Surgical Heating, Cooling Devices Linked To Infection Problems: FDA

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Federal regulators warn that some heating and cooling devices used to regulate body temperatures during surgery may increase the risk of Nontuberculous Mycobacteria (NTM) infections, especially following heart surgery. 

The FDA issued a safety communication on October 15, indicating that a large number of adverse event reports have been received involving problems with surgical heating/cooling devices.

No specific products were mentioned, as the FDA warning applies to all devices providing heated and/or cooled water to oxygenator heat exchangers, cardioplegia (paralysis of the heart) heat exchangers and warming/cooling blankets. These devices are used during cardiothracic surgeries and other medical procedures to warm or cool patients, and include a water tank that provides temperature-controlled water to the devices.

According to the agency, at least 32 medical device reports have been received involving patient infections or bacterial device contamination linked to surgical heater-cooler devices between January 2010 and August 2015.

About half of the cases were just reports of bacterial contamination with no known infected patients. However, 25 of those reports came from just this year. Only eight of the reports came from the U.S, associated with three events describing patient infections. The rest came from mostly western Europe.

Nontuberculous Mycobacteria (NTM) infections are usually harmless, but the FDA reports that in rare cases they can cause infections. The most common NTM infection appears as pulmonary disease, which is linked to at least 150,000 patients in the U.S. every year. However, it can also affect the lymphatic system, skin and soft tissues as well.

These infections typically only known to be acquired by environmental means, as there are no known cases of it being transmitted from one human to another or from an animal to a human.

It is unclear how many of these infections the devices have actually caused. The FDA noted that some cases of patient infection were linked back to devices used on them several months to years after their infections.

“It is possible that some cases have not been reported to the FDA. It is challenging for a health care facility, health care provider, manufacturer, or patient to recognize that infections, particularly NTM infections, may be associated with the use or exposure to a particular medical device,” the FDA warning notes. “The FDA continues to evaluate reports through follow up with health care facilities and manufacturers to determine which factors may have contributed to the reported events.”

The agency theorizes that while the water in the tanks is the most likely source of the NTM bacteria, which can inhabit tap water.

While that water never comes in direct contact with the patients, there is a chance that it enters other parts of the device, and that the bacteria is blown out into the air through the device’s exhaust vent, potentially infecting the patient through the surgical wound site. There have been no known cases of hospital staff infection.

The FDA issued a number of recommendations to help prevent the infections, such as not using tap water to rinse, fill or top off the water tanks, and instead using sterile water in both the tanks and in making any ice used. The agency also recommends directing exhaust vents away from the surgical field, establishing regular cleaning and maintenance schedules for the heater-cooler units, and immediately removing from service any that show discoloration or cloudiness in the fluid lines or circuits.

Hip and Knee Surgery Warming Device Infections

The FDA statement about water-based heating and cooling devices comes amid increasing concerns among consumers about an infection risk with forced-air surgical warming devices used during hip and knee surgery, such as the Bair Hugger warming blankets.

Unlike the devices involved in this recent FDA warning, Bair Hugger warming blankets involve the use of forced air, not water, to control body temperature during surgery. However, some patients have indicated that they developed severe infections following use of the forced air warming blanket during hip or knee surgery.

While the FDA has not issued any statements involving the safety of the Bair Hugger, a growing number of hip surgery infection lawsuits and knee surgery infection lawsuits have been filed in recent months, alleging that the use of the forced air system disrupts the laminar flow of the operating room, allowing bacteria and other contaminants from the floor to enter the surgical site.

Plaintiffs point to studies that indicate use of forced air warming blankets may be associated with substantial increases in the number of particles in the air near a surgical wound and higher rates of knee or hip sepsis infections following joint replacement surgery.

There are more than 50,000 Bair Hugger warming blankets in hospitals nationwide, and the devices have been used on millions of patients. The lawsuits claim that the manufacturer has known about the hip and knee surgical infection risk for years, yet failed to make design changes or provide warnings to the medical community.

As hip and knee infection lawyers continue to review cases for individuals who have experienced problems following surgery where a Bair Hugger was used, it is ultimately expected that several hundred cases will be filed against 3M in courts throughout the country.

In August, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to consolidate all Bair Hugger lawsuits pending throughout the federal court system, indicating that centralized management before one judge is necessary to reduce duplicative discovery, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the courts.

UPDATE NOVEMBER 5, 2015: This article was updated and revised to add further clarification that the Bair Hugger forced-air warming device was not part of the FDA safety communication issued on October 15. This related background information is included to provide details surrounding infection lawsuits linked to this different type of surgical warming device.

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