The verdict in both the U.S. and Europe is that the m. chimaera bacterium is present in heater-cooler devices used to optimize a patient’s body temperature during surgery – and as much as 70 percent of the resulting infections come from the Stockert 3T patient heater-cooler system.
However, nobody is certain how best to deal with the situation. Furthermore, the FDA is talking out both sides of its mouth: on one hand, it has updated its safety warning and recommending that hospitals “immediately remove from service any heater-cooler devices, accessories, tubing, and connectors that have tested positive for m.chimaera or have been associated with known m. chimaera patient infections” – but is also telling them not to have the devices tested for m. chinaera because of “technical challenges related to sample collection, the long culture time, and the high rate of false negative tests.”
Meanwhile, as many as half a million people have been exposed during open-heart surgery – and many of them may not even be aware of it. While m. chimaera, commonly found in the wild, poses little risk to healthy people, it can be deadly to those who are exposed during surgery and/or have a compromised immune system. The greatest danger of an m. chimaera infection is the incubation period: a patient may not present symptoms until months or even years after exposure.
One major problem is that removing a bacterial infestation from the Stockert 3T is virtually impossible. Simply cleaning the device has little effect, despite following the manufacturer’s recommended cleaning and disinfection methods. According to a study published last November by the Society for Healthcare Epidemiology of America (SHEA), any solution to the problem is going to pose serious challenges.
Dr. Rami Sommerstein, a surgeon at the University Hospital at Berne, Switzerland, says that one solution might be to raise the temperature – but this would threaten the surgical patient’s outcome. Another solution would be to construct an airtight, stainless steel containment housing for the device – but this would be expensive, complicated, and there would be no guarantee that it would eliminate the problem.
At the same time, there are tens of thousands Stockert units being used at hospitals throughout the world, leaving surgeons and hospitals with a decision to make. There are three potential ways to deal with the issue: first, take no action and wait to see if patients develop an infection, putting lives in danger and incurring serious liability. The second: remove Stockert 3T units from operating rooms, and purchase substitute devices that work as effectively but do not carry the same risk – something the profit generated medical profession has difficultly doing. The third way would be to inform the patient of the risks ahead of time and allow him/her to make the decision, which really no patient has the ability to do as they virtually always will defer to the treating doctor.
For now, hospitals are working to notify patients who may have been exposed to m. chimaera. Considering that more than 250,000 open-heart surgeries are performed in the U.S. every year and as many as 750,000 people may be at risk, it is a monumental task.