Current uses of transfusion administration sets: a cause for concern?

Area of Science:

• Medical Devices
• Biomedical Engineering
• Patient Safety

Background:

• Transfusion administration sets are used with infusion pumps for blood component delivery.
• Modern infusion pumps operate at negative pressures exceeding the capabilities of current transfusion set standards.
• Inadequate compatibility between infusion pumps and transfusion sets can compromise patient safety.

Purpose of the Study:

• Evaluate the adequacy of International Standard ISO 1135-4 for current transfusion set applications.
• Assess the suitability of UK-supplied infusion pumps for blood component administration.
• Identify necessary control measures for manufacturers and users to enhance patient safety.

Main Methods:

• Conducted a keyword literature search correlating transfusion parameters with adverse effects.
• Standardized units for occlusion pressure, flow rate, and hemolysis for comparison.
• Reviewed transfusion set instructions for use and surveyed UK infusion pump suppliers regarding their specifications and compatible sets.

Main Results:

• Clinically unacceptable hemolysis was previously shown above 40 kPa.
• Modern infusion pumps generate negative pressures up to 210 kPa, exceeding ISO 1135-4 testing capabilities (which omits negative pressure testing).
• Transfusion sets lacked validated information on flow/pressure restrictions and compatible blood components.

Conclusions:

• International Standard ISO 1135-4 requires updating to address modern infusion pump performance, particularly negative pressure.
• Recommendations are provided for manufacturers on pressure limitations and blood component compatibility.
• Users need guidance on selecting, configuring, and validating infusion pumps and associated disposables for safe blood transfusion.