February 18, 2016 — A type of medical device recently linked to serious patient infections may have played a more significant role in a deadly hospital outbreak in South Carolina two years ago than health officials have acknowledged, according to new research.
Last October, U.S. health officials warned the public for the first time about the risk of this commonly used device transmitting deadly bacteria to patients.
Since that federal warning four months ago, three U.S. hospitals have publicly linked this same device — known as a heater-cooler device — to serious bacterial infections, including to at least five patient deaths following open-chest surgical procedures performed in the operating room.
Update (Nov 28, 2016): The CDC has told The Daily Beast that contamination of the Sorin 3T heater-cooler device used by Greenville Memorial Hospital (Greenville, SC) could have contributed to some of the hospital’s deadly mycobacterial infections. This outbreak was publicly disclosed in the summer of 2014.
Deadly bacterial outbreak in South Carolina, in 2014
Almost two years ago, in March 2014, a patient at Greenville Memorial Hospital (Greenville, SC) tested “positive” for Mycobacterium abscessus — an atypical type of bacteria.
Within two months, several more of Greenville Memorial’s patients became infected with the same organism. Most of the infected patients had undergone complex cardiac procedures.
By the summer of 2014, a total of 15 of the hospital’s patients had tested positive for M. abscessus — four of whom died. Officials of the hospital have acknowledged that the infection may have contributed to these deaths.
Greenville Memorial is managed by the Greenville Health System (“GHS”), a nonprofit institution also located in Greenville (SC) with five medical campuses and a variety of outpatient and specialty facilities.
“NTM”
A rapidly growing bug, M. abscessus is a type of bacteria called nontuberculous mycobacteria, or “NTM.”
Mycobacterium chimaera is another species of NTM that also has been recently linked to serious infections in patients who underwent complex cardiac procedures using a heater-cooler device.
But because M. chimaera is slow-growing, patients infected with it may not display symptoms, or even know they are infected, until months — or even years — after surgery.
Infection with NTM may cause a fever and pain, heat, redness, or pus around the surgical incision, among other symptoms. Because of NTM’s natural resistance to certain drugs, the successful treatment for infected patients may require several antibiotics.
Commonly found in soil and even in tap water, NTM are not transmitted from one patient to another. Further, these bacteria are called “opportunistic” because they generally only infect ill or immuno-compromised patients.
Confidential Safety Reviews: Click here to read about Dr. Muscarella’s quality and safety services committed to assisting manufacturers, hospitals and patients reduce the risk of healthcare-associated infections, including mycobacterial outbreaks linked to contaminated heater-cooler devices.
The originally implicated equipment
Three months after Greenville Memorial Hospital’s first patient tested positive for M. abscessus, the hospital removed from its operating room certain medical equipment that it suspected might be the source of the outbreak.
Two weeks later, on June 20, 2014, officials publicly implicated this equipment as a potential source of Greenville Memorial’s deadly NTM outbreak, according to a local news source.
This same news source quoted a hospital epidemiologist to say, “We believe there was a piece of equipment compromised in some way and it has been taken out of service.”
At about the same time, GHS published an update of its investigation, writing that “equipment used for cardiopulmonary perfusion was removed. … That machine used a closed system in which cooled or heated water encased in tubes is run in close proximity to patient blood (also encased in tubes) as part of a heating/cooling procedure.”
This equipment, or machine, is known as a heater-cooler device. It uses water to heat and cool the patient’s blood during complex cardiac procedures, including cardiopulmonary bypass surgery. (The hospital also removed an ice machine from the operating room that was used during cardiac surgery, as a precaution.)
To date, health officials have not publicly disclosed the heater-cooler device’s manufacturer or model, although, as of early 2016, published reports have linked only one model — the Sorin 3T Heater-Cooler — to NTM infections.
LivaNova PLC — formerly known as the Sorin Group — manufacturers about 85 – 90% of the heater-cooler devices used in the U.S. including the Sorin 3T model. The purchase price of one of these devices can be $35,000, or higher.
Once Greenville Memorial removed the heater-cooler device from use, no additional patients tested positive for the mycobacteria, according to hospital officials.
180 patients notified of NTM exposure
In response to this outbreak, officials of Greenville Memorial informed approximately 180 surgical patients, in June 2014, of their potential exposure to the potentially fatal M. abscessus.
More details about this hospital’s outbreak are discussed in a related article I published in 2014: “4th Patient Dies, 15 Infected at Greenville Memorial Hospital Likely Due to Contaminated Tap Water.”
As reported by the York-Dispatch last October, I had suggested at the time, in that 2014 article, that Greenville Memorial’s NTM infections might be a national concern and risk, with public-health implications that extended to U.S. hospitals outside of South Carolina.
Since Greenville Memorial’s outbreak became public more than a year-and-a-half ago, three other U.S. hospitals — one earlier this month — have publicly warned more than 5,000 patients of their potential exposure to NTM during open-heart surgery.
CDC and DHEC help in the investigation
The investigation of Greenville Memorial’s NTM outbreak in 2014 was assisted by both the federal Centers for Disease Control and Prevention (CDC) and the South Carolina Department of Health and Environmental Control (DHEC).
Following its investigation, the DHEC published several recommendations to prevent additional mycobacterial infections. The DHEC’s report hints to a heater-cooler device as being a possible source of Greenville Memorial’s outbreak.
The heater-cooler device is no longer suspected, said SC officials in 2014
Greenville Memorial’s outbreak in 2014 was the first publicized outbreak of NTM in the U.S. among patients who underwent complex cardiac procedures using a heater-cooler device.
But, just a month after having implicated this equipment as the possible source of Greenville Memorial’s deadly NTM outbreak, officials reversed course:
- One local news source reported on July 21, 2014 that: “Preliminary findings show that the infection, Mycobacterium abscessus, could not be traced to one piece of equipment or process as originally thought.“
- This same news report quoted Greenville Memorial to say that an independent analysis showed that equipment was not responsible for the hospital’s NTM outbreak.
- The next day, another local news source similarly reported that, by the end of July 2014 — four months after the hospital’s first patient became infected with NTM — “no specific process or piece of equipment has been identified as the source.” Instead, according to this report, “GHS says preliminary findings point to” the hospital’s tap water was the source of the outbreak.
- Three days later, on July 25, 2014, a third news article stated that: “Officials originally thought the source of the infection was a piece of equipment — an ice machine or a cardiac perfusion machine. But a preliminary investigation cleared them both, officials said.”
Revealing tests the CDC had performed while assisting in this outbreak investigation — tests that would determine whether Greenville Memorial’s heater-cooler device was, in fact, contaminated with M. abscessus at the time of its outbreak in the summer of 2014, linking the device to the infections — have not been made public … until now.
When asked by a news reporter more than a year later, in the fall of 2015, whether a heater-cooler device might have contributed to Greenville Memorial’s deadly NTM outbreak, a CDC epidemiologist was both curious and circumspect, seeming to be genuinely unaware of what the CDC already knew.
That said, “linking” a contaminated device to an outbreak does not confirm that the device “caused” the outbreak. Additional data would be necessary to more precisely define the device’s role in the infections. A heater-cooler device can be contaminated without necessarily transmitting the bacteria to the patient causing infection.
CDC’s mum about heater-cooler device’s link to outbreak
Disclosed herein for the first time, a spokesman for the South Carolina’s DHEC told me this week that health officials in 2014 had isolated bacteria from the heater-cooler device used by Greenville Memorial at the time of its outbreak that were “closely related to the clinical isolates (of M. abscessus) from the cardiac cases.”
Resolving some confusion, this association between the contaminated heater-cooler device and the 15 patients infected with M. abscessus might explain why officials originally implicated the equipment, in June 2014, as the outbreak’s possible source.
This DHEC representative further informed me this week that these laboratory test results linking the heater-cooler device to the infected patients were shared between experts at both the DHEC and CDC “during numerous conference calls.”
When I asked the CDC earlier this week to comment and confirm the DHEC’s statement that the CDC had found in 2014 Greenville Memorial’s heater-cooler device to be contaminated with the outbreak’s M. abscessus, it responded stoically and tritely, saying: “CDC was consulted about this outbreak, but the state and local public health authorities had the lead on the investigation, so any questions about this situation will have to be directed to them.”
Previously published accounts since July 2014 stated that Greenville Memorial’s heater-cooler device was tested and ruled out as a possible cause of the hospital’s outbreak, with these reports often adding that the hospital’s tap water (not any medical equipment) was the outbreak’s source.
Medical device reporting
My research identified additional corroborating data — which are presented herein for the first time — that might further explain why health officials had originally implicated medical equipment used by Greenville Memorial Hospital in June 2014 as a possible source of its NTM deadly outbreak.
For background, federal regulations require manufacturers to file a medical device report, also known as an “MDR,” with the FDA within 30 days of learning that one of their medical devices malfunctioned, or — more importantly — might have caused or contributed to a patient’s death or serious injury, including a healthcare-associated infection.
These same federal regulations apply, in part, to U.S. hospitals too, requiring each to notify both the FDA and the manufacturer within 10 days of learning of an association between a medical device and a patient’s death. This requirement is discussed in more detail in a January report by Senator Patty Murray (D-WA), who investigated the causes of several recent ‘superbug’ outbreaks linked to another type of contaminated medical device.
While researching Greenville Memorial’s outbreak for this article, I identified a MDR (medical device report) filed by a hospital on July 30, 2014, around the time that Greenville Memorial had been investigating its NTM outbreak.
This MDR states that the use of a specific heater-cooler device used during surgery was a common factor for many of the infections, noting further that 15 of the hospital’s patients had become infected with mycobacteria, four of whom expired.
This MDR identifies the device to be the Sorin 3T Heater-Cooler. As is customary, however, the report does not disclose the hospital’s name, only the manufacturer’s.
The content of this MDR, which associates the heater-cooler device with infection, is consistent with the information I was told by the DHEC that health officials had cultured Greenville Memorial heater-cooler device in the summer of 2014 and confirmed it to be contaminated with mycobacteria “closely related” to the outbreak’s M. abscessus.
This MDR’s details are also consistent with the publicly disclosed facts about Greenville Memorial’s NTM outbreak in 2014, which involved the same number of infected and expired patients — 15 and four, respectively.
Referring to Sorin’s 3T Heater-Cooler, this MDR states that, “The common denominator for the cardiac surgeries is the profusion (sic) machine. The machine has ben (sic) cultured and found to have the mycobacterium in the water.”
Despite a number of email exchanges between me and representatives of Greenville Memorial this week, the hospital did not respond to my request for confirmation that the hospital filed this specific MDR in 2014.
Nor did the hospital confirm (or deny) the DHEC representative’s claim that bacteria collected from a heater-cooler device at the time of its outbreak’s investigation, in 2014, were found to be closely related to the outbreak’s M. abscessus.
A second medical device report (MDR)
One week later, on August 6, 2014, another MDR was filed with the FDA, again documenting a deadly mycobacterial outbreak linked to the Sorin 3T Heater-Cooler.
Like the MDR from a week earlier, this second report states that: “The machine has been cultured and found to have the mycobacterium in the water.” This second MDR is likely describing the same NTM outbreak as the earlier filed MDR.
Whether these two MDRs, dated July 30, 2014, and August 6, 2014, were filed by Greenville Memorial could not be confirmed.
But, other than these two reports, no other MDR filed with the FDA in the summer of 2014 might reasonably describe Greenville Memorial’s publicized outbreak. (Greenville Memorial presumably would have filed a MDR in 2014 documenting its deadly outbreak to comply with federal regulations.)
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Manufacturer’s response
On October 24, 2014, Sorin (now LivaNova) filed an MDR with the FDA, describing an outbreak of NTM at a hospital where 15 patients were infected, four of whom expired.
This report is Sorin’s formal response (as the heater-cooler device’s manufacturer) to this outbreak, pursuant to federal regulations. I could not confirm whether the outbreak described in this report was Greenville Memorial’s.
Sorin’s MDR may be the first report the company filed with the FDA documenting the possibility that its 3T Heater-Cooler model used in the U.S. could pose a risk of transmitting mycobacteria to surgical patients.
A device “recall”
Nine months later, on July 15, 2015, Sorin issued a voluntary recall officially notifying U.S. customers of the potential for the 3T Heater-Cooler to become colonized with bacteria, including NTM, “if proper disinfection and maintenance is not performed per instructions for use.”
This recall did not require that the heater-cooler be removed from U.S. hospitals, only that users be more vigilant about its decontamination requirements.
Three months later, on October 15 2015, the FDA issued a safety alert warning hospitals, for the first time, about the documented association of heater-cooler devices with NTM infections. The CDC issued a similar safety communication two weeks later, on October 27, 2015.
Both the FDA and CDC’s October alerts discussing this infection risk were published more than a year after both Greenville Memorial’s deadly NTM outbreak.
Then, on December 29, 2015, the FDA warned LivaNova in a letter that the 3T Heater-Cooler model was both “adulterated” and “misbranded,” and “subject to refusal of admission” (or entry) into the U.S.
Other heater-cooler manufacturers, models
Although to date only the Sorin 3T Heater-Cooler has been directly linked to NTM infections and outbreaks, other manufacturers have acknowledged that their heater-cooler devices are also prone to contamination with these bacteria.
LivaNova PLC (the Sorin 3T’s manufacturer) holds a commanding 85-90% share of the U.S. market for heater-cooler devices. Manufacturers holding the remaining 10-15% of the competing market in the U.S. include Maquet (Germany) and Cincinnati Sub Zero (Cincinnati, OH). These two companies sell, respectively, the HCU 40 Heater-Cooler and the Hemotherm CE Heater-Cooler.
Outbreak implications, closing remarks
Based on the new data provided herein, a contaminated heater-cooler device may have played a more significant role in Greenville Memorial’s deadly NTM outbreak in 2014 than health officials have publicly acknowledged, to date.
The rationale for health officials to have originally implicated medical equipment as a potential source of Greenville Memorial’s NTM outbreak, only to rule out the equipment a few weeks later as playing a role, is not obvious. The hospital did not respond to my requests to confirm (or to deny) that the hospital’s heater-cooler device had been directly linked to its M. abscessus outbreak in 2014.
While published reports to date have only linked the Sorin 3T model to NTM infections and outbreaks, heater-cooler models sold in the U.S. by other manufacturers appear, too, to be prone to contamination with NTM. More emphasis by the FDA and manufacturers on validating the safety and effectiveness of a heater-cooler device’s decontamination procedure for the prevention of NTM transmissions, prior to the device’s marketing and sale in the U.S., is recommended.
Health officials investigating Greenville Memorial’s outbreak did not publicize at that time what would prove to be crucial corrective actions for the prevention of additional NTM outbreaks in patients undergoing open-chest surgery in the U.S. using a heater-cooler device.
For example, health officials did not publicly underscore in the summer of 2014 the importance of hospitals cleaning and disinfecting heater-cooler devices — advice the FDA and CDC finally stressed, but more than a year later, in October 2015.
One publicized corrective action that Greenville Memorial officials reportedly implemented in the summer of 2014, in response to its M. abscessus outbreak, was the installation of a new water filtration system on all of GHS’s campuses. The clinical extent to which this action significantly reduces the risk of NTM infections in open-chest surgery patients is unclear.
In closing, the more proactive federal oversight of medical devices that would more promptly inform the public about the potential risks associated with a specific device appears warranted.
Article by: Lawrence F Muscarella, PhD. Posted February 18, 2016. LFM Healthcare Solutions, LLC Copyright 2016. LFM Healthcare Solutions, LLC. All rights reserved. 0001
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E: Larry@LFM-HCS.com. Twitter: @MuskiePhD