In late 2019, Safe-T-Vue® 6 and Safe-T-Vue® 10 became the first (and currently only) blood temperature indicators to earn the AABB’s new ‘Standards-Compliant’ seal of approval. The designation was awarded just weeks after the AABB launched its Standards-Compliant Product Evaluation (SCoPE) Program.
AABB SCoPE Program
As you know, becoming an AABB-accredited facility requires following rigorous standards – all geared toward delivering the highest quality and safety to patients and donors.
With its SCoPE Program, the association is now also giving vendors and manufacturers who serve blood banks and transfusion services the opportunity to apply for their ‘Standards-Compliant’ designation – certifying that a product is in compliance with AABB standards. The exacting approval process is exclusively for the make and model of the product submitted for AABB review. When a product or its user instructions are updated, changes need to be submitted to the AABB for further review to maintain the SCoPE compliance designation.
“This compliance is significant for us as a company, but we also feel it is important for our customers – especially those who already hold accreditation from AABB,” says Omar Prieto, Global Distribution Network Manager for Temptime Corporation, a Zebra Technologies Company and manufacturer of Safe-T-Vue temperature indicators. “We know that AABB develops standards for blood banks to promote patient safety and quality. Knowing that our product meets the same kind of demanding standards adds a lot of value for our current customers. It’s also helpful to new potential customers who are evaluating the use of our product.”
Temptime’s Quality Management system is based primarily on the FDA’s Quality System Regulations (QSR) found at 21 CFR Part 820, ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, and ISO 9001:2015, Quality Management Systems – Requirements. The company has implemented systems to manage the following aspects of product quality based on the appropriate regulation and/or ISO requirement:
- Document Control
- Complaint Management
- Internal Problems/Corrective and Preventative Actions (CAPAs)
- Customer Communication and Change Notification
Temptime’s Morris Plains, NJ facility is registered with FDA and was most recently inspected by the Agency in 2018, with no 483 issued.
The Safe-T-Vue temperature indicators were awarded the AABB ‘Standards-Compliant’ seal of approval in November of 2019. Visit the AABB website to learn more about the AABB SCoPE Program as well as what other products are have already earned compliance.