The FDA’s regulation of blood establishment computer software (BECS) and BECS accessories has enhanced the safety of blood transfusion. In the 90’s the FDA found numerous problems with BECS software, including the potential release of infectious blood. Part of the problem was that as the programs added complexity, the software testing utilized by the software companies became inadequate. In response, CBER started regulating BECS with 510(k) premarket reviews in August 1996. We believe that the FDA’s regulation of BECS has been an important improvement.
However, it should be noted that the only national statistics we have to measure safety are based on a passive reporting system. Analysis of the CDC’s National Blood Collection and Utilization Survey in 2009 suggested that it underestimates the number of adverse events. One study showed a 30-fold increase in bedside transfusion errors using active tracking instead of the current passive tracking[i]. In addition, studies have shown that the number of near-misses is nearly 18 times higher than the number of adverse events. Human error is the cause of many of these near-misses and adverse events. Blood establishment computer software (BECS) and BECS accessories, meanwhile, have greatly reduced adverse events and near-misses.
With that in mind, we strongly support the FDA’s suggested special controls for BECS and BECS accessories. We would like to emphasize the importance of the verification, validation, and hazard analysis. We urge you to ensure that this should include substantial system security testing.
We are concerned that the special controls do not specify the need for validation at the user facility. Numerous studies have emphasized the importance of training and usability for the success of BECS. Unsurprisingly, it turns out that human error can overcome even the best automation. One example illustrates this well: a user hands over unlabeled specimen bottles to colleagues because he doesn’t understand how to print the labels. Another common example is when users override the system because the users doesn’t think it is correct.
The FDA itself has a Guidance to Industry entitled “Blood Establishment Computer System Validation in the User’s Facility” which suggests the agency realizes the importance of this sort of testing. We agree and urge you to recommend that the agency explicitly specify this type of validation testing in the special controls.
In summary, we recommend that the Advisory Panel vote to classify BECS and BECS accessories as Class 2 with well-designed and carefully monitored special controls. Validation in the user’s facility should be required as one of the special controls listed.