Banking on Allograft Safety

Patient Safety

By: Victoria Steelman

Published: 10/10/2007

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How to ensure that bone and tissue implementation is successful.


It's easy to view an allograft as a surgical supply on the order of sutures, scalpels and sponges. You don't know where it came from and you don't bother asking. But allografts can be sources of infectious disease. More than 1.5 million allograft tissues are implanted into patients annually, with the number increasing every year, according to the American Association of Tissue Banks. The headlines over the past year about patients being implanted with tissue contaminated by mold, fungi, bacteria and viruses are good reminders that allografts can do more harm than good if they're not strictly controlled and delicately treated before we transplant them (see "Do You Know Where Your Allograft Tissue Is Coming From?" on page 68).

How do you know that your allograft tissue is safe and free of disease? Each link in the chain - from recovery centers to processing companies - is supposed to have quality assurance checks in place, but that's no excuse for not imposing the strictest of controls on the tissue you receive. Here's what you can do in your facility to help ensure allograft bone and tissue quality.

Start with the vendor
The FDA has regulated human tissue intended for transplantation since 1993. In May 2005, three new regulations took effect:

  • Companies that produce and distribute tissue-based products must register with the FDA;
  • donors must meet certain criteria to be eligible to donate tissue (this is often referred to as the "donor eligibility" rule) and
  • the "current Good Tissue Practices" rule governs the processing and distribution of the tissue.

Human tissue that is processed and distributed for transplantation by AATB-accredited tissue banks is subject to FDA regulations and AATB's standards. The FDA, however, doesn't require manufacturers of implants to terminally sterilize them.

The first thing you need to do is develop written criteria for your tissue vendors. It may sound trite, but it really will be a building block of a good tissue safety program. Well-thought-out guidelines will mandate that your vendor be certified by the AATB and registered with the FDA. Obtain documentation of FDA registration and AATB certification (which you'll keep with your tissue tracking logs) before you proceed. If it puts you at ease, do an on-site visit with the vendor - whatever you need to do to ensure you know about the company. The most important factor is that your vendor be in compliance with all regulations and that the AATB has reviewed it and found its processes to be acceptable.

Your Documentation Checklist

Well-thought-out tissue banking files should include the following:

  • copies of registration and certification;
  • a list of all tissue ordered, stored and used;
  • all steps of processes used;
  • a description of the package integrity upon receipt;
  • the transport temperature, both controlled and acceptable;
  • the source facility and any unique identifiers;
  • recall procedures; and
  • the procedure for disposal of tissue.

Source: FDA (2004), Federal Register69(226) 68612-68688.

Designate a duo
As you'll see as we go along, managing a tissue safety program, including receipt, storage and distribution within a facility, requires a coordinated effort. For this reason, I recommend that you assign an administrator and a medical director to handle different aspects of the task together.

The administrator may be a nurse, and needs to be familiar with all the very detailed national standards and regulations in order to maintain your tissue banking policies and procedures, as well as overseeing maintenance of your tissue tracking logs. She should also know what your accrediting agency requires, the ins and outs of informed consent and ethical considerations.

The medical director is going to be the go-to person for complex decisions about the appropriate use of different tissue as well as differences in opinion among your physicians. For example, if a physician wants to order tissue from a source other than what your facility has approved, the tissue banking medical director would step in to mediate. Or if a physician were to request that tissue be saved, the medical director would have the knowledge base and expertise to determine whether it's appropriate to have your tissue bank manage that process.

On the Web

Pertinent national standards and regulations:

AORN: www.findarticles.com/p/articles/mi_m0FSL/is_2_83/ai_n16359778
AATB: www.aatb.org/standards.htm
FDA: www.fda.gov/cber/tissue/docs.htm

Treat with diligence
The person who receives the tissue when it's delivered to your facility needs to inspect it, fill out a log and enter the information into the database. The information you should record includes the inspector's name, date, time, the tissue ID and the condition of the tissue upon receipt. Because you'll use the documentation both to track the tissue and in the patient chart, the designated inspector should be detail-oriented - a meticulous clerical staffer can do the job if well trained.

After inspection, properly store the tissue in a secure, environmentally monitored area. The area should be locked and have restricted access. Store tissue according to AATB standards and monitor the temperature of the storage conditions, even if it's considered "room temperature."

Monitor and alarm the freezers and have a backup plan to follow in case of freezer failure. The freezer alarm should sound in an area where someone is present 24-7. Don't forget to document where, when and how the tissue was stored, any deviations from approved temperatures and what was done to correct these.

Plan for surgery
When the patient is scheduled for surgery, that's when you need to identify the plan of care. In other words: as far in advance as possible. First of all, you need to plan for the tissue availability.

Educate the patient so he can give you his fully informed consent to receive the implanted tissue. To reduce the chance for waste, bring the tissue out of storage only when you know the procedure will proceed. And to ensure the allograft has made it into the OR, incorporate a check on the immediate availability of the tissue into the timeout. Because the last thing you want to hear when the patient's knee is open is the circulating nurse saying, "The tissue isn't here."

Do You Know Where Your Allograft Tissue Is Coming From?

The tissue banking industry has come under intense scrutiny over allograft tissue safety. To address these concerns, many tissue banks are investigating terminal sterilization of allografts after their traditional aseptic processing methods. All companies perform an FDA-approved process to lessen the bioburden during pre-harvesting of allografts. But even with strict donor screening, testing and low bioburden levels, unless tissue is sterilized through an effective process, there is a risk of disease transmission and infection. The trouble is that low-dose radiation, while enough to kill most organisms and not damage native tissue, may not be enough to kill everything that can kill your patients. Here's a quick look at the three companies that have developed proprietary methods to sterilize donor bone and soft tissue without impacting the structural or biomechanical integrity of the allograft:

  • AlloSource (www.allosource.org) AlloSource says its Low Dose Low Temperature Sterilization Process ensures the absence of bacteria and won't compromise the structural and biomechanical properties of the allograft.
  • Clearant (www.clearant.com) The Clearant Process is a terminal pathogen inactivation process that treats the tissue with a biocompatible radioprotectant solution before irradiation and controls temperature during irradiation so that the tissue temperature doesn't rise above -50'C. The Clearant Process is the only current pathogen inactivation technology designed to be used for allograft tissue in the final container, making the product ready for use in the OR, says the company.
  • Regeneration Technologies, Inc. (www.rtix.com) RTI's BioCleanse process is a low-temperature, sporicidal and virucidal chemical sterilization process that preserves biomechanical integrity. BioCleanse is fully validated to prevent infectious disease contamination and cross-contamination, says the company.

"At a bare minimum, you should only use tissue from nationally accredited tissue banks and, in my opinion, you should only implant tissue that has been sterilized," says Ty Endean, MD, an orthopedic surgeon with the Sports Institute of Tucson in Tucson, Ariz., who performs 75 to 100 ACL repairs each year.

Sterilizing musculoskeletal grafts presents a unique challenge, say experts. An optimal sterilization method should be effective against all types of pathogens, both known and emerging, without adversely affecting the biomechanical properties of the tissue. To assure sterility, a sterilization method must thoroughly penetrate tissues of all sizes and densities, and be capable of inactivating or removing the larger numbers of microorganisms that can contaminate tissues and cause HIV, hepatitis B, hepatitis C, West Nile virus or Creutzfeldt-Jakob Disease.

"Allograft infection happens very infrequently, but if you're that one-in-one-thousand, you have a catastrophic event," says Dr. Endean. "If I can add a layer of safety at any level, whether it's a pre-op antibiotic or using a sterilized graft, I'm gong to do it 10 out of 10 times."

- Dan O'Connor

Leftover or unused tissue doesn't happen very often in the outpatient setting. However, if for some reason the container is opened and some tissue is unused, dispose of it in accordance with state law. Remember that this isn't your average medical supply or even biohazardous waste. Plan in advance with pathology or infection control what would happen if this were to happen so you have a protocol to follow.

You also have to document the disposal and the procedures you followed. That way, if there is a recall for some reason, you can check the information you've logged and report immediately that you didn't implant that tissue into any patient, providing proof of where it went.

Ready to respond
You might need to deal with two kinds of adverse events. First, if an allograft patient presents with a related infection, you should report this issue to the vendor; at times, it might be advisable to do voluntary reporting to the FDA as well, but the vendor is accountable for reporting to the FDA.

If there's a tissue recall, however, you have to report back to patients. It would be nice to think we won't ever have another recall, but if it happens, you need to do the following:

  • Go through your documentation to determine if any of the recalled tissue remains in inventory. If it does, remove the tissue immediately to prevent accidental use.
  • Follow the instructions of the recall and any information provided by the CDC or FDA. For the recall last October, the CDC recommended that we contact every patient receiving the recalled tissue, disclose the situation to them and offer infectious disease testing, including HIV, hepatitis B and C, and syphilis. Our hospital went a step further, offering to travel to patients' homes to draw the blood for the testing. We weren't at fault, but you have to look at these rare situations from the public relations, patient satisfaction and patient safety perspectives.

FDA Answers to Tissue Safety Questions

Just a few months after the FDA instituted new regulations governing tissue recovery and processing, allograft bone and tissue processors nationwide began recalling their products, one by one, last fall.

The contamination scare started Sept. 30, when Branchburg, N.J.-based LifeCell Corp.'s internal quality processes raised questions about donor documentation and the company initiated a voluntary recall of certain AlloDerm, Repliform and GraftJacket products - with "certain" in this instance being "all lots of product that were produced using tissue from Biomedical Tissue Services," a tissue recovery company in Fort Lee, N.J., according to FDA recall notices.

"It was not lack of oversight from the FDA, it was, if the allegations are true, fraud, which is more difficult to detect," says Victoria Steelman, RN, PhD, CNOR. The scary part, then, is that, "the hospitals that used the tissue were not even aware what tissue recovery service the tissue came from." It was only due to LifeCell's scrutiny and subsequent reporting to the FDA that the situation started to be uncovered.

By the end of October, five tissue processors had recalled, according to an AATB estimate reported by the Associated Press, "fewer than 1,500 tissues." While the overall infectious risk was likely low, the FDA and CDC recommend that physicians offer patients access to testing for HIV, hepatitis B virus, hepatitis C virus and syphilis. Four executives at BTS now face charges.

It seems another tissue recovery service hasn't learned the lesson: On Aug. 30, the FDA issued a Public Health Notification that tissues recovered by Donor Referral Services of Raleigh, N.C., may not have met requirements for donor eligibility. The potential contamination was uncovered by the "FDA's ongoing investigation of Philip Guyett (DRS owner) and DRS," according to the notification. The federal agency went on to say that "no adverse reactions associated with these tissues have yet been reported, and subsequent processing should reduce the potential risks of infectious disease transmission," but recommended with the CDC that facilities inform patients and offer infectious disease testing because of "the potentially increased risk for infectious disease transmission."

Coinciding with the DRS situation and at least partly in response to the BTS scandal, the FDA formed the Human Tissue Task Force, which will be led by senior FDA officials from within the Center for Biologics Evaluation and Research and the Office of Regulatory Affairs. The multi-disciplinary committee will assess the effectiveness of the implementation of the new tissue regulations and review the "recently reported findings that some tissue recovery establishments are not following federal requirements for tissue recovery," according to a press release. The FDA stresses that it believes that most firms involved in tissue manufacturing comply with the new regulations.

"The primary goal of the new task force is to identify whether any additional steps are needed to further protect the public health while assuring the availability of safe products," says Jesse Goodman, MD, MPH, director of CBER. "The creation of this task force is part of the agency's overall plan to ensure that all human cells and tissues are as safe as possible."

By year's end, the task force is expected to develop an action plan and, where necessary, propose changes to existing policies, as well as generate a set of recommendations, identify what resources are needed to support these actions and report on how the agency can immediately implement its action plan.

- Stephanie Wasek

More commonly, you'll deal with patients who are simply concerned about the fact they have another person's tissue in their bodies. It's only natural, and it's important to handle these situations with speed and compassion. Designate a person for this task - during the last recall in my facility, I was the one - so that, if a patient calls, he is routed immediately to that person. I either met with patients individually or counseled them on the phone. If I wasn't at my desk and the patient left a message, it was the first callback I made when I sat down. We made putting patients at ease a high priority, and talking over concerns and answering questions was usually enough to minimize their concerns; because what they really want is someone to talk to, not all the details of the documentation.

A unique situation
I can't emphasize enough that you must give allograft tissue special treatment. It's not just a medical supply or implant. It's human or animal tissue. Think about it as you would the requirements for successfully handling blood. Review the AORN Recommended Practices for Surgical Tissue Banking, to give you more direction. Implanting tissue can be very safely and successfully done, as long as you manage it with very tight quality controls.

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