Quality issues in skin banking: a review

Title: Quality issues in skin banking: a review
Author: J. N. Kearney
Source: Burns Magazine; Volume 24, Issue 4, Pages 299-305
Publication: June 1998

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In the world of healthcare and medicine, consistency, reliability, and quality are highly appreciated. Doctors and hospitals follow national guidelines and procedures, striving to provide the best care for their patients and taking action to improve the dependability and the success rates of their services. Pharmaceutical and biotech companies must also adhere to predetermined standards by which they must formulate and manufacture their drugs. Likewise, assistive medical organizations, such as skin banks which harvest and store skin, have been recently forced to set high goals in regard to the quality of their ‘product’ or ‘service:’ the allocation and administration of skin for grafting.

In the June 1998 issue of the scientific journal, Burns, J.N. Kearney’s article, “Quality issues in skin banking: a review” explores the current, extensive checks and balances placed in the skin banking system to ensure the maintenance of safe and effective skin grafts. The article lends extensive insight into the depth and seriousness of the precautionary measures taken in the process of skin collecting and storage.

The history of tissue and skin banking standards is intriguing; up until as recently as 1993 in the USA, the government had created no national standards for the routine practices or upkeep protocol in an establishment such as a skin bank. By 1997, however, firm rules were set by organizations that met expressly to form those guidelines: the American Association of Tissue Banks (AATB) and the American Red Cross in the USA. The Food and Drug Administration also became involved in inspecting the banks, their records, and especially their methods for testing potential donors. Now that a standard system has been established, though, the 30-50 nationwide skin banks must adhere to a type of ‘quality framework’ in order to regulate administrative aspects such as staff education and the filing of records, as well as the medical aspects such as the thoroughness of donor testing and the consistency of environment for skin storage. Like major pharmaceutical companies, these skin banks must also adhere to GMP’s— Good Manufacturing Practices.

The article details the methods involved in testing for risk-factors such as cancer, HIV, Hepatitis B, and syphilis in both live and cadaver donors. The tests vary greatly in their process and target depending on the disease, and false results can often arise from the analysis of cadaver blood. The article also discusses the danger that lies in presence of bacteria and fungal flora on the grafted skin, and the sterilization techniques used to ensure successful disinfection. The skin must first be assessed for harmful bacteria, and then treated with an ‘antibiotic cocktail’ that is effective in removing abundances of microorganisms, but that will not eliminate the viability, or liveliness, of the skin cells. A distinction is clearly drawn between viable and non-viable skin samples; the viable skin can be expected to live and must be preserved using cryopreservation, while non-viable skin is non-living and is not stored with as much rigor. The viable skin grafts are stored in a cryoprotective agent, packed in sterile materials, and stored at a below-freezing temperature around -130 degrees Celsius. For non-viable skin, the goal is to remove the water during storage so as to avoid the degradation of the cells and tissue structure. To do this, either deep freezing or a process called lyophilization is used. The methods remove water from the skin cells to ice crystals and to the outer environment, respectively, in order to circumvent tissue breakdown.

But where did the impetus to create such a strict, regulatory system for tissue and skin banks arise? Published in 1993, Warren E. Leary’s article in the NYT, “US Moves to Regulate Tissue Transplant Industry,” effectively discusses the issues leading up to the tissue industry’s reforms. According to Leary, major attention was paid to the tissue banking system after 61 organs from a Virginian who happened to have HIV were distributed successfully to 40 different patients. When seven of the patients contracted the virus, there was an uproar; the government could see that the standardization of the system would be a necessity. Other issues due to improper shipment or handling of tissues before implantation arose regularly, further demonstrating the need for tighter controls on their harvesting, storing, and distribution. Soon after the publishing of this article, the four-year process of developing the rules and regulations for tissue and skin banks began.

“Quality issues in skin banking: a review” successfully illustrates and demonstrates the complexity of the skin banking system while making a point to emphasize the extreme nature of the guidelines forced upon these tissue establishments. However, further than the origin of the system’s reforms, another thing not adequately addressed by the review is effectiveness. Has the rate for bacterial or viral infection in patients with skin grafts decreased since the implementation of these rules? Have fever people contracted diseases due to less carelessness among skin graft harvesters and specialists? Are the national rules being effectively enforced? These are the most important questions to be asking, and yet, are not dealt with in this review or in any subsequent follow-up— in Burns, another major magazine, or a newspaper. Detailing the move toward a regimented, regulated system is certainly positive in terms of garnering awareness regarding the value of quality in the given medical area, but a report on the real outcome of this new set of standards would be even more revealing. As a patient should receive a follow-up appointment with her doctor after a major surgery or procedure, the medical community deserves a follow-up report to show the success of the major restructuring of the tissue bank system.

-JG