Toxicological Profiles are compilations of toxicological information on a hazardous substance and are important in guiding policy for the different uses of a given substance. The USA Agency for Toxic Substances and Disease Registry (ATSDR) compiles such profiles on several substances, and published a draft toxicological profile on DEHP in December 2019, which was available for Public Consultation until March 2020. The BTA has submitted a comment as blood bag sets containing DEHP are essential for blood storage and ensuring sufficient blood supply.
The BTA believes that plastic blood bag sets containing DEHP were introduced to facilitate separation and storage of blood components. The beneficial effect of DEHP is stabilization of the red blood cell membranes, resulting in a reduction of morphological lesions and haemolysis. Without this, the haemolysis rate will increase, meaning that free haemoglobin will be released into the blood stream, which poses a health risk to patient. Investigations to identify alternates to DEHP for red blood cell storage with equivalent performance have been conducted unsuccessfully for more than 40 years. Blood transfusion is highly regulated. Identifying and approving a safe replacement for DEHP in blood bag sets will require extensive investigation, testing and qualification of currently unknown duration.
BTA's comment can be accessed here, and you can find the toxicological profile here.
DEHP's toxicological profile available for Public Consultations
