Accordingly, the individuals and departments that respond to those orders for blood products are working within one of the most tightly regulated sectors in health care (or any other field, for that matter). The FDA is charged with ensuring the overall safety and efficacy of blood products, but The Joint Commission, the American Association of Blood Banks, and the College of American Pathologists are also among the entities imposing regulations and accreditation standards on blood use.

Compliance can be burdensome, but seems justifiable when one considers the number of variables—and, therefore, risks of error—that are involved in providing blood products to patients. Donors must be screened to reduce the likelihood of transmitting diseases for which blood is not (or cannot yet be) directly tested. Tissue matching must demonstrate the compatibility of the donation and its intended recipient, and the blood’s freedom from pathogens or adulterants must be ensured.

The donated blood must be separated into the necessary components and transferred to appropriate storage that keeps each part within its individual range of acceptable temperatures and elapsed times, since either heat or excess age will render the blood products useless. When the time arrives for administration to a patient, foolproof identification and documentation are required.

Throughout these operations, the information systems tracking the path of the donated blood must be up to date at all times so that it will be possible to trace blood products back to their donor and to review every step of that donation’s handling, in perpetuity.

Coping with Risk

Even more daunting than the high complexity of this handling sequence is the gravity of mistakes in this arena, since donor–patient mismatches and pathogen transmission can both, in worst-case scenarios, be fatal. Likewise, exposing workers to blood-borne pathogens can result in serious disease or death.

This high level of risk has historically driven innovation in blood-banking technology, and this continues to be true. Research into more efficient tissue-matching methods and systems is ongoing, and pathogen detection is an area of particularly vigorous work. Whenever a new blood-borne disease reaches a human population of significant size, a means of testing blood for that pathogen will soon be in development. While it may not be feasible to test all donated blood for the newly recognized pathogen, for economic and practical reasons, the ability to test donations in certain disease-affected regions or from target populations will remain in the arsenal of infection control, taking over for screening questions, when and where the changeover is warranted by the size and type of problem.

Economic concerns are also behind product development in blood banking, since the reimbursement available for the use of blood products is often low. For example, Medicare patients receive the majority of red-cell transfusions in the United States, but the level of Medicare payment is, by some estimates, too low to cover the total cost of transfusion. Blood banks, in response, must make the most of their staff time and supply budgets; product development has focused on reducing the cost of consumables and helping personnel work more efficiently.

As the survey that follows shows, manufacturers are certainly not neglecting the needs of any organization that handles blood. New products continue to be introduced, and existing ones continue to be refined, despite the limited budgets that blood-handling organizations may have available for both capital and consumable purchases.

Companies serving this market, survey answers indicate, are focusing on helping buyers use existing resources as well as possible, whether those scarce resources are considered in terms of money or staff time. In addition, survey respondents are helping organizations meet an obligation increasingly defined, in the public-health literature, as stewardship: taking care of the natural resource that is the supply of human blood.

Software and Automation

Of course, pressures to accomplish more with fewer resources are common throughout health care. Unique to blood banking, though, is the requirement that software used in blood handling have 510(k) approval from the FDA, just as a medical device would. This regulation, a legacy of the early years of the AIDS pandemic, has kept many of the software giants that are active in other areas of health care from approaching the blood-related market.

There have been some advantages, since the software suppliers working in this field have ensured that their products do precisely what their users require, instead of expecting them to adapt generic solutions to meet their needs. On the other hand, however, this exclusivity has made it more difficult for some blood-related systems to interface readily (and inexpensively) with larger laboratory and hospital information systems. There is speculation that involving more software companies in blood banking might bring down software costs through competition.

For this reason, the FDA convened its first conference to address changes in the regulation of blood-banking software in 2008. Bringing together representatives of blood banks, regulatory agencies, and software companies, the meeting was seen as a possible step toward relaxing the FDA’s software requirements. Action is still pending, but many attendees favored less regulation in this area, so it may become possible to improve standardization and reduce software costs for blood banking, perhaps replacing the custom-made nature of many software solutions with off-the-shelf alternatives.

If software regulation is reduced, a helpful side effect could be the improvement of automation capabilities in blood handling. At least to some extent, the difficulty of interfacing proprietary blood-handling software with laboratory automation systems has been blamed for slow growth in this area. While completely automated blood-handling systems do exist, they tend to be isolated, stand-alone products that may not communicate fully with other systems and data repositories. This leads to the creation of information silos, which are both inefficient and difficult to maintain.

In some organizations, such insular information systems are no longer permitted to exist and can never gain capital-budget approval, so many blood-banking operations are still relying on time-tested manual methods. Fortunately, manufacturers understand the problems that software regulation has created, and many have responded by making their manual systems as efficient as possible. Another approach has been the adoption of semiautomated systems. These perform routine and repetitive steps (such as decapping and recapping tubes) with neither human intervention nor connection to a full automation-control system, allowing the laboratory to improve safety and conserve staff time without the need for a costly interface.

2009 and Beyond

Whatever future innovations can be recruited to improve efficiency in blood banking will be welcome in this hard-pressed industry. The good news is that the number of units of blood donated in the United States appears to be increasing, perhaps by as much as 2% to 3% per year. Unfortunately, this increase is more than offset by additional demand for blood products, often attributed to the growing elderly population (which is more likely to require transfusion because of the higher incidence of surgery and cancer chemotherapy in this group). The need for blood may be increasing by as much as 6% to 8% per year.

To monitor news in blood banking products, watch our website.

Several times, in recent years, it has appeared that blood substitutes were nearing approval for clinical use, perhaps with the potential of taking some of the strain off the blood-banking system. Volume expanders have proven useful and are widely used, but the routine use of oxygen-carrying replacements for human blood has been approved, to date, only in Mexico and South Africa. Several products are still in development, but they must overcome their common flaw, which halted clinical trials of one promising blood substitute in the United States: they scavenge the body’s nitric oxide, creating vasoconstriction and, as a result, a rate of death that is about one-fourth to one-third higher than would be expected for conventional transfusion.

At least for the near future, we must continue to rely on the individuals who donate blood, the technologies that help us process and handle it effectively, and the personnel who dedicate themselves to seeing that the patients who need it are both saved in the short term and safe in the long term.

Kris Kyes is technical editor of CLP.