Allowash XG® is a patented and proprietary sterilization process that removes greater than 99% of bone marrow and blood elements from the internal bone matrix. Allowash XG renders allograft bio-implants sterile without compromising their biomechanical or biochemical properties.
Donor tissue goes through a stringent screening routine and is recovered in strict aseptic conditions. Allograft bio-implants then go through serological testing to further control and eliminate incoming bioburden. The allograft bio-implants are processed and preserved in facilities that maintain cleanliness levels that minimize or eliminate environmentally induced graft contamination. Allograft bio-implants are cleaned with key solutions that are forced into and through the bone matrix and then directed to waste, resulting in the lysis of cells and cleaning of the tissues. The decontamination, disinfection and cleaning regimens for the allograft bio-implants remove and eliminate viruses and bacteria. The final step is sterilization with a controlled and validated dose of gamma irradiation administered at low temperatures after the allograft bio-implants is packaged.
Allowash XG renders allograft bio-implants sterile without compromising the biomechanical or biochemical properties of allograft tissue for their intended surgical applications. This is achieved by:
Allowash XG renders allograft bio-implants sterile without compromising the biomechanical or biochemical properties of allograft tissue for their intended surgical applications. This is achieved by: Removing greater than 99% of extractable elements from the bone matrix Ensuring a Sterility Assurance Level (SAL) of 10-6 through chemical treatment and sterilization steps Inactivating enveloped and non-enveloped viruses
Allowash XG gives you sterility without compromising the biomechanical and biochemical properties of allograft tissue needed for surgical applications. Since the introduction of Allowash® in 1994, and the introduction of Allowash XG® in 2004, LifeNet Health has delivered over 2 million allograft bio-implants with no incident of disease transmission.
Matracell is a patented and validated process that renders allograft tissue acellular, without compromising the biomechanical or desired biochemical properties of an allograft bio-implant for its intended surgical application.
The Matracell process requires three steps:
Step One - Decellularization. Matracell utilizes an anionic, non-denaturing detergent, N-Lauroyl sarconsinate, to remove donor cells from the allograft bio-implant. N-Lauroyl sarcosinate is a common detergent used widely in cosmetic industry due to its bacteriodical properties and safety profile. To remove the donor DNA, a recombinant endonuclease, Benzonase® is applied to efficiently degrade the DNA without introducing the risk of prion disease transmission.
Step Two - Rinsing. Decellularization reagent residuals and donor cell remnants are removed from the allograft bio-implant. The process utilizes water that circulates through the allograft bio-implant and then a resin bed to remove the decellularization reagents and cell remnants from the water.
Step Three - Preservation. The allograft bio-implant is preserved with LifeNet Health’s proprietary technology that is comprised of USP glycerol and USP grade water. The allograft bio-implant is then frozen and stored at -80ºC.
Allograft bio-implants decellularized with Matracell technology have been successfully assessed in a large animal model for biocompatibility and durability. The processing reagents and biomechanical strength were thoroughly evaluated and the Matracell process was validated to remove greater than 99% of the donor DNA* in cardiac applications, and greater than or equal too 97% of the donor DNA in dermal applications. The end-point microbiological testing was validated in accordance with USP <71> and the end-point DNA testing was validated in accordance with ICH Harmonized Tripartite Guidelines Q2 (R1) “Validation of Analytical Procedures: Text and Methodology.”
*Matracell removes cells and greater than or equal to 97% DNA in decellularized dermis for soft tissue, sports medicine, dental, and soft tissue applications.
Matracell renders allograft bio-implants acellular without compromising the biomechanical properties for their intended surgical applications. Matracell is just another way LifeNet Health strives to provide allograft bio-implants to save lives, and restore health to thousands of patients annually.
Donation involves the recovery of organs and tissues after death to help patients in need. In transplanting organs, time is crucial but tissue may be donated up to 24 hours after a person's heart has stopped beating. After recovery, the tissue is processed at LifeNet Health and stored until a surgeon requests the tissue for an upcoming surgery. Tissues that can be recovered include skin, bone, eyes and corneas, ligaments and tendons, veins and arteries, and heart valves. Approximately one million tissue transplants are done each year, making tissue donation a remarkable success story.
Each person’s medical condition is evaluated at the time of their death to determine what organs and tissues are viable for donation. People living with chronic diseases or those who have a history of cancer or other serious diseases are still encouraged to join the donor registry.
Preserving your health and life is always the number one goal. The medical staff that care for you or your loved one at the hospital play no role in tissue donation. Organ and tissue recovery takes place only after all efforts to save your life have been exhausted and after death has been declared. Tissue recovery surgery is performed by highly-trained members of the LifeNet Health of Florida team and is usually performed in a hospital.
LifeNet Health of Florida treats each donor with the utmost care, respect and dignity. Donation does not normally affect customary funeral activities. Every effort will be made to minimize the visual change to the body to allow for an open-casket funeral.
Donation is considered a precious gift of life. Costs associated with recovery and processing organs and tissues for transplant are never passed on to the donor family.
Most major religions support organ and tissue donation. Typically, religions view organ and tissue donation as acts of charity and goodwill. LifeNet Health of Florida encourages you to discuss organ and tissue donation with your spiritual adviser if you have concerns on this issue.
Anyone may be a candidate for donation, regardless of age, race, medical history or religious beliefs.
PAD is a patented LifeNet Health technology that precisely manages the demineralization process to achieve the ideal residual calcium necessary for optimal osteoinductivity.
Over-demineralization can destroy Bone Morphogenic Proteins (BMPs) because the molecules become denatured and rendered ineffective. Under-demineralization compromises osteoinductive performance by preventing the timely release of BMPs.
Strict control of the residual calcium is achieved by enhancing the way the demineralizing acid is applied to the bone. In a series of computer-controlled steps, the vessel containing the bone is rapidly filled (pulsed) with the acid and then drained and neutralized with buffer. This continues until the specific desired residual calcium level is achieved.
A product can be designated as demineralized if the residual calcium level is < 8%. However, studies show that restricted calcium in the range of 1 to 4% provides the most osteoinductive product. This is the range that PAD Technology targets consistently.
LifeNet Health’s PAD demineralization technology is uniquely positioned to improve the inductive properties of allograft bio-implants and support better clinical outcomes, a benefit that serves everyone.
Traditional demineralization processes are competent but not optimal. Without strict control, the ideal residual calcium level cannot be achieved consistently. Patented PAD Technology ensures a predictable quality product that supports osteoinductivity and better clinical outcomes.
Allografts, or donor tissue, are frequently preferred over autografts, a person's own tissue, for a variety of reasons. Allografts (human tissue) can help patients regain mobility, restore function, enjoy a better quality of life, and even save a life in the case of cardiovascular tissue or skin.
Generally, since no second surgical site is required (as there is when an autograft is utilized), healing time may be shorter and less painful. In addition, autografts are only available in limited amounts, from limited areas of the body. Allografts are more readily available.
Before a donation, specially trained professionals perform rigorous medical and behavioral risk screenings to ensure the eligibility of the potential donor, as per Food and Drug Administration (FDA) guidelines.
All donor tissue is recovered in the United States in appropriate settings under strict aseptic conditions by dedicated and trained recovery personnel.
To ensure that the donated tissue poses the lowest possible health risk, a blood sample from the donor is tested for the following: * Blood tests for HIV, Hepatitis, and Syphilis * Procedures to ensure the absence of bacteria and fungi LifeNet Health meets and exceeds industry standards of disease testing. All testing is performed in government-certified (or equivalent) laboratories.
The quality control measures continue with LifeNet Health's patented allograft tissue processing. LifeNet Health's processing steps make the risk of disease transmission extremely remote. Musculoskeletal (bone and tendon) tissue is prepared in special controlled (cleanroom) processing suites and undergoes LifeNet Health's Allowash XG®
cleansing process. With Allowash XG® Technology, chemical (virucidal and bactericidal) agents penetrate allograft tissue and help to significantly reduce the potential transmission of disease. Compared to some other processing methods for musculoskeletal tissue, Allowash XG® results in dramatically cleaner allograft tissue. For cardiovascular tissue, an antibiotic disinfection regimen is employed to ensure that the possibility of bacterial transmission from allograft heart valves and cardiac tissue is extremely remote. Also, the tissue is carefully cryopreserved (frozen at a controlled rate) in an effort to preserve the original structural and biological integrity of the graft.
Tissue is released for distribution only after all final quality assurance checks have been met. LifeNet Health's Quality Assurance laboratory performs all required aerobic and anaerobic cultures and any applicable additional testing. Finally, all donor records are reviewed by LifeNet Health's Medical Director to determine eligibility for transplantation. Since the introduction of Allowash® in 1995, there has been no incident of disease transmission directly linked to tissue screened and processed by LifeNet Health. LifeNet Health standards are not indicative of those employed by other tissue banks and it should not be assumed that all banks are comparable. Since its establishment in 1982, LifeNet Health has developed a stringent quality control process. By setting exceptionally high standards, LifeNet Health provides leadership in the field of tissue recovery and processing.
Allografts have several advantages overautografts, which are grafts taken from yourown tissue. Autografts require that you undergosurgery elsewhere on your body to obtain thetissue, which can cause additional pain, scarring, and longer healing times. However, because allografts are human tissue taken from a deceased donor, it’s important to consider where the tissue is coming from, what testing it undergoes, how it is processed, and what other measures are taken to assure your safety. As you’ll see, LifeNet Health takes extraordinary steps to provide you and your surgeon with safe, healthy tissue.
LifeNet Health donations come from federally designated and regulated organ donation organizations and approved tissue recovery partners. We only work with qualified, accredited agencies that meet our strict standards for quality, and safety. In addition, we conduct regular inspections to ensure that our tissue recovery process meets current FDA regulations and AATB standards. You can be fully confident your allograft comes from a trusted source.
No one has higher standards for allograft safety than LifeNet Health. We begin with thorough donor screening, an essential step in preventing disease transmission. At LifeNet Health, this includes evaluating the donor’s medical and behavioral history. Blood tests are used to rule out diseases such as HIV, hepatitis, and syphilis, and the presence of any bacteria. Once the donor is approved, LifeNet Health applies special methods to clean or sterilize the tissue. These technologies have been designed to effectively remove all viruses and bacteria. In fact, our sterilizing technology is one of the best methods out there. Although current regulations do not require tissue banks to use processing methods that guarantee tissue sterility, LifeNet Health has adopted stringent guidelines set forth by the Association for the Advancement of Medical Instrumentation (AAMI) for invasive and surgically implanted medical devices. That means you are receiving the cleanest and healthiest tissue possible for your procedure.
LifeNet Health has an unmatched safety record in providing allografts. Since the introduction of our patented bio-implant sterilization technology Allowash® in 1995, we have distributed more than 2 million allografts with no incidence of disease transmission from tissue screened and processed by LifeNet Health. Our record is your assurance of utmost safety.
Not only does LifeNet Health use the most advanced process for ensuring safety, we also use the industry’s most advanced facilities and engineering to assure the highest quality allografts. All of our processing environments comply with FDA, state and federal requirements. All of our allograft tissue undergoes extensive engineering to ensure maximum performance that meets the demands of today’s active lifestyles.
LifeNet Health’s commitment to safety, quality, and patient outcomes is evident in everything we do, including our ongoing research and development efforts. LifeNet Health’s 52 patents include Allowash XG® sterilization technology, the industry standard in tissue processing, and other innovations that promote natural healing and improve mobility and function. You can count on us to continue working on new ways to enhance your care.
From screening to cleaning, all procedures are performed by trained LifeNet Health technicians. We strictly adhere to AATB and federal guidelines and our own high standards. Every step is documented and all records are evaluated to make sure every requirement is met and the tissue you receive is the finest it can be. Throughout our process, LifeNet Health leaves no room for error. However, LifeNet Health safety standards are not necessarily the same as those used by other tissue banks, and you should not assume that all tissue banks are alike. You may want to ask your physician if he or she plans to use a LifeNet Health allograft for your procedure. For more information, including additional information about LifeNet Health’s Quality Control and Safety measures, please visit our website, www.LifeNetHealth.org.
Every aspect of the LifeNet Health process honors the dignity and generosity of donors and their families. Their gifts have enabled many people to enjoy fuller, richer lives. Yet most donor families never hear about what their donations have meant to the patients who receive them. Here’s where you can make a difference. As an allograft tissue recipient, you may express your gratitude in an anonymous letter to the donor’s family. LifeNet Health will gladly facilitate the delivery of the letter. You can tell the donor family about yourself, share with them the progress you’ve made, and describe how your allograft has enhanced your everyday life. You can also share your success story with the public through LifeNet Health. Simply contact LifeNet Health Donor Family Services for more information at 1-888-847-7831, or email us at moderator@donorfamilies.net. You can also learn more on our transplant recipient website by visiting www.Thanks2You.org.
Preservon is a proprietary, glycerol-based preservation solution that allows allograft bio-implants to be stored in a fully hydrated state at ambient temperature. This eliminates the need to freeze or freeze-dry allograft bio-implants, doing away with lengthy thawing and rehydration times in the OR.
Glycerol, the active ingredient in Preservon, acts as a humectant, maintaining the moisture within the allograft, while providing a bacteriostatic environment. These properties allow ambient temperature storage of the allograft without decay. Widely used as a food additive, glycerol since 1991 has been used as a carrier in commercially available osteobiologics products such as Optium DBM® to enhance handling characteristics.
Testing conducted both by LifeNet Health and independent sources, including biocompatibility, osteoconductivity, and biomechanical analyses, have found the safety and performance of Preservon-treated and frozen or freeze-dried preserved allograft bio-implants to be comparable.
Your patients receive allograft bio-implants that offer uncompromised safety and performance, allowing them to resume a higher level of physical activity. For hospitals and surgeons, Preservon reduces costly OR time and offers a level of convenience not available with any other allografts. Preservon-treated allografts are packaged in the same PETG tray packaging currently used for freeze-dried allografts provided by LifeNet Health.
It’s much more efficient and convenient than conventional preservation methods allow. Frozen or freeze-dried allografts can require up to 60 minutes to thaw or re-hydrate, compared to as little as 30 seconds for Preservon-treated allograft bio-implants, while reducing the potential for brittle product.