The American Association of Blood Banks (AABB) represents institutions involved with transfusion medicine and biotherapy. The AABB develops standards for accreditation and offers educational programs that focus on optimizing care and safety for patients and donors. AABB members include physicians, nurses, scientists, researchers, administrators, medical technologists, and other health care providers in more than 80 countries.

AABB standards

The American Association of Blood Banks (AABB) represents institutions involved with transfusion medicine and biotherapy. The AABB develops standards for accreditation and offers educational programs that focus on optimizing care and safety for patients and donors. AABB members include physicians, nurses, scientists, researchers, administrators, medical technologists, and other health care providers in more than 80 countries.


AABB standards encompass internationally accepted requirements for quality management systems and relevant technical parameters. Hence, AABB standards can serve as the basis for accreditation anywhere in the world. One of the AABB standards applies to blood banks and transfusion services that store whole blood and blood products. The standard specifies proper designs for blood bank refrigerators and plasma freezers along with the associated documentation, maintenance requirements, and user parameters

Determining compliance

While AABB standards for blood bank refrigerators and freezers have been in circulation for decades, there was no certification process for products marketed as blood products. The US Food and Drug Administration (FDA) requirements in Section 864.9700 of 21 CFR Part 864 Subpart J, and European Medical Device Directive (MDD) MDD 93/42/EEC state that manufactures must list products intended for blood and blood product storage as Class II 510(k) exempt or Class lla medical devices, respectively. However, these listings pertain to quality and design control. A Class II 510(k) or Class lla listing does not guarantee that a device will fulfill industry needs.

Manufacturers have thus been left to self-declare product compliance according to AABB standards. The burden of interpreting the standards to determine whether a refrigerator or freezer satisfies industry requirements

is placed on the manufacturer and, by extension, the institutions that use the product. The AABB recently launched the Standards-Compliant Product Evaluation (SCoPE) Program. The program is intended to benefit manufacturers and institutions by providing assurance that products designed for the blood community comply with AABB standards. SCoPE participation in combination with FDA and MDD listings help ensure that manufacturers fulfill industry needs and have the necessary quality and design controls in place.

After a thorough evaluation by the AABB, Thermo Scientificâ„¢ TSX Series blood bank refrigerators and plasma freezers received SCoPE recognition. All 40 blood bank refrigerators and plasma freezers in the TSX series portfolio are designed with our innovative, variable-speed compressor V-drive technology and are available for purchase worldwide.

Ordering information

* 450mL whole blood bags.


Ordering information

* 250mL plasma boxes.

** Medical devices comply with the requirements of European Medical Device MDD 93/42/EEC (Class lla).


References

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=864.9700.
  2. https://www.aabb.org/about-aabb/aabb-services/scope-program.




 

 

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