610-378-2000 610-378-2000

Contact Us

EMERGENCY: 911
General: 610-378-2000 610-378-2000  
Referral Specialist: 610-378-2001 610-378-2001  
Patient Advocate: 610-378-2675 610-378-2675  
Spiritual Care: 610-378-2297 610-378-2297  
Billing: 610-378-2350 610-378-2350

NTM Infection

For Patients

We are contacting approximately 500 patients who had an open-heart surgery procedure at Penn State Health St. Joseph in the past four years. While there have been no patients affected at Penn State Health St. Joseph, we have learned that the devices we use in open-heart surgery have been linked to a rare-but treatable-bacterial infection. We are making this patient contact at the suggestion of the CDC.

This type of bacteria is called Nontuberculous Mycobacteria, or NTM. NTM grows slowly and is commonly found in soil and water, including tap water. It is usually not harmful, but in some cases it can cause infections in patients who have had invasive health care procedures – such as open-heart surgery – and those who may have weakened immune systems.

We want to explain what occurred and reassure you that we will do as much as we can to answer your questions and address your concerns.

If you have any other questions or concerns about this matter beyond the information on this site or want to speak with someone about any additional health care evaluations you may need, please call 610-208-4770 and leave a message for Mari Driscoll, RN, CIC, Infection Control and Prevention at Penn State Health St. Joseph

For Medical Professionals

We want to provide medical professionals in our community updated information about our recommendations related to patients who had a specific type of cardiac surgery at Penn State Health St. Joseph in the past four years. As a reminder, the concern is related to a rare bacterial infection caused by non-tuberculous mycobacterium (NTM) that federal agencies believe is connected to a type of device-a heater-cooler-that is used throughout the country. Out of approximately 500 patients, we have had no confirmed cases but we are making this communication at the suggestion of the CDC

As we move forward, we plan to risk-stratify patients to determine the type of follow-up that is most appropriate for the potentially exposed patients. We developed this plan based on reports about NTM infection from the literature, consensus opinion of our Infectious Diseases physicians and communication with a European investigator experienced in treating similarly situated patients abroad. There are no current published guidelines on screening patients potentially exposed to NTM but who are asymptomatic.

About the Bacteria

NTM is a slow-growing organism that is commonly found in soil and water, including tap water sources. It is typically not harmful, but can occasionally lead to pulmonary disease, and uncommonly can cause infections in very debilitated or immunocompromised persons. While generally not further categorized beyond the NTM group, the specific bacteria identified was Mycobacterium chimaera, which is part of the Mycobacterium avium complex (MAC). It is treated with the same antibiotics that would be prescribed for any other MAC infection.

It is believed that the bacteria are linked to the heater-cooler devices used during open-heart surgeries. Federal health authorities are concerned that this issue may be widespread and have issued health advisories to hospitals around the country in an effort to alert them of this problem. On October 15, the U.S. Food and Drug Administration (FDA) issued a Safety Communication on this matter. In that communication, the FDA noted that the agency had received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination between January 2010 and August 2015, and 25 of those reports were provided to the FDA in 2015.

Recommendations for Providers

If your patient does not wish to be evaluated at Penn State Health St. Joseph, or if you have questions about this screening process, please feel free to call 610-208-4770 and leave a message for Mari Driscoll, RN, CIC, Infection Control and Prevention at Penn State Health St. Joseph

We will not charge patients for the cost of assessments or the tests ordered and provided by our providers or at our facilities to screen for NTM infection. If patients are unable or unwilling to receive these services from us, we will work with them to coordinate the necessary tests with their local providers. In those cases, we will reimburse providers for reasonable charges for tests and other services we have pre-approved

If you have a clinical question pertaining to one of your patients, or if you have a symptomatic patient who requires additional evaluation for potential NTM infection, please call 610-208-4770 and leave a message for Mari Driscoll, RN, CIC, Infection Control and Prevention at Penn State Health St. Joseph

 

Frequently Asked Questions

Why have you contacted patients?
We learned that heater/cooler technology used in the operating room during open-chest heart has been link to a rare—treatable—bacterial infection. We are following CDC direction to alert patients even though there have been no reported infections at Penn State Health St. Joseph.

How do you know when people were at risk for this infection?
The problem seems to be relatively recently recognized, based on reports to the FDA, so we are being cautious by going back four years. In addition, infections related to the heater-cooler units have become apparent within less than four years (usually months to 3 1/2 years), so if a patient had open-heart surgery more than four years ago, the infection should have shown up by then.

How many patients have been notified about this matter?
Penn State Health St. Joseph notified about 500 patients who underwent open-heart surgery within the past four years.

What type of bacterium is involved?
The bacterium is called Nontuberculous Mycobacteria, or NTM. It grows slowly and is commonly found in soil and water, including tap water. It is usually not harmful, but in some cases it can cause infections in patients who have weakened immune systems or underlying lung disease, and uncommonly in patients who have had invasive health care procedures – such as open-heart surgery.

How did this happen?
Penn State Hershey staff became concerned about a potential association with open-chest heart surgery in July 2015 after patients who underwent open-chest heart surgery at another hospital in our region were treated at our hospital for NTM infection. At about that same time, several other hospitals in Europe reported this same rare infection in open-heart surgery patients, and the manufacturer of a heater-cooler device used in open-heart surgery issued an alert about infections potentially arising from the use of the devices. Upon identifying these cases, coupled with this additional information, our Medical Center began a voluntary review of our own of heater-cooler devices used in open-heart surgery. We identified three cases of NTM infections in patients who underwent open-heart surgery at our Medical Center (out of more than 2,300 over four years).

What is a heater-cooler device and how is it be related to this problem?
A heater-cooler device is used during open-chest heart surgeries to warm or cool a patient’s blood as part of their usual surgical care. It is not on or touching the patient. There is a water reservoir inside the device. During use, some water evaporates and enters the air. The evaporation could make contact with a patient’s open wound during the procedure. Due to the recently recognized association of NTM infections with heater-cooler devices, we replaced our devices.

Is this an isolated or a widespread problem?
There have been similar infections documented in Europe. In the United States, Federal health agencies are concerned the heater-cooler device-associated NTM infections could be widespread. The agencies have issued recent advisories and safety warnings to hospitals across the country in an effort to alert them of the potential problem and prevent infections in other patients. With the recent identification of NTM infections potentially associated with heater-cooler devices in our region, we agree with federal health agencies that this problem may be prevalent but not yet be fully recognized in some healthcare facilities.

Are patients who had non-invasive heart procedures at risk?
No, the heater-cooler device is not used for procedures such as stents, pacemakers, defibrillators, ablations and transcatheter aortic valve replacements (TAVRs).

Is Penn State Hershey Medical Center able to perform open-heart surgery cases at this time?
Yes. We were able to quickly obtain new equipment and are performing surgeries using the new heater-cooler machines.

If my odds of having this infection are so low, why are you reaching out to patients?
While the chances of you getting this infection seem to be extremely low, we want you to know about this risk so that you and your provider can be aware of the signs and symptoms.

Why are you offering to evaluate patients?
Although the risk is very low, we are taking precautionary steps to ensure appropriate follow-up and care. To date, patients known to have developed an invasive NTM infection following heart surgery with an open chest at our hospital, other hospitals in the country and in Europe have undergone complex procedures like heart transplantation, heart valve reconstruction or surgeries involving the implantation of foreign material. This includes patients who have undergone surgeries for: tissue or mechanical heart valves, vascular grafts, left ventricular assist devices (LVADs), or total artificial heart devices. We recommend patients who had these types of surgeries be seen in our dedicated clinic.

Importantly, we are unaware that any patients have developed invasive NTM infections after undergoing less complex heart surgeries with an open chest but without placement of foreign material, as listed above. For this reason, we recommend that you or your loved one who may have had this type of surgery continue to be followed by your primary care provider. We are asking these providers to monitor their patients for any future concerns.

Will patients be billed for the evaluation described above?
No. We will not charge patients for the cost of clinic evaluations or tests that are ordered and performed by our providers or at our facilities to screen for NTM infection.

How serious is this problem?
Most patients will not develop an infection. But you should be aware of this possibility and let your provider know if you develop any symptoms (see next section).

What are the symptoms of an NTM infection?
Symptoms can vary quite a bit. They may be localized to a single site of the body or may be more widespread. Symptoms may include: pain, redness, heat or pus around a surgical incision; fever; night sweats; joint pain; muscle pain; weight loss; and fatigue. Usually there is a combination of symptoms. These symptoms are not specific for NTM and can be due to many other causes, but NTM should be considered if you had possible exposure from cardiac surgery and the cause of your symptoms is unexplained. NTM infection could take a long time to develop after potential exposure – from a few weeks up to several years. Therefore, those who may have been exposed to NTM should continue to look for symptoms and see their provider for further evaluation if any develop.

How is this infection detected?
Because NTM infection can have a delayed onset after surgery, and can present with many different types of symptoms, the infection can be challenging to accurately diagnose. Thus patients and their clinicians need to be alert to the possibility of NTM infection. If you have symptoms suggesting possible NTM infection and a source is suspected, then special testing can be done at the area of the body where the infection is suspected. NTM test results can take up to 4-6 weeks because the bacterium grows very slowly.

Is NTM infection contagious?
No. An NTM infection cannot be spread to your family and friends.

Do patients need to be regularly evaluated for possible NTM infection? You and your provider should be aware of the possibility of developing NTM infection for several years from the time of your open chest cardiac surgery. You should be evaluated if you develop any suggestive symptoms.

Can NTM infection be treated?
There are antibiotics available to treat NTM. Usually at least three antibiotics are prescribed for a prolonged period of time.

If a patient develops NTM infection and needs to be treated, will Penn State Hershey pay for the treatment costs?
Yes. If you are confirmed to have an NTM infection that is felt to be associated with your cardiac surgery, Penn State Health St. Joseph will provide you with the treatment necessary for the NTM infection.

If you have any other questions or concerns about this matter beyond the information on this site or want to speak with someone about any additional health care evaluations you may need, please call 610-208-4770 and leave a message for Mari Driscoll, RN, CIC, Infection Control and Prevention at Penn State Health St. Joseph