Contamination of Laparoscopic Insufflators with Patient Fluids

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Contact: MDB Enquiries

---

No. 106 February 3, 1995

To: Hospital Administrators

Attention: Biomedical Engineering and Operating Room Staff

Subject: Contamination of Laparoscopic Insufflators with Patient Fluids

The Health Protection Branch has been informed of several recent incidents in which the internal gas circuit of a laparoscopic insufflator was contaminated with patient fluids during a laparoscopic procedure, after the gas flow had been temporarily shut off. Tests conducted by the Branch on this model verified that backflow of gas or patient fluids can occur when the flow selector switch is turned to the standby position or the power switch is turned off to suspend flow.

Contamination of the internal gas circuit of the insufflator with liquids or gases from the patient cavity creates a potential hazard of cross infection. Furthermore, backflow of liquid into the insufflator can damage internal components such as pressure transducers and the patient pressure relief valve. Once the insufflator is contaminated, the internal gas circuit and components cannot be sterilized, and the unit must be replaced. In one of the incidents reported, a filter had been used, but it failed to provide protection against liquid backflow. Subsequent discussions with the filter manufacturer revealed that it was not recommended for backflow prevention.

The Health Protection Branch considers these failures as having occurred under normal operating conditions and is examining regulatory options to address this problem. Insufflators of this design are made by a number of different manufacturers.

Other insufflator designs examined by the Branch did not allow backflow under normal operating conditions. However, most brands of insufflators will allow backflow under single fault conditions, such as leaving the insufflator on while replacing an empty cylinder, or the presence of leaks in the tubing or connectors. Therefore, it is recommended that the following safety precautions be followed when using any insufflator:

• Always use a hydrophobic bacterial filter recommended for backflow prevention by the manufacturer of the insufflator, and change it after each procedure;
• Ensure that the tubing to the patient is transparent and not permeable to CO2;
• Position the patient port of the insufflator and as much of the associated tubing as is practical above the insufflation site, so that any patient fluids inadvertently entering the tubing do not drain back into the insufflator under gravity;
• Flush the system with the insufflation gas before each procedure, and replace the unit with a clean one if any evidence of liquid contaminantion is found;
• Disconnect or occlude the patient tubing when the CO2 cylinder is exhausted, and during its replacement;
• When the pressure in the laparoscopic cavity has to be reduced, deflation should be accomplished by disconnecting the tubing from the trocar cannula;
• Disconnect the patient tubing or occlude it with a stopcock or roller clamp before the power switch or flow selector is turned off;
• Regularly test the insufflator for leakage as recommended by the manufacturer, for example, prior to the first laparoscopic procedure of the day.

Inquiries concerning this hazard and reports of similar incidents should be addressed to the Director, Medical Devices Bureau, Environmental Health Directorate, Health Protection Branch, Tunney's Pasture, Ottawa, Ontario, K1A 0L2. Telephone: (613) 952­7125, Fax: (613) 957­7318. Medical device problems may also be reported through the toll free Medical Devices Hotline at 1­800­267­9675.

Kent R. Foster
Assistant Deputy Minister

^© Minister of Supply and Services, 1995