.

A.3.6 Check the pacemaker function normally after each defibrillation.

A.3.7 Keep away from other sources of interference, such as high-frequency electrosurgical equipment. If it is necessary to perform electrosurgery on pacing patients, the pacing should be set in fixed mode.

A.4 automatic defibrillator A.4.1 Indications for automatic defibrillators are critically ill patients with no breathing, no pulse, no reaction.

A.4.2 Meet A.1.3~A.1.8.

A.4.3 The one-time paste electrode automatically enters the automatic defibrillation mode after being connected to the automatic defibrillator, and the voice prompt is completed according to the whole operation stage.

Defibrillation and cardiopulmonary resuscitation process.

references

[1] GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety [2] GB 9706.25 Medical electrical equipment - Part 2-27. Safety requirements for ECG monitoring equipment [3] Medical Device Safety Management Specification for Clinical Use (Trial) Physician Management [2010] No. 4 [4] Medical and health institutions, medical equipment management methods, health regulations, financial development [2011] No. 24

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 7 pages — is available in the English PDF.

Referenced standards

Normative references

YY/T 0841Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

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