JaSECT established the “Installation Standards of Safety Devices during Cardiopulmonary Bypass” in 2007 and issued them as advisory. Since then, we monitor the spread of safety devices and the occurrence of incidents related to cardiopulmonary bypass based on a survey every two years, and use this information to revise the advisory. The latest advisory was issued in 2018 and is the sixth edition.
The advisory are as follows and are provided to ensure the safety of patients undergoing cardiopulmonary bypass. JaSECT members are advised to adhere to the recommendations as much as possible and to consider the appropriate applications of the safety devices used.

ADVISORY (Version 6)

February 17, 2018

Installation Standards of Safety Devices during Cardiopulmonary Bypass

(from the Japan Society of Extra-corporeal Technology in Medicine)

1.Constant monitoring venous blood saturation (SvO₂) is mandatory.

  1-1. Constant monitoring of arterial blood gas is recommended.

2.Installing level sensor on the reservoir is mandatory.

  2-1. Regulating the arterial pump by the level sensor is strongly recommended.

3.Installing bubble detector on the arterial line is mandatory.

  3-1. Regulating the arterial pump by the bubble detector is also strongly recommended.

4.Constant monitoring of the arterial pressure between the arterial pump and the oxygenator is mandatory.

  4-1. Alarm function for a high pressure is mandatory.

  4-2. Regulating the arterial pump at a high pressure when using roller pump is strongly recommended.

  4-3. Regulating the centrifugal pump at a high pressure is also recommended.

  4-4. Constant monitoring of the pressure at the inlet of the arterial filter is also recommended.

  4-5. Monitoring of the inlet pressure of the arterial filter is mandatory.

        (It should be monitored by either interchangeably or by additional line.)

  4-6. Monitoring pressure between the arterial cannulae and the arterial filter is recommended.

5.Use of a flow meter for centrifugal pump is mandatory.

  5-1. Use of a low flow alarm is recommended.

6.Prevention measures for retrograde flow when using centrifugal pump is strongly recommended.

7.Use of an arterial filter or bubble trap on the arterial line is mandatory.

7-1. Use of an arterial filter is strongly recommended.

8.Use of a one-way valve on the vent line is strongly recommended.

9.Use of a purge line with a one-way valve on the arterial filter and on the oxygenator is recommended.

10.Monitoring the infusion pressure (with alarm) for cardioplegia is mandatory.

  10-1. Regulating the infusion pump at a high pressure is recommended.

11.Use of a bubble detector on the cardioplegia line is mandatory.

  11-1. Regulating the infusion pump by the bubble detector is recommended.

12.Having a manual hand crank device for the arterial pump always available is mandatory.

  12-1. Having a battery equipped with the arterial pump is mandatory.

  12-2. Battery backup for the full system is strongly recommended.

  12-3. Preparing a spare power cable for the pump system is recommended.

  12-4. Preparing a spare pump is recommended.

  12-5. Ability to hand crank (manually operate) all pumps including cardioplegia pump is strongly recommended

13.Preparing spare sensors is recommended

Notes:

 Mandatory: must be observed to ensure safety

 Strongly recommended: should be observed as much as possible for safety

 Recommended: better to be observed