title: A retrospective study on annual evaluation of radiation processing for frozen bone allografts complying to quality system requirements.
abstract: Bone allografts have been used widely to fill up essential void in orthopaedic surgeries. The benefit of using allografts to replace and reconstruct musculoskeletal injuries, fractures or disease has obtained overwhelming acceptance from orthopaedic surgeons worldwide. However, bacterial infection and disease transmission through bone allograft transplantation have always been a significant issue. Sterilization by radiation is an effective method to eliminate unwanted microorganisms thus assist in preventing life threatening allograft associated infections. Femoral heads procured from living donors and long bones (femur and tibia) procured from cadaveric donors were sterilized at 25 kGy in compliance with international standard ISO 11137. According to quality requirements, all records of bone banking were evaluated annually. This retrospective study was carried out on annual evaluation of radiation records from 1998 until 2012. The minimum doses absorbed by the bones were ranging from 25.3 to 38.2 kGy while the absorbed maximum doses were from 25.4 to 42.3 kGy. All the bones supplied by our UMMC Bone Bank were sterile at the required minimum dose of 25 kGy. Our analysis on dose variation showed that the dose uniformity ratios in 37 irradiated boxes of 31 radiation batches were in the range of 1.003-1.251, which indicated the doses were well distributed.
authors: UMMC Bone Bank, Department of Orthopaedic Surgery, Faculty of Medicine, National Orthopaedic Centre of Excellence in Research and Learning (NOCERAL), University of Malaya, 50603, Kuala Lumpur, Malaysia. sit_sarav@yahoo.com.
authors: Saravana
authors: S
authors: Ramalingam
authors: UMMC Bone Bank, Department of Orthopaedic Surgery, Faculty of Medicine, National Orthopaedic Centre of Excellence in Research and Learning (NOCERAL), University of Malaya, 50603, Kuala Lumpur, Malaysia.
authors: Suhaili
authors: S
authors: Mohd
authors: UMMC Bone Bank, Department of Orthopaedic Surgery, Faculty of Medicine, National Orthopaedic Centre of Excellence in Research and Learning (NOCERAL), University of Malaya, 50603, Kuala Lumpur, Malaysia.
authors: Sharifah Mazni
authors: SM
authors: Samsuddin
authors: UMMC Bone Bank, Department of Orthopaedic Surgery, Faculty of Medicine, National Orthopaedic Centre of Excellence in Research and Learning (NOCERAL), University of Malaya, 50603, Kuala Lumpur, Malaysia.
authors: N G Wuey
authors: NG
authors: Min
authors: UMMC Bone Bank, Department of Orthopaedic Surgery, Faculty of Medicine, National Orthopaedic Centre of Excellence in Research and Learning (NOCERAL), University of Malaya, 50603, Kuala Lumpur, Malaysia.
authors: Norimah
authors: N
authors: Yusof
authors: UMMC Bone Bank, Department of Orthopaedic Surgery, Faculty of Medicine, National Orthopaedic Centre of Excellence in Research and Learning (NOCERAL), University of Malaya, 50603, Kuala Lumpur, Malaysia.
authors: Azura
authors: A
authors: Mansor
mesh_terms: D064591:Allografts / Q000592:standards; D001419:Bacteria / Q000528:radiation effects; D018586:Bone Banks / Q000592:standards* / Q000706:statistics & numerical data; D016025:Bone Transplantation / Q000592:standards* / Q000706:statistics & numerical data; D001842:Bone and Bones / Q000382:microbiology* / Q000528:radiation effects*; D015925:Cryopreservation / Q000379:methods / Q000592:standards* / Q000706:statistics & numerical data; D004307:Dose-Response Relationship, Radiation; D005720:Gamma Rays; D019983:Guideline Adherence; D006801:Humans; D008296:Malaysia; D008485:Medical Audit; D017410:Practice Guidelines as Topic; D011829:Radiation Dosage; D012189:Retrospective Studies; D013242:Sterilization / Q000592:standards* / Q000706:statistics & numerical data
keywords: Absorbed dose; Bone allograft; Ceric/cerous; Dose uniformity ratio (DUR); Gamma irradiation