The Centers for Disease Control & Prevention, and the U.S. Food & Drug Administration, have been warning hospitals, medical centers, and doctors about contaminated heater-cooler devices used in cardiothoracic surgery. These devices appear to have left their manufacturing plant already contaminated with non-tuberculous mycobacteria (NTM), and a design defect is alleged to allow the bacteria to spread.
What are non-tuberculous mycobacteria?
NTM are slow-growing bacteria that are commonly found in soil and water samples. They are usually harmless, and most people will not be infected by these bacteria simply from touching the water or soil. However, when you develop an NTM infection which is goes undiagnosed and untreated, you could become very ill; in some cases, these bacteria have proven deadly.
How is the infection spreading?
The heater-cooler devices (HCDs) left their manufacturing plant in Germany already contaminated with bacteria, so the risk of infection already existed in any facility that uses Sorin/ Stöckert 3T HCDs. The bacteria incubate in the water, and then aerosolize through the exhaust system. Even in cases where the doctors have done everything correctly, patients were at risk.
However, the most likely reason is a lapse in protocol. Hospital acquired infections, also known as healthcare associated infections, are a significant problem in facilities throughout Kentucky and Ohio. The FDA had to issue a list of recommendations about how to properly sterilize the equipment and the rooms where these HCDs were used, which indicates that the bacteria are being spread from person to person. Since NTM normally do not spread in this way, there must be some kind of direct contact.
Signs and symptoms of non-tuberculous mycobacteria
Most NTM infections present with flu-like symptoms, including:
- Fatigue
- Fever
- Nausea
- Vomiting
- Night sweats
- Muscle pain
- Weight loss
Some people may also experience swelling and tenderness in their skin, and may see pus or discharge.
Why are doctors failing to diagnose NTM in patients?
NTM may incubate inside of a person for years before that person exhibits any symptoms. If you underwent surgery six years ago, and then go to the doctor for relief from what you think is the flu, that doctor may fail to diagnose the problem.
However, the CDC and FDA has been issuing safety warnings about possible contamination since 2015 – yet hospitals throughout Ohio and Kentucky are only now sending out letters that point to potential infection. It is worth asking what it took them so long to warn their patients that they could be harboring deadly bacteria.
At Crandall & Pera Law, we protect the rights of people who have sustained injuries or developed illnesses because of defective medical devices. If you or your loved one developed a potentially deadly infection after a procedure with a Sorin/ Stöckert 3T heater-cooler device, we want to help. To speak with a skilled medical negligence attorney, call our Kentucky team at 877-686-8879, our Ohio team at 877-686-8879, or fill out our contact form.