It is estimated that each year more than 2.5 million allografts are implanted in the United States. These grafts are utilized in almost all surgical disciplines including orthopedic, neurology, gynecology, cardiac surgery, burn care and many others. Over time physicians have realized the benefits of using allograft tissues over other alternatives such as autografts and synthetics, and this realization has tremendously increased the demand for allograft tissues. We have taken some of the most commonly asked questions and answered them for you. We hope the following information is helpful when deciding about the use of allograft tissue.
FAQs
- Is Lifelink Tissue Bank for profit?
No, LifeLink Tissue Bank is one of the largest not-for-profit Tissue Banks in the Southeast and one of the largest in the country. We believe in the altruistic nature of donation. LifeLink Tissue Bank does not have shareholders or any other profit-making entity.
- How much advanced notice does my facility need to order allografts in order to receive it for a scheduled surgery?
Most allografts are shipped two-day standard delivery. We can also ship priority for a fee if we have the allograft in inventory. Advance ordering is recommended to ensure prompt delivery. LifeLink Tissue Bank will utilize every resource to ensure that allografts are made available.
- When our facility orders an allograft, occasionally there is confusion about what to call it. Why is this? How can I cross-reference so that we receive like product?
There is no real standardization of nomenclature in the tissue banking industry. For example, what one facility calls a strut another may call a plate. Fortunately, our customer service and technical support representatives can help you determine exactly what you need.
- Should disease transmission be a concern?
LifeLink Tissue Bank has implemented stringent donor screening and quality assurance programs in our industry to decrease the concern for disease transmission. LifeLink Tissue Bank has safely placed hundreds of thousands of allografts since our inception in 1985.
- Who determines that an allograft is safe to use?
Donors are subject to a donor eligibility determination by a LifeLink Tissue Bank Medical Director which includes a comprehensive review of relevant information such as past medical history, infectious disease test and microbial culture results. In addition, all documentation related to the processing of the allografts generated from the donated tissue is reviewed by the Quality department to ensure compliance with procedures and specifications. Allografts may be released for clinical use after successful donor eligibility determination and comprehensive review of all processing records by the Quality department.
- How are LifeLink allografts cleaned and disinfected?
LifeLink processing methods include the revolutionary Allowash® method which allows our allografts to be cleaner and safer while maintaining their clinical effectiveness. Viral inactivation studies indicate that the processing of allograft tissue using Allowash® technology is highly effective for the inactivation of many types of viruses.
Although this technology is a visible breakthrough in the cleaning process, it will never act as a substitute for the strict donor-screening guidelines employed by LifeLink Tissue Bank.
Allowash Technology® involves a series of mechanical and reagent cleaning and disinfection steps designed to reduce any potential bioburden, bone marrow, blood elements, and lipids. This process includes the use of Allowash® solution, a combination of biological detergents that work in conjunction with traditional treatments such as alcohol and hydrogen peroxide to enhance the solubilization and removal of bone marrow, blood, and lipids (elements that may possibly act as a reservoir for disease transmission). In addition, antibiotics (Bacitracin, Gentamicin, and Polymyxin B) are also utilized in the processing of allografts. Tissue to be demineralized is further processed using Hydrochloric Acid and Sodium Phosphate Buffer.
- How many patient recipients can one donor provide tissue to?
On average one donor can provide allografts for up to 50 recipients.
- Is tissue provided frozen, freeze-dried, fresh, or cryopreserved?
LifeLink provides Frozen or Freeze-dried tissue to our end user customers. However, we do provide a fresh birth tissue product and cryopreserved product to specific contract partners.
Freeze drying: Also known as lyophilization, reduces the residual moisture of tissue to a specified level to maintain tissue quality through the shelf-life of the allografts to be stored at ambient temperatures.
Frozen: A method in which grafts are packaged and then stored at temperatures of -40 degrees Celsius or colder to maintain tissue quality through the shelf-life of the allograft.
Fresh: Tissue that is stored at refrigerated conditions (0-10C) to preserve beneficial properties and has never been frozen or dried.
- How do the Allografts need to be stored upon receipt?
Our allografts must be stored according to the defined temperature range that is displayed on the label or package insert. For freeze dried allografts, these must be stored between 11°C-25°C/ 52°F-77°F. For frozen allografts, these must be stored at -20C or colder for short term storage (6 months or less) or at -40C or colder for long term storage.
- Is an account needed to order allografts?
Yes, there must be an active account in place for ordering allografts. To set up a new account, please contact Hospital Services and ask to speak with a Hospital Services Coordinator who can assist.
- Can allografts be shipped directly to my home?
No, allografts can only be shipped to Hospitals, Surgery Centers, or distributors that are registered with the FDA to store/distribute bone and tendons.