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Defective medical devices may escape FDA notice

A device used to regulate the temperature of patients undergoing heart surgeries has been tied to numerous infections and a dozen deaths in the U.S. alone. The Food and Drug Administration's slow reaction to the problem demonstrates a gap in the way safety regulators evaluate medical devices for defects. Infections are a well-known problem in hospitals and may be treated as a general or background problem because of their frequency. Medical devices can be defective in ways not connected to the immediate purpose they serve. A device that facilitates an infection is defective, even if it operates in the way it was intended.

Caught off guard

The FDA admitted that it was surprised by the nature of the threat posed by the Sorin heater-cooler devices. It received reports of infections tied to the device as early as 2009, but failed to launch an investigation until 2014. Countless procedures occurred in the interim, and an untold number of infections likely resulted. The FDA has defended its response to the threat, but critics suggest it is part of a larger problem in the way regulators and hospitals regard infections. If the device failed in some other way, the response likely would have been faster and more decisive. 

Healthcare-associated infections

Hospitals are well aware of the problem of healthcare-associated infections (HAIs). The U.S. Centers for Disease Control and Prevention estimated that 721,800 HAIs occurred in acute care hospitals in the United States in 2011. Since then, efforts to contain the problem have seen mixed results. Some facilities take the problem more seriously than others and progress has been slow.

With so many patients suffering from HAIs, it is easy to ignore a connection between a defective device and this particular outcome. The FDA eventually connected the Sorin device to a particular strain mycobacteria rare enough to make the connection. In most cases, the source of an infection is never discovered. Post-surgical infections are treated as an unfortunate, but unavoidable complication of operating. The FDA would be wise to avoid that presumption and remain open to the possibility that other devices could pose a similar threat of infection.

Source: MedCity News, "Infection-related deaths expose deficiencies in FDA oversight of medical devices" by Chad Terhune and Christina Jewett, 29 November 2016 

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