A Multi-Level Patient Safety Strategy
Guidance issued by the world’s Regulatory Authorities has confirmed that current water-based heater cooler systems have the potential to infect patients with Mycobacterium Chimera. Significant investigatory work has been undertaken to develop cleaning protocols to improve patient safety. However, anecdotal evidence indicates that these protocols are often ineffective and short term at best.
A key principle within a risk mitigation strategy is that it is required to be active for the life cycle of the product. A contamination event can occur at any time which means that formulating a patient safety strategy on a fixed cleaning cycle will be problematic. This is further complicated by the simple fact that there is no continuous monitoring technology that can alert the user when a contamination event has occurred.
Therefore, an implemented risk management process must eliminate the need for regular cleaning cycles and is continuous in operation.
The Mr. Frosty Patient Safety Strategy,
The Spectrum Medical “Mr. Frosty” Heater-Cooler technology employs a multi-level safety strategy to minimize, if not eliminate, patient mortality rates associated with Mycobacterium Chimera infections.
Level 1) A “base-level” Bio Static Capability
To achieve a “base-level” Biostatic capability i.e., creating an environment that stops the growth of Mycobacterium Chimera colonies, Spectrum Medical has selected Glycol for its Heat Transfer Fluid (HTF). Glycol is a well-accepted technology used in applications requiring a Biostatic capability.
Level 2) A Mitigation Strategy in the event of Cross-Contamination
The Spectrum Medical solution is to reformulate its Biostatic HTF into a Biocidal HTF. This is accomplished with the addition of Monomeric Glutaraldehyde (MGA). Spectrum Medical has confirmed with long-term testing, equivalent to 6 years of clinical usage, that Biocidal HTF performs in excess of Log 6 Reduction. Considering that for a fluid to be classified Biocidal, it need, to perform greater than Log 4 Reduction, this is a noteworthy achievement.
Level 3) Containment
The concept of Containment is the ultimate risk mitigation strategy that assumes that Safety Levels 1 and 2 have failed i.e., Mycobacterium Chimera can be detected, living, in the HTF.
However, in the unlikely event that there is cross contamination, a critical question that must be answered is whether the Mycobacterium Chimera within the HTF compromises patient safety by being released into the Operating Room and more importantly the sterile field?
Central to the Mr. Frosty technology is the concept of containment. To eliminate the potential unlikely aerosolization of Mycobacterium Chimera the hydraulic system has been designed to be a sealed system which operate without large circulatory fans.
Independent testing by Virginia Tech has confirmed a world first that there is NO detectable aerosolization from grossly contaminated Mr. Frosty Heater-Coolers.
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