CUT ABOVE Look for tissue banks that exceed minimum safety requirements.

More than 1 million skin, tissue and bone allografts are used each year in the United States. "But the chance of getting an infection from implanted grafts is pretty close to zero, because of the steps many banks take to ensure the safety of donor tissue," says Ross Wilkins, MD, the medical director at The Denver Clinic for Extremities at Risk and senior medical director at AlloSource, a non-profit tissue bank in Centennial, Colo. Here are 3 tips to ensure your facility partners with a reputable provider.

1. Look for accreditation
Obtain tissue from an accredited provider, says Steven Gitelis, MD, a specialist in orthopedic oncology and hip and knee replacements at Midwest Orthopaedics at Rush in Chicago, Ill. The American Association of Tissue Banks (AATB) is the only accrediting body for sources of conventional tissue. "These are voluntary accreditations," says Scott A. Brubaker, CTBS, chief policy officer at AATB in McLean, Va. "Banks seek accreditation, and it's a lot to work toward." He suggests you ensure a bank is registered with the FDA as a tissue establishment (tinyurl.com/ly5yqfl). Also check that the bank is a state-licensed facility, if that's required by local law, suggests the Joint Commission, the only accrediting body with standards for safe tissue handling. Then check with the AATB to search for accredited tissue banks that handle the type of tissues you need (aatb.org/accredited-bank-search).

State licensure and permit is just one of the checkboxes ticked by AATB inspectors, who assess much more than what the FDA regulates. Mr. Brubaker discourages tissue banks from sharing PDFs of their accreditation certificates, but many still do when facilities ask for evidence of AATB approval. He suggests you check the list of accredited banks on the AATB website. "There are some that say they comply with AATB standards, but have no proof that they've been inspected and accredited," says Dr. Wilkins. "That's a very important distinction to make."

2. Know the source
Tissue is cultured for bacteria at the time of procurement, and each bank has a different algorithm on how it treats and processes tissue, says Dr. Wilkins. "Most have a single pathway — the tissue comes in and is decontaminated," he says. "Some banks go a step further and sterilize the tissue."

That secondary sterilization process may include washing, sub-chemical treatment and radiation treatment in order to reduce risk of bacterial and viral contamination. "Secondary processing has a significant impact on bone and soft tissue," says Dr. Gitelis. "Most of the processes involve radiation, which ensures bacterial, but not viral, sterility."

The downside of using radiation for secondary processing is that it can have a detrimental impact on the mechanical and biological performances of the graft, according to Dr. Gitelis. "Some surgeons want added security," he says, "while others prefer implants that are as strong as possible and choose not to take grafts that are secondarily sterilized."

You have some assurance that AATB-accredited banks meet a certain criteria level in screening tissue donors, but your due diligence is still needed. For example, Dr. Wilkins warns against using tissue obtained from foreign donors. Some banks import grafts from Eastern Europe, and although the paperwork says they've been tested for HIV and hepatitis, that might not always be the case. "There have been instances where those records have been falsified," says Dr. Wilkins. "I'd never take a donor from outside the U.S., because you can't be sure that the testing is accurate or even legit."

3. Focus on safety
Negotiating the best price for tissue grafts is no different than haggling over the pricing of metallic implants or medical devices, especially for base products such as bone proteins that most banks produce. For higher-end grafts — specialized implants for fresh joint replacements and stem cell grafts used during spine surgery for non-healing bones, for example — price is not as important as tissue quality, accuracy of the tissue's measurements and the bank's service, says Dr. Wilkins.

No matter which grafts you use, Dr. Wilkins suggests you involve surgeon-users in the selection process, because they're ultimately responsible for case outcomes. He also believes patient safety should drive your decision-making when shopping your options. Tissue banks have agreed to establish individual bar-coded tissue identifiers over the next 2 years so every piece of tissue can be tracked back to the original donor. That will help link adverse events to specific banks so you'll be able to better assess their safety records. "It's an evolving system," says Dr. Wilkins, "but everyone is interested in making the process safer."