While autologous blood transfusion has been in use since 1818, only now has AAMI released the first standard for the necessary equipment. The protocol is the re-use of the patient’s own blood, processed by a machine during surgery, rather than by the transfusion of blood from another donor. Sometimes called blood salvage, being able to collect the patient’s blood and return it to him avoids a wide range of negative outcomes. So the release of the new AAMI AT6, “Autologous transfusion devices,” is a positive move for the medical devices industry.
This standard covers sterile, disposable systems and the hardware that collects, filters, and/or processes blood. Challenges that are addressed include anticoagulation, collection, storage, processing, filtration, and reinfusion. These devices are similar to chest drainage systems, taking advantage of the fact that often in trauma blood accumulates in various body cavities.
However, certain problems are inherent in the process. Depending on where the blood is harvested, there may be contamination issues or issues with oxygenation. Further, the variety of situations where this technology is used means that the operators of the machinery itself need to be well trained and an increase in safety features to cover different scenarios is certainly a must.
As you will often find in such standards, the first 3 sections cover scope, referenced documents, and definitions. These sections are almost always included in these types of documents to set the stage for the detailed requirements that follow.
Surprisingly enough, these requirements begin with labeling. This includes not only what information needs to be on the machine itself, but also on components (like disposable blood contact components) and in the operator’s manual. It turns out that the AT6 has been developed in support of various medical device labeling regulations from the FDA.
These FDA criteria come from the 21 CFR Parts 820.120 and 820.130, as well as from Part 801 Chapter 1. And the standard also supports the section 501 of the U.S. Food, Drug, and Cosmetic Act which again addresses labeling. It’s clear that because of the nature of working with blood, the need for extraordinary care to avoid errors is of the highest importance.
The Section 5 covers the tests required of the equipment itself. These tests correspond in the main to the various clauses of the labeling section 4. You’ll find direction on how to confirm cleanliness, device anticoagulation, filtration, and 5 other essential requirements.
And as a further aid to the user, Annex A again goes through the various clauses as defined in the labeling section 4. The rationale for each clause is defined so that the user will understand how the AAMI AT6 relates to regulatory requirements.
The bibliography at the end of the standard is an extensive list of pertinent publications, 39 references in all.
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