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FDA Pens Warning to the Manufacturer of Devices Linked to Local Infections

Recently, thousands of patients in two local hospitals have been advised of outbreaks of NTM (non-tuberculous mycobacteria) infection in connection with heater-cooler devices used during cardiac surgeries.
On December 29, 2015, the Federal Drug Administration issued a Warning Letter to the manufacturer of the heater-cooler devices, LivaNova (formerly Sorin Group), advising the company of multiple, serious regulatory violations affecting the safety of the devices. The FDA Warning Letter can be accessed here.
The Letter states that the 3T heater-cooler devices were “adulterated” and “misbranded”, as defined under federal regulations. One particularly serious violation includes the failure of the company to demonstrate that its new “Instructions for Use”, issued after it received notice of complaints of patient deaths due to infection, would be effective in eliminating the risk of waterborne infection.
In a potentially critical finding, the FDA states that the device is adulterated because the company did not have an approved application for pre-market approval (510(k)) in effect at the time the devices were commercially distributed to consumers. Of note was the fact that the device includes significant labeling changes which required a separate 510(k) in order to be assured that appropriate testing and validation of cleaning and disinfecting protocols have taken place. Without this approval, the devices were not legally marketed.
As a result, the FDA advised the company that “the Heater Cooler 3T devices, and other devices manufactured by [its facility in Munchen, Germany] are subject to refusal of admission” and the “FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination” until the violations are corrected.
While the FDA’s action sounds alarming, even more disturbing is the fact that these devices may still be in use in U.S. Hospitals. If the heater cooler devices have not been legally marketed and pose a serious, recognized risk to patients because inadequate and untested disinfection and cleaning instructions were included with the device, why allow the continued operation of these devices? Isn’t it time to protect patients and issue a mandatory recall?