Safety Steps in Eye Banking Ellen Heck, MT, MA, CEBT Transplant Services Center UT Southwestern Medical Center at Dallas Safety Asepsis Sterility Screening Screening Safety Donor Recruitment Public Education Professional Education leads to an leads to Informed Historian Expert Resource Consent Process Rejected Consent Process Declined (Initial screening with hospital personnel) Screening Rejection (in-depth medical/social History & Review approximately 45 questions) EBAA Medical Standards December 2001 D1.120 Contraindications – Tissue from donors with the following are potentially health threatening for the recipient(s) or pose a risk to the success of the surgery and shall not be offered for surgical purposes. 2: Death with neurologic disease of unestablished diagnosis EBAA Medical Standards December 2001 D1.120 Contraindications continued 3. Dementia, unless due to cerebrovascular disease, brain tumor, or head trauma. Donors with toxic or metabolic- induced dementia may be acceptable pending documentation of consultation with the Medical Director. The approval of the Medical Director is required. Screening questions specific to CJD Any progressive change in mental status Loss of Memory Inappropriate Responses Confusion Gait changes History of Human Derived Pituitary Growth Hormone administration Dura Mater transplant Screening questions specific to CJD Personal or blood relative history of CJD Did the deceased suffer from: Alzheimer’s Seizures Brain tumors Other neurological disorders Screening Physical Assessment Rejection of the Donor Physical Assessment Testing Procurement Rejection Previously unreported findings Procedure Deviation Procurement Testing Rejection Review Review Rejection (review of medical chart, history, testing, and all available information) Processing Rejection Process Deviation (excision error rim size) Review Rejection Process Deviation (clear zone) New History or Testing Information Final Labeling Release Transplant Recall Audit The second safety step: Sterility or Sterilization Sterility Sterility: Safety One sterile instrument set per donor Outside (conjunctiva) instruments Inside (rim separation) instruments Instrument Sterility Sterile Instrument Kits Post donation decontamination Rinse instruments and package them moist to return to laboratory Arrange one set of instruments per tray Sterilize instruments at 132° to135ºC for 30 minutes Sterility Post donation decontamination continued Following sterilization wash instruments and scrub as required Check function Place in Cidex bath for 30 minutes rinse Sterility Post donation decontamination continued Place in milk bath for 30-45 seconds Rinse with 70% isopropyl alcohol Dry Lubricate Package and sterilize with either ETO or steam with spore test indicator appropriate to method The Third Safety Step: Asepsis Asepsis Asepsis: Procurement Retrieval area (established for each donor) In situ Establish sterile field Don personal protective apparel Prep donor Sterile instrument kit Aseptic technique Processing Safety Removal/Processing Area Laboratory (performed between each donor) Clean hood Don personal protective apparel Establish sterile field Sterile instruments Aseptic technique Processing Safety Labeling Single Patient Application 2 corneas = 2 grafts 2 sclera = 2 or 8 grafts BATCHING Processing Safety Statements: graft is not considered sterile Is intended for single patient use Tamper resistant Seal When the FDA speaks, Eye Banks jump! But… Without Safety we could not fulfill our mission !