Terumo Cardiovascular Group

Make the Safe Choice

Many oxygenators available today contain polymer-based heat exchangers. Communications from various device manufacturers indicate that polymer heat exchangers present a potential risk of diffusion of hydrogen peroxide, or other chemicals into patient bloodstreams1 during cardiopulmonary bypass. CAPIOX® FX and RX oxygenators from Terumo Cardiovascular Group feature heat exchangers made from the highest quality stainless steel, an impermeable material that does not allow chemicals used in the heater-cooler to leach into the patient’s blood.

Protective Qualities of Stainless Steel

When hydrogen peroxide (H2O2) is added to the heater-cooler as a preservative to limit the development of microorganisms and prevent biofilm formation, the hydrogen peroxide decomposes into water (H2O) and a free radical of oxygen (O2). The surface of a stainless steel heat exchanger does not allow these byproducts of decomposition to leach into the patient’s blood, as the surface of the steel acts as an impenetrable barrier. This is not the case with a polymer heat exchanger. A polymer barrier does not offer the same protection because of its simple molecular structure.

Molecular Structures of Heat Exchangers

In the molecular structure of stainless steel, the atoms are organized in tightly packed groups that leave no room for the disassociated ions in the heater-cooler water to pass through. The molecular structure of stainless steel keeps the contents of both the blood side and water side separate.

In contrast, the molecular structure of a polymer is not packed as tightly as stainless steel. The polymer’s atoms are arranged in long chains and there is more space between polymer chains when compared to stainless steel metallic crystals. The additional space between polymer chains has the potential to allow ions and small molecules to pass through thin-walled structures.

There is variability in the degree of diffusion in polymer heat exchangers dependent upon the device’s design, polymer fiber characteristics and manufacturing process. Regardless of manufacturer, heat exchanger fibers made of polymer offer less protection from diffusion into the blood side and can increase the risk of blood contamination.

Blood Contamination

Blood contamination is a serious issue. Vigilant testing is required to monitor the concentration of chemical agents in the heater-cooler’s water. Increasing chemical concentrations in the heater-cooler may increase the likelihood that chemical diffusion quantities will exceed the allowable limits recommended by the oxygenator’s manufacturer. In addition, the patient’s allowable limit may also be exceeded based upon patient weight and length of exposure as well as patient’s sensitivity to hydrogen peroxide.

Polymer heat exchangers may put a cardiopulmonary bypass patient at risk by allowing even minimal levels of stabilizing chemicals used in the heater-cooler to diffuse through the heat exchanger and into a patient’s blood.

CAPIOX FX and RX oxygenators with stainless steel heat exchangers are designed to be safe from chemical diffusion. Diffusion prevention is the best method to protect both the patient and the hospital.

Working together with your surgery team, Terumo Cardiovascular Group helps save lives every day. That’s why we never compromise quality.

Make a safe choice that may lead to better surgical outcomes for your patients.

Choose stainless steel. Choose a CAPIOX Oxygenator.

Contact a Terumo Sales Representative

1 June 30, 2017 LivaNova MEDICAL DEVICE CORRECTION Letter for 3T Heater-Cooler Devices and December 19, 2015 Maquet Field Safety Corrective Action Letter for Maquet Oxygenators.

 

Stainless Steel atoms

Tightly packaged atoms (the atoms from one layer nest themselves in the empty space between the atoms of the adjacent layer) do not allow the disassociated ions in the heater-cooler to pass into the patient’s blood.

Polymer

Polymeric chain orientation can allow ions and small molecules to pass through the thin-walled polymer structure.