Standards and technical guidelines for heart valve banking

Abstract

The American Association of Tissue Banks (A.A.T.B.) and the European Association of Tissue Banks (E.A.T.B.) have both issued general standards for tissue banking within their continents and several governments and organisations in Europe have formulated their own standards and technical guidelines which can differ from those of the E.A.T.B. The Asia Pacific Association of Surgical Tissue Banks have as yet not issued any standards, but the Australian Government have issued a section in their Code of Good Manufacturing Practice for Therapeutic Goods on Human Tissue, which is more similar to the Standard Operating Procedures issued by some banks. Many non commercial organisations on both sides of the Atlantic have also publicly available guidelines or technical manuals to which they work. There are parts of the A.A.T.B. Standards that are legally required if the bank requests accreditation from the Food and Drug Administration of that country, whereas those of the E.A.T.B. are a voluntary code and have no effect in law. Both sets of standards cover tissue banking in general and are then designed to have specific sections for each tissue, but in the case of E.A.T.B. only the sperm banking specialised section has been completed. The A.A.T.B. document is considerably more complex than the E.A.T.B. one and the aim of this chapter is to give an outline of the topics covered in these standards. The American Standards are subdivided into 12 sections, whilst the European ones have seven, three of the extra sections being needed as tissue banking in America tends to be performed by companies like Cryolife and Lifenet, whereas in Europe tissue banks are usually parts of hospitals or blood transfusion service.