|Trends & Perspectives|
IVD manufacturers have long wrestled with the challenge of producing consumer diagnostics that are increasingly sensitive and accurate, yet still safe and simple to operate. Recent FDA recalls of some blood glucose meter (BGM) models have renewed questions about how best to incorporate human factors engineering in consumer IVDs.
In October, Abbott Diabetes Care (Alameda, CA) began notifying healthcare professionals and registered users that the displayed unit of measure for meters sold under a dozen model and brand names could be inadvertently changed by patients from milligrams per deciliter to millimoles per liter. This could lead to a misinterpretation of test results and potentially life-threatening alterations in diet or insulin dosing. The company filed 17 medical device reports out of the 2.25 million users of its meters in the United States. In a news release issued at the end of October 2005, FDA also said it had received information about “several cases” of hyperglycemia, or abnormally high blood glucose concentration, that appeared in users of the meters.
The problem with Abbott Diabetes Care's meters comes on the heels of a similar measurement display issue with OneTouch blood glucose testing systems produced by LifeScan Inc. (Milpitas, CA). Between early 2004 and mid-March 2005, LifeScan received 40 reports of adverse events associated with the meters out of an estimated 4.7 million users. In April 2005, LifeScan notified patients worldwide of the problem.
In both cases, FDA signaled the potential severity of the problem by issuing Class I recalls of the affected meters. Although neither company's products were withdrawn from the market, the manufacturers did opt to take corrective actions. In April, LifeScan began locking the units of measurement in its BGMs specific to the country in which they are sold. Abbott Diabetes Care started such locking of its meters in October.
Thomas M. Tsakeris, president of Devices and Diagnostics Consulting Group Inc. (Rockville, MD) and former director of FDA's Division of Clinical Laboratory Devices, says that for the fast-growing BGM market, incidences of user error are hardly surprising. “Each new product design is directed at increasing portability, convenience, and rendering rapid test results while decreasing the pain and inconvenience of sample collection,” he says. “All of these attributes have a human factors dimension, so it is not surprising that some factors may be overlooked.”
Historically, says Tsakeris, BGMs have ranked highest among IVDs in consumer complaints, but he adds that this does not point to lapses in design. “I believe that BGM manufacturers are exerting heightened vigilance in detecting and responding to user-related errors more because of legal-liability concerns than concerns over any regulatory actions from FDA.”
Even so, the Center for Devices and Radiological Health (CDRH) has indicated that it is considering integrating greater human factors scrutiny into FDA's premarket process. Last June, at a conference sponsored by the Association for the Advancement of Medical Instrumentation (Arlington, VA), CDRH director Daniel Schultz, MD, spoke about the need to focus on user safety as consumer-use devices become increasingly complex. “Both healthcare providers and patients are using and programming smart devices,” he said, “and many of these products are being delivered to people outside of traditional environments who are not trained to use them.” Schultz urged manufacturers to take human factors engineering into account when considering risk management.
Steven Gutman, MD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety, agrees that in recent years FDA has been taking a different tack in assessing the potential for user error. “FDA does have a more sophisticated approach to addressing human factors than in the past,” he says, “and is keenly aware that well-designed and -labeled products can go a long way toward mitigating human factors risks.” He adds that the identification of unit-of-display problems with BGMs speaks to the strength of FDA's quality system regulations and corrective and preventive action requirements. In addition, FDA has hired new staff to handle human factors issues and continues its push to educate consumers, physicians, and manufacturers about avoiding user errors.
Despite these efforts, Gutman acknowledges that vigilance, though essential, cannot eliminate all human error, and that some error is inevitable. “Premarket studies provided to FDA represent snapshots in time but do not always perfectly predict the nuances of performance under the stress of widespread use in multiple patients at multiple sites,” he says. “For lab tests, I know of no example where the first report of the test didn't look different from the scaled-up widespread use of the test. This is true for all aspects of diagnostic performance, including elements of human factors performance.”
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