Reports to FDA reveal widespread device infection issue
WellSpan York Hospital is one of just a handful of health care facilities to publicly acknowledge that a device it uses during open-heart surgeries may have put patients at increased risk of a potentially deadly infection.
But reports filed to the U.S. Food and Drug Administration indicate the issue is widespread.
The FDA held a two-day panel in June to discuss heater-cooler devices, which have been linked to bacterial infections — known as nontuberculous mycobacteria, or NTM — found in patients at hospitals in Pennsylvania and Iowa.
Experts across the medical field have agreed these devices are critical to patient care, but transcripts from the FDA panel show disagreement on when, or if, patients should be notified of a potential risk.
Prior to the panel, the devices had been publicly linked to 16 infections and nine deaths at York Hospital, Penn State Milton S. Hershey Medical Center and University of Iowa Hospitals and Clinics.
Mercy Medical Center, in Des Moines, Iowa, has since identified two such infections at the facility, according to its website. And earlier this month, Penn Presbyterian Medical Center sent a letter to patients that it had identified four such infections.
At the panel, a presentation revealed the FDA has actually received Adverse Medical Device Reports related to heater-cooler devices from 16 facilities in 10 U.S. states since 2010.
These reports are available through a searchable database on the FDA's website, but incident locations, even the name of the state, are redacted.
The York Dispatch filed an open-records request and found that facilities in seven states other than Pennsylvania and Iowa have reported their heater-cooler devices tested positive for mycobacteria.
The reports: The majority of reports from seven states — Michigan, North Carolina, Georgia, South Carolina, Texas, Washington and Kentucky — were submitted after York Hospital's investigation last October led to advisories from the FDA and Centers for Disease Control and Prevention, and detailed that no patient infections resulted from the contaminated heater-cooler devices.
The exceptions are reports from facilities in South Carolina and Michigan.
Multiple reports from South Carolina note that 15 patients who underwent surgery were diagnosed with mycobacterium infections, and four have died.
The details and event date listed on the report, May 21, 2014, match up with a cluster of patient infections announced at Greenville Memorial Hospital.
According to a Greenville Health System news release, the heater-cooler device was never specifically implicated in the infections, but the devices were temporarily removed for precaution.
The report to the FDA does state that the device tested positive for bacteria, and at least one of those 15 patients infected has filed a lawsuit against Sorin, the manufacturer of the device.
A report from Michigan, sent last October, states that all seven of its heater-cooler devices were found contaminated with mycobacterium.
The reports released to The York Dispatch redact user facility names, but a Spectrum Health System spokesman confirmed the Michigan report is related to Spectrum Health Medical Center in Grand Rapids.
At the time of the report, no infections had been identified, but spokesman Bruce Rossman said two patients have since been diagnosed with NTM infections. Both patients are alive and going through treatment.
Following in the footsteps of York Hospital, Spectrum Health sent notifications to its patients who had undergone cardiac surgery dating back to Jan. 1, 2012, but Rossman declined to provide the number of patients that included.
Unlike York Hospital, Spectrum Health did not publicly disclose the issue, and Rossman confirmed that a phone call from The York Dispatch is the first media inquiry the company has received regarding the infections.
Rossman said the company's "first and foremost concern was getting information to patients potentially exposed" because NTM — a slow-growing organism often found in tap water or dirt that can take several months or years to turn into an infection — can "go unnoticed for years."
"It's just the nature of the infection," Rossman said. "It was the right thing to do (to notify patients)."
Patient notification: The FDA panel, however, concluded that patient notification was not a priority, noting in its summary of the conference that the panel did not recommend notifying all potentially exposed patients, even if a patient was identified with an NTM infection.
"The panel was more receptive to recommending notification of all patients at a facility if more than one patient infection has been identified," the summary states.
Transcripts from the conference reveal that high costs was one reason discussed as a deterrent to patient notification.
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Jeff Miller, a representative from the Pennsylvania Department of Health, told panelists at the conference that the total costs of patient notification, clinical and lab tests, and surveillance was about $1.6 million, according to transcripts.
"I'm a little loath to make a recommendation that's going to cost a hospital a million and a half dollars based on one case," panelist Dr. Richard Hopkins, a Kansas City cardiac surgeon, said in the transcript.
WellSpan and the state health department would not confirm whether the figure relates to York Hospital.
That figure does not include lawsuits, though York Hospital and Sorin have been named in five lawsuits relating to the infections, according to documents filed in the York County Court of Common Pleas. Each suit seeks "an amount in excess of $50,000."
Avoiding panic among patients was another reason discussed among panelists.
"I think if you can identify the machine and you have more accuracy to be able to do it, then you would do it," panelist Dr. Colleen Gallagher, an ethicist, said in the transcript. "But if you don't have that kind of accuracy, you scare an awful lot of people needlessly."
Charla Acker, a Gettysburg woman whose husband was one of about 1,300 York Hospital patients to receive notification about the infection risk, scoffed at the notion of health care officials wanting to protect patients from needless panic.
Fear of her husband contracting the infection has been "devastating to live with," she said, but she's still glad she knows about it so she can be on alert.
Symptoms of the infection include: fever, weight loss, back aches, pus at the site of incision, cough, lack of appetite, night sweats and loss of energy, according to the CDC.
"If he woke up with night sweats before, I'd probably ignore it," Acker said, noting that her husband is being tested four times per year. "Now I'm more aware. It makes a big difference."
Not all panelists at the FDA conference necessarily agreed with the final recommendation regarding patient notification.
Dr. Larry Givner, an infectious disease professor at Wake Forest, told the panelists he thinks all patients who have cardiac surgery with a heater-cooler device should be notified of the risk, and Dr. Jonathan Zenilman, an infectious disease physician at Johns Hopkins, said a case could be made "that one case is an outbreak."
Dr. Joseph Falkinham, a microbiologist at Virginia Tech, has been working with two heater-cooler manufacturers, including Sorin, and was a guest speaker at the conference.
Falkinham, in an interview with The York Dispatch, said the nature of these bacteria, which he has been studying for many years, make it very difficult to quickly identify.
"It surprises me that patient notification is not a priority," he said, adding that patients need to be alert to symptoms.
No patient infections?: Falkinham said he is reasonably sure that the only way to know definitively whether a patient who was exposed to NTM has an infection is to get their blood cultured, which can take as long as two months.
There has been no indication that such tests occurred at facilities that submitted reports to the FDA about infected heater-cooler devices, though each asserted no patients were infected.
Representatives from state health departments in Georgia, Washington and Kentucky could not be reached for comment.
Chris Van Deusen, spokesman for the Texas Department of State Services, wrote in an email that the department received a report last November of a mycobacterium infection, but it is unaware of whether a heater-cooler device was involved in that patient's surgery.
A report the FDA received in February 2016 states Sorin, the manufacturer of the device in a vast majority of these reports, received a report that a Texas facility's heater-cooler system "tested positive for bacterial contamination after use."
Kate Murphy, spokeswoman for the North Carolina Department of Health and Human Services, wrote in an email that many facilities in its state conducted voluntary testings of heater-cooler devices in 2015 in response to guidance from the FDA and CDC.
"The state did receive verbal reports of devices testing positive for NTM, but none of these positive results were linked to patient infections," Murphy wrote, adding that the facilities conducted internal assessments to determine if there were any patient infections.
"In general, this involved generating lists of patients who had procedures involving heater-cooler units and comparing them to laboratory data to see if anyone on those lists had been diagnosed with an NTM infection," she wrote.
WellSpan's initial investigation, which lasted more than three months and included the help of the state health department and CDC, revealed eight patients with the infection. After patient notification, four more have been identified.
WellSpan spokesman Brett Marcy said patient notification was critical to identifying those additional patients.
"The key is to make sure they're alert to any signs of the infection," he said. "As a result of (notifying patients), we've been able to consistently monitor their health."
Provider notification: Ultimately, the FDA panel recommended that provider notification should be health care's priority to ensure that hospitals and physicians are aware of the risk and correctly diagnosing the infection.
The details claimed through several of the lawsuits against York Hospital and Sorin reveal that the infection was often misdiagnosed, resulting in improper and delayed treatment.
During the June conference, several panelists suggested that they believe provider awareness of the issue in the U.S. is still low, despite the CDC and FDA's alerts.
Dr. Suzanne Schwartz, the FDA's acting director of emergency preparedness, told the panelists that the FDA and CDC put a call out to all 50 states' public health departments to discuss the issue, but fewer than 10 departments participated.