What we know: NTM bacterial infection outbreak

Since WellSpan first alerted 1,300 York Hospital open-heart surgery patients in October of increased risk of bacterial infections, the story has evolved.

David Weissman
WellSpan York Hospital. (Bill Kalina - bkalina@yorkdispatch.com)

The York Dispatch and other local media outlets have been covering a local bacterial infection outbreak since WellSpan first announced its discovery of affected and potentially affected York Hospital patients on Oct. 26. Here's what we know so far:

The infection: What is it and who's affected?

— On Oct. 26, WellSpan sent letters to 1,300 patients who had open-heart surgery at York Hospital between Oct. 1, 2011, and July 24, 2015, alerting them of possible exposure to Nontuberculous mycobacteria, or NTM, according to a company press release.

— At the time of the release, WellSpan had identified eight patients with an NTM infection, four of whom had died. One additional infected patient has since died.

— NTM, often found in tap water and dirt, is typically not harmful, but can cause infections in patients who have had invasive healthcare procedures, especially in people with weakened immune systems.

— NTM is a slow-growing organism and can take several months to develop into an infection and years before it is correctly diagnosed.

— The vague symptoms of an NTM infection make the infection particularly difficult to diagnose, according to state Department of Health officials. Symptoms include: fever, weight loss, back aches, pus at the site of incision, cough, lack of appetite, night sweats and loss of energy.

— On Nov. 10, Penn State Milton S. Hershey Medical Center began alerting approximately 2,300 patients who had open-heart surgery at the center between Nov. 5, 2011, and Nov. 5, 2015, of possible NTM exposure. The hospital has identified three infected patients, two of whom have died.

The device: What is causing these infections and how was this discovered?

A heater-cooler device at York Hospital, Monday, Oct. 26, 2015, might have caused infections in 10 of York Hospital's open-heart surgery patients. Bill Kalina - bkalina@yorkdispatch.com

—  According to WellSpan's release, the infections have been linked to a heater-cooler device used during open-heart surgeries. The device is intended to provide temperature-controlled water to heat exchanger devices used

during open-heart surgeries lasting six hours or less. It has no direct contact with the patient during surgery.

— WellSpan launched a joint investigation into the device in July with the state Department of Health and Centers for Disease Control and Prevention after a series of events, including the manufacturer of the device significantly changing its cleaning and disinfection procedures, notification of a report linking infections to the device in Europe, and Hershey Med alerting York Hospital officials that it was treating three patients with the rare NTM infection who had open-heart surgery at York Hospital.

— According to the U.S. Food and Drug Administration, there is the potential for contaminated water to enter other parts of the device or transmit airborne bacteria through the device's exhaust vent into the environment and to the patient.

— The department ordered York Hospital to replace its devices in July, at the start of the investigation. It ordered Heshey Med to replace its devices in November, after receiving confirmation that the hospital had identified open-heart surgery patients with the infection.

— During its investigation, the CDC was able to find evidence of the bacteria in York Hospital's devices. Hershey Med has not yet found evidence of the bacteria in its devices, but it did not work directly with the CDC, and its investigation is ongoing.

— Sorin Group, the German-based manufacturer of the device linked to all the infections thus far, issued a Field Safety Notice in June to its customers alerting them of the potential risks and updated cleaning and disinfection procedures. The original process was about six steps, according to WellSpan spoeksman Brett Marcy. The new process, posted in a video on Sorin's website, is 56 steps.

— Sorin owns about 85 percent to 90 percent of the market share on the heater-cooler devices in the U.S., according to Dr. Carol Freer, Hershey Med's chief medical officer.

The hospitals: Why have only two central Pennsylvania hospitals been able to identify this issue in the U.S.?

— WellSpan admitted in its press release that an internal investigation revealed York Hospital had not been completely following the manufacturer's original cleaning procedures for the heater-cooler devices. Freer did not know whether Hershey Med was completely following cleaning protocols prior to August, when the hospital began testing its devices.

— Sorin claims it sent an "Important Information" letter to its customers in July 2014 alerting them of the newly identified infection risk and reminding them of the importance of following its cleaning and disinfection procedures. WellSpan officials have been unable to confirm receipt of this letter.

— While trying to locate the letter, WellSpan learned that in August 2014 York Hospital had received a bulletin via a third-party notification system that contained information about possible issues with the machine, but the bulletin was not fully shared throughout the WellSpan organization. The infected patient who died in November was operated on at York Hospital in December 2014.

— WellSpan and Hershey Med are both strictly adhering to Sorin's updated cleaning procedures, according to the companies. York Hospital has documented proof of staff training on the new procedures and a system of checklists to ensure each step is followed, according to spokesman Brett Marcy.

A similar case of NTM infections was investigated beginning in May 2014 at Greenville Memorial Hospital in South Carolina, where 15 patients were infected, four of whom died. The CDC was involved off-site in the investigation but wasn't able to test the hospital's heater-cooler devices. The investigation resulted in the hospital removing any source of tap water used in the surgical environment, including the heater-cooler devices.

The governing bodies: Who regulates these devices and what are they doing about this issue?

— The FDA has the authority under the Federal Food, Drug, and Cosmetic Act to regulate certain heater-cooler devices, including Sorin's, as Class II medical devices, according to spokeswoman Deborah Kotz.

— The FDA groups medical devices into Class I, II, or III, with Class I being considered low-risk and Class III being considered high-risk. Only Class III devices are subject to Premarket Approval, which includes an in-depth scientific review process by the FDA's Center for Devices and Radiological Health.

— Manufacturers of Class II devices, which include heater-cooler devices and condoms, just need to submit a Premarket Notification, which the FDA must clear before the devices can be marketed. Successful Premarket Notification applications are contingent on the manufacturer providing proof of substantial equivalence to a device that's already been approved by the FDA. These are referred to as predicate devices.

— According to Premarket Notifications available on the FDA's website, heater-cooler devices, and other Controller, Temperature, Cardiopulmonary Bypass devices, date back to 1981 and have always been Class II devices, meaning they were never subject to Premarket Approval. In an email, Kotz wrote that the heater-cooler devices are considered lower risk because they do not come into direct contact with the patient, but she could not identify the predicate device that would've been needed for Premarket Notification clearance on the first heater-cooler device.

— According to Kotz, the first such device must have used a predicate device "grandfathered in" via the Medical Device Amendments of 1976, at which time a Classification Panel reviewed all existing devices and recommended each into Class I, II or III based on risk assessments.

— The FDA, state Department of Health and CDC each posted alerts in October urging health care facilities to be aware of the potential issue and follow updated manufacturer cleaning procedures.

— The FDA is allowing hospitals to continue using the device, but is still working with manufacturers to review its updated protocol. Sorin has been working with the FDA on this investigation since 2014.

— Kotz's statement on why the FDA is electing not to remove the devices from use until further review can be completed: "Heater cooler units are important medical devices used to regulate body temperature during certain types of surgical procedures, such as cardiac bypass procedures, heart valve replacements or heart transplants. Removal of these devices from hospitals could potentially result in delaying treatment of patients who have critical conditions requiring life-saving surgery. We believe the benefits these devices provide outweigh the risk of infection."

— The state Department of Health is asking all Pennsylvania hospitals that perform open-heart surgeries and use heater-cooler devices to review their records to try to identify any patients who might have been infected with NTM during surgery.

— York Hospital has been assured by the department that the devices are safe to use with the updated manufacturer procedures, according to Marcy. The department is directly reaching out to all potentially affected health care facilities to make sure they're aware of the updated procedures, according to spokeswoman Amy Worden.

— In an email, Worden wrote that department does not validate manufacturers' instructions for use, but it's working with the CDC and FDA on this issue, and determined that the updated procedures currently represent best practice and should be strictly adhered to.

— Worden also wrote that, though risk estimates are currently imprecise, NTM infections appear to occur very infrequently and available information on the outbreaks locally and in Europe suggest patients and providers should not delay cardiac surgeries after informed consent.

The affected: Where do infected and potentially infected patients (and their families) go from here?

— Patients who received York Hospital's or Hershey Med's letter are urged to alert their primary care physicians of the potential infection and closely monitor their health for potential symptoms.

— WellSpan set up a nurse's call center at (866) 217-2970 and a website at http://www.wellspan.org/yorkopenheart for patient questions or concerns. Hershey Med has done the same at 1-877-467-7484 and http://www.pennstatehershey.org/web/guest/patientcare/open-heart. WellSpan has also offered to completely cover any medical costs associated with the infection for patients who are determined to have contracted it during surgery, and recently transitioned from the call center to a dedicated nurse navigator to work with patients and their primary care physicians.

— Several local attorneys have been advertising in association with the infections, potentially looking into pursuing medical malpractice lawsuits. April Strang-Kutay, a medical malpractice attorney in Lancaster for Goldberg Katzman, said attorneys must look at each individual case, but ultimately, even if negligence is established, you have to establish measurable damages, which can prove difficult because patients undergoing open-heart surgeries likely already suffered from serious medical issues.

— John Elmer Bosley, of Red Lion, filed a notice of medical negligence claim in November against York Hospital in connection with the infections. Bosley, who had open-heart surgery there during Nov. 2013, was not one of the eight patients WellSpan originally identified with the infection. Bosley's case is still in the early stages of litigation as medical records are reviewed to determine probable cause, according to his attorney Donald Reihart.

Reach David Weissman at dweissman@yorkdispatch.com.