[383248]
Tissue infection event regarding the anterior tibialis tendon that was transplanted. The surgeon took a swab culture and a "snippet" of the allograft prior to implantation. The culture was reported as positive (heavy growth) for salmonella arizonii (don't know whether from swab or snippet, or both). This same microorganism was confirmed by the public health lab. The pt was put on antibiotics during surgery and prohphylactically after receipt of the culture results several days after the surgery. In 5/04, mtf made the determination that the donor met all suitability criteria. Two mos later, the tissues were shipped on dry ice for pre-treatment processing with gamma irradiation (10-18 kgy). The tissues were returned to mtf and aseptically processed. They were unpacked in a class 10 clean room, and thawed in a gentamicin bath. The soft tissue was rinsed with water, measured, cut & shaped, and put in the final pkg. The entire surface of each tissue was swabbed, and then the tissue was preserved at -70 degrees. Bone tissue receives add'l processing, a 60 min detergent soak followed by a 60 min alcohol soak. There is no terminal sterilization. 84 units remain in inventory and are on hold because of this event (probably all bone, but there may be an achilles tendon). The processing cultures (14 day usp method) for all 108 tissues showed no sterility failures. Environmental testing results from the processing days were reviewed and were acceptable. Mtf does not know at this point how many of the distributed tissues have actually been implanted. To date, this event is the only complaint that mtf has received relative to tissues from the subject donor. Mtf has not previously ever received a complaint regarding salmonella. Cdc indicated that the salmonella arizonii organism is one that is found associated with reptiles (in oral cavity), eg, in people who handle (and kiss) turtles and other reptiles, and it's very unusual to find it in a surgical suite. No organs were procured from the donor, however, the heart valves went to cryolife, and although it was unlikely that the corneas were taken because of the head trauma experienced by the donor, consent was given for the corneas. Mtf indicated that they will notify cryolife, and they will confirm that the corneas were not recovered. Mtf will first contact the consignees of the 9 soft tissues, and then the consignees of the 15 bone products to recall extant tissues from the donor.
Patient Sequence No: 1, Text Type: D, B5