Cost analysis of fresh-frozen femoral head allografts: is it worthwhile to run a bone bank?

To assess the sustainability of our institutional bone bank, we calculated the final product cost of fresh-frozen femoral head allografts and compared these costs with the use of commercial alternatives. Between 2007 and 2010 all quantifiable costs associated with allograft donor screening, harvesting, storage, and administration of femoral head allografts retrieved from patients undergoing elective hip replacement were analysed. From 290 femoral head allografts harvested and stored as full (complete) head specimens or as two halves, 101 had to be withdrawn. In total, 104 full and 75 half heads were implanted in 152 recipients. The calculated final product costs were €1367 per full head. Compared with the use of commercially available processed allografts, a saving of at least €43 119 was realised over four-years (€10 780 per year) resulting in a cost-effective intervention at our institution. Assuming a price of between €1672 and €2149 per commercially purchased allograft, breakeven analysis revealed that implanting between 34 and 63 allografts per year equated to the total cost of bone banking.

A cost-effective method for femoral head allograft procurement for spinal arthrodesis: an alternative to commercially available allograft.

STUDY DESIGN: A cost-effective procurement process for harvesting, storing, and using femoral head allografts is described. A brief review of the literature on the use of these allografts and a discussion of costs are provided. OBJECTIVE: To describe a cost-effective method for the harvesting, storage, and use of femoral heads from patients undergoing total hip arthroplasty at our institution as a source of allograft bone. SUMMARY OF BACKGROUND DATA: Spine fusion surgery uses a large proportion of commercially available bone grafts and bone substitutes. As the number of such surgical procedures performed in the United States continues to rise, these materials are at a historically high level of demand, which is projected to continue. Iliac crest bone autograft has historically been the standard of care, although this may be losing favor due to potential donor site morbidity. Although many substitutes are effective in promoting arthrodesis, their use is limited because of cost. METHODS: Femoral heads are harvested under sterile conditions during total hip arthroplasty. The patient is tested per Food and Drug Administration regulations, and the tissue sample is cultured. The tissue is frozen and quarantined for a 6-month minimum pending repeat testing of donors and subsequently released for use. The relative cost-effectiveness of this tissue as a source of allograft bone is discussed. RESULTS: The average femoral head allograft is 54 to 56 mm in diameter and yields 50 cm of bone graft, with an average cost of US $435 for processing of the tissue resulting in a cost of US $8.70 per cm of allograft produced. Average production costs are significantly lower than those for other commonly available commercial bone grafts and substitutes. CONCLUSION: Femoral head allograft is a cost-effective alternative to commercially available allografts and bone substitutes. The method of procurement, storage, and use described could be adopted by other institutions in an effort to mitigate cost and increase supply. LEVEL OF EVIDENCE: N/A.

[Cost-effectiveness of a local bone bank based on thermodisinfection according to § 20 b and c AMG and alternatives]. / Zulassung einer lokalen Knochenbank nach § 20 b und c AMG und Einführung einer Thermodesinfektion: Lohnt sich der Aufwand?

INTRODUCTION: The German tissue law creates a different and more difficult situation for German musculoskeletal tissue banks. The objective aim of the new regulations was an increased safety and a reduction of viral and non-viral disease transmissions. In the authors' case, the government officials demanded a thermodisinfection for human femur heads. As a consequence of the requirements we aimed at an analysis of the cost-effectiveness of an admission according to § 20 b and c "Arzneimittelgesetz" (AMG) and implementation of the "lobator bonebank system™". METHOD: We calculated the working hour requirements for all medical staff involved in the tissue procedure. Additional costs were the current consumptions of two freezers (cooling power - 80 °C) for one year, the current consumption of one thermodisinfection process, the material cost of one disinfection and documentation set, expenses for laboratory examinations and the non-recurrent expenses for the admission according to § 20 b and c AMG and the "lobator bonebank system". Non-recurrent expenses were calculated for five years according to 610 tissue donations. We compared the overall costs for one processed femur head with the charges of an industrial chemical treating and irradiation. RESULTS: Expenses for medical doctors were 14.13 € and for nurses 3.71 €. Energy costs were 15.20 € for each stored femur head. Costs for the disinfection and documentation sets were 105.15 €, laboratory expenses were 107.25 €. The non-recurring fee for the admission according to § 20 b and c AMG was 2650 €, the cost for the lobator-sd2 was 12 495 €. The overall expenses for one disinfected femur head were 274.82 € compared to 535.23 € in a tissue service. CONCLUSION: To comply with legal requirements, operating expenses of the new tissue act increased. Nevertheless we could still prove the cost-effectiveness of a local bone bank in Germany.

Cost comparison of femoral head banking versus bone substitutes.

PURPOSE: To compare the costs of femoral head banking versus bone substitutes. METHODS: Records of femoral head banking from 1998 to 2008 were reviewed. The cost of allogenic cancellous bone graft was calculated by estimating the direct expenditure of femoral head procurement, screening tests, and storage, and then divided by the amount of bone harvested. RESULTS: 326 females and 141 males (mean age, 80.3 years) donated 470 femoral heads. Each transplantable femoral head costs US$978. Each gram of transplantable allogenic bone graft costs US$86, compared with US$9 to 26 per gram for commercially available bone substitutes. CONCLUSION: Compared with bone substitutes, femoral head banking in Hong Kong was less economical. Unless allografts yield superior outcomes, harvesting femoral heads for general usage (such as filling bone voids for fresh fractures) is not justified from a financial perspective, especially in banks dedicated to procuring bone from femoral heads only.

The effect of the EU tissues and cells directive on bone banking in Denmark: a case study.

As a result of the EU Tissues and Cells Directive (2004/23/EC), therapeutic tissue banking is currently being restructured throughout Europe. The stated objectives are to enhance a safe and stable supply of bone and tissue in Europe and to facilitate internal exchange. We conducted an interview study to explore the effect of the Directive on Danish bone banks in terms of (1) organizational restructuring, (2) supply and range of exchange, (3) economic costs. We found that the Directive stimulated extensive re-organization of bone banks with a substantial adjoining workload; that it is doubtful whether it will increase supply and range of exchange; and that the transposition of the Directive is associated with considerable extra cost. Additionally, we found that elements in the documentation of safety were fabricated by surgeons to avoid what was seen as unnecessary questioning of potential donors.

The expense for one implantation of a banked bone allograft from a cadaveric donor and the issues affecting current advanced medical treatment in the Japanese orthopaedic field.

Demand for banked bone allografts is increasing in Japan; however, there are too few bone banks and the bone bank network is not well-established. One reason for this was lack of funding for banks. Bone banks had to bear all material expenses of banked bone allografts themselves because this was not designated a covered expense. In December 2004, the Japanese government started a new "Advanced Medical Treatment" administration system which allowed an approved institution to charge the expense of authorized advanced medical treatments directly to patients. The treatment named "Cryopreserved allogenic bone and ligamentous tissue retrieved from cadaveric donor" was approved as an advanced medical treatment in March 2007. We present the calculation method and the expense per implantation of a banked bone allograft from a cadaveric donor under this treatment and raise issues which affect this advanced medical treatment and remain to be resolved in the Japanese orthopaedic field.

[Analysis of the effectiveness of an internal hospital bone bank]. / Effektivitätsanalyse einer klinikinternen allogenen Knochenbank.

BACKGROUND: The EU guidelines 2004/23/EG and 2006/17/EG and their national implementation redefine the framework for allogenic bone banking and transplantation. Against this background an established internal hospital bone bank was analysed concerning threshold of allogenic bone and cost effectiveness in comparison to alternative methods. METHOD: Over a 30-month period we registered all arrivals and outgoings of our bone bank and their destination. We further noted all declined donations. We analysed all costs incurred and calculated costs for alternative methods. RESULTS: By means of our bone bank we are currently able to meet our own demand for bone substitutes. The maintenance costs are below the prices of alternative methods. Some donations (8%) have to be discarded due to procedural errors. CONCLUSION: Maintaining an internal hospital bone bank utilizing fresh-frozen allogenic bone is an efficient and cost-effective method of supplying bone substitutes even under the new EU guidelines if the existing process covers most conditions of the producer authorisation according to section sign 13 AMG. By harmonizing the organizational process it is possible to further improve its effectiveness.

[Bone bank management using a thermal disinfection system (Lobator SD-1). A critical analysis]. / Knochenbankmanagement bei Verwendung eines thermischen Desinfectionssystem (Lobator SD-1). Eine kritische Analyse.

In the study presented on 380 allogenic bone donations from living and organ donors, we analyzed the safety of allograft handling bone-band documentation, logistics and costs. For transplant treatment we routinely used a thermal disinfection system (Lobator SD-1). From 380 allograft donors, 400 bone transplants were gained. The rejection rate was 12.2%. After thermal disinfection for 1 h at 80 degrees C, the grafts were cryopreserved at -80 degrees C and released from the bone bank for potential transplantation after 14-16 days. Five of 730 microbiological specimens showed bacterial contamination after thermal graft decontamination. The bacterial species found on the allografts normally have an inactivation temperature under 80 degrees C. Therefore, only secondary contamination can explain the positive bacteriological test results. With reform of the health care system the economical aspects of bone banking have triggered more interest. The cost for one bone transplant released from the bone bank was 424.75 DM: the overall cost for the bone bank in one year was 75,076 DM. Laboratory (58.2%) and material costs (22.5%) were the major factors. Personnel costs and apparatus costs were relatively low (< 20%). With introduction of the thermal disinfection system (Lobator SD-1) into the bone bank, the safety of allogenic bone transplants was greatly improved. Clinical and serological donor screening must be performed according to international bone bank directives. Considering the low rejection rate and the short turnover rate, the economical costs could be reduced. Using an appropriate disinfection system (thermal disinfection at 80 degrees C), laboratory tests covering venereal diseases, malaria and cytomegalia are no longer required. Also, secondary HIV testing of living donors can be omitted without reducing the safety of the transplant.