Tissue management and automation: Aligning for success in the OR
What is tissue?
The FDA describes tissue as “human cells, tissues, and cellular- and tissue-based products.” (For simplicity, this article uses the term tissue.) Examples of tissue include bone, cornea, skin, heart valves/conduits, tendons, fascia, dura, bone marrow, veins, arteries, cartilage, sperm, embryos, eggs, stem cells, cord blood, synthetic tissue, and other cellular- and tissue-based transplant or implant products.
Collagen or certain synthetic tissues, such as those derived from plastics and polymers, are not considered tissue because they are not cellular based.
Meeting the regulations
Regulations and standards related to tissue fall into three categories:
- the federal government, primarily the FDA
- state and local health authorities
- organizations and associations, primarily the American Association of Blood Banks (AABB), American Association of Tissue Banks (AATB), the Joint Commission, and AORN.
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Organizations that screen, test, process, label, package, or distribute tissue must register the organization each December with the FDA. During an accreditation visit, the hospital must be able to quickly retrieve a copy of the most recent annual registration letter for those organizations they work with.
Rosing suggests keeping copies in a binder for easy access.
If a hospital sends tissue to another facility off campus, the FDA would then consider the originating hospital a source facility, or supplier, which means it would have to register as such and adhere to federal regulations.
“The other facility has to be on the same campus for sharing to occur without a hospital being designated as a supplier,” Rosing says. Isolated, urgent situations where tissue is sent to another facility off campus might be acceptable, but the reasons why those situations occurred must be well documented.
The lot number and expiration date of the solution used to reconstitute the tissue must be recorded so that it can be explored as a possible source if infection occurs.
Proper storage of tissue is vital from both financial and patient safety perspectives. Those responsible for tissue management in the OR should follow AORN and Joint Commission guidelines related to storage. These include:
- continuous temperature monitoring, with temperature recorded at least daily (when the department is open), and documented manually, mechanically, or electronically
- alarm system that notifies personnel when temperature falls outside the desired range
- an emergency system that includes a plan if equipment fails
A backup plan is essential to protect the hospital’s financial outlay. “There is a large investment in these products, so you have to know what you’ll do in an emergency situation such as a power outage or an inability to maintain proper humidity,” Mitchell says. “For example, we have dry ice kits and the personal protective equipment staff will need to wear when using dry ice to move tissue.”
The plan should cover refrigerated, frozen, and ambient tissue, and a list of emergency contacts should be readily available. “Check and validate your plan,” Mitchell says. “If you don’t, you could be in trouble if something happens.”
A growing field
OR managers will need to continue keeping a close eye on tissue management. “It’s a field that’s rapidly expanding,” Chenoweth says. “It used to be some Achilles tendons and a couple of bones, but now there are so many different tissue types that it can be incredibly complex; you have to have a really good management program.”
The opinions expressed on this site, "Tissue Management & Automation: Aligning for success in the OR," are those of OR Manager and do not reflect the views of Cardinal Health.
- AORN. Guideline for autologous tissue management. Guidelines for Perioperative Practice. 2016. Denver: AORN, 2016. www.aorn.org.
- AORN. Autologous tissue. Clinical FAQs. https://www.aorn.org/guidelines/clinical-resources/clinical-faqs/autologous-tissue
- Bashaw M A. Guideline implementation: Autologous tissue management. AORN Journal. 2015;102(3):270-280.
- Food and Drug Administration. Human cells, tissues, and cellular and tissue-based projects. Electronic Code of Federal Regulations, Title 21, Part 1271. Current as of August 11, 2016. http://www.ecfr.gov/cgi-bin/text-idx?SID=124a822bd07e5458e1286864e3c11360&mc=true&node=pt21.8.1271&rgn=div5
- Joint Commission. Adverse tissue reaction policies. Standards frequently asked questions. April 6, 2007.
- Lazarus E F. FDA basics: Tissue safety. Webinar. September 20, 2012.
- Sions J A, Cheuvront K A, Grove G L, et al. A team approach to improving tissue management. AORN Journal. 2016;103(4):380-387.