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Focus on Safety:
The Economic Impact of Allograft Sterilization
 As a leader in bio-implant technology and regenerative medicine, LifeNet Health achieves the highest sterility assurance rating possible without compromising function or durability. LifeNet Health focuses on the safest product possible, while minimizing the economic impact of infections.
Differences and discrepancies exist between sterility requirements for medical devices and biotechnology supply organizations. The same sterility standards are not applied to organizations supplying bone and tissue allografts. In fact, one tissue supplier’s “sterile” label may not carry the same assurance as another’s claim. The implications of this variation are significant in terms of infection potential to allograft recipients and associated costs.
A recent study demonstrated that the infections acquired through bacterial contamination of allografts have the potential to result in substantial complications or death.1 The Centers for Disease Control (CDC) recently identified allograft-associated infection as a major public health risk.2 These grave clinical concerns are coupled with the significant financial impact of surgical site infections (SSI). Infections erode hospital profits and hold legal ramifications if hospitals fail to implement best practices in infection control. In 2007, the Centers for Medicare and Medicaid Services (CMS) announced its decision to cease paying hospitals for some of the care made necessary by “preventable complications” – including SSIs following certain elective orthopedic surgeries. Considering the prevalent use of allografts in orthopedic reconstructive surgery, it is clear that allograft-associated infections are within the CMS’s purview to scrutinize as preventable complications, and thus, non-reimbursable. These costs can range from $10,000 to more than $30,000 per patient.
Economic, clinical, legal and political factors make allograft safety a serious risk management issue. Prevention is the key; and preventive measures must begin with rigorous screening, stringent aseptic tissue processing and sterilization procedures. LifeNet Health, the leader in regenerative medicine, offers an innovative bio-implant technology that places the company at the forefront of higher sterility standards. Through its proprietary Allowash XG® sterilization process, LifeNet Health bio-implants achieve the highest sterility assurance rating without compromising function or durability. This difference in sterility assurance holds clinical and economic significance.
LifeNet Health has made a commitment to achieve the most rigorous terminal sterilization of 10-6 for most of its allografts using the patented Allowash XG® technology without compromising function or durability. This proprietary sterilization process provides an intense decontamination, disinfection and scrubbing regimen designed to remove and inactivate viruses and bacteria without harming structural integrity, osteoinductive or osteoconductive potential.
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1. Kainer MA, Linden JV, Whaley DN, et al. Clostridium infections associated with musculoskeletal-tissue allografts. N Engl J Med 2004; 350:2564-2571.
2. Mroz T, Joyce M, Steinmetz M, Lieberman I, Wang J. Musculoskeletal allograft risks and recalls in the United States. J Am Acad Ortho Surg 2008; I 6: 559-565.
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