In 2014, medical device manufacturer Sorin and the FDA came under fire after news broke that a heater-cooler device for heart surgery was linked to infections. The FDA waited 14 months before issuing a public alert concerning the risks, leading many experts to question the FDA's oversight of medical devices, according to Kaiser Health News.
Here are eight key thoughts:
1. In 2002, Sorin's 3T heater-cooler device came under question when a German hospital physician found the device was rather difficult to disinfect. The physician published a study regarding the device and presenting the findings at a New Orleans conference. The provider said the device manufacturers "do not provide any technology to reduce bacterial or other contamination," KHN reports.
2. In 2011, the FDA toured Sorin's Munchen, Germany plant to assess the situation and safety concerns related to the device. However, a Sorin spokesperson said the company was not aware of the airborne mycobacteria threat associated with its device until a 2014 report from Swiss authorities. The news prompted Sorin to begin an investigation that year, with the company notifying hospitals in July 2014 that some of its heater-coolers may be contaminated and there is a risk of mycobacteria infecting cardiac patients.
3. The FDA began investigating Sorin halfway through 2014 after the FDA became aware of the alert Sorin sent to hospitals. The agency said it became aware of the mycobacteria risk in 2015 and "it came as a surprise to the healthcare community at large," said Suzanne Schwartz, an associate director at the FDA's center for regulating medical device, according to KHN.
4. The agency issued detailed recommendations in October 2016, nearly two years later, to hospital and patients about the devices. Some critics argue if the agency had issued a public alert and detailed recommendations sooner, many patients would not have been exposed to potentially fatal bacteria.
5. Many are questioning the FDA's timelines with the public alert. The FDA has said the heater-coolers are essential for patient care until an alterative hits the market. With pending lawsuits and watchdog groups voicing concern over patient safety, many hospitals are operating at a loss of how to proceed. Some have placed enclosures around machines while others are using sterile of filtered water.
6. London-based LivaNova purchased Sorin last year. A LivaNova spokesperson said the company is currently working with regulators on next steps that address their concerns while also providing physicians access to the device.
7. Ms. Schwartz referred to the Sorin case as an "evolving story" in which new information is coming to light due to ongoing studies and research efforts. She said, "It might seem to have taken a fair amount of time, but one of the challenges has been raising awareness in the healthcare community that this is a problem that needs to be addressed."
8. Michael Bell, MD, a CDC deputy director, told KHN, "I don't think we have a one-size-fits-all solution for this. The reality is this is a wakeup call for the design of many medical devices, especially those in critical places like the operating room."