How to Prevent Commingling

Patient Safety and Therapeutic Efficacy are Extremely Important

In 2009, IEC/ISO published an international standard on patient warming technology that includes a clause specifically addressing the issue of commingling.

IEC 80601-2-35 Particular Requirements for the Basic Safety and Essential Performance of Heating Devices Using Blankets, Pads or Mattresses and Intended for Heating in Medical Use requires the blanket documentation to include, among other things, “a statement identifying which controllers [warming units] can be used safely with the blanket. The description shall include, as applicable, the controller model number, revision level, product version, options or any other element that could affect the safety of the combination.”

Combining products without this written information leaves the user and patient exposed to unknown and potentially unsafe operating conditions. Integrity of the safety of skin warming, effectiveness, and fault conditions must all be addressed relative to the entire system.