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A call for vigilance against device-related accidents at CEAI

by David Dennis, Contributing Reporter | August 25, 2016
Cardiology Medical Devices Risk Management

Only intricate analysis of the combination of human and technical factors could have brought that particular cause to light, and enabled all parties to work toward a long-term procedural solution.

In another case, an EKG machine provided two reports of a mild conduction defect and one of a heart attack. The family physician ignored the latter, and the patient died three days later from myocardial infarction.

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Deep comparative analysis of the three strips demonstrated that the algorithms of interpretive electrocardiographs can result in both false positives and negatives when measurements come in near their mathematically determined diagnostic threshold. Therefore, Fennigkoh asserted, clinicians should not rely exclusively on the machine interpretations of ECGs. They should always be read over by a cardiologist.

The death of an infant during a CPAP sleep study lead to a traumatic search for causes by heartbroken hospital staff, parents, as well as manufacturers. In the end, forensic investigation showed that there were no problems with the medical devices or their application. The infant had a congenital birth defect that likely contributed to an ill-fitting face mask that shifted and caused oxygen desaturation.

Eliminate the tendency to blame

Hazards to patient safety, according to Fennigkoh, are always a combination of inadvertent “holes” lining up despite a series of defenses erected by manufacturers, administrators, clinicians and engineers. The way to minimize them is to collaborate across all these tiers without a culture of mutual recrimination.

The lessons of these and other cases, he concluded, are to treat every adverse event, injury, and accidental death as a precious learning opportunity; to identify the active failures and latent conditions within the system that contributed the event; to break from the habit of managing the last error; and, above all, “eliminate the tendency to blame.”

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