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 include internationally accepted requirements for quality management systems and relevant technical parameters. They can serve as the basis for accreditation anywhere in the world. The AABB standard we’ll be discussing in this article applies to blood banks and transfusion services that store whole blood and blood products. It specifies design requirements for blood bank refrigerators and plasma freezers including required documentation, maintenance, and user parameters.
AABB standards for blood bank refrigerators and freezers have existed for decades, but there is no certification process for products marketed as blood products. The U.S Food and Drug Administration (FDA) requirements in section 864.9700 of 21 CFR Part 864, Subpart J and European Medical Device Directive MDD 93/42/EEC state that manufacturers must list products intended for blood and blood product storage as Class II 510K exempt or Class IIa medical devices, respectively.
These listings only pertain to quality and design control; a Class II 510K or Class IIa Iisting does not guarantee that a device will fulfill industry needs. This leaves manufacturers 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.
To address this issue, 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 listing helps ensure that manufacturers fulfill industry needs and have the necessary quality and design controls in place.
We are proud to announce that, after a thorough evaluation by the AABB, Thermo Scientific™ TSX Blood Bank Refrigerators and TSX Plasma Freezers received SCoPE recognition. All 40 blood bank refrigerators and plasma freezers in the TSX series are designed with our innovative, variable-speed compressor V-drive technology and are available for purchase worldwide. If your blood bank is looking for dependable, AABB certified equipment, Thermo Fisher Scientific is here to meet your needs.