The US Food and Drug Administration (FDA) issued a warning letter to medical device maker LivaNova (formerly Sorin Group) for inadequately validating and verifying certain processes intended to clean and disinfect the company's Heater Cooler 3T devices.
Because of the violations FDA says it is "taking steps to refuse entry" of devices made at LivaNova's Munich facility until the company addresses the violations. The agency also says that some of the changes in recent versions of the device's instructions for use (IFU) "are significant labeling changes that can affect the safety or effectiveness of the device, and therefore require a new 510(k)."
The device, which is used to control patient temperature during cardiothoracic surgery, has been associated with multiple infections and deaths from nontuberculous mycobacteria infections in patients who underwent heart surgery.
While heater coolers do not come into physical contact with patients, it is possible for water circulating in the device to become colonized by bacteria and aerosolized by its exhaust vent.
According to FDA, nontuberculous mycobacteria are common —found everywhere from soil to tap water—and generally do not pose a threat to humans, but in rare cases can cause deadly infections in sick or immunocompromised patients.
In October 2015, FDA issued a safety communication alerting healthcare providers to the risk of infection from these devices, providing recommendations to reduce those risks. FDA representative Deborah Kotz told Focus that the agency is maintaining those recommendations in light of the warning letter.
In August and September 2015, FDA inspectors visited two Sorin facilities in Munich, Germany and Arvada, Colorado.
Following the inspection of the Munich facility, FDA investigators issued Sorin a Form 483 detailing several violations. FDA addresses these violations, as well as Sorin's response dated 15 September 2015 in a warning letter dated 29 December 2015.
First, FDA says the company failed to validate several design change orders to the product's cleaning IFU issued in 2012 and 2015.
According to FDA, the company's 2012 design change order was inadequately validated, as the company did not document testing the cleaning IFU "under actual or simulated use conditions."
In July 2015, Sorin issued a Field Safety Notice instructing its customers to follow new disinfection and maintenance procedures in an updated cleaning IFU to reduce the risk of infection. Here, FDA says Sorin did not adequately verify or validate the new cleaning IFU, pointing to seven issues found in the test used to verify the new cleaning procedures.
Second, FDA says Sorin failed to validate a new process for disinfection and drying its 3T devices, noting that the company was missing documentation and did not provide technical parameters for several aspects of the disinfection process.
Third, investigators found issues with Sorin's medical device reporting (MDR) procedures, saying the procedures fail to "establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements [or] timely transmission of complete medical device reports.
LivaNova Press Release