The Food and Drug Administration has issued a warning letter to LivaNova, a London-based medical device manufacturer, stating the company does not provide adequate cleaning information to prevent bacteria from accumulating inside its heater-cooler machines, which were linked to deaths at WellSpan York (Pa.) Hospital in October and Penn State Hershey Medical Center in November. Between the two hospitals, 3,600 patients were notified that they may be at risk from infections due to the devices.
The heater-cooler devices, used during open heart surgery to regulate temperature, never come into contact with patients. However, the machines are at risk of accumulating biofilm, which contains harmful bacteria that can be transmitted to patients through the air during surgery. Between Penn State Hershey Medical Center and WellSpan York Hospital, at least six deaths have been linked to the devices. In addition to finding the manufacturer-issued device-cleaning protocol to be ineffective, the FDA's investigation revealed the devices were misbranded and the company was operating without an approved application for pre-market approval.
"Given the serious nature of the violations … the FDA is taking steps to refuse entry of these devices in the U.S., known as 'detention without physical examination,' until these violations are corrected," the letter reads.
The FDA has demanded LivaNova to provide a written response detailing its plans to correct the numerous violations cited in the warning letter.