title: Temporal bone bank: complying with European Union directives on human tissue and cells.
abstract: BACKGROUND
  Availability of allograft tympano-ossicular systems (ATOS) provides unique reconstructive capabilities, allowing more radical removal of middle ear pathology. To provide ATOS, the University of Antwerp Temporal Bone Bank (UATB) was established in 1988. ATOS use was stopped in many countries because of safety issues concerning human tissue transplantation. Our objective was to maintain an ATOS tissue bank complying with European Union (EU) directives on human tissues and cells.
  
  
  METHODS
  The guidelines of the Belgian Superior Health Council, including EU directive requirements, were rigorously applied to UATB infrastructure, workflow protocols and activity. Workflow protocols were updated and an internal audit was performed to check and improve consistency with established quality systems and changing legislations. The Belgian Federal Agency of Medicines and Health Products performed an inspection to examine compliance with national legislatives and EU directives on human tissues and cells. A sample of important procedures was meticulously examined in its workflow setting next to assessment of the infrastructure and personnel.
  
  
  RESULTS
  Results are reported on infrastructure, personnel, administrative workflow, procurement, preparation, processing, distribution, internal audit and inspection by the competent authority. Donors procured: 2006, 93 (45.1%); 2007, 64 (20.6%); 2008, 56 (13.1%); 2009, 79 (6.9%). The UATB was approved by the Minister of Health without critical or important shortcomings. The Ministry accords registration each time for 2 years.
  
  
  CONCLUSIONS
  An ATOS tissue bank complying with EU regulations on human allografts is feasible and critical to assure that the patient receives tissue, which is safe, individually checked and prepared in a suitable environment.
authors.affiliation: University Department of Otorhinolaryngology and Head and Neck Surgery, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, 2650, Edegem-Antwerp, Belgium.
authors.forename: Vincent
authors.initials: V
authors.lastname: Van Rompaey
authors.forename: Wouter
authors.initials: W
authors.lastname: Vandamme
authors.forename: Ludo
authors.initials: L
authors.lastname: Muylle
authors.forename: Paul H
authors.initials: PH
authors.lastname: Van de Heyning
mesh_terms: D018586:Bone Banks / Q000331:legislation & jurisprudence* / Q000592:standards; D002477:Cells; D054869:Clinical Audit / Q000592:standards; D004282:Documentation; D046148:Donor Selection; D005062:European Union; D019983:Guideline Adherence / Q000331:legislation & jurisprudence* / Q000592:standards; D006801:Humans; D009926:Organ Preservation / Q000592:standards; D013701:Temporal Bone; D014180:Transplantation / Q000331:legislation & jurisprudence* / Q000592:standards; D014495:Universities; D000078329:Workforce