Following a thorough evaluation conducted by the American Association of Blood Banks, B Medical Systems’ blood management solutions obtained AABB Standards-Compliant Product Evaluation (SCoPE) recognition. B Medical Systems is currently the only company to achieve accreditation for plasma storage freezers, contact shock freezers, and combined cooling systems.
The SCoPE Program is an initiative that was launched by AABB in September 2019 with the aim of providing assurance that products designed for the blood community are AABB standards-compliant.
“AABB is a reference association that fosters high standards in the field of immunohematology. Receiving the SCoPE accreditation reflects our commitment to quality. It certifies that the medical devices we design for the safe management of blood components meet the most rigorous standards for donor and patient safety”, said Luc Provost, CEO of B Medical Systems.
The SCoPE Program included an exhaustive approval procedure of B Medical Systems’ equipment, process control, and document control. The members of AABB’s Accreditation Department reviewed all the technical documents available for the users, including the operating instructions, maintenance and service manuals, as well as the documentation of B Medical Systems’ quality systems related to the products submitted for approval.
In total, 19 models of blood bank refrigerators, plasma storage freezers and contact shock freezers received the SCoPE seal. The AABB-approved portfolio offers an innovative technology to freeze plasma in an industry-leading time (48 bags in less than 30 min), as well as a wide variety of storage volumes (52L-895L) and temperature requirements (-41°C, -32°C, +4°C) to blood collection or transfusion medicine facilities, who are looking for reliable solutions to store their blood components in a safe and controlled environment.
The AABB recognition adds an extra layer of quality assurance for the purchase of medical devices. They are also medical devices class II according to FDA regulation 21 CFR Part 864.9700, and class IIa according to the European Medical Device Directive 93/42/EEC.